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Loperamide Hydrochloride Tablets Monograph by Roxana Calderón is a document available to read on EtoBox.

What is Loperamide Hydrochloride Tablets Monograph about?

This revision bulletin summarizes changes made to the official monograph for Loperamide Hydrochloride Tablets. A new Dissolution Test 2 was added to accommodate an FDA-approved drug product. This test was validated using a Zorbax RX-C8 brand of L7 column, with a typical retention time of 4 minutes for loperamide. The revision bulletin supersedes the previously official monograph and will be incorporated into the First Supplement of USP 40-NF 35. Any questions should be directed to the specified USP contact.

Author

Roxana Calderón

Language

EN