Sapropterin Hydrochloride Tablets

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BRIEFING

Sapropterin Hydrochloride Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.

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 7 min.
The liquid chromatographic procedure used in the test for Organic Impurities is based on analyses performed using the Partisil SCX brand of column with L6 packing. The typical retention time for sapropterin is about 17 min.

(SM3: S. Ramakrishna)

Case ID—SUB-14

USP REFERENCE STANDARDS FOR PURCHASE

USP Sapropterin Dihydrochloride RS

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