BRIEFING
Nelarabine 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 XBridge BEH C18 brand of column with L1 packing. The typical retention time for nelarabine is about 7.5 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the XBridge BEH C18 brand of column with L1 packing. The typical retention time for nelarabine is about 20.1 min.
(SM1: S. Parepalli)
Case ID—SUB-1586