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Merck
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Key Documents

MATFSL1

Millipore

FSL-1 Non-Endotoxin Pyrogen (NEP) Control

for use with PyroMAT®

别名:

Lipoprotein

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About This Item

agency

EP
JP 4.06
USP

品質等級

形狀

lyophilized

應用

pharmaceutical
pyrogen testing

相容性

for use with PyroMAT®

運輸包裝

ambient

儲存溫度

2-8°C

適合性

pyrogenic bacteria

相关类别

一般說明

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.

應用

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.

法律資訊

PYROMAT is a registered trademark of Merck KGaA, Darmstadt, Germany

儲存類別代碼

11 - Combustible Solids

水污染物質分類(WGK)

WGK 3

閃點(°F)

Not applicable

閃點(°C)

Not applicable


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