<div><p><strong>Understanding how to read the resulting data of high-performance liquid chromatography (HPLC) helps turn raw detector output into confident decisions about purity, identity, and assay results. When you know how to read HPLC peaks and baselines, you can quickly spot problems, verify method performance, and support regulatory‑ready reports.</strong></p></div><div><div><div><div><h3><strong>What is an HPLC Chromatogram?</strong></h3></div></div></div></div><div><p>An HPLC chromatogram is a plot of detector signal versus time that shows how each compound in your sample moves through the column and reaches the detector. Every peak corresponds to a different component, with the position on the time axis giving its retention time and the peak size relating to concentration.</p><p>In routine work, you read retention time to confirm identity and rely on peak area or height for concentration, so learning how to read an HPLC chromatogram is essential for everyday assay workflows.</p></div><div><div><div><div><h3><strong>Why Is It Important to Read HPLC Chromatograms Correctly?</strong></h3><p>Reading HPLC results correctly matters because retention time and peak response are key parameters for separating, identifying, and quantifying compounds in complex mixtures. Misreading the baseline or peak shape can distort area integration, which affects assay accuracy and impurity quantitation.</p><p>Good <a target="_blank" rel="noopener noreferrer" href="https://www.phenomenex.com/resources/knowledge-center/hplc-knowledge-center/what-are-chromatograms"><strong>chromatogram</strong></a> interpretation also helps you detect method drift early, keep system suitability within limits, and avoid costly repeat injections or failed batches.</p></div></div></div></div><div><div><div><div><h3><strong>Key Components of an HPLC Chromatogram</strong></h3></div></div></div></div><div><p>Before you interpret a run, you must recognize the fundamental parts of a chromatogram. Each visual element gives you specific data about the separation and the analytes present in your sample.</p><h4><strong>Baseline</strong></h4><p>The baseline is the detector signal when no analyte peak is eluting, and a stable, flat baseline makes integration and quantification reliable. More detailed descriptions of baseline noise and drift are covered in the troubleshooting section below. In a nutshell, it is enough to note that any instability can affect how confidently you integrate and compare peaks.</p><h4><strong>Peaks</strong></h4><p>Peaks represent eluting analytes and appear as Gaussian‑like shapes rising above the baseline. Symmetric peaks with clear separation are easier to integrate and give more reliable responses for quantitative work.</p><h4><strong>Retention Time</strong></h4><p>Retention time, <i>t</i><sub>R</sub>, is the time from injection until the apex of a peak, reflecting how long an analyte spends in the column compared with the mobile phase. The solvent front or void peak corresponds to the dead time, <i>t</i><sub>0</sub>, which is the passage of unretained material through the system.</p><h4><strong>Peak Area and Height</strong></h4><p>Peak area is generally more reliable than peak height for quantitative analysis, because it better reflects the total amount of analyte passing the detector. In validated methods, you relate peak area or, in some cases, peak height to concentration through calibration curves and internal standards.</p><h4><strong>Resolution</strong></h4><p>Resolution describes how well two peaks are separated and depends on efficiency, selectivity, and retention. Adequate resolution means peaks do not overlap significantly, which improves identification confidence and quantification for closely eluting impurities.</p><h4><strong>Dead Time (t₀)/Void Time</strong></h4><p>Dead time, <i>t</i><sub>0</sub>, or hold‑up time, <i>t</i><sub>M</sub> (or void time), is the time taken by unretained species or the mobile phase front to pass through the column and reach the detector. You use <i>t</i><sub>0</sub> as the reference for calculating capacity factor and for assessing how strongly analytes interact with the stationary phase.</p></div><div><div><div><div><h3><strong>Step‑by‑Step Guide to Reading an HPLC Chromatogram</strong></h3></div></div></div></div><div><p>Interpreting your data requires a systematic approach to guarantee you capture all critical details. Follow this sequential process to evaluate your chromatographic results confidently and accurately.</p><h4><strong>Identify the Baseline Stability</strong></h4><p>Start by checking if the baseline is flat or if you see random noise and slow drift across the run. Significant drift or high noise suggests issues with temperature control, solvent quality, or detector stability, which must be addressed before trusting quantitation.</p><h4><strong>Locate and Count Peaks</strong></h4><p>Next, scan the chromatogram to locate all distinct peaks above the baseline and note their relative sizes. Counting peaks versus expectations from standards or sample composition helps you detect co‑elution, extra peaks, or missing analytes.</p><h4><strong>Determine Retention Time</strong></h4><p>Measure retention time, <i>t</i><sub>R</sub>, for each peak and record these values alongside known standards or system-suitability data. Consistent <i>t</i><sub>R</sub> values within defined windows support correct identification, while larger shifts can indicate changes in temperature, mobile phase composition, or flow rate.</p><h4><strong>Calculate Capacity Factor (k') Using t<sub>M</sub> and t<sub>R</sub></strong></h4><p>Capacity factor, <i>K'</i> (or retention factor), describes how much longer an analyte is retained compared with unretained material and is calculated from the chromatogram. Using the dead time, <i>t</i><sub>M</sub>, (void peak) and analyte retention time, <i>t</i><sub>R</sub>, you apply<strong> </strong><i><strong>k</strong></i><strong> = (</strong><i><strong>t</strong></i><strong><sub>R</sub> – </strong><i><strong>t</strong></i><strong><sub>M</sub>)/</strong><i><strong>t</strong></i><strong><sub>M</sub></strong> to assess whether the analyte is sufficiently retained under the chosen conditions.</p><p>Knowing how to analyze HPLC results with capacity factor helps you judge if peaks elute too close to <i>t</i><sub>0</sub>, or spend an appropriate time interacting with the column, which guides method refinement.</p><h4><strong>Analyze Peak Area for Quantification (H3)</strong></h4><p>For quantification, integrate each peak to obtain the area and compare it with calibration standards or internal standards to calculate concentration. Reliable peak area measurements depend on good baseline definition and stable detector response, so always verify baseline quality before finalizing your measurements.</p><h4><strong>Evaluate Peak Shape and Resolution</strong></h4><p>Assess whether peaks are symmetric or show tailing, fronting, or broadening, and examine spacing between adjacent peaks for resolution. Changes in peak shape across the chromatogram can reveal extra‑column effects, packed bed issues, or interaction with active sites on the stationary phase.