Endotoxin Assay Water (Water for Bacterial Endotoxins Test)

Endotoxin Assay Water, also known as Water for Bacterial Endotoxins Test, is a high-purity, sterile, and pyrogen-free water specifically manufactured for use in Limulus Amebocyte Lysate (LAL) assays and other bacterial endotoxin testing applications. It is rigorously validated to meet the specifications of USP <85>, EP 2.6.14, and other relevant pharmacopoeial standards, ensuring it is free of detectable endotoxins and any interfering substances.

This water is essential for the preparation of reagents, dilution of test samples, and reconstitution of lyophilized endotoxin standards such as Control Standard Endotoxin (CSE) and Reference Standard Endotoxin (RSE). Its uncompromised purity helps maintain assay accuracy and prevents false positive or negative results due to contamination.

Endotoxin Assay Water is compatible with various LAL/TAL reagent systems (gel-clot, turbidimetric, and chromogenic methods) and supports reliable endotoxin detection in pharmaceutical, medical device, and biological product testing. It is also suitable for use with depyrogenated labware in aseptic environments.

Intended Use

1. Reconstitution of Lyophilized LAL Reagents
2. Negative Control – Serves as a control in endotoxin testing.
3. Dissolution & Dilution of CSE & ECV – Suitable for dissolving and diluting Control Standard Endotoxin (CSE) and Endotoxin Challenge Vials (ECV).
4. Dissolution & Dilution of Samples – Can be used for preparing test samples in bacterial endotoxin testing.
5. Sample preparation for pharmaceutical-grade endotoxin testing

Specifications

• Packaging Options:
  • 8 mL per bottle, 10 bottles per box
  • 250 mL per bottle
  • 500 mL per bottle

This endotoxin-free water ensures reliable and accurate bacterial endotoxin testing, making it an essential component in laboratory and pharmaceutical quality control settings.