Elemental impurity limits in excipients

By all accounts, analytical limit testing in USP <231> has rarely produced positive results, implying that no individual metal was present at a higher specified limit. Although there were issues with the accuracy and recovery of metals, particularly mercury, using the sulfide precipitation met...

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Bibliographic Details
Main Author: Shireesh Apte
Format: Article
Language:English
Published: International Pharmaceutical Excipients Council
Series:Journal of Excipients and Food Chemicals
Online Access:http://jefc.scholasticahq.com/article/1098-elemental-impurity-limits-in-excipients.pdf