Is the dissolution test required even if there is no official method(B.P OR USP )??
AM90 (AMNA OSMAN) #1
Ajitmane (Ajit Vitthal mane) #2
Yes it is necessary.
No matter this is official or not dissolution test require for percentage drug release with respect to time.
amitkalyan005 (Amit Kalyan) #3
YES, IN-HOUSE DISSOLUTION PARAMETERS TO SET FOR PRODUCTS WHICH ARE NOT IN PHARMACOPOEIA.