The United States Pharmacopeia, the National Formulary, Volumes 1-3; Volume 30, Parts 2-3United States Pharmacopeial Convention, Incorporated, 2007 - Medicine The USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. The current version of USP–NF standards deemed official by USP are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States. |
Contents
General Tests and Assays | 2505 |
General Requirements for Tests and Assays | 2544 |
11 USP Reference Standards | 2552 |
Copyright | |
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100-mL volumetric flask accurately measured volume accurately weighed quantity acetonitrile alcohol Buffer Calculate the quantity chloride chloroform chromatograph is equipped Chromatographic Chromatographic system Chromatography 621 contains not less deviation for replicate dilute with water directed for Procedure dissolved Endotoxin equivalent formula hydrochloric acid Hydrochloride Hydrocortisone impurity inject equal volumes known concentration labeled amount less than 90.0 major peaks meets the requirements methanol Metoprolol mg per mL mixture mL of water mL per minute Mobile phase monensin Neomycin Nifedipine Nystatin obtain a solution Ondansetron oxycodone Oxytetracycline Packaging and storage-Preserve Paroxetine Penicillin percent Polymyxin Procedure Separately inject quantity of USP record the chromatograms record the peak Reference standards 11)-USP related compound relative standard deviation replicate injections responses as directed Separately inject equal sodium hydroxide Standard preparation storage-Preserve in tight sulfuric acid system see Chromatography System Suitability Tablets Test solution USP Reference standards volumetric flask water to volume