Hello group!

I'm starting with method suitability for a water-soluble tablets as per
European Pharmacopaeia. The monograph states to perform tamc and tymc with
10g of product, but does anyone have experience in performing the test with
1 g instead of 10? If so, do we need to justify it and wait for the
autority approval for the test? The justification should be the price of
product, would that be a reasonable justification?

Thank you in advance for your help!

Best regards,

Irene

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