Download PDF by The United States Pharmacopeial Convention: USP NF 2009 (United States Pharmacopeia 32 National

By The United States Pharmacopeial Convention

ISBN-10: 1889788732

ISBN-13: 9781889788739

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Nonmonograph tests and acceptance criteria suitable for detecting and controlling impurities that may result from a change in the processing methods or that may be introduced from external sources should be employed in addition to the tests provided in the individual monograph, where the presence of the impurity is inconsistent with applicable good manufacturing practices or good pharmaceutical practice. 10. Other Impurities in USP and NF Articles If a USP or NF monograph includes an assay or organic impurity test based on chromatography, other than a test for residual solvents, and that monograph procedure does not detect an impurity present in the substance, the amount and identity of the impurity, where both are known, shall be stated in the labeling (certificate of analysis) of the official substance, under the heading Other Impurity(ies).

Manufacturers or packagers of PPPA-regulated OTC preparations are allowed to package one size in non–child-resistant packaging as long as popular-size, special packages are also supplied. 5). Various types of child-resistant packages are covered in ASTM International Standard D-3475, Standard Classification of Child-Resistant Packaging. Examples are included as an aid in the understanding and comprehension of each type of classification. 30. Storage Temperature and Humidity Specific directions are stated in some monographs with respect to the temperatures and humidity at which official articles shall be stored and distributed (including the shipment of articles to the consumer) when stability data indicate that storage and distribution at a lower or a higher temperature and a higher humidity produce undesirable results.

Regardless of quantity, where no specific storage directions or limitations are provided in an individual NF monograph or stated in the labeling of an article recognized in NF, the conditions of storage and distribution shall include protection from moisture, freezing, excessive heat, and, where necessary, from light. 20. Containers The container is that which holds the article and is or may be in direct contact with the article. The immediate container is that which is in direct contact with the article at all times.

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USP NF 2009 (United States Pharmacopeia 32 National Formulary 27) by The United States Pharmacopeial Convention


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