How do you test for bacterial endotoxin?

Test procedure: A BET involves analyzing the liquid sample or sample extract using Limulus Amebocyte Lysate (LAL). LAL is a reagent made from the blood of the horseshoe crab. In the presence of bacterial endotoxins, the lysate reacts to form a clot or cause a color change depending on the technique.

Which of the following USP chapters provides guidance on the testing for bacterial endotoxins?

Having reached Stage 6 of the PDG process, the <85> Bacterial Endotoxins Test General Chapter has been formally approved by the USP General Chapters—Microbiology Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.

What is the permissible limit of bacterial endotoxin?

Water for Injection, Sterile Water for Injection and Sterile Water for Irrigation have an allowable endotoxin limit of 0.25 Endotoxin Units (EU)/ml.

Is USP 85 harmonized with EP?

The current USP General Chapter <85> “Bacterial Endotoxin Test” has been harmonized with the European and Japanese Pharmacopeia. Pacific BioLabs analysts are qualified to conduct the kinetic-chromogenic test. The most potent pyrogens originate from gram negative bacteria, which are common water-borne organisms.

What is the difference between IU and EU?

The conversion of results of an LAL ASSAY / TAL ASSAY expressed in EU/ml or IU/ml : 1 EU=1 IU. The USP (United States Pharmacopoeia), the WHO (World Health Organization) and the European Pharmacopoeia have adopted a common standard. EU= Endotoxin Unit. IU=International Unit.

How is endotoxin measured?

Endotoxin is measured in endotoxin units per milliliter (EU/mL). One EU equals approximately 0.1 to 0.2 ng endotoxin/mL of solution. Currently there are three forms of the LAL assay, each with different sensitivities.

Why do we test for bacterial endotoxin?

All injectable pharmaceutical products and implantable medical devices need to be tested to ensure there is no presence of endotoxin, which can lead to a pyrogenic response (fever) and symptoms of septic shock. Endotoxins can be detected in these products and devices through bacterial endotoxin testing (BET).

Why is LAL important?

The LAL (limulus amebocyte lysate) testing, also known as bacterial endotoxin testing, is an in vitro assay used to detect the presence and concentration of bacterial endotoxins in drugs and biological products, and is an important part of pharmaceutical microbiology.

How do you convert IU ml to EU ML?

How do I convert from EU to IU? The conversion of results of an LAL test expressed in EU/mL into IU/mL is very easy: 1 EU=1 IU. The United States Pharmacopoeia, the World Health Organization and the European Pharmacopoeia have adopted a common standard.

Is USP 61 harmonized with EP?

USP / EP / JP Compliance In 2006, the United States Pharmacopeial Convention published a revised Chapter 61, and introduced a new Chapter 62, that cover the Microbiological Examination of Nonsterile Products. (1) These chapters are harmonized with the European Pharmacopeia (2) and the Japanese Pharma- copeia (3).

How do you calculate endotoxin limits?

Think about it this way:

1. If the dose is 1 mg/kg/hr, the endotoxin limit is (5 EU/kg/hr) ÷ (1 mg/kg/hr) = 5 EU/mg.
2. If the dose is 10 mg/kg/hr, the endotoxin limit is (5 EU/kg/hr) ÷ (10 mg/kg/hr) = 0.5 EU/mg.
3. If the dose is 100mg/kg/hr, the endotoxin limit is (5 EU/kg/hr) ÷ (100 mg/kg/hr) = 0.05 EU/mg.