MATFSL1
FSL-1 Non-Endotoxin Pyrogen (NEP) Control
for use with PyroMAT®
Synonym(s):
Lipoprotein
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About This Item
UNSPSC Code:
41116129
NACRES:
NA.74
Agency
EP
JP 4.06
USP
Quality Level
form
lyophilized
application(s)
pharmaceutical
pyrogen testing
compatibility
for use with PyroMAT®
shipped in
ambient
storage temp.
2-8°C
suitability
pyrogenic bacteria
General description
FSL-1 is a non-endotoxin pyrogen which will serve as a positive control during pyrogen testing with PyroMAT® system.Non- Endotoxin Pyrogen (NEP) Control FSL-1 is a synthetic lipoprotein derived from Mycoplasma salivarium, supplied in a lyophilized form. FSL-1 Non- Endotoxin Pyrogen (NEP) Control activates TLR2/TLR6 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
FSL-1 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
Storage Class Code
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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