</p><p>If you see persistent problems, review your <a target="_blank" rel="noopener noreferrer" href="https://labrulez.com/en-us/lcms/products?category=48&amp;manufacturerItems=50"><strong><u>HPLC column</u></strong></a> choice, sample preparation, and gradient or isocratic settings to refine separation.</p></div><div><div><div><div><h3><strong>Common Problems in HPLC Chromatograms and How to Identify Them</strong></h3><p>Even well-developed methods can degrade over time and produce visual cues that signal system or chemistry faults. Recognizing these characteristic peak and baseline distortions is your first step in troubleshooting.</p><h4><strong>Peak Tailing</strong></h4><p><a target="_blank" rel="noopener noreferrer" href="https://www.phenomenex.com/resources/knowledge-center/hplc-knowledge-center/how-to-reduce-peak-tailing-in-hplc"><strong><u>Peak tailing</u></strong></a> appears when the right side of a peak stretches out into a long tail instead of dropping back to the baseline symmetrically. On the chromatogram, the trailing edge slopes slowly and the peak looks skewed to the left, which makes integration boundaries less obvious and can hint at dispersion or secondary interactions. You can reduce tailing by minimizing extra‑column volume and checking column packing and active sites.</p><h4><strong>Peak Fronting</strong></h4><p><a target="_blank" rel="noopener noreferrer" href="https://www.phenomenex.com/resources/knowledge-center/hplc-knowledge-center/peak-fronting"><strong><u>Peak fronting</u></strong></a> shows a steep leading edge and a compressed front portion of the peak, so the apex seems pulled forward relative to the rest of the peak profile. Visually, the peak looks like it is leaning in the direction of flow and the front overlaps more strongly with neighboring peaks, which can distort apparent purity for fast‑eluting components.</p><p>Consider lowering sample load or injection volume and matching diluent strength to the mobile phase, and when fronting persists, consult Phenomenex resources on <a target="_blank" rel="noopener noreferrer" href="https://www.phenomenex.com/resources/knowledge-center/gc-knowledge-center/peak-shape-problems-tailing-peaks"><strong><u>peak-shape problems</u></strong></a>.</p><h4><strong>Noise and Drift</strong></h4><p>Baseline noise appears as small, rapid fluctuations around the baseline that make it harder to see low‑level peaks. Baseline drift shows up as a slow rise or fall of the baseline across the run, so the line no longer stays flat; this can cause apparent changes in peak height and shifts in where you draw integration baselines. Simple checks like improving solvent degassing, stabilizing temperature, and cleaning detector flow cells help reduce noise and drift.</p><h4><strong>Co‑Elution</strong></h4><p>Co‑elution is easy to spot when two peaks do not fully separate and instead form a shoulder or merged profile on the chromatogram.You may see one peak with a plateau or a visible kink where two components overlap, and the valley between them does not return to the baseline, which complicates assignments for closely eluting impurities. To resolve co‑elution, adjust selectivity by changing mobile phase composition, gradient profile, or column chemistry.</p><h4><strong>Broad Peaks</strong></h4><p>Broad peaks have a noticeably wider base and lower height compared with well‑focused peaks of similar are. They often span more time units on the x‑axis and show gentle slopes on both sides, indicating band spreading that reduces resolution and makes small shoulders harder to detect. Narrowing broad peaks usually involves reducing extra‑column volumes and confirming column performance and particle size suitability.</p><h4><strong>Retention-Time Shifting</strong></h4><p>Retention-time shifting is seen when all peaks move earlier or later in the chromatogram compared with previous runs, while their shapes remain similar. When you overlay chromatograms, consistent shifts in peak positions along the time axis, often on the order of a few percent, indicate changes in conditions such as temperature or mobile phase that must be tracked carefully. Fixing retention time shifts starts with stabilizing temperature and verifying mobile phase composition and flow rate settings across runs.</p></div></div></div></div><div><div><div><div><h3><strong>Tips for Accurate HPLC Chromatogram Interpretation</strong></h3></div></div></div></div><div><p>To read HPLC chromatograms accurately, maintain a stable temperature, use well‑degassed mobile phases, and keep detector flow cells and optics clean. Regularly check capacity factor and selectivity values against method expectations, and verify that resolution is adequate for critical pairs before accepting results.</p><p>When retention times drift or peak shapes degrade, review your <a target="_blank" rel="noopener noreferrer" href="https://www.phenomenex.com/resources/knowledge-center/gc-knowledge-center/understanding-retention-time"><strong><u>retention-time</u></strong></a> trends alongside system maintenance logs so you can correct problems early.</p></div><div><div><div><div><h3><strong>FAQs on Reading HPLC Chromatograms</strong></h3></div></div></div></div><div><h4><strong>How Do You Calculate Capacity Factor (k') from a Chromatogram?</strong></h4><p>Capacity factor, <i>k</i>, is calculated using the analyte retention time, [Equation], and the dead time, <i>t</i><sub>R</sub>, measured from the unretained peak. Apply <i>k</i> = (<i>t</i><sub>R</sub> – <i>t</i><sub>M</sub>)/<i>t</i><sub>M</sub>, so higher k values indicate stronger interactions with the stationary phase and longer retention.</p><h4><strong>How Is Selectivity (α) Calculated Using Chromatogram Data?</strong></h4><p>Selectivity (α) describes how well two components are separated and is defined as the ratio of their retention factors, α = <i>k</i><sub>2</sub>/<i>k</i><sub>1</sub>, for peaks, where <i>k</i><sub>2</sub> &gt; <i>k</i><sub>1</sub>. Values higher than 1.2 show separation, and larger α values correspond to better selectivity between the peaks.</p><h4><strong>What Does Peak Area Indicate in HPLC?</strong></h4><p>Peak area reflects the total amount of analyte that reaches the detector and is generally more reliable than peak height for quantitative work. Build calibration curves that relate peak area to concentration, then apply them only when the baseline and detector response remain stable across all injections.</p><h4><strong>How Is Retention Time Used in HPLC Analysis?</strong></h4><p>Retention time is used as a qualitative index because each compound elutes at a characteristic time when conditions are held constant. Compare sample retention times with those of standards and then pair that information with peak area or height to confirm identity and calculate concentration in routine analyses.</p></div>

