In pharmaceuticals production, prior to preparation, raw materials are weighed and dispensed to be used. What is the +-% allowable tolerance for raw materials dispensed weight? Are there any regulations for this issue, and how can we determine this percentage? because production can’t dispense the perfect exact weight all the time. For example, if we need 50 kg of a certain excipient to be dispensed, should a dispensed weight of 49.75 kg- 50.25 kg (+- 0.5% variation) be acceptable?
Dear Awad,
pls check GRAS excipient list. There you will see, excipients usage in different dosage forms and their quantities used. pls note that these quantities are the one which are filed by applicant to FDA per unit dosage form. They might not be maximum.
ranjita
During quantitative analysis pharmacopoeia limits are referred. For usage in formulation gras excipient list can be referred.
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