Residual Solvents Analysis in Pharmaceuticals by HS-GC-FID with Newly Added Compounds –USP Procedure A

User Benefits

- Good separation was achieved with newly added compounds - Cost effective when using nitrogen as carrier gas instead of helium

Introduction

United States Pharmacopeia (USP) <467> Residual Solvents is a compendium that defines acceptable amounts of residual solvents in pharmaceuticals and provides procedures to analyze residual solvents. The recommended limit or classification of the solvent in USP <467> would be updated when new safety data on more solvents become available. Methyl isobutyl ketone was reclassified as a Class 2 solvent in USP <467> in 2020 (previously a Class 3 solvent). Meanwhile, tertiary butyl alcohol and cyclopentyl methyl ether were proposed to be classified as Class 2 residual solvents in 2021. Here, we describe headspace-gas chromatography (HS-GC) method using nitrogen carrier gas to analyse Class 1 and Class 2 solvents, following USP<467> Procedure A, updated with 3 new solvents, namely cyclopentyl methyl ether, tertiary butyl alcohol and methyl isobutyl ketone.

March 23, 2022 GMT