1235831

Enoxaparin sodium for Bioassays

United States Pharmacopeia (USP) Reference Standard

• Synonym(s): Heparin sodium salt
• CAS Number: 9041-08-1
• MDL number: MFCD00081689
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: pharmaceutical primary standard
• API family: enoxaparin
• form: powder
• manufacturer/tradename: USP
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• SMILES string: [Na+].[S](=O)(=O)(NC1C(OC(C(C1O[S](=O)(=O)O)OC4OC(C(C(C4O[S](=O)(=O)O)O)O)C(=O)O)CO)OC2C(OC(C(C2O)O[S](=O)(=O)O)OC3C(OC(C(C3O)NC(=O)C)O)CO[S](=O)(=O)O)C(=O)O)O
• InChI: 1S/C26H42N2O37S5.Na/c1-4(30)27-7-9(31)13(6(56-23(7)39)3-55-67(43,44)45)58-26-19(65-70(52,53)54)12(34)16(20(62-26)22(37)38)60-24-8(28-66(40,41)42)15(63-68(46,47)48)14(5(2-29)57-24)59-25-18(64-69(49,50)51)11(33)10(32)17(61-25)21(35)36;/h5-20,23-26,28-29,31-
• InChI key: JRTRSJGZMRQDHI-UHFFFAOYSA-N

Description

General description

This reference standard is specifically designed for biological assay calibration involving enoxaparin sodium. It is critical for evaluating anticoagulant activity in vitro, ensuring assay reproducibility and accurate dose-response relationships. This USP standard supports biological potency testing required for batch release and regulatory compliance.

The USP biologics carbohydrates category includes a variety of carbohydrate-based substances that are essential in the development and manufacturing of therapeutic products. These carbohydrates play crucial roles in biological processes and are often utilized as excipients, stabilizers, or active ingredients in pharmaceuticals. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of carbohydrate therapeutics throughout their lifecycle.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.

Enoxaparin Sodium is the sodium salt of a depolymerized heparin. It consists of a complex set of oligosaccharides that have not yet been completely characterized. The majority of the components have a 4-enopyranose uronate structure at the nonreducing end of their chain. About 20% of the materials contain a 1,6-anhydro derivative on the reducing end of the chain, the range being between 15% and 25%. Enoxaparin sodium USP Reference Standard is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including MSDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia.
For further information and support please go to the website of the issuing Pharmacopoeia.

Application

Enoxaparin sodium for Bioassays USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia. Also, for use with USP monographs such as:

• Enoxaparin Sodium Injection
• Enoxaparin Sodium

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

Enoxaparin Sodium is the sodium salt of a depolymerized heparin. It consists of a complex set of oligosaccharides that have not yet been completely characterized. The majority of the components have a 4-enopyranose uronate structure at the nonreducing end

Enoxaparin Sodium is the sodium salt of a depolymerized heparin. It consists of a complex set of oligosaccharides that have not yet been completely characterized. The majority of the components have a 4-enopyranose uronate structure at the nonreducing end of their chain. About 20% of the materials contain a 1,6-anhydro derivative on the reducing end of the chain, the range being between 15% and 25%. Enoxaparin sodium USP Reference Standard is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including MSDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

This product is part of the USP Biologics program.

Sales restrictions may apply.

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 2
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable