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Pentosan Polysulfate Sodium
4-O-Methyl-α-d-glucurono-β-d-xylan (hydrogen sulfate), (1→4)-β-d-Xylan 2,3-bis(hydrogen sulfate), sodium salt [140207-93-8]

BRIEFING

 Pentosan Polysulfate Sodium. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is being proposed.

  1. The HPLC procedure used in Identification B is based on analyses performed using the MCX brand of column with L22 packing, manufactured by PSS Polymer Standards Service GmbH. The typical retention time for pentosan polysulfate sodium is about 22.3 min.

  2. The HPLC procedure in the Assay is based on analyses performed using the MCX brand of column with L22 packing, manufactured by PSS Polymer Standards Service GmbH. The typical retention time for pentosan polysulfate sodium is about 21.8 min.

  3. The HPLC procedure in the Impurities test for Sodium Sulfate is based on analyses performed using the Thermo Scientific IonPac Cryptand A1 brand of column with L129 packing. The typical retention time for sulfate is about 3.11 min.

 (BIO1: J. Sun)

 Case ID—SUB-506

USP REFERENCE STANDARDS FOR PURCHASE

USP Dextrose RS
USP Pentosan Polysulfate Sodium RS
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