USP Dissolution Calibrators: Re-examination and Appraisal
نویسندگان
چکیده
منابع مشابه
Suppository Dissolution Utilizing USP Apparatus
Standardized in-vitro dissolution testing of suppositories has been of interest to the pharmaceutical industry since the early works of Giabaldi and Gundhofer in 1975.(1) Anthony Palmieri exam ined standard izin g suppository dissolutions in his work at the University of Wyoming (2). Palmieri developed a slotted dissolution basket for suppositories that is ---------widely used by many individua...
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This report summarizes some trends observed in drug dissolution testing, based upon the United States Pharmacopeia (USP) dissolution Apparatus Suitability Test results and the preliminary data obtained from an international collaborative study to assess the pharmaceutical quality of furosemide products in different countries. Based on the USP calibrator data submitted by the participants, repre...
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Drug dissolution studies are commonly conducted using compendial methods employing USP Paddle and Basket apparatuses. In many cases, dissolution studies can be of limited benefit especially for product-dependent dissolution procedures like in extended release (ER) formulations. The high variability in dissolution testing, that is not productrelated, emphasizes the need for developing new method...
متن کاملStatistical Properties of the Dissolution Test of USP
Introduction The dissolution test as defined in the United States Pharmacopoeia (1) is used in judging the quality of pharmaceutical products. Dissolution testing is a method for evaluating physiological availability that depends upon having the drug in a dissolved state. The USP Dissolution testing involves three stages and the acceptance criteria are defined for each stage as a function of a ...
متن کاملEstimation of the probability of passing the USP dissolution test.
To ensure that a drug product will meet standards for identity, strength and stability as specified in the United States Pharmacopedia and National Formulary (USP/NF), it needs to pass a number of tests such as the content uniformity test and dissolution test at various stages of the manufacturing process. The sponsors usually have in-house specification limits based on some lower bounds of the...
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ژورنال
عنوان ژورنال: Dissolution Technologies
سال: 2005
ISSN: 1521-298X
DOI: 10.14227/dt120105p6