Analysis of Crude Heparin by HPLC/SAX for Oversulfated Chondroitin

Analysis of Crude Heparin by HPLC/SAX for Oversulfated Chondroitin Sulfate

Effective Date:
March 22, 2010

Document Uncontrolled if Printed
3/25/2010

1. Purpose
The purpose of this procedure is to determine the concentration of oversulfated chondroitin sulfate (OSCS) in crude heparin samples.

2. Scope
This procedure is designed to apply to crude heparin samples. It may be adapted to analyze heparin API samples, as well.

3. Responsibilities
3.1 Staff
Adhere to this procedure for the analysis of oversulfated chondroitin sulfate (OSCS) in crude heparin samples.
3.2 Supervisor
Review the performance and results of this procedure.

4. References
4.1.1
David A. Keire, Michael L. Trehy, John C. Reepmeyer, Richard E. Kolinski, Wei Ye, Jamie Dunn, Benjamin J. Westenberger, and Lucinda F. Buhse, “Analysis of crude heparin by 1H-NMR, CE, and SAX-HPLC for FSCS contamination,” manuscript to be submitted for publication, September 2009.

4.1.2
Analysis of heparin sodium by SAX-HPLC for contaminants and impurities, J. Pharm. Biomed. Anal. 49 (2009) 670-673.

5. Records

5.1 Chromatograms
5.2 Calculations

6. Definitions
6.1 OSCS: Oversulfated Chondroitin Sulfate. Sometimes referred to as FSCS.

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