Polymorphic form determination Sample Clauses

Polymorphic form determination. 1) Qualification of the method to be addressed, with USP<761> and ICH Q2 (R1). Only specificity is required. To perform the specificity, Prana need to supply other morph (Form-II) in pure form. Initially ▇▇.▇▇▇▇▇’▇ have checked the method for Form-I & impure Form-II and data was shared with Prana. Prana will try and provide some pure Form II. 2) Analysis will be outsourced; reports will be prepared and shared by ▇▇.▇▇▇▇▇’▇ team.