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About This Item
grade
pharmaceutical primary standard
agency
USP
API family
erythropoietin
manufacturer/tradename
USP
application(s)
USP Biologics
pharmaceutical
General description
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.
Application
Other Notes
Storage Class
11 - Combustible Solids
wgk
WGK 2
flash_point_f
Not applicable
flash_point_c
Not applicable
Regulatory Information
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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.
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。
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