How to Read an HPLC Chromatogram: Step‑by‑Step Guide to Interpreting Results

<p><i><span><strong>Are you currently using single-column batch chromatography to isolate and purify target compounds, but struggling with high solvent demand, low product concentration, or limited throughput? Simulated Moving Bed chromatography offers an alternative approach that can address many of these limitations through continuous multi-column separation.</strong></span></i></p><h4><span><strong>What is Simulated Moving Bed Chromatography (SMB)?</strong></span></h4><p><span>Simulated Moving Bed (SMB) chromatography is a continuous multi-column separation technique designed to make more efficient use of the stationary phase while minimizing solvent consumption. It is particularly well suited to the purification of binary and pseudo-binary mixtures, including enantiomers, sugars, petrochemical products, and fine chemicals.</span></p><h4><span><strong>Conventional Batch Chromatography</strong></span></h4><p><span>In traditional batch chromatography, the sample is introduced onto a single chromatographic column and transported through the stationary phase by the mobile phase. Individual compounds interact with the stationary phase to different extents and therefore travel through the column at different rates:</span></p><ul><li><span>Weakly retained compounds migrate more rapidly.</span></li><li><span>Strongly retained compounds move through the column more slowly.</span></li></ul><p><span>The separated substances consequently leave the column at different retention times and can be collected as individual fractions (Fig. 1). Before a new sample is normally introduced, the previous sample must be completely eluted and the column prepared for the next separation.</span></p><p><span>Although single-column batch chromatography is versatile and comparatively easy to operate, several disadvantages become increasingly important at production scale. The stationary phase is not continuously involved in useful separation, which can limit productivity. Other drawbacks include substantial solvent consumption, diluted product fractions, repeated column regeneration, and potential loss of valuable product.</span></p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/KNAUER_Figure_1_Single_column_separation_A_fast_eluting_component_B_retaining_component_cda8ef66ef.jpg" alt="KNAUER: Figure 1: Single column separation; A – fast eluting component, B – retaining component" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_KNAUER_Figure_1_Single_column_separation_A_fast_eluting_component_B_retaining_component_cda8ef66ef.jpg 76w," sizes="100vw" width="394" height="800"></p><h4><span><strong>From True Moving Bed to SMB</strong></span></h4><p><span>The principle behind SMB originates from the theoretical <strong>True Moving Bed (TMB)</strong> process. In an ideal TMB system, the liquid mobile phase and the solid stationary phase continuously travel in opposite directions. This counter-current arrangement takes advantage of differences in the affinity of individual compounds toward the two phases.</span></p><p><span>Consider a binary mixture containing components A and B. Component A interacts more strongly with the stationary phase, whereas component B is less strongly retained and preferentially follows the liquid mobile phase. Under appropriate operating conditions, the two substances effectively migrate in opposite directions and can be collected continuously through separate outlets (Fig. 2).</span></p><p><span>While this concept is highly efficient from a theoretical perspective, continuously moving a packed solid chromatographic adsorbent is technically difficult to realize.</span></p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/KNAUER_Figure_2_True_Moving_Bed_concept_e1eac66028.jpg" alt="KNAUER: Figure 2: True Moving Bed concept" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_KNAUER_Figure_2_True_Moving_Bed_concept_e1eac66028.jpg 186w," sizes="100vw" width="954" height="800"></p><p><span>Four process ports divide the system into four functional zones (Zone I–IV):</span></p><ol><li><span>Eluent (desorbent) inlet</span></li><li><span>Extract outlet</span></li><li><span>Feed inlet</span></li><li><span>Raffinate outlet</span></li></ol><p><span>Feed and eluent are introduced continuously, while two product streams are simultaneously withdrawn:</span></p><ul><li><span><strong>Extract</strong> – the strongly retained, later-eluting component</span></li><li><span><strong>Raffinate</strong> – the less strongly retained, earlier-eluting component</span></li></ul><h4><span><strong>The Four Functional Zones</strong></span></h4><p><span>Each of the four zones has a defined purpose and operates at its own internal flow rate (VI–VIV):</span></p><ul><li><span><strong>Zone I</strong> regenerates the stationary phase.</span></li><li><span><strong>Zone II</strong> prevents the weakly retained component from entering the extract stream.</span></li><li><span><strong>Zone III</strong> prevents the strongly retained component from contaminating the raffinate.</span></li><li><span><strong>Zone IV</strong> enables recovery and internal reuse of the remaining solvent.</span></li></ul><h4><span><strong>How is the TMB Principle Implemented in SMB?</strong></span></h4><p><a target="_blank" rel="noopener noreferrer" href="https://www.knauer.net/smb"><span>SMB</span></a><span> eliminates the need to physically move the stationary phase. Instead, the adsorbent remains fixed inside the chromatographic columns, while the positions of the liquid inlet and outlet ports are periodically shifted.</span></p><p><span>From the perspective of these moving connection points, the stationary phase appears to travel in the opposite direction to the liquid phase. SMB therefore reproduces the counter-current behavior of a TMB system without physically transporting the packed adsorbent (Fig. 3).</span></p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/KNAUER_Figure_3_Transfer_TMB_concept_to_SMB_concept_e4b8905269.jpg" alt="KNAUER: Figure 3: Transfer TMB concept to SMB concept" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_KNAUER_Figure_3_Transfer_TMB_concept_to_SMB_concept_e4b8905269.jpg 245w," sizes="100vw" width="1372" height="800"></p><p><span>A typical SMB setup consists of several chromatographic columns arranged in a closed loop. A standard configuration often uses eight columns, although the number can be adapted according to the application.</span></p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/KNAUER_Figure_4_SMB_concept_fb005cdfa1.jpg" alt="KNAUER: Figure 4: SMB concept" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_KNAUER_Figure_4_SMB_concept_fb005cdfa1.jpg 195w," sizes="100vw" width="1001" height="800"></p><p><span>After a predefined switching time, all inlet and outlet positions move forward by one column in the direction of the mobile-phase flow. The columns themselves stay in place, but their functional roles within the process change.</span></p><p><span>By repeatedly shifting the ports, the system creates the effect of a stationary phase moving counter-currently to the mobile phase. With eight columns, eight switching steps are required to complete one full SMB cycle.</span></p><p><span>Following an initial transition period, the process reaches a cyclic steady state. Concentrations continue to fluctuate during individual switching intervals, but the overall concentration profile repeats after every complete cycle.</span></p><p><span>Increasing the number of columns and reducing the size of individual switching steps allows the SMB system to reproduce ideal TMB behavior more closely. Systems containing fewer columns exhibit more pronounced discrete switching effects and can require more sophisticated dynamic modeling during process development.</span></p><h3><span><strong>What are the Main Advantages of SMB?</strong></span></h3><h4><span><strong>1. Continuous Operation and Higher Productivity</strong></span></h4><p><span>The key benefit of SMB chromatography is continuous operation. Feed and eluent enter the system continuously, while purified extract and raffinate streams are removed at the same time.</span></p><p><span>As a result, SMB systems can operate for prolonged periods—from several days to even several weeks—with very limited interruption.</span></p><p><span>Because several chromatographic columns perform different separation functions simultaneously, the stationary phase is utilized much more effectively than in conventional batch chromatography. This can translate into higher productivity, improved process efficiency, and a continuous supply of purified product.</span></p><h4><span><strong>2. Reduced Solvent Consumption</strong></span></h4><p><span>Conventional batch chromatography can require substantial volumes of mobile phase to achieve separation and product recovery. The collected fractions are often highly diluted, creating an additional need for downstream concentration.</span></p><p><span>SMB maintains concentration profiles within the circulating system and uses the mobile phase more efficiently. Partial internal recycling of solvent is an inherent part of the process.</span></p><p><span>Lower solvent consumption can lead to:</span></p><ul><li><span>Reduced raw-material costs</span></li><li><span>Lower volumes of liquid waste</span></li><li><span>Reduced energy requirements for solvent evaporation</span></li><li><span>More concentrated product streams and less downstream concentration</span></li></ul><h4><span><strong>3. High Recovery and Reproducible Product Quality</strong></span></h4><p><span>Once the process reaches cyclic steady state, SMB can continuously generate product streams with stable and reproducible composition.</span></p><p><span>Additional advantages can include high product recovery, lower product dilution, more efficient use of the stationary phase, and straightforward integration into continuous manufacturing strategies.</span></p><h4><span><strong>What are the Differences Between Batch LC and SMB?</strong></span></h4><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/KNAUER_differences_between_batch_LC_and_SMB_eba3897f65.jpg" alt="KNAUER: Differences between batch LC and SMB" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_KNAUER_differences_between_batch_LC_and_SMB_eba3897f65.jpg 245w," sizes="100vw" width="1061" height="638"></p><h4><span><strong>Where is SMB Used?</strong></span></h4><p><span>SMB technology is established across several industries and can be applied to purification processes ranging from gram-scale production to several tons per day (Fig. 5).</span></p><p><span>Typical and emerging applications include:</span></p><ul><li><span>Sugar purification</span></li><li><span>Petrochemical separations</span></li><li><span>Chiral separations</span></li><li><span>Fine chemical production</span></li><li><span>Pharmaceutical intermediates</span></li><li><span>Selected biomolecule separations</span></li></ul><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/KNAUER_Figure_5_SMB_application_areas_7109ff703f.jpg" alt="KNAUER: Figure 5: SMB application areas; author's illustration" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_KNAUER_Figure_5_SMB_application_areas_7109ff703f.jpg 245w," sizes="100vw" width="1500" height="512"></p><h4><span><strong>Limitations of SMB</strong></span></h4><p><span>Although SMB can provide substantial advantages, it is not necessarily the ideal solution for every chromatographic separation.</span></p><p><span>The instrumentation and process configuration are more complex than conventional single-column chromatography. Several pumps, valves, columns, and liquid pathways must be controlled precisely. Successful method development therefore requires a solid understanding of adsorption equilibria, mass-transfer effects, and fluid dynamics.</span></p><p><span>Classical four-zone SMB is primarily intended for binary and pseudo-binary separations. More complicated mixtures may require modified SMB configurations, additional purification steps, or multiple coupled SMB systems.</span></p><p><span>SMB is generally most economically attractive when relatively large quantities of a consistent feed material are processed continuously over extended periods.</span></p><p><span>Batch chromatography can remain the better option for small-scale production, frequent changes between products, complex multicomponent mixtures, or applications that depend on flexible gradient separations.</span></p><h4><span><strong>Conclusion</strong></span></h4><p><span>Simulated Moving Bed chromatography converts the theoretical counter-current principle of True Moving Bed separation into a practical continuous chromatographic process. Instead of physically transporting the stationary phase, SMB periodically changes the positions of the feed, eluent, extract, and raffinate connections. This reproduces the effect of counter-current movement between stationary and mobile phases.</span></p><p><span>Compared with conventional batch chromatography, SMB can provide higher productivity, more efficient stationary-phase utilization, substantially lower solvent consumption, and more concentrated product streams. Continuous operation makes the technology particularly attractive for demanding large-scale binary separations, including the purification of pharmaceutical enantiomers.</span></p><p><span>Although successful SMB implementation requires accurate process data, careful method development, and precise control of operating conditions, the technology demonstrates how an idealized chromatographic principle can be transformed into a robust and efficient industrial separation strategy.</span></p>

Simulated Moving Bed Chromatography: Efficient Continuous Separation

News from LabRulezLCMS Library - Week 44, 2026

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Everything from the world of analytical chemistry in one place. We connect people in solving their problems. At Labrulez you will find all the necessary information easily, quickly and clearly. Stop searching and start finding.

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Phenomenex is a global technology leader committed to developing novel analytical chemistry solutions that solve the separation and purification challenges of researchers in industrial, government and academic laboratories.

Phenomenex

Based in Berlin, KNAUER is a medium-sized, owner-managed company that has been serving the sciences since 1962. We develop and manufacture scientific instruments of superior quality for liquid chromatography, including: Analytical HPLC/UHPLC, Preparative HPLC, Fast protein liquid chromatography (FPLC), Multi-column chromatography/Simulated moving bed (SMB) chromatography. High pressure dosing, in-line detection systems, and osmometry are additional business areas.

KNAUER

Endotoxin analysis

LAL analysis for detection and quantification of bacterial endotoxins in liquid solutions and lyophilised samples, with results reported in EU/ml or EU/vial.

