Endotoxin Testing Helps in Quality Control of Parenteral Preparations
Endotoxin Testing is performed to ensure that injectable preparations and medical devices are free from pyrogens and safe for human use.
Pyrogens constitute a heterogeneous group of fever causing substances which comprise both microbial and non-microbial substances. The most potent and most widely known are the endotoxins or lipopolysaccharides (LPS), which are cell wall components of gram-negative bacteria. Gram-positive bacteria are also sources of pyrogens, in particular lipoteichoic acid (LTA), as are particles from yeasts and viruses. Non-microbial pyrogens often emanate from production environments. Small particles of packaging materials are a typical example.
Pyrogen contamination can induce life threatening fever. It is mandatory for manufacturers to perform endotoxin testing to ensure product safety. Therefore, endotoxin testing is an important quality control test.
The bacterial endotoxin test (BET) is a test to detect or quantify endotoxins from Gram-negative bacteria using amoebocyte lysate from the horseshoe crab (Limulus polyphemus orTachypleus tridentatus). There are three endotoxin testing methods:
Method 1. The gel-clot technique, which is based on gel formation;
Method 2. The turbidimetric technique, based on the development of turbidity after cleavage of an endogenous substrate;
Method 3. The chromogenic technique, based on the development of color after cleavage of a synthetic peptide-chromogen complex.
Official Endotoxin Testing Sources:
USP <85> Bacterial Endotoxin Test
ANSI/AAMI ST72- Bacterial Endotoxin Test
USP <161>- Transfusion and infusion assemblies and similar medical devices
EP 2.6.14 Endotoxin Test
FDA Guidance for Industry Pyrogen and Endotoxin Testing: Questions and Answers
Gibraltar Laboratories performs Endotoxin Testing by Gel-clot technique and Kinetic Chromogenic techniques on drug substances, drug products and medical devices.
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To learn more about Endotoxin Testing Services from Gibraltar Laboratories, Inc., please call us at (973) 227-6882 or by clicking here.