These tests will allow quantitative enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions. The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality.
These tests allow the determination of the absence or limited occurrence of specified micro-organisms that may be detected under the conditions described. The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality.
The test for bacterial endotoxins is used for the detection or determination of endotoxins of Gram-negative bacteria using the using amoebocyte lysate from the horseshoe crab (Limulus polyphemus or Tachypleus tridentatus). The CUP laboratories offer three techniques for this test: the gel formation technique, the turbidimetric technique and the technique with chromogen, which are based on the formation of a gel, the development of a turbidity after cleavage of an endogenous substrate or a color development after cleavage of a synthetic peptide-chromogen complex.
The potency of an antibiotic is estimated by comparing the inhibition of growth of sensitive micro-organisms produced by known concentrations of the antibiotic to be examined and a reference substance. The reference substances used in the assays are substances whose activity has been precisely determined with reference to the corresponding international standard or international reference preparation.
If a pharmaceutical preparation does not itself have adequate antimicrobial activity, antimicrobial preservatives may be added, particularly to aqueous preparations, to prevent proliferation or to limit microbial contamination which, during normal conditions of storage and use, particularly for multidose containers, could occur in a product and present a hazard to the patient from infection and spoilage of the preparation.