Analysis of Residual Solvents in Pharmaceuticals An Analysis Method for Class 2 Solvents (Water- Soluble Samples) Unsuited to Headspace GC Methods

Testing methods for residual solvents in pharmaceuticals are defined in the Japanese Pharmacopoeia Seventeenth Edition and USP (U.S. Pharmacopeia), General Chapters <467> Residual Solvents. While these testing methods mainly describe the detailed testing procedures for Class 1 and Class 2 residual solvents using headspace GC methods, there is no mention of testing methods for solvents possibly used in the testing of compounds and water-insoluble pharmaceuticals, which are unsuited to headspace analysis. This article presents an analysis and examination of the watersoluble samples listed in Table 1, "Solvents Possibly Used in the Testing of Compounds and Water-Insoluble Pharmaceuticals Unsuited to Headspace Analysis (Class 2C)."

Content Type:
Application News
Document Number:
G303
Product Type:
Gas Chromatography (GC)
Keywords:
residual solvents, pharmaceuticals, class 2 solvents, water-soluble, headspace gc, Pharma & Biopharma, QA/QC Manufacturing, GC-2030
Language:
English
File Size:
103kb

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For Research Use Only. Not for use in diagnostic procedures.

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