9H-Purin-2-amine, 9-β-d-arabinofuranosyl-6-methoxy-;
2-Amino-9-β-d-arabinofuranosyl-6-methoxy-9H-purine [121032-29-9]
BRIEFING
Nelarabine. Because there is no existing USP monograph for this drug substance, 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 Kromasil C18 brand of column with L1 packing. The typical retention time for nelarabine is about 11 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the Kromasil C18 brand of column with L1 packing. The typical retention time for nelarabine is about 45 min.
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The liquid chromatographic procedure in the test for Enantiomeric Purity was validated using the Chiralpak IG-3 brand of column with L135 packing. The typical retention time for nelarabine enantiomer is about 10 min.
Description and solubility information: White to off-white powder. Soluble in dimethyl sulfoxide.
(SM1: S. Parepalli)
Case ID—SUB-1792