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MATPAM3CSK4

PAM3CSK4 Non-Endotoxin Pyrogen (NEP) Control

for use with PyroMAT®

Synonym(e):

Lipopeptide, Triacylated Lipopeptide

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Über diesen Artikel

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
Preise und Verfügbarkeit sind derzeit nicht verfügbar.
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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

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Dieser Artikel
MATFLAGELLINMATFSL1PYR0MATKIT
description

for use with PyroMAT®

description

for use with PyroMAT® System

description

for use with PyroMAT®

description

kit containing all reagents to perform the Monocyte Activation Test (MAT) for Pyrogen testing, including the IL-6 Standard (control) and IL-6 ELISA kit, suitable for pyrogen testing

manufacturer/tradename

PyroMAT®

manufacturer/tradename

PyroMAT®

manufacturer/tradename

PyroMAT®

manufacturer/tradename

PyroMAT®

suitability

pyrogenic bacteria

suitability

pyrogenic bacteria

suitability

mycoplasma pyrogenic

suitability

-

compatibility

for use with PyroMAT®

compatibility

configured for PyroDetect System, for use with PyroMAT® System

compatibility

for use with PyroMAT®

compatibility

configured for PyroMAT® System

Quality Level

400

Quality Level

400

Quality Level

400

Quality Level

400

application(s)

pharmaceutical
pyrogen testing

application(s)

pharmaceutical
pyrogen testing

application(s)

pharmaceutical
pyrogen testing

application(s)

pyrogen testing, pharmaceutical

agency

JP 4.06, USP, EP

agency

-

agency

JP 4.06, EP, USP

agency

EP Chapter 2.6.30


Lagerklasse

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable



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