MilliporeSigma
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MATFSL1

Millipore

FSL-1 Non-Endotoxin Pyrogen (NEP) Control

for use with PyroMAT®

Synonym(s):
Lipoprotein

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

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This Item
MATHKSAMATPAM3CSK4MATFLAGELLIN
application(s)

pharmaceutical
pyrogen testing

application(s)

pharmaceutical
pyrogen testing

application(s)

pharmaceutical
pyrogen testing

application(s)

pharmaceutical
pyrogen testing

compatibility

for use with PyroMAT®

compatibility

configured for PyroDetect System, configured for PyroMAT® System

compatibility

for use with PyroMAT®

compatibility

configured for PyroDetect System, configured for PyroMAT® System

storage temp.

2-8°C

storage temp.

2-8°C

storage temp.

2-8°C

storage temp.

−20°C

suitability

pyrogenic bacteria

suitability

pyrogenic bacteria

suitability

pyrogenic bacteria

suitability

pyrogenic bacteria

Quality Level

400

Quality Level

400

Quality Level

400

Quality Level

400

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


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