BRIEFING
Pentosan Polysulfate Sodium Capsules. 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 HPLC procedure in the Assay is based on analyses performed using the Phenomenex BioSep SEC-S2000 brand of column with L33 or L35 packing. The typical retention time for pentosan polysulfate sodium is about 8.5 min.
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The HPLC procedure in the test for Limit for Free Sulfate is based on analyses performed using the ES Industries Chromegabond SAX brand of column with L14 packing. The typical retention time for sulfate is about 15 min.
(BIO1: J. Sun)
Case ID—SUB-1981