Transcription of <1151> PHARMACEUTICAL DOSAGE FORMS - DrugFuture
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<1151> PHARMACEUTICAL DOSAGE FORMS - DrugFuture
USP 35 General Information / 1151 PHARMACEUTICAL DOSAGE Forms765maceutical preparations, which are given elsewhere in thistent uniformity does not rely on the assumption of and can be applied in all cases. Successful devel-opment and manufacture of DOSAGE FORMS requires carefulevaluation of API particle or droplet size, incorporation tech-niques, and excipient (see also PHARMACEUTICAL stability 1150 ) Drugproduct stability involves the evaluation of chemical stability ,physical stability , and performance over time. The chemicalChange to read: stability of the API in the DOSAGE form matrix must supportthe expiration dating for the commercially prepared dosageforms and a beyond-use date for a compounded DOSAGE 1151 PHARMACEUTICAL form.
Change to read: physical stability, and performance over time. The chemical stability of the API in the dosage form matrix must support the expiration dating for the commercially prepared dosage 〈1151〉 PHARMACEUTICAL forms and a beyond-use date for a compounded dosage form. Test procedures for potency must be stability indicat-
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