High-Sensitivity Analysis of Residual Solvents in Drug Products - USP <467> Residual Solvents Procedure A

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Headspace GC methods specified in the USP (U.S. Pharmacopeia), General Chapters <467> Residual Solvents, are commonly used for analysis of residual solvents. In this analysis, high sensitivity, resolution, accuracy and reproducibility are necessary.

This Application News presents data obtained using the Shimadzu HS-20 Headspace Sampler and Nexis GC-2030 Gas Chromatograph, from Class 1 and Class 2 standard solutions, in accordance with Water Soluble Articles, Procedure A, in USP <467> Residual Solvents. For Class 1 standard solution, the system easily fulfilled the sensitivity requirements including the low-responding carbon tetrachloride. On the other hand, chromatographic resolution of acetonitrile and methylene chloride that is required for Class 2 standard mixture was completely achieved at a resolution of 2.4.

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