Quality Level
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.
−20°C
suitability
pyrogenic bacteria
General description
Resiquimod is a non-endotoxin pyrogen which will serve as a positive control during pyrogen testing with PyroMAT® system.Non- Endotoxin Pyrogen (NEP) Control Resiquimod is an imidazoquinolinone compound possessing a potent anti-viral activity, supplied in a lyophilized form. It is designed to mimic the NEPs of viral origin. Resiquimod Non- Endotoxin Pyrogen (NEP) Control activates TLR7/TLR8 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.
Application
Resiquimod Non- Endotoxin Pyrogen (NEP) 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.
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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