purpose and %age of overage?
There could be several reasons of adding overages of active ingredients in the formulations.
These could be as follows,
- to compensate for loss during shelf life (like vitamins, antibiotics which are unstable).
- to compensate for moisture content which is a part of molecule. (in terms of unhydrous basis).
- for potency correction.
- Any other justified reason provided it is as per Regulatory norms.
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how much %age can be added?
For further details please refer Schedules of the Drug & cosmetics act 1940 and rules there under 1945. There is a specific schedule in which overages of active ingredients to be added in unstable drug products are specified.