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USP

Erythropoietin

United States Pharmacopeia (USP) Reference Standard

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About This Item

Empirical Formula (Hill Notation):
C809H1301N229O240S5
CAS Number:
Molecular Weight:
18235.70
UNSPSC Code:
41116107
NACRES:
NA.24

API family

erythropoietin

form

solid

manufacturer/tradename

USP

application(s)

pharmaceutical

General description

Erythropoietin is a bioactive glycoprotein hormone that stimulates the production of red blood cells. It plays a vital role in regulating erythropoiesis, the process of red blood cell formation, and maintaining oxygen delivery throughout the body. Epoetin is the recombinant form of human erythropoietin. It is a 165-amino acid glycoprotein manufactured using recombinant DNA technology. The presence of the impurities, host cell DNA, and host cell protein in Epoetin is process-specific and controlled through purification. The impurity levels are determined by validated methods and limits approved by the competent regulatory authority. Erythropoietin 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

Erythropoietin 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 Epoetin

Other Notes

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


Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Epoetin
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 41(5), 1657-1657 (2018)

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