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TOPICS : 04- EUROPEAN PHARMACOPOEIA & INTERNATIONAL HARMONISATION / 01- General Chapters and Monographs  / 09- MICROBIOLOGY 

• 01. In Chapter 2.6.12 under section 4-4 ‘GROWTH PROMOTION OF THE MEDIA’, there is a statement that reads “For solid media, growth obtained must not differ by a factor greater than 2 from the calculated value for a standardised inoculum’’. Does the statement mean that the difference can be twice or half the calculated value of inoculum?

• 02. Frequently asked technical questions about the harmonised Microbiology Chapters 2.6.12 and 2.6.13: ‘‘Can I use other strains than those cited in the European Pharmacopoeia? What is the purpose of the negative control? What does the factor 2 mean? Why are bacteria counted as part of TYMC? etc...’’


 
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