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