USP revised glycol and sorbitol monographs published.
New US Pharmacopeial Convention (USP) monographs designed to prevent adulteration of key excipients with diethylene glycol (DEG) and ethylene glycol (EG) have been published ahead of their official implementation date in February.
The monographs, which cover propylene glycol, sorbitol, sorbitol sorbitan and noncrystallizing sorbitol, were released in draft form in July after the US Food and Drug Administration (FDA) asked the USP to tackle DEG and EG contamination.
The USP set a limit of no more than 0.10 per cent of either DEG or EG in any of the four excipients and sets out appropriate testing methods.
The revised monographs are available here.
