Hi,
In the SUPAC(Scale-Up and Postapproval
Changes) guideline for immediate Release Solid Oral
Dosage Forms, below is written for Level 1 changes(for ex :excipient section);
Documentation
- Test Documentation
a. Chemistry Documentation
Application/compendial release requirements and stability
testing.
b. Dissolution Documentation
None beyond application/compendial requirements.
What is meant by Application/compendial release requirements and stability
testing. and None beyond application/compendial requirements.
Assume that I have a compendial method for phenobarbital tablets (USP 26)
Is it enough to perform release and stability testing in that USP method ?
Thanks in Advance…