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Merck
CN

1248218

USP

Erythropoietin

United States Pharmacopeia (USP) Reference Standard

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经验公式(希尔记法):
C809H1301N229O240S5
化学文摘社编号:
分子量:
18235.70
MDL编号:
UNSPSC代码:
41116107
NACRES:
NA.24
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等级

pharmaceutical primary standard

Agency

USP

API类

erythropoietin

表单

solid

制造商/商品名称

USP

应用

USP Biologics
pharmaceutical

一般描述

Erythropoietin (EPO) is a glycoprotein hormone produced by the kidneys to regulate red blood cell production. Recombinant EPO is used in treating anemia due to chronic kidney disease or chemotherapy. The USP standard supports bioidentity and potency testing using validated cell-based assays.

The USP biologics proteins category provides critical standards and reference materials necessary for the development and manufacturing of therapeutic proteins. These proteins, which can be naturally derived or genetically engineered, are essential in treating various diseases and conditions, ensuring that they meet quality, safety, and efficacy standards.

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.

应用

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

其他说明

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

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历史批次信息供参考:

分析证书(COA)

Lot/Batch Number

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

相关内容

提供适用USP-NF各论的全面标化的一级标准物质,可用于检验药物成分和剂型、药用辅料、食品和膳食补充剂。

Order from a broad range of highly characterized primary reference standard materials to use with USP-NF monographs for the testing of drug substances & dosage forms, pharmaceutical excipients, food ingredients and dietary supplements.

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