Can any body clarify that A stability report for a product should specify pharmacopeial reference i.e., EP/Bp/USP/IP. Suppose we do tests for an API as per BP specifications which are stability indicating can we claim the same stability report for USP documentation also.
I request you to Reframe your sentence so that I will try to explain to my best ability.
Ohh Got it .
Yes, we have to perform the tests as per Lable claim
That is USP/BP/IP/JP-- WHAT EVER MENTIONED ON your lable.
Hi prasadjammula,
Yes, we can evaluate the data as per the other pharmacopoeia provided that the analytical method remains same…only calculations…
Hopes clarify.
Happy Reading !
Thank you Sir,
We are doing stablity study for an APi as per BP specifications and methods. Now one of our customer asks stability report for the same API USP where testing method and specifications are different. can we give the stability report as USP for the same API.
Hi,
Good evening !
well, if the testing methodology is different than you have to test samples inline with USP & only after that you can provide the information.
In addition to this just evaluate your Mfg. process wheter that is capable to meet the USP are not ?
Happy Reading !
what exactly he asking is
he manufacture a product, testing done as per B.P and U.S.P methods, sold to US market as well as EU.
DOES HE NEED TO CARRY OUT THE STABILITY STUDY AS PER b.p or U.S.P or BOTH as per the frequency? since both the methods are stability indicative.
Yes, He must do the testing as per both specs. since the testing methodology is different as stated earlier.
Happy Reading !