What is lable claim? how we calculate? How we calculate the tablets weight using lable claim and average weight?
Please refer USFDA Guidance of Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules Guidance for Industry- June 2015. This guideline is for generic drug products developement for ANDA submissions.
Label claim is the amount (usually in mg) of Active ingredient(s) (as API) added in one unit (Tablet, Capsule) and each unit dose (per 5 ml, 15 ml) in case of oral liquid preparations, and as percentage (%) in case of semi solid dosage forms (Cream, Ointment, Lotion) and Aerosol preparations.
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