BRIEFING

 Bacitracin Zinc. This proposal is based on the version of the monograph official as of May 1, 2016. The following changes are proposed:

1. Update the structure of Bacitracin Zinc.

2. Add a test for Organic Impurities, which is the same as the Related substances test in the European Pharmacopoeia monograph for Bacitracin Zinc. The proposed liquid chromatographic procedure was validated using an ACE C18 brand of column with L1 packing of 3-µm particle size. The typical rentention time of bacitracin A is about 20 min.

3. Revise the test for Composition of Bacitracin. The proposed liquid chromatographic procedure is based on the same chromatographic conditions as proposed in the test for Organic Impurities.

4. In the Packaging and Storage section, modify the storage condition from “store below 25°” to “do not store above 25°” to better reflect the conditions in the stability studies performed for the drug substances.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 (BIO4: Y. Han)

 Case ID—SUB-2110