MATFSL1

FSL-1 Non-Endotoxin Pyrogen (NEP) Control

for use with PyroMAT^®

• Synonym(s): Lipoprotein
• UNSPSC Code: 41116129
• NACRES: NA.74

Properties

• Agency: EP; JP 4.06; USP
• Quality Level: 400
• form: lyophilized
• manufacturer/tradename: PyroMAT^®
• application(s): pharmaceutical; pyrogen testing
• compatibility: for use with PyroMAT^®
• shipped in: ambient
• storage temp.: 2-8°C
• suitability: pyrogenic bacteria

Description

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

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable