Hi Mahaveer, thanks for your query. 10 mg or 10% w/w IP ka criteria hai while 25mg or 25%w/w USP ka criteria hai. Please refer the video link mentioned below; ru-vid.com/video/%D0%B2%D0%B8%D0%B4%D0%B5%D0%BE-mmPyGimG15o.html
Thanks for your query, Please listen video carefully. I hv told that for surface application formulations i. e. Crems, ointments, lotion etc. mein UOC test is not applicable.
If conclusion comes fail, then we have to log OOS and need to do the investigation to find out the root cause. Accordingly corrective and preventive action to be taken.
Sry sir I want you explained that in the case of 10 tables if one table assay is in between 74% to 125% …. Then the test will be pass….if not met then we have to go to the 20 tablets and the 20 tablets have must to 85-115% otherwise the test will be failed 👍
Hi Soumya, thanks for your query but in case of any content out of 10 tab at initial stage, is beyond 85 -115% but lies within range 75-125%, we must go for additional 20 units to get the conclusion for passing or failing the test parameter.