4. In excepient compatibility studies, during DP you found that an impurity peak is increasing and is above detection limit. What can you conclude to formulation

Question

Accepted Answer

The increasing impurity peak above the detection limit in excipient compatibility studies suggests a potential issue with the formulation.

The impurity peak may indicate degradation or reaction of the excipient with the drug product (DP).
Further investigation is needed to identify the impurity and its source.
The formulation may need to be modified to prevent or reduce the impurity formation.
Additional stability studies should be conducted to assess the long-term impact of the impurity on the DP.
Regulatory guidelines should be consulted to determine the acceptable limits for impurities in the DP.

4. In excepient compatibility studies, during DP you found that an impurity peak is increasing and is above detection limit. What can you conclude to formulation

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