6H-Purin-6-one, 2-amino-1,9-dihydro-9-[4-hydroxy-3-(hydroxymethyl)butyl]-;
9-[4-Hydroxy-3-(hydroxymethyl)butyl]guanine [39809-25-1]
BRIEFING
Penciclovir. Because there is no existing USP monograph for this drug substance, 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 Zorbax StableBond-Phenyl brand of column with L11 packing. The typical retention time for penciclovir is about 11 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 penciclovir is about 10 min.
Description and solubility information: White to pale-yellow powder. Slightly soluble in pH 2 aqueous buffer; very slightly soluble in water; practically insoluble in methanol and in propylene glycol.
(SM1: S. Shane)
Case ID—SUB-1713
USP REFERENCE STANDARDS FOR PURCHASE
USP Penciclovir RSUSP Penciclovir Related Compound A RS
USP Penciclovir Related Compound B RS