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Description

Course Description: Heparin sodium is an important anticoagulant with many indications, use in blood transfusions and dialysis procedures and the treatment of embolisms. In addition to its function as a drug product, the heparin sodium drug substance is the starting material for low-molecular-weight heparins used in the treatment of deep vein thrombosis, such as enoxaparin and dalteparin. The raw material used to make heparin sodium is most notably derived from porcine, making it susceptible to livestock-related supply issues and potential adulteration. USP has many tools available for the quality assessment of heparin sodium drug substance and low-molecular-weight heparins, including impurity methods, potency assays, and NMR methods for identification. USP is leveraging these tools in approaching standards for alternative sources of heparin, including bovine derived material. This webinar will describe some of these methods and how they can be applied to bovine heparin and future standards for heparin from alternative species. This “What’s New in Biologics?” webinar is fifth in a series that shares the knowledge and expertise from USP staff and global experts on topics that will shape the future of biologics. This event will be hosted live so that participants can submit questions to the speakers. It will then be available for on-demand viewing. Who should participate: Manufacturers of Heparin products, Porcine and Bovine, Lab personnel in research and development, manufacturing and production of Heparin products, Regulatory professionals, Quality assurance and quality control specialists and auditors.

Miscellaneous

Certificate of Analysis (specimen)

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Product data sheet

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USP | United States Pharmacopeia

US Pharmacopeia Standards set a global benchmark, enabling efficient, reliable, and cost-effective development and quality control of pharmaceuticals.

Official USP Reference Standards are highly characterized physical specimens intended for quality control use when conducting assays and tests for medicines as described in the USP-NF. When you conduct tests and assays required by the USP-NF using the USP reference standards specified, the results can be considered conclusive.

As a USP-Authorized Distributor, we offer the following products and services:

  • USP Reference Standards
  • USP Pharmaceutical Analytical Impurities
  • USP Training and educational programs