BRIEFING
Rocuronium Bromide Injection. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed.
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The liquid chromatographic procedure in the Assay was validated using the Hypersil Silica brand of column with L3 packing. The typical retention time for rocuronium is about 9 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the Atlantis Premier BEH C18 AX brand of column with L78 packing. The typical retention time for rocuronium is about 30 min.
(SM4: R. Ivaturi)
Case ID—SUB-1508, SUB-2875