4(1H)-Pteridinone, 2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-, dihydrochloride, (6R)-;
(6R)-2-Amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride [69056-38-8]
BRIEFING
Sapropterin Dihydrochloride. 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 used in the Assay is based on analyses performed using the Partisil SCX brand of column with L6 packing. The typical retention time for sapropterin is about 11 min.
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The liquid chromatographic procedure used in the Organic Impurities test is based on analyses performed using the Partisil SCX brand of column with L6 packing. The typical retention time for sapropterin is about 16 min.
Description and Solubility information: White to off-white crystalline powder. Very soluble in water; sparingly soluble in methanol and ethanol; insoluble in ether.
(SM3: S. Ramakrishna)
Case ID—SUB-13