MATFSL1
FSL-1 Non-Endotoxin Pyrogen (NEP) Control
for use with PyroMAT®
别名:
Lipoprotein
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NACRES:
NA.74
UNSPSC Code:
41116129
Agency:
EP, JP 4.06, USP
Suitability:
mycoplasma pyrogenic
Manufacturer/tradename:
PyroMAT®
Application(s):
pharmaceutical
pyrogen testing
pyrogen testing
Storage temp.:
2-8°C
Quality Segment
agency
EP, JP 4.06, USP
product line
PyroMAT®
form
lyophilized
manufacturer/tradename
PyroMAT®
application(s)
pharmaceutical
pyrogen testing
compatibility
for use with PyroMAT®
shipped in
ambient
storage temp.
2-8°C
suitability
mycoplasma pyrogenic
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. It is designed to mimic the NEP of Mycoplama origin. 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
存储类别
11 - Combustible Solids
怎么回事？
WGK 3
闪点 (F)
Not applicable
闪点 (°C)
Not applicable