1.44161

Reference Standard Endotoxin

EDQM endotoxin standard for Monocyte Activation Test

• Synonym(s): Endotoxin standard
• UNSPSC Code: 41116130
• NACRES: NA.24

Properties

• Agency: EP Chapter 2.6.30
• Quality Level: 200
• form: solid
• feature: performs endotoxin standard curve in the MAT
• packaging: pkg of 1 vial
• manufacturer/tradename: PyroMAT^®
• application(s): pharmaceutical; pyrogen testing
• compatibility: configured for PyroDetect System; configured for PyroMAT^® System
• shipped in: dry ice
• storage temp.: −20°C
• suitability: pyrogenic bacteria

Description

General description

The Reference Standard Endotoxin (RSE) is the endotoxin standard recommended by the European Pharmacopeia. The endotoxin activates the TLR4 receptor of monocytes.

Application

The Reference Standard Endotoxin is used to perform the endotoxin standard curve required to quantify pyrogens with the Monocyte Activation Test during pyrogen detection.

Features and Benefits

Officially valid for the uses prescribed in the European Pharmacopoeia

Components

Endotoxin Standard, lyophilized - 1μg

Reconstitution

Reconstituted RSE at -40°C or below

Recommended products

PyroDetect Kit (1.44154)
PyroDetect Cryoblood (1.44155)
PyroMAT^® Kit (PYR0MATKIT)
PyroMAT^® Cells (PYR0MATCELLS)
NEP Control of HKSA (MATHKSA)
NEP Control of Flagellin (MATFLAGELLIN)

Legal Information

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

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 2