<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

Sterility Testing (TAMC + TYMC)

TAMC + TYMC microbial testing for aerobic microorganisms, yeasts, and molds in unopened vials, ampoules, and liquid samples.

<p><strong>The Sterility Testing service is designed to assess microbial contamination in suitable samples using Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) cultivation tests.</strong></p><p>The analysis is intended primarily for unopened peptide vials, ampoules, and other liquid samples where microbial contamination may affect product quality and safety.</p><h4><strong>About TAMC and TYMC</strong></h4><p>TAMC determines the total number of viable aerobic microorganisms present in a sample, while TYMC evaluates the presence of viable yeasts and molds.</p><p>Together, these cultivation-based tests provide an assessment of the overall microbial burden of the sample. Results are reported as Pass or Fail according to the applied acceptance criteria.</p><h4><strong>Key Features</strong></h4><ul><li>Cultivation-based microbial testing</li><li>Total Aerobic Microbial Count (TAMC)</li><li>Total Yeast and Mold Count (TYMC)</li><li>Suitable for unopened peptide vials, ampoules, and selected liquid samples</li><li>Recommended sample amount of two unopened peptide vials</li><li>Alternative sample formats include two 1 ml ampoules or one 10 ml vial</li><li>Results reported as Pass or Fail</li><li>Average turnaround time of 14 days</li></ul><h4><strong>Analysis Parameters</strong></h4><ul><li><strong>Testing method:</strong> Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC)</li><li><strong>Amount required for the test:</strong> Two unopened peptide vials recommended, two 1 ml ampoules, or one 10 ml vial (e.g. oil-based samples)</li><li><strong>Result format:</strong> Pass or Fail</li><li><strong>Average turnaround time: </strong>14 days</li></ul><blockquote><p><strong>Important Notice</strong></p><ul><li>Unopened vials or ampoules are required to minimise the risk of contamination during shipping and handling.</li><li>Submitting less than the recommended sample amount is possible, but it may affect the reliability of the results.</li><li>This test is not recommended for oral products, as oral dosage forms are not generally required to be sterile for safe use.</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>

2,4-Dinitrophenol (DNP) Analysis

Targeted HPLC analysis of 2,4-dinitrophenol (DNP) in pills, tablets, capsules, and raw API powders, confirming identity and determining content.

<p><strong>The 2,4-Dinitrophenol (DNP) Analysis is a targeted laboratory test designed to confirm the identity and determine the amount of 2,4-dinitrophenol in oral dosage forms and raw active pharmaceutical ingredient (API) powders.</strong></p><p>The analysis is suitable for pills, tablets, and capsules, with results reported in milligrams per tablet or capsule. Raw API powders can be evaluated by percentage content, with optional purity reporting in % (m/m).</p><h4><strong>About 2,4-Dinitrophenol (DNP)</strong></h4><p>2,4-Dinitrophenol (DNP) is a synthetic chemical compound that acts as an uncoupler of oxidative phosphorylation, disrupting normal cellular energy production and increasing heat generation.</p><p>DNP has historically been investigated for several industrial and biological applications but is highly toxic and is not approved as a weight-loss drug. Exposure can cause serious and potentially life-threatening adverse effects.</p><h4><strong>Key Features</strong></h4><ul><li>Targeted identification and quantification of 2,4-dinitrophenol (DNP)</li><li>Suitable for pills, 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>Results for raw API powders reported as percentage content</li><li>Optional purity reporting in % (m/m) for raw API powders</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>2,4-Dinitrophenol</li><li><strong>Other name: </strong>DNP</li><li><strong>Testing method: </strong>HPLC</li><li><strong>Minimum amount of target compound for evaluation in oral products:</strong> 20 mg per pill, tablet, or capsule</li><li><strong>Minimum content of target compound for evaluation in raw API powders: </strong>5%</li><li><strong>Result format for oral products:</strong> mg per tablet or capsule</li><li><strong>Result format for raw API powders:</strong> % [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>This analysis is specifically intended for 2,4-dinitrophenol (DNP). It does not automatically screen the sample for related compounds, contaminants, or undeclared substances.</li><li>For oral products, the minimum amount of DNP required for evaluation is 20 mg per pill, tablet, or capsule. For raw API powders, the minimum content is 5%. Samples below these values may not be reliably evaluated within the standard scope of the analysis.</li><li>Purity reporting in % (m/m) is available only for raw API powders.</li><li>DNP is a highly toxic compound. Laboratory analysis should not be interpreted as confirmation that a product is safe for human consumption.</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>Alternative Result Format: Purity in % (m/m) – only for raw API powders</li><li>Batch Variance Testing</li><li>Fentanyl Screening</li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2524"><strong>GCMS Contamination Screening</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>

