Analysis of Residual Solvents in Pharmaceuticals by Nexis™ GC-2030 + HS-20 (JP17 Supplement II, USP 467)
The United States Pharmacopeia (USP) General Chapters <467> Residual Solvents provide test methods for residual solvents in pharmaceuticals, and headspace gas chromatography (GC) is mainly used. Residual solvents in pharmaceuticals are classified from Class 1 to 3 based on their potential human health risk and are strictly controlled. The list of residual solvents is continuously reviewed and methylisobutylketone (MIBK) has been newly added to the Japanese Pharmacopoeia 17th Edition Supplement II (JP17 Supplement II) in 2019.
In this article, MIBK was analyzed and its chromatogram was overlaid with that of Class 2A as a reference.
- Content Type:
- Application
- Document Number:
- G324
- Product Type:
- Gas Chromatography
- Keywords:
- Analysis of residual solvents in pharmaceuticals, Japanese Pharmacopoeia 17th Edition Supplement II, UPS 467, headspace method, methylisobutylketone, Pharmaceutical, Life Science, Nexis GC-2030
- Language:
- English
- File Name:
- jpc120013.pdf
- File Size:
- 109kb