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The USP is published in a combined volume with the National Formulary (a formulary) as the USP-NF. [2] If a drug ingredient or drug product has an applicable USP quality standard (in the form of a USP-NF monograph), it must conform in order to use the designation "USP" or "NF".
Monographs may also detail USP Reference Standards and/or other materials needed for test performance. The FCC's appendices contain step-by-step guidance for general physical and chemical tests, and apparatus use, as well as generally useful information, such as food ingredient good manufacturing practices .
In United States Pharmacopeia (USP) General Chapter <711> Dissolution, there are four dissolution apparatuses standardized and specified. [6] They are: USP Dissolution Apparatus 1 – Basket (37 °C ± 0.5 °C ) USP Dissolution Apparatus 2 – Paddle (37 °C ± 0.5 °C) USP Dissolution Apparatus 3 – Reciprocating Cylinder (37 °C ± 0.5 °C)
The 1699 Edinburgh Pharmacopoeia. A pharmacopoeia, pharmacopeia, or pharmacopoea (from the obsolete typography pharmacopœia, meaning "drug-making"), in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.
Monographs summarize the nomenclature, properties, actions, and uses of each substance. A chapter on supplementary drugs and other substances covers monographs on new drugs, those not easily classified, herbals, and drugs no longer clinically used but still of interest. Monographs of some toxic substances are also included.
Cover of the European Pharmacopoeia, 11th Edition. The European Pharmacopoeia [1] (Pharmacopoeia Europaea, Ph. Eur.) is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. [1]
USP Strong Iodine Tincture is defined in the NF as containing in each 100 mL, 6.8 to 7.5 gram of iodine, and 4.7 to 5.5 gram of potassium iodide. Purified water is 50 mL and the balance is alcohol. Purified water is 50 mL and the balance is alcohol.
Desiccated thyroid has been described in the United States Pharmacopoeia for a century as "the cleaned, dried, and powdered thyroid gland previously deprived of connective tissue and fat... obtained from domesticated animals that are used for food by man" (USP XVI). [15] In the last few decades, pork alone is the usual source.