BRIEFING
Acetaminophen Injection. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedure in the Assay was validated using the Hypersil BDS C18 brand of column with L1 packing. The typical retention time for acetaminophen is about 4 min.
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The liquid chromatographic procedure in the test for Limit of 4-Aminophenol was validated using the Zorbax SB C8 brand of column with L7 packing. The typical retention time for 4-aminophenol is about 5 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the Zorbax SB-Aq brand of column with L96 packing. The typical retention time for acetaminophen is about 7 min.
(SM2: F. Gu)
Case ID—SUB-1677; SUB-1705