API In House Specification

vijay1 · May 8, 2018, 7:35am

Sir I have one question pls ans
Ornidazole API is not official in BP & USP so is it possible to consider Ornidazole IP Monograph as Inhouse Specification for Export purpose.AS Such IP grade wont be acceptable for export.do we have any guideline regarding this topic.

Ankur · May 10, 2018, 9:07am

Yes you can consider any IP specification as your in-house specification.

vijay1 · May 10, 2018, 9:26am

Thank you.

rastogikn · May 10, 2018, 10:18am

Yes, you can use IP monograph as in house specification for export purpose. In the monograph itself in introduction part you can add source of information as IP including edition.

vijay1 · May 10, 2018, 11:45am

thank you sir for sharing thoughts on this topic.