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Merck
CN

1235831

USP

肝素 钠盐

United States Pharmacopeia (USP) Reference Standard

别名:

Heparin sodium salt

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关于此项目

CAS Number:
9041-08-1
MDL编号:
MFCD00081689
UNSPSC代码:
41116107
NACRES:
NA.24

主要文件

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等级

pharmaceutical primary standard

API类

enoxaparin

表单

powder

制造商/商品名称

USP

应用

USP Biologics
pharmaceutical (small molecule)

包装形式

neat

储存温度

2-8°C

SMILES字符串

[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

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一般描述

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.

应用

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

分析说明

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.  ​

其他说明

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.
Sales restrictions may apply.
This product is part of the USP Biologics program.

储存分类代码

11 - Combustible Solids

WGK

WGK 2

闪点(°F)

Not applicable

闪点(°C)

Not applicable

法规信息

监管及禁止进口产品

历史批次信息供参考:

分析证书(COA)

Lot/Batch Number

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Enoxaparin Sodium
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 48(3), 1623-1623 (2020)
Enoxaparin Sodium Injection
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 37(1), 1626-1626 (2020)

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