Statistical Properties of the Dissolution Test of USP
نویسندگان
چکیده
منابع مشابه
Statistical 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 ...
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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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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...
متن کاملUSP Dissolution Test with Pooled Samples Statistical Analysis of the Third Stage
Introduction In the third stage of the USP Dissolution Test with pooled samples (1), (criteria shown in Table 1), the average value of the lot submitted to inspection is compared with the value of the parameter Q specified in the monograph. When the third stage is reached,the calculation of the average of the 3 values obtained in the three stages,can originate the question if the value of the t...
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ژورنال
عنوان ژورنال: Dissolution Technologies
سال: 2004
ISSN: 1521-298X
DOI: 10.14227/dt110304p25