Overages to compensate loss on storage


(Anurag Tiwari) #1

How much overages of active ingredient can be added in manufacturing of tablets .Please send supporting documents for various sop / rules for overages. How much overages can be added for Alprazolam tablets 0.25 mg ,being a low dose and narcotic and pyscotropuc substance.


(Ajay Sharma) #2

This all depends upon the validation and stability studies performed for the active ingredients used in formulation.