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MATHKSA

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NEP Control HKSA- PyroMAT® System MAT

Non-endotoxin pyrogen control of heat killed Staphyloccus aureus for use in monocyte activation test

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Synonym(s):
NEP, NEP control

feature

Non-endotoxin pyrogen control of heat killed Staphyloccus aureus for use in monocyte activation test

Quality Level

packaging

pkg of 1 vial

manufacturer/tradename

PyroMAT®

application(s)

pharmaceutical
pyrogen testing

compatibility

configured for PyroDetect System
configured for PyroMAT® System

shipped in

ambient

storage temp.

2-8°C

suitability

pyrogenic bacteria

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This Item
PYR0MATKITMATPAM3CSK4PYR0MATCELLS
vibrant-m

PYR0MATKIT

PyroMAT® kit

vibrant-m

PYR0MATCELLS

PyroMAT® cells

Quality Level

400

Quality Level

400

Quality Level

400

Quality Level

400

suitability

pyrogenic bacteria

suitability

pyrogenic bacteria

suitability

pyrogenic bacteria

suitability

pyrogenic bacteria

compatibility

configured for PyroDetect System, configured for PyroMAT® System

compatibility

configured for PyroMAT®

compatibility

for use with PyroMAT®

compatibility

configured for PyroMAT® System

storage temp.

2-8°C

storage temp.

2-8°C

storage temp.

2-8°C

storage temp.

-

application(s)

pharmaceutical
pyrogen testing

application(s)

pharmaceutical
pyrogen testing

application(s)

pharmaceutical
pyrogen testing

application(s)

pharmaceutical
pyrogen testing

General description

The PyroMAT® System uses cryopreserved Mono-Mac-6 (MM6) human monocytic cells as a source of monocytes. The response to a full range of pyrogens, including endotoxins and non-endotoxin pyrogens (NEPs)is determined by the measurement of interleukin-6 (IL-6) produced by the Mono-Mac-6 cells using ELISA.
NEP control HKSA is a heat-killed preparation of Staphylococcus aureus, supplied in a lyophilized form. HKSA is a non-endotoxin pyrogen (NEP) that activates the TLR2 receptor of monocytes and can be used as a positive control with the PyroMAT® System (Monocyte Activation Test for pyrogen detection).

Specificity

TLR-2 agonist

Application

NEP control of heat-killed Staphylococcus aureus 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.

Features and Benefits

Endotoxin-free product at concentration of use in MAT

Storage and Stability

Store unopened vials at 2-8°C
Do not use unopened vials after expiration date
Store resuspended aliquots at -20°C
Shelf life of aliquots can be found on the technical datasheet

Legal Information

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

also commonly purchased with this product

pictograms

Skull and crossbones

signalword

Danger

hcodes

Hazard Classifications

Acute Tox. 2 Oral

Storage Class

6.1A - Combustible, acute toxic Cat. 1 and 2 / very toxic hazardous materials

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


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