Efficient Analysis of Residual Solvents in Pharmaceuticals Using the Compact Model, Brevis GC-2050 (2)

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 comply with the analysis methods of the pharmacopoeias. - Analysis can be performed on tert-butyl alcohol and cyclopentyl methyl ether, which have been newly added as Class 2 solvents in ICH Q3C (R8).

Introduction

The methods of testing for residual solvents in pharmaceuticals are strictly prescribed in the Japanese Pharmacopoeia 18^th Edition (JP18) and the United States Pharmacopeia (USP) General Chapters <467> Residual Solvents. In order to efficiently perform tests for residual solvents in pharmaceuticals under prescribed test methods, it is important to increase the number of instruments installed in laboratories, which often have limited space. The Brevis GC-2050 has a compact design, and compared with existing GC, the width of the system can be reduced by about 35 %. In addition, headspace samplers with ultra-short transfer lines can be used to further increase the number of units in the lab and enhance analysis efficiency. This article introduces the results of analysis of Class 1 and 2 water- insoluble samples using the compact Brevis GC-2050, in accordance with Supplement 2 of the JP18. DMF was used as the solvent.

3 de septiembre de 2023 GMT