Description
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 (Kinetic Chromogenic Endotoxin Test and Gel Clot Endotoxin Test Assay) 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
- Reconstitution of Lyophilized LAL Reagents
- Negative Control – Serves as a control in endotoxin testing.
- Dissolution & Dilution of CSE & ECV – Suitable for dissolving and diluting Control Standard Endotoxin (CSE) and Endotoxin Challenge Vials (ECV).
- Dissolution & Dilution of Samples – Can be used for preparing test samples in bacterial endotoxin testing.
- Sample preparation for pharmaceutical-grade endotoxin testing
Specifications
| Pack Size | Catalog Number | Price |
|---|---|---|
| 8 mL/vial × 10 vials/kit | FGPW008-10 | $49.00 |
| 100 mL/bottle | FGPW100 | $39.00 |
| 250 mL/bottle | FGPW250 | $59.00 |
| 500 mL/bottle | FGPW500 |
$89.00 |
This endotoxin-free water ensures reliable and accurate bacterial endotoxin testing, making it an essential component in laboratory and pharmaceutical quality control settings.
Product Q&A
Q: Which products require the use of Endotoxin Assay Water for reconstitution?
A: The following FireGene products require Endotoxin Assay Water for reconstitution or dilution:
- Gel-Clot Endotoxin Test Kit — LAL/TAL reagent reconstitution
- Kinetic Chromogenic Endotoxin Test Kit — reagent reconstitution and standard curve preparation
- Control Standard Endotoxin (CSE) — vial reconstitution and serial dilution
Q: What type of water should be used to reconstitute Control Standard Endotoxin (CSE)?
A: Control Standard Endotoxin (CSE)
→ Requires reconstitution with Endotoxin Assay Water for accurate standard curve generation.
Q: How should Reference Standard Endotoxin (RSE) be diluted?
A: Reference Standard Endotoxin (RSE)
→ Must be diluted in endotoxin-free water to serve as a validated endotoxin reference.
Q: Do Endotoxin Testing Kits require special water for reagent preparation?
A: Endotoxin Testing Kits
→ Many kits specify the use of Endotoxin Assay Water for reagent preparation and sample dilution to ensure test validity.
Q: Are there specific assay systems that need Endotoxin Assay Water?
A: Kinetic Turbidimetric and Chromogenic Assay Systems
→ These high-sensitivity detection systems require ultra-pure, endotoxin-free water to maintain assay performance.
Q: Why is Endotoxin Assay Water used with depyrogenated glassware?
A: Depyrogenated Glassware and Accessories
→ Often used in conjunction with Endotoxin Assay Water to ensure validated aseptic preparation and avoid endotoxin contamination.
Q: What is the endotoxin specification of this water?
A: FireGene Endotoxin Assay Water contains less than 0.005 EU/mL endotoxin, validated per USP <85> and EP 2.6.14 requirements for Water for Bacterial Endotoxins Test. Each lot is tested prior to release. Certificate of Analysis available on request — email service@firegene.com with your lot number.
Files Download Links
Endotoxin Assay Kits and Components
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