In cleaning validation, when we say 10 ppm acceptance criteria, is this 10 ppm of active ingredient or 10 ppm of the finished product.
Please advise ???
10 ppm of active ingradient , because in cleaning validation we are intrested in detection of residue of active ingradients.
10 ppm of active ingrdient from product A to finished product B(active+ excipients).
[quote=rmrs]In cleaning validation, when we say 10 ppm acceptance criteria, is this 10 ppm of active ingredient or 10 ppm of the finished product.
Please advise ???[/quote]
10 ppm is not a rigid limits, it is a MACO calculation approach, and it deals with Active ingredients,
Regards,
[quote=rmrs]In cleaning validation, when we say 10 ppm acceptance criteria, is this 10 ppm of active ingredient or 10 ppm of the finished product.
Please advise ???[/quote]
yes, this is the criteria for API used in the formulation.
Can someone help with the calculation on 10ppm.
How do i calculate if sab collected or rinse contain the API of 10 ppm with UV spectrophotometer.
Just provide with the overall calculation