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
agency
EP, USP, JP 4.06
agency
-
agency
EP, JP 4.06, USP
agency
-
application(s)
pharmaceutical pyrogen testing
application(s)
pharmaceutical pyrogen testing
application(s)
pharmaceutical pyrogen testing
application(s)
pharmaceutical pyrogen testing
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