1248218

Erythropoietin

United States Pharmacopeia (USP) Reference Standard

• Empirical Formula (Hill Notation): C₈₀₉H₁₃₀₁N₂₂₉O₂₄₀S₅
• CAS Number: 113427-24-0
• Molecular Weight: 18235.70
• UNSPSC Code: 41116107

Properties

• API family: erythropoietin
• form: solid
• manufacturer/tradename: USP
• application(s): pharmaceutical

Description

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 (EPO) USP reference standard is used to prepare standard solutions for specified compendial tests such as:

• Peptide mapping; N-Glycan profiling
• System suitability test to determine the limit of high molecular weight proteins
• Isoform distribution

Further information is available in the monograph, Epoetin, USP43-NF38 – 1657 of United States Pharmacopeia (USP).

Other Notes

This product is part of the USP Biologics program.

Safety Information

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