Automated QbD-Based Method Development and Validation of Oxidative Degraded Atorvastatin

Peptide Mapping: A Quality by Design (QbD) Approach Application Note Bio-Pharmaceutical Authors Abstract Sreelakshmy Menon and Peptide mapping is a widely used technique for the characterization of proteins. Suresh babu C.V. This Application Note demonstrates a robust LC method and…

Quality-by-Design Approach to Stability Indicating Method Development for Linagliptin Drug Product Application Note Pharmaceutical QA/QC Authors Abstract Syed Salman Lateef and Vinayak AK A traditional approach to method development could fail to meet desired Agilent Technologies, Inc. separation during validation,…

QbD Based Method Development on an Agilent 1290 Infinity UHPLC System Combined with a Seamless Method Transfer to HPLC Using Intelligent System Emulation Technology Application Note Pharmaceutical QA/QC Author Abstract Vinayak A.K In this Application Note, a method was developed…

Regulations for Analytical development USFDA/ICH/USP perspectives Manu Grover M.S (Pharma) Business Development ManagerPharma Markets Santa Clara (US) [email protected] DE94720144 Outline ICH Guidelines and USP chapters Method development guidelines from ICH Journey of Method development related regulations. • ICH Q2(R2) •…