Meeting System Suitability for USP Abacavir and Lamivudine Tablets Assay
Abacavir and Lamivudine in combination are used with other medications to treat Human Immunodeficiency Virus (HIV) infection. In this technical note, we report the separation of Lamivudine from its related chiral and diastereomeric impurities in Abacavir and Lamivudine tablets per the USP monograph. The allowable adjustments pertaining to gradient separations are highlighted together with the necessary calculations that are required for the adjusted method conditions to remain compliant with the original monograph.
Nitrosamines, Meeting Regulatory Requirements
September 23rd 2024The necessity to analyse drug products for nitrosamines and NDSRIs (Nitrosamine Drug Substance Related Impurities) is well documented. In this document we provide an overview of 7 of our most recent applications in this area, together with links to the relevant technical notes.
Glucagon-Like-Peptide-1 (GLP-1) Analogues Applications Notebook
September 23rd 2024This applications notebook provides background information on GLP-1 analogues, together with information on the columns suitable for their purification and analysis. Finally it provides a range of reversed phase, size exclusion and preparative applications for a number of GLP-1 analogues.
Demystifying L/dp Ratio When Working with Allowable Adjustments
September 23rd 2024This white paper explores L/dp ratio for pharmacopeia allowable adjustments. It considers efficiency, explaining why L/dp ratio can be used as a proxy for efficiency, and illustrates the allowable adjustments through reviewing at a selection of different monographs.
