grade
pharmaceutical primary standard
form
solid
manufacturer/tradename
USP
application(s)
USP Biologics
pharmaceutical
format
neat
storage temp.
−20°C
General description
Prekallikrein Activator is a contaminant derived from glass surfaces or manufacturing processes, known to artificially activate coagulation assays. The USP standard is used to detect and quantify this impurity in therapeutic protein and plasma product preparations.
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
存储类别
11 - Combustible Solids
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
法规信息
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