Transcription of <1151> PHARMACEUTICAL DOSAGE FORMS - …
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<1151> PHARMACEUTICAL DOSAGE FORMS - …
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 . Test procedures for potency must be stability indicat-ing (see Validation of compendial Procedures 1225 ).
766 〈1151〉 Pharmaceutical Dosage Forms / General Information USP 35 Figure 1. Compendial Taxonomy for Pharmaceutical Dosage Forms. volumes recommended in the accompanying table are usu- Identification—Identification tests are discussed in the
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