Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
The revised monograph for Propylene Glycol (PG) includes test for Ethylene Glycol (EG) and Diethylene Glycol (DEG). The monograph revision is in response to the discovery of EG and DEG in several drug products using Propylene Glycol as reported in WHO Alerts. The revision includes changing the limit for EG to 620 ppm to bring it in line with the requirement described in general chapter 5.4 Residual solvents and the ICH Q3C guideline. Limit for DEG shall be 0.10%. The revised monograph also includes an identification test by IR (Infrared Spectroscopy) and an improved procedure for test of Acidity.
Earlier in May 2023, USFDA also issued a Guidance for Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol. The USFDA guidance prescribed a limit of 0.10% each for residue content of EG and DEG and testing of samples from all containers as a specific identity analysis.
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