产品名称
PAM3CSK4 Non-Endotoxin Pyrogen (NEP) Control, for use with PyroMAT®
agency
EP
JP 4.06
USP
form
lyophilized
manufacturer/tradename
PyroMAT®
application(s)
pharmaceutical
pyrogen testing
compatibility
for use with PyroMAT®
shipped in
ambient
storage temp.
2-8°C
suitability
pyrogenic bacteria
Quality Level
Application
PAM3CSK4 control can be used as a positive control with the PyroMAT® System. It is to be used for Product Specific Validation (PSV) and routine testing to show that the system can detect non-endotoxin pyrogen contaminants in pharmaceutical products.
General description
PAM3CSK4 is a non-endotoxin pyrogen which will serve as a positive control during pyrogen testing with PyroMAT® system. Non- Endotoxin Pyrogen (NEP) Control PAM3CSK4 is a synthetic synthetic triacylated lipopeptide, supplied in a lyophilized form. PAM3CSK4 Non- Endotoxin Pyrogen (NEP) Control activates TLR1/TLR2 receptor of monocytes and is used as a positive control for PyroMAT® system. The response to pyrogenic substances is determined by measuring the Interleukin-6 (IL-6) produced by the monocytes using ELISA microplate.
Legal Information
PYROMAT is a registered trademark of Merck KGaA, Darmstadt, Germany
存储类别
11 - Combustible Solids
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
法规信息
新产品
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