Why we are having specification 100% above in case of assay as there is only 100% of compound?
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Answer / rambabu cherukuri
in my knowledge, that was fixed by considering the following parameters like, analytical errors, absorption of moisture by product, content uniformity etsetra...
If wrong correct me
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Answer / vishal patil
Yes you are right no compound can be 100% pure,
but when we do API analysis and tell that API is suppose 99.0 % pure than, while formulating the drug product (Tablet, capsule etc) formulator take overage (i.e. 1% extra to make it 100%)
| Is This Answer Correct ? | 0 Yes | 6 No |
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