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What is the difference between specified impurity and
Identified impurity
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Answer / sanjay prajapati
individual impurities with a specific acceptance criterion that are included in the specification for a drug substance are referred to as specified impurities. Specified impurities can be identified or unidentified.
identified impurity : for those impurities whose chemical structure are known
| Is This Answer Correct ? | 9 Yes | 2 No |
Answer / asha latha
Specified impurity is having path formed from api but identified impurity may not have a path
| Is This Answer Correct ? | 5 Yes | 8 No |
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