5-Amino-1-methylquinolinium Analysis

Targeted HPLC analysis of 5-Amino-1-methylquinolinium in pills, tablets, capsules, and raw API powders for identity and amount determination.

<p><strong>The 5-Amino-1-methylquinolinium Analysis is a targeted laboratory test designed to confirm the identity and determine the amount of 5-Amino-1-methylquinolinium in oral dosage forms and raw active pharmaceutical ingredient (API) powders.</strong></p><p>The analysis is suitable for pills, tablets, and capsules, with results reported in milligrams per tablet or capsule. Raw API powders can be evaluated by mass-by-mass purity in %. Please note that 5-Amino-1-methylquinolinium is not a peptide, and peptide purity is therefore not determined.</p><h4><strong>About 5-Amino-1-methylquinolinium</strong></h4><p>5-Amino-1-methylquinolinium, also known as 5A1MQ or 5-Amino-1MQ, is a small-molecule research compound investigated as an inhibitor of nicotinamide N-methyltransferase (NNMT). It is not a peptide.</p><p>NNMT is an enzyme involved in nicotinamide and cellular methylation metabolism. 5-Amino-1-methylquinolinium has been studied primarily in preclinical research related to cellular metabolism and adipose tissue biology.</p><h4><strong>Key Features</strong></h4><ul><li>Targeted identification and quantification of 5-Amino-1-methylquinolinium</li><li>Suitable for pills, 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 reported as 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> 5-Amino-1-methylquinolinium</li><li><strong>Other names: </strong>5A1MQ, 5-Amino-1MQ</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 raw API powders:</strong> % [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>5-Amino-1-methylquinolinium is not a peptide. Peptide purity is therefore not measured as part of this analysis.</li><li>This analysis is specifically intended for 5-Amino-1-methylquinolinium. It does not automatically screen the sample for related compounds, contaminants, or undeclared substances unless an additional screening service is ordered.</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>Alternative Result Format: Purity in % (m/m) – only for raw API powders</li><li>Batch Variance Testing</li><li>Fentanyl Screening</li><li>Iodide/Chloride Analysis</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>

AICAR analysis

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

<p><strong>The AICAR Analysis is a targeted laboratory test designed to confirm the identity and determine the amount of AICAR in finished lyophilised vials and raw active pharmaceutical ingredient (API) powders.</strong></p><p>For finished vials, results are reported in milligrams per vial. Raw API powders can be evaluated using an alternative result format based on purity in % (m/m). AICAR is not a peptide, and peptide purity is therefore not determined as part of this analysis.</p><h4><strong>About AICAR</strong></h4><p>AICAR is a small-molecule research compound widely used in studies of cellular energy metabolism and AMP-activated protein kinase (AMPK) signalling. After cellular uptake, AICAR riboside can be phosphorylated to ZMP, an AMP analogue that can activate AMPK.</p><p>AICAR has been investigated extensively in preclinical research examining metabolic regulation, glucose and lipid metabolism, and cellular responses to changes in energy availability. Its effects are not exclusively mediated through AMPK, and additional AMPK-independent mechanisms have also been described.</p><h4><strong>Key Features</strong></h4><ul><li>Targeted identification and quantification of AICAR</li><li>Suitable for finished lyophilised vials and raw API powders</li><li>Analysis by HPLC</li><li>Results for finished vials reported in mg per vial</li><li>Alternative purity reporting 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> AICAR</li><li><strong>Testing method: </strong>HPLC</li><li><strong>Result format for finished vial: </strong>mg per vial</li><li><strong>Alternative result format: </strong>Purity in % (m/m)</li><li><strong>Minimum sample amount for finished vial: </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>AICAR is not a peptide. Peptide purity is therefore not measured as part of this analysis.</li><li>For finished products, 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) – only for raw API powders</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><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2527"><strong>Sterility Testing</strong></a> (<span>TAMC and TYMC)</span></li><li>Additional Laboratory Report</li></ul>

BAC Water (Benzyl Alcohol) Analysis

HPLC analysis of benzyl alcohol in bacteriostatic water, including confirmation and concentration determination in mg/ml.

