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2.6. BIOLOGICAL TESTS - uspbpep.com

EUROPEAN PHARMACOPOEIA BIOLOGICAL TESTS01/2008 STERILITYThe test is applied to substances, preparations or articleswhich, according to the Pharmacopoeia, are required to besterile. However, a satisfactory result only indicates thatno contaminating micro-organism has been found in thesample examined in the conditions of the test. Guidancefor using the test for sterility is given at the end of this AGAINST MICROBIAL CONTAMINATIONThe test for sterility is carried out under aseptic order to achieve such conditions, the test environmenthas to be adapted to the way in which the sterility test isperformed. The precautions taken to avoid contaminationare such that they do not affect any micro-organisms whichare to be revealed in the test.

Dipotassium hydrogen phosphate 2.5 g Glucose monohydrate/anhydrous 2.5 g/2.3 g Water R 1000 ml pH of the medium after sterilisation 7.3 ± 0.2 Dissolve the solids inwater R,warmingslightlytoeffect solution. Cool the solution to room temperature. Add1M sodium hydroxide, if necessary, so that after sterilisation the medium will have a pH of 7.3 ...

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