<p><strong>The Endotoxin Analysis is a laboratory test designed to detect and quantify bacterial endotoxins in suitable samples using the LAL (Limulus Amebocyte Lysate) assay.</strong></p><p>The analysis is intended for liquid solutions and lyophilised samples in vials. Results are reported in endotoxin units (EU), either per vial or per millilitre depending on the sample format.</p><h4><strong>About Endotoxins</strong></h4><p>Endotoxins are lipopolysaccharides (LPS) found in the outer membrane of Gram-negative bacteria. They can remain present even after bacterial cells are no longer viable and are therefore an important quality and safety parameter for pharmaceutical and laboratory products.</p><p>The LAL assay is widely used for the detection and quantification of bacterial endotoxins due to its high sensitivity.</p><h4><strong>Key Features</strong></h4><ul><li>Detection and quantification of bacterial endotoxins</li><li>Analysis by LAL assay</li><li>Suitable for liquid solutions and lyophilised samples in vials</li><li>Results for lyophilised samples reported in EU/vial</li><li>Results for liquid solutions reported in EU/ml</li><li>Minimum sample amount of 1 ml solution or 1 vial</li><li>Standard analysis accurately quantifies values up to 10 EU/vial</li><li>Average turnaround time of 7 business days</li></ul><h4><strong>Analysis Parameters</strong></h4><ul><li><strong>Testing method: </strong>LAL assay</li><li><strong>Amount of sample required:</strong> 1 ml solution or 1 vial</li><li><strong>Result format for vial with lyophilisate: </strong>EU/vial</li><li><strong>Result format for liquid solution: </strong>EU/ml</li><li><strong>Average turnaround time: </strong>7 business days</li></ul><blockquote><p><strong>Important Notice</strong></p><ul><li>The standard endotoxin analysis provides accurate results for values up to 10 EU/vial. Values above 10 EU/vial are estimated.</li><li>If a fully quantitative result above this range is required, an additional test using another vial and an appropriate dilution is necessary. Sending two vials is therefore recommended when elevated endotoxin levels may be expected.</li><li>If values above 10 EU/vial are expected in advance, this should be communicated before testing so that the sample can be analysed using an appropriately calibrated procedure.</li><li>Endotoxin analysis is not offered for oils, raw API powders, tablets, or capsules.</li></ul></blockquote><h4><strong>Optional Additional Analyses</strong></h4><p>The following optional laboratory services are available:</p><ul><li>Additional Laboratory Report</li></ul>

Epithalon Analysis

HPLC analysis of Epithalon for identity confirmation, amount determination and peptide purity in lyophilized samples and raw API powders.

<p><span><strong>This analysis is designed to confirm the identity and determine the amount and peptide purity of Epithalon in lyophilized samples and raw API powders. HPLC testing provides information about the target peptide content of the sample and its purity relative to chromatographically detectable impurities.</strong></span></p><h4><span><strong>Epithalon</strong></span></h4><p><span>Epithalon, also known as Epitalon, is a short synthetic <strong>tetrapeptide</strong> composed of four amino acid residues. Its sequence is <strong>H-Ala-Glu-Asp-Gly-OH</strong>, and its molecular weight is approximately 390 Da.</span></p><p><span>This analysis is specifically intended for standard Epithalon. Other variants or modified forms, such as <strong>NA Epithalon</strong>, are not the target compound of this method and require an appropriate separate analysis.</span></p><p><span>HPLC analysis confirms the presence of Epithalon in the sample, determines its amount and evaluates peptide purity.</span></p><h5><span><strong>What the Analysis Determines</strong></span></h5><ul><li><span>Identity of Epithalon</span></li><li><span>Amount of Epithalon in the sample</span></li><li><span>Peptide purity</span></li><li><span>Results in a format appropriate for the submitted sample type</span></li></ul><h5><span><strong>Analysis Parameters</strong></span></h5><ul><li><span><strong>Target compound:</strong> Epithalon</span></li><li><span><strong>Other name:</strong> Epitalon</span></li><li><span><strong>CAS number:</strong> 64082-79-7</span></li><li><span><strong>Molecular weight:</strong> 390 Da</span></li><li><span><strong>Sequence:</strong> H-Ala-Glu-Asp-Gly-OH</span></li><li><span><strong>Testing method:</strong> HPLC</span></li><li><span><strong>Detection limit:</strong> less than one twentieth of the usual dosage per vial</span></li><li><span><strong>Result format for lyophilizates:</strong> mg per vial and peptide purity</span></li><li><span><strong>Alternative result format:</strong> m/m purity and peptide purity</span></li><li><span><strong>Minimum lyophilizate sample:</strong> one whole unopened vial containing the lyophilizate</span></li><li><span><strong>Minimum raw API powder sample:</strong> 30 mg in a sealed glass vial to prevent moisture absorption</span></li><li><span><strong>Average turnaround time:</strong> 7 business days</span></li></ul><blockquote><h5><span><strong>Important Notice</strong></span></h5><p><span>Before ordering the analysis, make sure that the sample contains standard Epithalon. Other variants, such as NA Epithalon, are not the target compound of this test.</span></p><p><span>The alternative m/m purity result format is intended exclusively for raw API powders. For lyophilized samples, the standard result format provides the amount of Epithalon in mg per vial together with peptide purity.</span></p></blockquote><h4><span><strong>Additional Analyses</strong></span></h4><h5><span><strong>TFA Analysis</strong></span></h5><ul><li><span>Detection and measurement of trifluoroacetic acid (TFA) in the sample.</span></li></ul><h5><span><strong>Raw Data</strong></span></h5><ul><li><span>Delivery of the available raw analytical data from the primary test and all applicable additional analyses.</span></li></ul><h5><span><strong>Fentanyl Presence Analysis</strong></span></h5><h5><span><strong>Alternative Result Format – </strong></span><i><span><strong>m</strong></span></i><span><strong>/</strong></span><i><span><strong>m</strong></span></i><span><strong> Purity</strong></span></h5><ul><li><span>Alternative reporting of the result as mass-by-mass purity. This option is intended exclusively for raw API powders.</span></li></ul><h5><span><strong>Variance Testing</strong></span></h5><ul><li><span>Analysis of multiple sample units to assess variation within a single batch. All submitted samples must originate from the same batch of the same product.</span></li></ul><h5><span><strong>pH Measurement</strong></span></h5><h5><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2522"><span><strong>Endotoxin Analysis</strong></span></a></h5><ul><li><span>Measurement of bacterial endotoxins, particularly lipopolysaccharides (LPS), in the sample. This analysis is available only for finished products and should not be ordered for raw powders.</span></li><li><span>The standard test provides accurate results up to 10 EU per vial. Values above 10 EU per vial are estimated and require an additional test with a different dilution for precise determination. Sending two vials is therefore recommended.</span></li><li><span>Where endotoxin levels above 10 EU per vial are expected, the method can be calibrated for the higher range in advance.</span></li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://icpms.labrulez.com/products/2526"><span><strong>CHNS Mass Report</strong></span></a></h5><ul><li><span>Elemental analysis providing accurate measurement of nitrogen and sulphur content. The results can be used to determine Net Peptide Content (NPC).</span></li></ul><h5><span><strong>Additional Report</strong></span></h5><ul><li><span>A separate additional laboratory report issued under a different client name.</span></li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2524"><span><strong>LC-MS Screening for Peptide Contamination</strong></span></a></h5><ul><li><span>LC-MS screening for contamination with other peptides or peptide degradation products. Detection is limited to peptides included in the available testing portfolio.</span></li><li><span>The initial screening provides identification only. If contamination is detected, quantitative measurement may subsequently be ordered.</span></li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2527"><span><strong>Sterility Testing</strong></span></a></h5><ul><li><span>TAMC and TYMC testing checks the product for the presence of bacteria, yeasts and moulds. Additional unopened sample units must be submitted for analysis. The average turnaround time for this test is 14 days.</span></li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://icpms.labrulez.com/products/2525"><span><strong>Heavy Metals Analysis</strong></span></a></h5><ul><li><span>Detection of arsenic, cadmium, lead and mercury in the sample. Testing for other metals can be arranged individually.</span></li></ul>

FOXO4-DRI Analysis

HPLC analysis of FOXO4-DRI for identity confirmation, amount determination and peptide purity in lyophilized samples and raw API powders.

