BRIEFING
Butalbital and Acetaminophen Capsules. 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 procedures in the Assay and Dissolution test are based on validation performed with the XTerra RP18 brand of column with L1 packing. The typical retention times for acetaminophen and butalbital are about 3.5 and 12.7 min, respectively.
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The liquid chromatographic procedure in the Organic Impurities test is based on validation performed with the XTerra RP18 brand of column with L1 packing. The typical retention times for acetaminophen and butalbital are about 12 and 44 min, respectively.
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The liquid chromatographic procedure in the Limit of 4-Aminophenol test is based on validation performed with the Atlantis dC18 brand of column with L1 packing. The typical retention time for 4-aminophenol is about 2.5 min.
(SM2: F. Gu)
Case ID—SUB-682