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Microbial Testing

Microbial tests, refers to a measuring method choosing appropriate microbe to determine the content of a substance under prescribed conditions, commonly includes liquid dilution method and solid plate diffusion method.

Both the article 2.6.12 and 2.6.13 in European pharmacopoeia 7.0(EP7.0) are two measuring methods
2.6.12 is a microbial limit testing method used in the non-sterile product, which is a microbial counting test. It is a quantitative detection that describes the mesophilic bacteria and fungal species under aerobic conditions. The test is designed primarily to determine whether a substance or preparation compiles with an established specification for microbiological quality. In order to achieve this purpose, we need to comply with the description and method mentioned. At the same time, the test is not applicable to the products contained microorganisms as active ingredients.

Microbial limit test is a method determining the polluted degree of the sterile preparations which is without stipulation, its raw materials as well as accessories. The testing program includes bacteria number, mold number, yeast number and the examination of the control bacteria.

Through the cultivation of microbial samples under different conditions, we can check the samples’ polluted degree which caused by microbes.

2.6.13 is a non-sterile pharmaceutical microbial testing method. As a specific microbial test, it checks the limitation of specific microorganisms under the test condition. The test is designed primarily to determine whether a drug substance or preparation compiles with an established specification for microbiological quality.

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