<p><span><strong>This analysis is designed to confirm the identity and determine the amount and peptide purity of FOXO4-DRI, also referred to as FOX04-DRI, in lyophilized samples and raw API powders. HPLC testing provides information about the target peptide content of the sample and its purity relative to chromatographically detectable impurities.</strong></span></p><h4><span><strong>FOXO4-DRI</strong></span></h4><p><span>FOXO4-DRI is a synthetic peptide with a molecular weight of approximately 5,358 Da. Its sequence contains <strong>46 amino acid residues</strong> and includes a highly basic C-terminal region rich in <strong>arginine and lysine</strong> residues.</span></p><p><span>HPLC analysis confirms the presence of FOXO4-DRI in the sample, determines its amount and evaluates peptide purity.</span></p><h5><span><strong>What the Analysis Determines</strong></span></h5><ul><li><span>Identity of FOXO4-DRI</span></li><li><span>Amount of FOXO4-DRI in the sample</span></li><li><span>Peptide purity</span></li><li><span>Results in a format appropriate for the submitted sample type</span></li></ul><h5><span><strong>Analysis Parameters</strong></span></h5><ul><li><span><strong>Target compound:</strong> FOXO4-DRI</span></li><li><span><strong>Other name:</strong> FOX04-DRI</span></li><li><span><strong>CAS number:</strong> 2460055-10-9</span></li><li><span><strong>Molecular weight:</strong> 5,358 Da</span></li><li><span><strong>Sequence:</strong> Leu-Thr-Leu-Arg-Lys-Glu-Pro-Ala-Ser-Glu-Ile-Ala-Gln-Ser-Ile-Leu-Glu-Ala-Tyr-Ser-Gln-Asn-Gly-Trp-Ala-Asn-Arg-Arg-Ser-Gly-Gly-Lys-Arg-Pro-Pro-Pro-Arg-Arg-Arg-Gln-Arg-Arg-Lys-Lys-Arg-Gly-OH</span></li><li><span><strong>Testing method:</strong> HPLC</span></li><li><span><strong>Detection limit:</strong> less than one twentieth of the usual dosage per vial</span></li><li><span><strong>Result format for lyophilizates:</strong> mg per vial and peptide purity</span></li><li><span><strong>Alternative result format:</strong> m/m purity and peptide purity</span></li><li><span><strong>Minimum lyophilizate sample:</strong> one whole unopened vial containing the lyophilizate</span></li><li><span><strong>Minimum raw API powder sample:</strong> 30 mg in a sealed glass vial to prevent moisture absorption</span></li><li><span><strong>Average turnaround time:</strong> 7 business days</span></li></ul><blockquote><h5><span><strong>Important Notice</strong></span></h5><p><span>The alternative m/m purity result format is intended exclusively for raw API powders. For lyophilized samples, the standard result format provides the amount of FOXO4-DRI in mg per vial together with peptide purity.</span></p></blockquote><h4><span><strong>Additional Analyses</strong></span></h4><h5><span><strong>TFA Analysis</strong></span></h5><ul><li><span>Detection and measurement of trifluoroacetic acid (TFA) in the sample.</span></li></ul><h5><span><strong>Raw Data</strong></span></h5><ul><li><span>Delivery of the available raw analytical data from the primary test and all applicable additional analyses.</span></li></ul><h5><span><strong>Fentanyl Presence Analysis</strong></span></h5><h5><span><strong>Alternative Result Format – </strong></span><i><span><strong>m</strong></span></i><span><strong>/</strong></span><i><span><strong>m</strong></span></i><span><strong> Purity</strong></span></h5><ul><li><span>Alternative reporting of the result as mass-by-mass purity. This option is intended exclusively for raw API powders.</span></li></ul><h5><span><strong>Variance Testing</strong></span></h5><ul><li><span>Analysis of multiple sample units to assess variation within a single batch. All submitted samples must originate from the same batch of the same product.</span></li></ul><h5><span><strong>pH Measurement</strong></span></h5><h5><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2522"><span><strong>Endotoxin Analysis</strong></span></a></h5><ul><li><span>Measurement of bacterial endotoxins, particularly lipopolysaccharides (LPS), in the sample. This analysis is available only for finished products and should not be ordered for raw powders.</span></li><li><span>The standard test provides accurate results up to 10 EU per vial. Values above 10 EU per vial are estimated and require an additional test with a different dilution for precise determination. Sending two vials is therefore recommended.</span></li><li><span>Where endotoxin levels above 10 EU per vial are expected, the method can be calibrated for the higher range in advance.</span></li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://icpms.labrulez.com/products/2526"><span><strong>CHNS Mass Report</strong></span></a></h5><ul><li><span>Elemental analysis providing accurate measurement of nitrogen and sulphur content. The results can be used to determine Net Peptide Content (NPC).</span></li></ul><h5><span><strong>Additional Report</strong></span></h5><ul><li><span>A separate additional laboratory report issued under a different client name.</span></li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2524"><span><strong>LC-MS Screening for Peptide Contamination</strong></span></a></h5><ul><li><span>LC-MS screening for contamination with other peptides or peptide degradation products. Detection is limited to peptides included in the available testing portfolio.</span></li><li><span>The initial screening provides identification only. If contamination is detected, quantitative measurement may subsequently be ordered.</span></li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2527"><span><strong>Sterility Testing</strong></span></a></h5><ul><li><span>TAMC and TYMC testing checks the product for the presence of bacteria, yeasts and moulds. Additional unopened sample units must be submitted for analysis. The average turnaround time for this test is 14 days.</span></li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://icpms.labrulez.com/products/2525"><span><strong>Heavy Metals Analysis</strong></span></a></h5><ul><li><span>Detection of arsenic, cadmium, lead and mercury in the sample. Testing for other metals can be arranged individually.</span></li></ul>

GHRP-2 Analysis

HPLC analysis of GHRP-2 for identity confirmation, amount determination and peptide purity in lyophilized samples and raw API powders.

<p><span><strong>This analysis is designed to confirm the identity and determine the amount and peptide purity of GHRP-2 in lyophilized samples and raw API powders. HPLC testing provides information about the target peptide content of the sample and its purity relative to chromatographically detectable impurities.</strong></span></p><h4><span><strong>GHRP-2</strong></span></h4><p><span>GHRP-2, or <strong>Growth Hormone Releasing Peptide-2</strong>, is a synthetic peptide composed of <strong>six amino acid residues</strong>. It is also known as Growth Hormone Secretagogue 2.</span></p><p><span>Its sequence is <strong>H-D-Ala-D-2Nal-Ala-Trp-D-Phe-Lys-NH<sub>2</sub></strong> and contains several modified amino acid residues, including D-alanine, D-2Nal and D-phenylalanine. The molecular weight of GHRP-2 is approximately 818 Da.</span></p><p><span>HPLC analysis confirms the presence of GHRP-2 in the sample, determines its amount and evaluates peptide purity.</span></p><h5><span><strong>What the Analysis Determines</strong></span></h5><ul><li><span>Identity of GHRP-2</span></li><li><span>Amount of GHRP-2 in the sample</span></li><li><span>Peptide purity</span></li><li><span>Results in a format appropriate for the submitted sample type</span></li></ul><h5><span><strong>Analysis Parameters</strong></span></h5><ul><li><span><strong>Target compound:</strong> GHRP-2</span></li><li><span><strong>Other names:</strong> Growth Hormone Releasing Peptide-2, Growth Hormone Secretagogue 2</span></li><li><span><strong>CAS number:</strong> 158861-67-7</span></li><li><span><strong>Molecular weight:</strong> 818 Da</span></li><li><span><strong>Sequence:</strong> H-D-Ala-D-2Nal-Ala-Trp-D-Phe-Lys-NH2</span></li><li><span><strong>Testing method:</strong> HPLC</span></li><li><span><strong>Detection limit:</strong> less than one twentieth of the usual dosage per vial</span></li><li><span><strong>Result format for lyophilizates:</strong> mg per vial and peptide purity</span></li><li><span><strong>Alternative result format:</strong> m/m purity and peptide purity</span></li><li><span><strong>Minimum lyophilizate sample:</strong> one whole unopened vial containing the lyophilizate</span></li><li><span><strong>Minimum raw API powder sample:</strong> 30 mg in a sealed glass vial to prevent moisture absorption</span></li><li><span><strong>Average turnaround time:</strong> 7 business days</span></li></ul><blockquote><h5><span><strong>Important Notice</strong></span></h5><p><span>The alternative m/m purity result format is intended exclusively for raw API powders. For lyophilized samples, the standard result format provides the amount of GHRP-2 in mg per vial together with peptide purity.</span></p></blockquote><h4><span><strong>Additional Analyses</strong></span></h4><h5><span><strong>TFA Analysis</strong></span></h5><ul><li><span>Detection and measurement of trifluoroacetic acid (TFA) in the sample.</span></li></ul><h5><span><strong>Raw Data</strong></span></h5><ul><li><span>Delivery of the available raw analytical data from the primary test and all applicable additional analyses.</span></li></ul><h5><span><strong>Fentanyl Presence Analysis</strong></span></h5><h5><span><strong>Alternative Result Format – </strong></span><i><span><strong>m</strong></span></i><span><strong>/</strong></span><i><span><strong>m</strong></span></i><span><strong> Purity</strong></span></h5><ul><li><span>Alternative reporting of the result as mass-by-mass purity. This option is intended exclusively for raw API powders.</span></li></ul><h5><span><strong>Variance Testing</strong></span></h5><ul><li><span>Analysis of multiple sample units to assess variation within a single batch. All submitted samples must originate from the same batch of the same product.</span></li></ul><h5><span><strong>pH Measurement</strong></span></h5><h5><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2522"><span><strong>Endotoxin Analysis</strong></span></a></h5><ul><li><span>Measurement of bacterial endotoxins, particularly lipopolysaccharides (LPS), in the sample. This analysis is available only for finished products and should not be ordered for raw powders.</span></li><li><span>The standard test provides accurate results up to 10 EU per vial. Values above 10 EU per vial are estimated and require an additional test with a different dilution for precise determination. Sending two vials is therefore recommended.</span></li><li><span>Where endotoxin levels above 10 EU per vial are expected, the method can be calibrated for the higher range in advance.</span></li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://icpms.labrulez.com/products/2526"><span><strong>CHNS Mass Report</strong></span></a></h5><ul><li><span>Elemental analysis providing accurate measurement of nitrogen and sulphur content. The results can be used to determine Net Peptide Content (NPC).</span></li></ul><h5><span><strong>Additional Report</strong></span></h5><ul><li><span>A separate additional laboratory report issued under a different client name.</span></li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2524"><span><strong>LC-MS Screening for Peptide Contamination</strong></span></a></h5><ul><li><span>LC-MS screening for contamination with other peptides or peptide degradation products. Detection is limited to peptides included in the available testing portfolio.</span></li><li><span>The initial screening provides identification only. If contamination is detected, quantitative measurement may subsequently be ordered.</span></li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2527"><span><strong>Sterility Testing</strong></span></a></h5><ul><li><span>TAMC and TYMC testing checks the product for the presence of bacteria, yeasts and moulds. Additional unopened sample units must be submitted for analysis. The average turnaround time for this test is 14 days.</span></li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://icpms.labrulez.com/products/2525"><span><strong>Heavy Metals Analysis</strong></span></a></h5><ul><li><span>Detection of arsenic, cadmium, lead and mercury in the sample. Testing for other metals can be arranged individually.</span></li></ul>

