Overage percentage


(Sajjad Ahmad) #1

purpose and %age of overage?


(Sunil R. Budhkar) #2

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.

(Sajjad Ahmad) #3

how much %age can be added?


(Sunil R. Budhkar) #4

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.