BRIEFING
Linezolid in Dextrose 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 for Linezolid was validated using the SymmetryShield RP18 brand of column with L1 packing. The typical retention time for linezolid is about 5 min.
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The liquid chromatographic procedure in the Assay for Dextrose was validated using the Alltima Amino brand of column with L8 packing. The typical retention time for dextrose is about 5 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the SymmetryShield RP18 brand of column with L1 packing. The typical retention time for linezolid is about 40 min.
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The liquid chromatographic procedure in the test for Limit of 5-Hydroxymethylfurfural was validated using the SymmetryShield RP18 brand of column with L1 packing. The typical retention time for 5-hydroxymethylfurfural is about 4 min.
(SM1: M. Fadadu)
Case ID—SUB-985