Quote from Chief Pharmacist on October 30, 2024, 4:25 pm

It's not mandatory for stability study as it is confirmed by Assay test.

Quote from ariyan on November 1, 2024, 2:45 am

What is the significant change in stability study?

Quote from Chief Pharmacist on November 13, 2024, 9:34 am

In general, “significant change” for a drug product is defined as:

1. A 5% change in assay from its initial value; or failure to meet the acceptance criteria for potency when using biological or immunological procedures;
2. Any degradation product’s exceeding its acceptance criterion;
3. Failure to meet the acceptance criteria for appearance, physical attributes, and functionality test (e.g., color, phase separation, resuspendibility, caking, hardness, dose delivery per actuation); however, some changes in physical attributes (e.g., softening of suppositories, melting of creams) may be expected under accelerated conditions; and, as appropriate for the dosage form:
4. Failure to meet the acceptance criterion for pH; or
5. Failure to meet the acceptance criteria for dissolution for 12 dosage units.