Efficient Analysis of Residual Solvents in Pharmaceuticals Using the Compact Model, Brevis GC-2050 (1)

User Benefits

- The slim and compact design of the Brevis GC-2050 enables the expansion of the number of operational units in the laboratory, allowing for efficient high-throughput analysis. - Brevis GC-2050 can perform analysis using alternative carrier gases. - Analysis can be performed with tert-butyl alcohol and cyclopentyl methyl ether, which have been newly added as Class 2 solvents in ICH Q3C (R8).

Introduction

Residual solvents in pharmaceuticals are defined as organic volatile chemical substances that are used or produced in the manufacture of drug substances or additives or in the preparation of drug products. In the Japanese Pharmacopoeia 18^th Edition (JP18) or the United States Pharmacopeia (USP) General Chapters <467> Residual Solvents, residual solvents are classified as Class 1 to 3, according to their risk to human health, and the headspace GC method is mainly used to analyze them. The carrier gas that is normally used is He. However, He supply shortages have become an issue recently, so there is a demand to perform analysis using alternative carrier gases, such as H₂ or N₂. This article introduces the results of analysis of Class 1 and 2 water-soluble samples using the compact design Brevis GC- 2050. For the Procedure A, H₂ and N₂ in addition to He were used. When using an alternative carrier gas, it is necessary to first verify the operation based on USP General Chapter <1467>.

3 de septiembre de 2023 GMT