RE: RE: RE: RE: Purpose of API stability study
Contribution from Arun written on 4/20/2012 at 08:59
Original contribution: RE: RE: RE: Purpose of API stability study written by srilatha lingabathula on 4/14/2012 at 18:19)
The shelf life of the drug product is based on the stability study of the drug product (API + excipients). This is performed by the drug product manufacturer.
In this case, what is the value of the API stability study which is done individually by the API manufacturer.Since the API is not going to be consumed as such by the patients but its the forumlation that goes for human consumption.
Answering this Contribution: