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Focus -Â Escherichia Coli
E. coli is well known as a pathogen, it is often in the news causing outbreaks of food poisoning. It is a Gram negative, facultative anaerobic coliform, commonly found in the intestine of mammals and birds. Most strains are harmless, but E. coli is also one of the most diverse species of bacteria, and those strains that produce shiga toxin are particularly lethal. The important point regarding E. coli is that it is a coliform, or fecal contaminant, and clearly indicates that the drug product that was not made under GMP conditions.
Any other coliform whose identify is confirmed while conducting the USP test for E. coli may be considered objectionable. These include Enteroobacter sp., Klebisella sp., Citrobacter sp., and others.
10 gm of product is required to perform the test. E. coli can be tested with the same 10 gm of product which was used for Salmonella, if both organisms are tested concurrently.
