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November 2019


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Michael Barton <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Tue, 19 Nov 2019 08:29:21 +0000
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Good morning all,

I was under the imprerssion that for the testing of non-sterile products that during suitability and in routine testing the pH of the product in diluent must be checked and verified to be between 6-8.

I have just been reading <61> and under 'Suitability of the Counting Method in the Presence of Product' - 'Preparation of the sample' there are 5 product type options and only pH check and adjustment is detailed for water-soluble products and nonfatty products insoluble in water.  There is no mention of pH check within the remaining three types.

My question is therefore;
If i am tetsing a product 'Fluids or solids in aerosol form' (one of the other three product types) do i or dont i need to check the pH and have it in the range of 6-8 for suitability and routine?

Why do you only need to check the pH for the two it specifically mentions?


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