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.
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.
Legal Information
PYROMAT is a registered trademark of Merck KGaA, Darmstadt, Germany
configured for PyroDetect System, configured for PyroMAT® System
compatibility
for use with PyroMAT®
compatibility
configured for PyroDetect System, configured for PyroMAT® System
Quality Level
400
Quality Level
400
Quality Level
400
Quality Level
400
application(s)
pharmaceutical pyrogen testing
application(s)
pharmaceutical pyrogen testing
application(s)
pharmaceutical pyrogen testing
application(s)
pharmaceutical pyrogen testing
agency
EP, USP, JP 4.06
agency
-
agency
EP, JP 4.06, USP
agency
-
Storage Class
11 - Combustible Solids
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
Certificates of Analysis (COA)
Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.
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includes Interleukin IL-6 Standard and Interleukin-6ELISA kit, suitable for (suitable for Monocyte Activation Test (MAT)), suitable for pyrogen testing