MATFSL1

FSL-1 Non-Endotoxin Pyrogen (NEP) Control

for use with PyroMAT^®

• Sinonimo/i: Lipoprotein
• NACRES: NA.74
• UNSPSC Code: 41116129
• Agency: EP, JP 4.06, USP
• Suitability: mycoplasma pyrogenic
• Manufacturer/tradename: PyroMAT^®
• Application(s): pharmaceutical; pyrogen testing
• Storage temp.: 2-8°C

Proprietà

• Quality Segment: 400
• 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

Descrizione

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

Informazioni sulla sicurezza

• Classe di stoccaggio: 11 - Combustible Solids
• Che succede?: WGK 3
• Punto di infiammabilità (°F): Not applicable
• Punto di infiammabilità (°C): Not applicable