<p><strong>The BAC Water (Benzyl Alcohol) Analysis is a targeted laboratory test designed to confirm the presence and determine the concentration of benzyl alcohol in bacteriostatic water.</strong></p><p>The analysis is performed by HPLC, with results reported in milligrams of benzyl alcohol per millilitre of sample.</p><h4><strong>About Benzyl Alcohol</strong></h4><p>Benzyl alcohol is an aromatic alcohol commonly used as a preservative in pharmaceutical and laboratory formulations. In bacteriostatic water, it is added to help inhibit microbial growth after a vial has been opened.</p><p>This analysis specifically determines the concentration of benzyl alcohol in the submitted liquid sample.</p><h4><strong>Key Features</strong></h4><ul><li>Targeted identification and quantification of benzyl alcohol</li><li>Designed for bacteriostatic water and similar liquid samples</li><li>Analysis by HPLC</li><li>Results reported in mg/ml</li><li>Minimum concentration for evaluation: 1 mg/ml</li><li>Minimum sample amount: 1 ml</li><li>Average turnaround time of 7 business days</li></ul><h4><strong>Analysis Parameters</strong></h4><ul><li><strong>Target compound: </strong>Benzyl Alcohol</li><li><strong>Testing method:</strong> HPLC</li><li><strong>Minimum concentration of target compound for evaluation: </strong>1 mg/ml</li><li><strong>Result format:</strong> mg/ml</li><li><strong>Minimum sample amount:</strong> 1 ml</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 benzyl alcohol in liquid samples. It does not automatically screen the sample for other preservatives, active compounds, contaminants, or undeclared substances.</li><li>Samples containing less than 1 mg/ml benzyl alcohol may not be reliably evaluated within the standard scope of the analysis.</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>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>GC–MS Contamination Screening</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><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2527"><strong>Sterility Testing</strong></a> (<span>TAMC and TYMC)</span></li></ul>

BAM-15 analysis

Targeted HPLC analysis of BAM-15 in pills, tablets, capsules, and raw API powders. The test confirms compound identity and determines its content.

<p><strong>The BAM-15 Analysis is a targeted laboratory test designed to confirm the identity and determine the amount of BAM-15 in oral dosage forms and raw active pharmaceutical ingredient (API) powders.</strong></p><p>The analysis is suitable for pills, 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). BAM-15 is not a peptide, and peptide purity is therefore not determined as part of this analysis.</p><h4><strong>About BAM-15</strong></h4><p>BAM-15 is a small-molecule research compound that acts as a mitochondrial uncoupler. It increases proton transport across the inner mitochondrial membrane, thereby uncoupling nutrient oxidation from ATP production and altering cellular energy metabolism.</p><p>BAM-15 has been investigated mainly in preclinical research focused on mitochondrial function, energy expenditure, glucose and lipid metabolism, and related metabolic processes</p><h4><strong>Key Features</strong></h4><ul><li>Targeted identification and quantification of BAM-15</li><li>Suitable for pills, 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>BAM-15</li><li><strong>Other name: </strong>BAM15</li><li><strong>Testing method:</strong> HPLC</li><li><strong>Result format for oral products:</strong> mg per tablet or capsule</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 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>BAM-15 is not a peptide. Peptide purity is therefore not measured as part of this analysis.</li><li>This analysis is specifically intended for BAM-15. It does not automatically screen the sample for related compounds, contaminants, or undeclared substances unless an additional screening service is ordered.</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) – only for raw API powders</li><li>Batch Variance Testing</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>

Clenbuterol Analysis

Targeted HPLC analysis of clenbuterol in pills, tablets, capsules, and raw API powders. The test confirms compound identity and determines its content.

<p><strong>The Clenbuterol Analysis is a targeted laboratory test designed to confirm the identity and determine the amount of clenbuterol in oral dosage forms and raw active pharmaceutical ingredient (API) powders.</strong></p><p>The analysis is suitable for pills, tablets, and capsules, with results reported in micrograms per tablet or capsule. Raw API powders can be evaluated by percentage content, with optional purity reporting in % (m/m).</p><h4><strong>About Clenbuterol</strong></h4><p>Clenbuterol is a synthetic beta-2 adrenergic agonist with bronchodilator activity. It stimulates beta-2 adrenergic receptors and can affect smooth muscle tone, cardiovascular function, and metabolic processes.</p><p>Clenbuterol has been used therapeutically in some countries for respiratory conditions, but it is not approved for human use in many jurisdictions. It is also known for non-medical use related to its stimulant and metabolic effects.</p><h4><strong>Key Features</strong></h4><ul><li>Targeted identification and quantification of clenbuterol</li><li>Suitable for pills, tablets, capsules, and raw API powders</li><li>Analysis by HPLC</li><li>Results for oral products reported in mcg per tablet or capsule</li><li>Results for raw API powders reported as percentage content</li><li>Optional purity reporting in % (m/m) for raw API powders</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>Clenbuterol</li><li><strong>Other name: </strong>Clen</li><li><strong>Testing method: </strong>HPLC</li><li><strong>Minimum amount of target compound for evaluation in oral products: </strong>15 mcg per pill, tablet, or capsule</li><li><strong>Minimum content of target compound for evaluation in raw API powders: </strong>5%</li><li><strong>Result format for oral products: </strong>mcg per tablet or capsule</li><li><strong>Result format for raw API powders:</strong> % [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>This analysis is specifically intended for clenbuterol. It does not automatically screen the sample for other beta-2 agonists, related compounds, contaminants, or undeclared substances.</li><li>For oral products, the minimum amount of clenbuterol required for evaluation is 15 mcg per pill, tablet, or capsule. For raw API powders, the minimum content is 5%. Samples below these values may not be reliably evaluated within the standard scope of the analysis.</li><li>Purity reporting in % (m/m) is available only for raw API powders.</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><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://icpms.labrulez.com/products/2525"><strong>Heavy Metals Analysis (As, Cd, Pb, Hg)</strong></a></li><li>Additional Laboratory Report</li></ul>

Dihexa analysis

HPLC analysis of Dihexa for identification, amount and purity in tablets, capsules, lyophilized samples and raw API powders, with optional solvent selection.

