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Merck
CN

1304107

USP

Heparin Sodium Molecular Weight Calibrant

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

Heparin sodium salt solution

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About This Item

CAS Number:
9041-08-1
MDL number:
MFCD00081689
UNSPSC Code:
41116107
NACRES:
NA.24

Key Documents

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grade

pharmaceutical primary standard

API family

heparin

form

powder

manufacturer/tradename

USP

application(s)

USP Biologics
pharmaceutical (small molecule)

format

neat

storage temp.

−20°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

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General description

This molecular weight calibrant standard is essential for the determination of heparin′s molecular weight distribution via size exclusion chromatography. Accurate molecular profiling ensures the safety and efficacy of heparin products and supports regulatory submission data.

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.

Heparin Sodium is a mixture of sulfated glycosaminoglycans in the form of sodium salt. It is composed of heterogeneous molecules with different molecular weights, collectively exhibiting multiple activities that affect various factors involved in the blood clotting process. This substance naturally occurs in mammalian tissues and is typically derived from sources such as the intestinal mucosa or other applicable tissues obtained from domestic mammals commonly consumed as food by humans. Heparin Sodium Molecular Weight Calibrant 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

Heparin Sodium Molecular Weight Calibrant USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia. Also, for use with USP monograph such as Heparin Sodium

Other Notes

Heparin Sodium is a mixture of sulfated glycosaminoglycans in the form of sodium salt. It is composed of heterogeneous molecules with different molecular weights, collectively exhibiting multiple activities that affect various factors involved in the bloo
Heparin Sodium is a mixture of sulfated glycosaminoglycans in the form of sodium salt. It is composed of heterogeneous molecules with different molecular weights, collectively exhibiting multiple activities that affect various factors involved in the blood clotting process. This substance naturally occurs in mammalian tissues and is typically derived from sources such as the intestinal mucosa or other applicable tissues obtained from domestic mammals commonly consumed as food by humans. Heparin Sodium Molecular Weight Calibrant 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.

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

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Heparin Sodium
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 41(6), 2195-2195 (2018)
Heparin Sodium
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 44(5) (2020)

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