Transcription of 1151 PHARMACEUTICAL DOSAGE FORMS - USP
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Printed on: Fri May 14 2021, 10:26:22 AM Official Status: Currently Official on 14-May-2021 DocId: 1_GUID-431F93A9-1 FEC-42AE-8556-AA5B604B2E36_8_en-US. (EST). Printed by: Deborah Nishikawa Official Date: Official as of 01-May-2021 Document Type: GENERAL CHAPTER @2021 USPC. 1. 1151 PHARMACEUTICAL DOSAGE FORMS . Change to read: GENERAL CONSIDERATIONS. This chapter provides general descriptions of and definitions for drug products, or DOSAGE FORMS , commonly used to administer the drug substance (active PHARMACEUTICAL ingredient; API). It discusses general principles involved in the manufacture or compounding of these DOSAGE FORMS .
chemical stability of the drug substance in the dosage form matrix must support the expiration dating for the commercially prepared dosage forms and a beyond-use date for a compounded dosage form. Test procedures for potency must be stability indicating (see Validation of Compendial Procedures á1225ñ). Degradation products should be quantified.
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