<p><span><strong>This analysis is designed to confirm the identity and determine the amount and peptide purity of Dihexa in tablets, capsules, lyophilized samples and raw API powders. HPLC testing provides information about the target compound content and its purity relative to chromatographically detectable impurities.</strong></span></p><h4><span><strong>Dihexa</strong></span></h4><p><span>Dihexa is a synthetic peptide-derived compound with the sequence <strong>Hexanoyl-Tyr-Ile-Ahx-NH<sub>2</sub></strong>. Its molecular weight is approximately 504 Da.</span></p><p><span>An important consideration in <strong>Dihexa analysis</strong> is its <strong>limited solubility in water</strong>. The choice of solvent can therefore significantly affect how much of the compound enters solution and can subsequently be measured by HPLC. Water is used as the standard preparation procedure for lyophilized samples, while DMSO and methanol are available as alternative solvents.</span></p><h5><span><strong>What the Analysis Determines</strong></span></h5><ul><li><span>Identity of Dihexa</span></li><li><span>Amount of Dihexa in the sample</span></li><li><span>Peptide purity</span></li><li><span>Dihexa content per tablet or capsule</span></li><li><span>Dihexa content in mg per vial for lyophilized samples</span></li><li><span>Optional m/m purity for raw API powders</span></li></ul><h5><span><strong>Analysis Parameters</strong></span></h5><ul><li><span><strong>Target compound:</strong> Dihexa</span></li><li><span><strong>CAS number:</strong> 1401708-83-5</span></li><li><span><strong>Molecular weight:</strong> 504 Da</span></li><li><span><strong>Sequence:</strong> Hexanoyl-Tyr-Ile-Ahx-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 oral products:</strong> mg per tablet or capsule and peptide purity</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 oral sample:</strong> 3 tablets or capsules</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>Default solvent for lyophilized samples:</strong> water</span></li><li><span><strong>Optional solvents:</strong> DMSO or methanol</span></li><li><span><strong>Average turnaround time:</strong> 7 business days</span></li></ul><h4><span><strong>Important Notice – Dihexa Solubility</strong></span></h4><p><span>Dihexa has limited solubility in water, which must be considered particularly when analyzing lyophilized samples.</span></p><h5><span><strong>Water – Standard Procedure</strong></span></h5><p><span>Water is the default solvent used for standard sample preparation. However, Dihexa is poorly soluble in water. Insoluble particles are removed by filtration before HPLC analysis because only material transferred into solution can be analyzed.</span></p><p><span>If part of the Dihexa remains undissolved, it may be removed during filtration and the measured concentration may therefore be lower than the total amount originally present in the sample.</span></p><h5><span><strong>DMSO</strong></span></h5><p><span>DMSO provides improved dissolution of Dihexa and reduces potential losses caused by removing insoluble particles before analysis. When DMSO is selected, the prepared solution is intended for analytical testing only.</span></p><h5><span><strong>Methanol</strong></span></h5><p><span>Methanol provides very good dissolution of Dihexa and is suitable when maximizing extraction of the target compound before HPLC analysis is required. The resulting solution is likewise intended for analytical testing only.</span></p><p><span>For tablets and capsules, the standard analytical procedure is recommended.</span></p><p><span>The alternative m/m purity result format is intended exclusively for raw API powders.</span></p><h4><span><strong>Additional Analyses</strong></span></h4><h5><span><strong>Solvent – Methanol</strong></span></h5><ul><li><span>Methanol can be used instead of the standard aqueous preparation procedure. Its improved ability to dissolve Dihexa can reduce losses associated with removal of insoluble material.</span></li></ul><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>Solvent – DMSO</strong></span></h5><ul><li><span>DMSO can be used to dissolve Dihexa before analysis. This option can improve transfer of the target compound into solution and reduce losses during filtration.</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>

DSIP analysis

HPLC analysis of DSIP 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 DSIP 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>DSIP</strong></span></h4><p><span>DSIP, or <strong>Delta Sleep-Inducing Peptide</strong>, is a short peptide composed of nine amino acid residues. It is also known as Sleep-Promoting Peptide.</span></p><p><span>Its sequence is <strong>H-Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu-OH</strong>, and its molecular weight is approximately 849 Da.</span></p><p><span>HPLC analysis confirms the presence of DSIP 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 DSIP</span></li><li><span>Amount of DSIP 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> DSIP</span></li><li><span><strong>Other names:</strong> Delta Sleep-Inducing Peptide, Sleep-Promoting Peptide</span></li><li><span><strong>CAS number:</strong> 62568-57-4</span></li><li><span><strong>Molecular weight:</strong> 849 Da</span></li><li><span><strong>Sequence:</strong> H-Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu-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 DSIP 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>

Elamipretide (SS-31) Analysis

HPLC analysis of Elamipretide (SS-31) 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 Elamipretide (SS-31) 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>Elamipretide (SS-31)</strong></span></h4><p><span>Elamipretide, also known as SS-31, is a synthetic mitochondria-targeting <strong>tetrapeptide</strong>. Its structure contains alternating basic and aromatic amino acid residues, and research has particularly investigated its interactions with mitochondrial membranes and mitochondrial bioenergetics.</span></p><p><span>Its peptide sequence is <strong>H-D-Arg-Tyr(2,6-diMe)-Lys-Phe-NH<sub>2</sub></strong> and includes D-arginine and the modified amino acid 2,6-dimethyltyrosine. Elamipretide is also widely referred to as SS-31.</span></p><p><span>HPLC analysis confirms the presence of SS-31 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 Elamipretide (SS-31)</span></li><li><span>Amount of Elamipretide 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> SS-31</span></li><li><span><strong>Other name:</strong> Elamipretide</span></li><li><span><strong>CAS number:</strong> 736992-21-5</span></li><li><span><strong>Sequence:</strong> H-D-Arg-Tyr(2,6-diMe)-Lys-Phe-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 Elamipretide 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>

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