GHRP-6 Analysis

HPLC analysis of GHRP-6 for identity confirmation, amount determination and peptide purity in lyophilized samples and raw API powders.

<p><span><strong>This analysis is designed to confirm the identity and determine the amount and peptide purity of GHRP-6 in lyophilized samples and raw API powders. HPLC testing provides information about the target peptide content of the sample and its purity relative to chromatographically detectable impurities.</strong></span></p><h5><span><strong>GHRP-6</strong></span></h5><p><span>GHRP-6, or <strong>Growth Hormone Releasing Peptide-6</strong>, is a synthetic peptide composed of six amino acid residues. It is also known as Growth Hormone Secretagogue 6.</span></p><p><span>Its sequence is <strong>H-DL-His-DL-Trp-DL-Ala-DL-Trp-DL-Phe-DL-Lys-NH<sub>2</sub></strong>, and its molecular weight is approximately 873 Da.</span></p><p><span>HPLC analysis confirms the presence of GHRP-6 in the sample, determines its amount and evaluates peptide purity.</span></p><h5><span><strong>What the Analysis Determines</strong></span></h5><ul><li><span>Identity of GHRP-6</span></li><li><span>Amount of GHRP-6 in the sample</span></li><li><span>Peptide purity</span></li><li><span>Results in a format appropriate for the submitted sample type</span></li></ul><h5><span><strong>Analysis Parameters</strong></span></h5><ul><li><span><strong>Target compound:</strong> GHRP-6</span></li><li><span><strong>Other names:</strong> Growth Hormone Releasing Peptide-6, Growth Hormone Secretagogue 6</span></li><li><span><strong>CAS number:</strong> 87616-84-0</span></li><li><span><strong>Molecular weight:</strong> 873 Da</span></li><li><span><strong>Sequence:</strong> H-DL-His-DL-Trp-DL-Ala-DL-Trp-DL-Phe-DL-Lys-NH2</span></li><li><span><strong>Testing method:</strong> HPLC</span></li><li><span><strong>Detection limit:</strong> less than one twentieth of the usual dosage per vial</span></li><li><span><strong>Result format for lyophilizates:</strong> mg per vial and peptide purity</span></li><li><span><strong>Alternative result format:</strong> m/m purity and peptide purity</span></li><li><span><strong>Minimum lyophilizate sample:</strong> one whole unopened vial containing the lyophilizate</span></li><li><span><strong>Minimum raw API powder sample:</strong> 30 mg in a sealed glass vial to prevent moisture absorption</span></li><li><span><strong>Average turnaround time:</strong> 7 business days</span></li></ul><blockquote><h5><span><strong>Important Notice</strong></span></h5><p><span>The alternative m/m purity result format is intended exclusively for raw API powders. For lyophilized samples, the standard result format provides the amount of GHRP-6 in mg per vial together with peptide purity.</span></p></blockquote><h4><span><strong>Additional Analyses</strong></span></h4><h5><span><strong>TFA Analysis</strong></span></h5><ul><li><span>Detection and measurement of trifluoroacetic acid (TFA) in the sample.</span></li></ul><h5><span><strong>Raw Data</strong></span></h5><ul><li><span>Delivery of the available raw analytical data from the primary test and all applicable additional analyses.</span></li></ul><h5><span><strong>Fentanyl Presence Analysis</strong></span></h5><h5><span><strong>Alternative Result Format – </strong></span><i><span><strong>m</strong></span></i><span><strong>/</strong></span><i><span><strong>m</strong></span></i><span><strong> Purity</strong></span></h5><ul><li><span>Alternative reporting of the result as mass-by-mass purity. This option is intended exclusively for raw API powders.</span></li></ul><h5><span><strong>Variance Testing</strong></span></h5><ul><li><span>Analysis of multiple sample units to assess variation within a single batch. All submitted samples must originate from the same batch of the same product.</span></li></ul><h5><span><strong>pH Measurement</strong></span></h5><h5><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2522"><span><strong>Endotoxin Analysis</strong></span></a></h5><ul><li><span>Measurement of bacterial endotoxins, particularly lipopolysaccharides (LPS), in the sample. This analysis is available only for finished products and should not be ordered for raw powders.</span></li><li><span>The standard test provides accurate results up to 10 EU per vial. Values above 10 EU per vial are estimated and require an additional test with a different dilution for precise determination. Sending two vials is therefore recommended.</span></li><li><span>Where endotoxin levels above 10 EU per vial are expected, the method can be calibrated for the higher range in advance.</span></li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://icpms.labrulez.com/products/2526"><span><strong>CHNS Mass Report</strong></span></a></h5><ul><li><span>Elemental analysis providing accurate measurement of nitrogen and sulphur content. The results can be used to determine Net Peptide Content (NPC).</span></li></ul><h5><span><strong>Additional Report</strong></span></h5><ul><li><span>A separate additional laboratory report issued under a different client name.</span></li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2524"><span><strong>LC-MS Screening for Peptide Contamination</strong></span></a></h5><ul><li><span>LC-MS screening for contamination with other peptides or peptide degradation products. Detection is limited to peptides included in the available testing portfolio.</span></li><li><span>The initial screening provides identification only. If contamination is detected, quantitative measurement may subsequently be ordered.</span></li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2527"><span><strong>Sterility Testing</strong></span></a></h5><ul><li><span>TAMC and TYMC testing checks the product for the presence of bacteria, yeasts and moulds. Additional unopened sample units must be submitted for analysis. The average turnaround time for this test is 14 days.</span></li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://icpms.labrulez.com/products/2525"><span><strong>Heavy Metals Analysis</strong></span></a></h5><ul><li><span>Detection of arsenic, cadmium, lead and mercury in the sample. Testing for other metals can be arranged individually.</span></li></ul>

Estradiol Blind Screening

Blind HPLC screening of estradiol and selected estradiol esters in oil samples and raw API powders, including identification and quantification of mixtures.

