Acceptance criteria for residue carry over Contribution from Venkatesh S Rao written on 9/4/2010 at 15:01
What should be the basis for acceptance criteria, for residue carry over of a product (API) in another product (API)?
Is it based on
1.MACO calculations - as per daily therapeutic dosage & batch size
2.NMT 0.1% of normal therapeutic dose of any product to appear in maximum daily dose of following.
3.NMT 10ppm of any product to appear in another product
4.Limits from 10ppm upto 0.1% as per ICH impurity document
Is mandatory that we need to implement 10ppm criteria or other criteria as mentioned is sufficient provided it is validated?
Venkatesh S Rao
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