Table of Contents
Know More about USP 63 Mycoplasma Testing
An overview of the USP chapter 63 shows that all the texts and the tables in that chapter were mainly based on E.P 2.6.7 with few aspects obtained from 1993 PTC. When a comparison of the three documents USP 63, 1993 PTC, and EP 2.6.7 is done, it shows that there are methodological differences in some areas.
These include assessing the nutritive properties of the agar for testing mycoplasma, inhibitory substances in the test material, the temperature for incubation and the number and kinds of positive controls. Let’s know about all those assessments in brief.
Nutritive Properties
Nutritive properties in mycoplasma testing are the same as growth advancement in sterility testing. The growth media can support the growth and detection of mycoplasma organisms. As per EP and Mycoplasma USP 63 documents, it is mandatory not to inoculate over 100 CFU of model mycoplasma into every batch of the growth medium.
EP 2.6.7 states that a solid medium fulfills the test when adequate growth is seen for every test microorganism.
Inhibitory Substances
Test materials under evaluation for the occurrence of infectious mycoplasma can inhibit the organism’s growth, thus causing interference with the detection endpoint. Thus, both EP 2.6.7 and USP 63 report the inhibitory substance evaluation within the material that is to be tested for mycoplasma.
As per EP 2.6.7, if plates are directly inoculated with that product that is to be examined and contain less than 1/5 of several colonies of those inoculated without the examined product.
As per USp 63 mycoplasma testing, when plates are directly inoculated with test article or the material and they are not within the 0.5 log unit range of the number of colonies of those that are inoculated without test material.
The acceptance range of the USP mycoplasma testing is tighter than EP 2.6.7, thus making it more strict.
Temperature for Incubation
There is a minor difference in temperature for incubation between USP 63 compliant mycoplasma detection assays and EP 2.6.7. For USP 63, it’s 36 ± 1 °C and for EP 2.6.7 it’s 35–38 °C.
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