<p><strong>The Estradiol Blind Screening is a targeted laboratory test designed to identify and quantify estradiol and selected estradiol esters in oil-based samples and raw active pharmaceutical ingredient (API) powders.</strong></p><p>With blind testing, the specific estradiol ester does not need to be declared in advance. All target compounds included in the analysis are screened, identified, and quantified, including mixtures containing more than one estradiol form.</p><h4><strong>About Estradiol and Estradiol Esters</strong></h4><p>Estradiol is a naturally occurring estrogen hormone. Esterification of estradiol produces derivatives with different physicochemical and pharmacokinetic properties.</p><p>This screening covers estradiol without an ester as well as several commonly encountered estradiol esters, including benzoate, cypionate, enanthate, undecylenate, and valerate. Estradiol hemihydrate is also included in the screening.</p><h4><strong>Key Features</strong></h4><ul><li>Blind identification and quantification of estradiol and selected estradiol esters</li><li>No need to specify the expected ester before testing</li><li>Detection of multiple estradiol forms within mixtures</li><li>Suitable for oil-based samples and raw API powders</li><li>Analysis by HPLC</li><li>Results for oil samples reported in mg/ml</li><li>Alternative results for raw API powders reported as percentage content</li><li>Minimum sample amount of 0.5–1 ml for oil samples</li><li>Minimum sample amount of 200 mg for raw API powders</li><li>Average turnaround time of 7 business days</li></ul><h4><strong>Analysis Parameters</strong></h4><ul><li><strong>Target compounds:</strong> Estradiol hemihydrate, Estradiol benzoate, Estradiol cypionate, Estradiol enanthate, Estradiol no ester, Estradiol undecylenate, Estradiol valerate</li><li><strong>Testing method: </strong>HPLC</li><li><strong>Result format for oil samples: </strong>mg/ml</li><li><strong>Alternative result format for raw API powders:</strong> % [98%+, 96%+ or % value such as 94.15%]</li><li><strong>Minimum sample amount for oil samples: </strong>0.5–1 ml of oil</li><li><strong>Minimum sample amount for raw API powders:</strong> 200 mg</li><li><strong>Average turnaround time:</strong> 7 business days</li></ul><blockquote><p><strong>Important Notice</strong></p><ul><li>Due to limitations of the analytical method, estradiol hemihydrate will be identified as <strong>estradiol no ester (estradiol base)</strong>.</li><li>The analysis covers only the estradiol forms listed in the analysis parameters. It does not automatically screen the sample for other estrogens, related compounds, contaminants, or undeclared substances.</li></ul></blockquote><h4><strong>Optional Additional Analyses</strong></h4><p>The following optional laboratory services are available:</p><ul><li>Complete Raw Analytical Data</li><li>Fentanyl Screening</li><li>Alternative Result Format: Purity in % (m/m)</li><li>pH Measurement</li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2524"><strong>GC–MS Contamination Screening</strong></a></li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2527"><span><strong>Sterility Testing (TAMC + TYMC)</strong></span></a></li><li><a target="_blank" rel="noopener noreferrer" href="https://icpms.labrulez.com/products/2525"><strong>Heavy Metals Analysis (As, Cd, Pb, Hg)</strong></a></li><li>Additional Laboratory Report</li></ul>

Follistatin Analysis

Targeted HPLC analysis of follistatin in lyophilised vials and raw API powders, confirming identity and determining the amount of the compound.

<p><strong>The Follistatin Analysis is a targeted laboratory test designed to confirm the identity and determine the amount of follistatin in lyophilised vials and raw active pharmaceutical ingredient (API) powders.</strong></p><p>For lyophilised samples, results are reported in milligrams per vial. Raw API powders can be evaluated using an alternative result format based on purity in % (m/m). Follistatin is a protein rather than a peptide, and peptide purity is therefore not determined as part of this analysis.</p><h4><strong>About Follistatin</strong></h4><p>Follistatin is a naturally occurring glycoprotein that binds activin with high affinity and regulates its biological activity. It also interacts with other members of the TGF-β superfamily and has been studied in connection with processes including muscle growth, reproduction, and tissue regulation.</p><p>Follistatin occurs in several molecular forms and is widely used as a research target in studies of activin signalling and related biological pathways.</p><h4><strong>Key Features</strong></h4><ul><li>Targeted identification and quantification of follistatin</li><li>Suitable for lyophilised vials and raw API powders</li><li>Analysis by HPLC</li><li>Results for lyophilised samples reported in mg per vial</li><li>Alternative result format based on purity in % (m/m)</li><li>Minimum sample amount of one whole unopened vial with lyophilisate</li><li>Minimum sample amount of 30 mg for raw API powder</li><li>Average turnaround time of 7 business days</li></ul><h4><strong>Analysis Parameters</strong></h4><ul><li><strong>Target compound: </strong>Follistatin</li><li><strong>Testing method:</strong> HPLC</li><li><strong>Result format for lyophilisate: </strong>mg per vial</li><li><strong>Alternative result format: Purity in % (m/m)</strong></li><li><strong>Minimum sample amount for lyophilisate: </strong>One whole unopened vial with lyophilisate</li><li><strong>Minimum sample amount for raw API powder: </strong>30 mg in a sealed glass vial to prevent the sample from absorbing moisture</li><li><strong>Average turnaround time: </strong>7 business days</li></ul><blockquote><p><strong>Important Notice</strong></p><ul><li>Follistatin is a protein rather than a peptide. Peptide purity is therefore not measured as part of this analysis.</li><li>For lyophilised samples, one whole unopened vial containing lyophilisate is required.</li><li>Raw API powder should be supplied as at least 30 mg in a sealed glass vial to minimise moisture absorption.</li></ul></blockquote><h4><strong>Optional Additional Analyses</strong></h4><p>The following optional laboratory services are available:</p><ul><li>Complete Raw Analytical Data</li><li>Fentanyl Screening</li><li>Alternative Result Format: Purity in % (m/m)</li><li>Batch Variance Testing</li><li>pH Measurement</li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products?search=Endotoxin"><strong>Endotoxin Analysis</strong></a></li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2524"><strong>LCMS Screening For Peptide Contamination</strong></a></li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2527"><span><strong>Sterility Testing (TAMC + TYMC)</strong></span></a></li><li><a target="_blank" rel="noopener noreferrer" href="https://icpms.labrulez.com/products/2525"><strong>Heavy Metals Analysis (As, Cd, Pb, Hg)</strong></a></li><li>Additional Laboratory Report</li></ul>

L-Carnitine analysis

Targeted HPLC analysis of L-carnitine in tablets, capsules, liquid samples, and raw API powders, confirming identity and determining content.

