Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Heparin, also known as unfractionated heparin (UFH), is an anticoagulant drug widely used in the treatment of heart attacks. Heparin exerts its anticoagulant effect by potentiating the activity of plasma coagulation inhibitors.
Of all the commonly known glycosaminoglycans, only heparin contains a specific pentasaccharide sequence that can bind to the plasma coagulation inhibitor, antithrombin (AT). Heparin is not a thrombolytic, it prevents progression of existing clots by inhibiting further clotting.
Heparin Sodium for Assays pharmaceutical secondary standard is intended for use as a working standard for quantitative applications.
Features and Benefits
The potency of Heparin is directly dependent on the Antifactor IIa and Xa potency, it is a critical parameter in the quality control of Heparin production.
Certified potency value of the pharma secondary product can be used to compare and determine the potency of the Heparin sample.
The potency of this product is certified by comparison against USP Heparin for Assays (RS).
The assay to determine the anti-factor potency of Heparin PHR was developed based on the USP General Chapter method <208>.
Both the factor IIa and Xa potency were determined by a chromogenic assay.
These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.
This secondary biopharma certified reference material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.
This product′s purpose is for testing. THIS PRODUCT IS NOT INTENDED FOR HUMAN OR THERAPEUTIC USE.
Storage Class Code
11 - Combustible Solids
Certificates of Analysis (COA)
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