Can you give me some advice in using NIR in content uniformity as regard of legal requirement?
I am confusing about “weight correct” term in content uniformity, please help me to clarify
For example, I am perform testing of content uniformity in tablet (10 tablet) by HPLC and which calculation formular is correct
a) % label claim = peak area of sample x dilution of sample x potency of standard x weight of standard/(peak area of STD x dilution of STD x label quantity)
b) % label claim= peak area of sample x dilution of sample x potency of standard x weight of standard x average weight of 10 tablets /(peak area of STD x dilution of STD x label quantity x weight of tablet)
thank you very much!