grade
pharmaceutical primary standard
form
lyophilized
manufacturer/tradename
USP
application(s)
USP Biologics
pharmaceutical
format
neat
storage temp.
−20°C
General description
The CD34+ Cell Enumeration System Suitability standard is designed for assessing the performance of analytical systems used in the enumeration of CD34+ hematopoietic stem and progenitor cells. This USP reference standard ensures accuracy and reproducibility in flow cytometry-based assays, which are crucial for evaluating stem cell doses in transplantation and cell therapy. It provides a consistent benchmark for laboratory systems, validating system suitability and operator performance in cell enumeration workflows.
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.
For further information and support please go to the website of the issuing Pharmacopoeia.
The USP CD34+ Cell Enumeration System Suitability Reference Standard comprises fixed and lyophilized human leukocytes, erythrocytes, and CD34+ cells derived from mobilized peripheral blood collected by apheresis of a G-CSF mobilized donor.
Application
Also, use to prepare system suitability standard solution during flow cytometric enumeration of cd34+ cells.
Additionally, used to assess the reagents and ensures correct gating during data acquisition and analysis, detection, and quantitation of CD34+ HSCs.
Analysis Note
Other Notes
存储类别
11 - Combustible Solids
wgk
WGK 2
flash_point_f
Not applicable
flash_point_c
Not applicable
法规信息
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