SP 06 - Evaluation of Hydrogen as a Carrier Gas in the Analysis of Residual Solvents in Pharmaceuticals by HS_GC_MS
SP 06 - Evaluation of Hydrogen as a Carrier Gas in the Analysis of Residual Solvents in Pharmaceuticals by HS_GC_MS
Residual solvents and organic volatile impurities (OVIs) in pharmaceuticals can result from the manufacturing process of the active pharmaceutical ingredients (API) and the final product. The level of residual solvents can also be affected by the packaging, storage and transportation of pharmaceutical products. All drug substances, excipients and drug products must be monitored and controlled for safety, their effect on crystalline form, solubility and stability [1]. This communication evaluates the use of hydrogen to optimise and produce robust and repeatable methods for the analysis of residual solvents in pharmaceuticals, using GC-MS and generated hydrogen carrier gas. With the price of helium constantly increasing, and variation in supply, this communication shows that there is no reason why hydrogen should not be considered as an alternative to helium as the carrier gas in GC-MS applications, in particular for analysis of residual solvents in pharmaceuticals by HS-GC-MS.
European Medicine Agency, ICH guideline Q3C (R6) on impurities: guideline for residual solvents EMA/CHMP/ICH/82260/2006 [9 August 2019]