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MATPAM3CSK4

PAM3CSK4 Non-Endotoxin Pyrogen (NEP) Control

for use with PyroMAT®

Sinónimos:

Lipopeptide, Triacylated Lipopeptide

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

pyrogenic bacteria

General description

PAM3CSK4 is a non-endotoxin pyrogen which will serve as a positive control during pyrogen testing with PyroMAT® system. Non- Endotoxin Pyrogen (NEP) Control. It is designed to mimic the NEP of Gram positive and Gram negative cell walls origin. PAM3CSK4 is a synthetic synthetic triacylated lipopeptide, supplied in a lyophilized form. PAM3CSK4 Non- Endotoxin Pyrogen (NEP) Control activates TLR1/TLR2 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

PAM3CSK4 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


Clase de almacenamiento

11 - Combustible Solids

WGK

WGK 3

Punto de inflamación (°F)

Not applicable

Punto de inflamación (°C)

Not applicable



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