<p><strong>The L-Carnitine Analysis is a targeted laboratory test designed to confirm the identity and determine the amount of L-carnitine in oral dosage forms, liquid samples, and raw active pharmaceutical ingredient (API) powders.</strong></p><p>The analysis is suitable for tablets and capsules, with results reported in milligrams per tablet or capsule, as well as liquid samples, with results reported in mg/ml. Raw API powders can be evaluated using an alternative result format based on purity in % (m/m).</p><h4><strong>About L-Carnitine</strong></h4><p>L-carnitine is a naturally occurring compound involved in mitochondrial fatty-acid metabolism. Its primary biological role is to transport long-chain fatty acids across the inner mitochondrial membrane, enabling their subsequent beta-oxidation and use as a source of cellular energy.</p><p>In the human body, L-carnitine is obtained from dietary sources and can also be synthesised endogenously from the amino acids lysine and methionine. It is concentrated particularly in tissues with high energy demands, such as skeletal and cardiac muscle, and is also used therapeutically in the management of primary and secondary carnitine deficiencies.</p><h4><strong>Key Features</strong></h4><ul><li>Targeted identification and quantification of L-carnitine</li><li>Suitable for tablets, capsules, liquid samples, and raw API powders</li><li>Analysis by HPLC</li><li>Results for oral products reported in mg per tablet or capsule</li><li>Results for liquid samples reported in mg/ml</li><li>Alternative result format based on purity in % (m/m)</li><li>Minimum sample amount of three tablets or capsules</li><li>Minimum liquid sample amount of 0.5–1 ml</li><li>Minimum sample amount of 200 mg for raw API powders</li><li>Average turnaround time of 7 business days</li></ul><h4><strong>Analysis Parameters</strong></h4><ul><li><strong>Target compound: </strong>L-Carnitine</li><li><strong>CAS number: </strong>541-15-1</li><li><strong>Testing method: </strong>HPLC</li><li><strong>Result format for oral products: </strong>mg per tablet or capsule</li><li><strong>Result format for liquid samples:</strong> mg/ml</li><li><strong>Alternative result format:</strong> Purity in % (m/m)</li><li><strong>Minimum sample amount for oral products:</strong> Three tablets or capsules</li><li><strong>Minimum sample amount for liquid samples:</strong> 0.5–1 ml</li><li><strong>Minimum sample amount for raw API powders: </strong>200 mg</li><li><strong>Average turnaround time: </strong>7 business days</li></ul><blockquote><p><strong>Important Notice</strong></p><ul><li>This analysis is specifically intended for L-carnitine. It does not automatically screen the sample for related carnitine derivatives, contaminants, or undeclared substances unless an additional screening service is ordered.</li><li>Purity reporting in % (m/m) is available as an alternative result format.</li></ul></blockquote><h4><strong>Optional Additional Analyses</strong></h4><p>The following optional laboratory services are available:</p><ul><li>Complete Raw Analytical Data</li><li>Fentanyl Screening</li><li>Alternative Result Format: Purity in % (m/m)</li><li>Batch Variance Testing</li><li>pH Measurement</li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2524"><strong>LCMS Screening For Peptide Contamination</strong></a></li><li><a target="_blank" rel="noopener noreferrer" href="https://icpms.labrulez.com/products/2525"><strong>Heavy Metals Analysis (As, Cd, Pb, Hg)</strong></a></li><li>Additional Laboratory Report</li></ul>

Lipo-C (L-Carnitine content, L-Arginine Content, B12 Content, Total Solids)

Lipo-C analysis determines L-carnitine, L-arginine, vitamin B12, and total solids content, with target compounds analysed by HPLC.

<p><strong>The Lipo-C Analysis is a targeted laboratory test designed to determine the content of L-carnitine, L-arginine, and vitamin B12, together with the total solids content of a Lipo-C sample.</strong></p><p>The target compounds are analysed by HPLC, with results reported in mg/ml. Total solids provide an additional measure of the overall amount of solid material present in the sample, helping assess the composition of the formulation beyond the individual quantified compounds.</p><h4><strong>About the Analyzed Compounds</strong></h4><p>L-carnitine is involved in mitochondrial fatty-acid metabolism and facilitates the transport of long-chain fatty acids into mitochondria for beta-oxidation. L-arginine is an amino acid involved in several metabolic pathways and serves as a precursor for nitric oxide synthesis.</p><p>Vitamin B12 (cobalamin) is an essential micronutrient that functions as a cofactor for enzymes involved in important metabolic reactions and DNA synthesis.</p><p>Total solids represent the overall solid material present in a sample, including dissolved and suspended material. This measurement complements the targeted determination of L-carnitine, L-arginine, and vitamin B12.</p><h4><strong>Key Features</strong></h4><ul><li>Targeted determination of L-carnitine, L-arginine, and vitamin B12</li><li>Total solids determination included</li><li>Analysis of target compounds by HPLC</li><li>Results reported in mg/ml</li><li>Suitable for Lipo-C liquid samples</li><li>Minimum sample amount of one whole unopened vial</li><li>Average turnaround time of 7 business days</li></ul><h4><strong>Analysis Parameters</strong></h4><ul><li><strong>Target compounds: </strong>L-Carnitine, L-Arginine, Vitamin B12</li><li><strong>Additional determination: </strong>Total Solids</li><li><strong>Testing method: </strong>HPLC</li><li><strong>Result format: </strong>mg/ml</li><li><strong>Minimum sample amount:</strong> One whole unopened vial</li><li><strong>Average turnaround time:</strong> 7 business days</li></ul><blockquote><p><strong>Important Notice</strong></p><ul><li>This analysis is specifically designed to determine L-carnitine, L-arginine, vitamin B12, and total solids in a Lipo-C sample.</li><li>The analysis does not automatically screen the sample for other active compounds, ingredients, contaminants, or undeclared substances.</li></ul></blockquote><h4><strong>Optional Additional Analyses</strong></h4><p>The following optional laboratory services are available:</p><ul><li>Complete Raw Analytical Data</li><li>Fentanyl Screening</li><li>Batch Variance Testing</li><li>pH Measurement</li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2522"><strong>Endotoxin Analysis</strong></a></li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2524"><strong>LCMS Screening For Peptide Contamination</strong></a></li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2527"><strong>Sterility Testing </strong><span><strong>(TAMC + TYMC)</strong></span></a></li><li><a target="_blank" rel="noopener noreferrer" href="https://icpms.labrulez.com/products/2525"><strong>Heavy Metals Analysis (As, Cd, Pb, Hg)</strong></a></li><li>Additional Laboratory Report</li></ul>

NAD+ analysis

Targeted HPLC analysis of NAD+ in tablets, capsules, and raw API powders, confirming compound identity and determining its amount.

<p><strong>The NAD+ Analysis is a targeted laboratory test designed to confirm the identity and determine the amount of NAD+ in oral dosage forms and raw active pharmaceutical ingredient (API) powders.</strong></p><p>The analysis is suitable for tablets and capsules, with results reported in milligrams per tablet or capsule. Raw API powders can be evaluated using an alternative result format based on purity in % (m/m). NAD+ is not a peptide, and peptide purity is therefore not determined as part of this analysis.</p><h4><strong>About NAD+</strong></h4><p>NAD+ (nicotinamide adenine dinucleotide) is the oxidized form of an essential cellular coenzyme involved in redox reactions and energy metabolism. It accepts electrons during metabolic reactions and is converted to its reduced form, NADH, which participates in cellular energy production.</p><p>NAD+ is present throughout cellular metabolism and plays an important role in maintaining the balance between oxidation and reduction reactions required for normal cellular function.</p><h4><strong>Key Features</strong></h4><ul><li>Targeted identification and quantification of NAD+</li><li>Suitable for tablets, capsules, and raw API powders</li><li>Analysis by HPLC</li><li>Results for oral products reported in mg per tablet or capsule</li><li>Alternative result format based on purity in % (m/m)</li><li>Minimum sample amount of three tablets or capsules</li><li>Minimum sample amount of 200 mg for raw API powders</li><li>Average turnaround time of 7 business days</li></ul><h4><strong>Analysis Parameters</strong></h4><ul><li><strong>Target compound:</strong> NAD+</li><li><strong>Testing method:</strong> HPLC</li><li><strong>Minimum amount of target compound for evaluation:</strong> Less than 1/20 of the usual dosage per vial</li><li><strong>Result format for oral products:</strong> mg per tablet or capsule</li><li><strong>Result format for raw API powders:</strong> m/m purity in % [98%+, 96%+ or % value such as 94.15%]</li><li><strong>Minimum sample amount for oral products:</strong> Three tablets or capsules</li><li><strong>Minimum sample amount for raw API powders:</strong> 200 mg</li><li><strong>Average turnaround time:</strong> 7 business days</li></ul><blockquote><p><strong>Important Notice</strong></p><ul><li>NAD+ is not a peptide. Peptide purity is therefore not measured as part of this analysis.</li><li>This analysis is specifically intended for NAD+. It does not automatically screen the sample for related compounds, degradation products, contaminants, or undeclared substances unless an additional screening service is ordered.</li><li>The stated detection limit cutoff is less than 1/20 of the usual dosage per vial.</li></ul></blockquote><h4><strong>Optional Additional Analyses</strong></h4><p>The following optional laboratory services are available:</p><ul><li>Complete Raw Analytical Data</li><li>Fentanyl Screening</li><li>Alternative Result Format: Purity in % (m/m)</li><li>Batch Variance Testing</li><li>pH Measurement</li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2522"><strong>Endotoxin Analysis</strong></a></li><li><a target="_blank" rel="noopener noreferrer" href="https://icpms.labrulez.com/products/2526"><strong>CHNS Mass Report</strong></a></li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2524"><strong>LCMS Screening For Peptide Contamination</strong></a></li><li><a target="_blank" rel="noopener noreferrer" href="https://icpms.labrulez.com/products/2525"><strong>Heavy Metals Analysis (As, Cd, Pb, Hg)</strong></a></li><li>Additional Laboratory Report</li></ul>

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