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USP compendial methods for analysis of heparin: chromatographic determination of molecular weight distributions for heparin sodium

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Fig. 1
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Abbreviations

BST:

Broad standard table

FDA:

Food and Drug Administration

HP:

Heparin sodium drug product

Mn :

Number-average molecular weight

Mp :

Peak molecular weight

Mw :

Weight-average molecular weight

MW:

Molecular weight

RSD:

Relative standard deviation

SD:

Standard deviation

SEC:

Size-exclusion chromatography

USP:

United States Pharmacopeia

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Acknowledgments

The participants in both stages of the study are acknowledged with gratitude. They are I. Capila and J. Glajch (Momenta Pharmaceuticals, Cambridge, MA, USA), E. K. Chess and W. Wasylenko (Baxter Healthcare, Round Lake, IL, USA), Huihong Fan (NICPBP, Beijing, China), D. Fulchiron (Bay Bioanalytical Laboratories, Hercules, CA, USA), L. Rao and Y. Wang (Scientific Protein Laboratories, Wanaukee, WI, USA), S. Bertini and G. Torri (Istituto Ronzoni, Milan, Italy), W. Jeske (Loyola University, Maywood, IL, USA), C. S. Venkatesan (Gland Pharma, Hyderabad, India), R. van Herpen (Aspen, Oss, The Netherlands), P. Torralba (APP, Skokie, IL, USA), S. O. Herr (Leo Pharma, Ballerup, Denmark), H. Chen (Sepax Technologies, Newark, DE, USA), J. Oman (Pfizer, Franklin, OH, USA), R. Van Gorp (Celsus Laboratories, Cincinnati, OH, USA), Z. Xiang (Changzhou Qianhong Biopharm, Changzhou City, China), Hao Meixia (Yantai Dongcheng Biochemicals, Yantai, China), H. Stefan-Hinrichs (Sandoz, Kundl, Austria), Li Tan (Shenzhen Hepalink Pharmaceutical, Shenzhen, China), L. Liverani (Opocrin, Corlo di Formigine, Italy), J. Cabañas (Bioiberica, Palafolls, Spain), Yu-juan Song and Huihong Fan (NIFDC, Beijing, China), R. Yin (Chongqing Imperial Biochem, Chongqing, China), G. Gratzl (Boehringer Ingelheim, Ben Vue Laboratories, Bedford, OH, USA), and C. Martinez and P. Anger (Sanofi-Aventis, Aramon, France). Members of the USP Unfractionated Heparin Expert Panel (W. E. Workman, E. Chess, E. Gray, F. Huihong, K. Johansen,P. Torralba and C. Viskov) are thanked for fruitful discussions.

Author information

Author notes

  1. Barbara Mulloy

    Present address: Institute of Pharmaceutical Science, King’s College London, Franklin-Wilkins Building, 100 Stamford Street, London, SE1 9NH, UK

Authors and Affiliations

  1. National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, EN6 3QG, UK

    Barbara Mulloy & Alan Heath

  2. Department of Biological Engineering, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge, MA, 02139, USA

    Zachary Shriver

  3. Biologics and Biotechnology, The United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD, 20852-1790, USA

    Fabian Jameison, Tina S. Morris & Anita Y. Szajek

  4. Office of New Drug Quality Assessment, CDER, FDA, 10903 New Hampshire Avenue, Building 21, Room 2524, Silver Spring, MD, 20993, USA

    Ali Al Hakim

Authors
  1. Barbara Mulloy

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  2. Alan Heath

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  3. Zachary Shriver

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  4. Fabian Jameison

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  5. Ali Al Hakim

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  6. Tina S. Morris

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  7. Anita Y. Szajek

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Corresponding author

Correspondence toBarbara Mulloy.

Additional information

The findings and conclusions presented have not been formally disseminated by the FDA and should not be construed to represent any FDA determination or policy.

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Mulloy, B., Heath, A., Shriver, Z.et al. USP compendial methods for analysis of heparin: chromatographic determination of molecular weight distributions for heparin sodium.Anal Bioanal Chem406, 4815–4823 (2014). https://doi.org/10.1007/s00216-014-7940-3

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