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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

Synonym(s):

NEP, NEP control

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About This Item

UNSPSC Code:
41116130
NACRES:
NA.24

feature

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

Quality Level

400

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

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

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pictograms

Skull and crossbones
GHS06

signalword

Danger

hcodes

H300

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

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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