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Quality-Control Analytical Methods: Homogeneity of Dosing Forms

Author(s):  Kupiec Thomas C, Vu Nicole, Branscum David

Issue:  Jul/Aug 2008 - Hormone Replacement Therapy
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Page(s):  340-343

Quality-Control Analytical Methods: Homogeneity of Dosing Forms Page 1
Quality-Control Analytical Methods: Homogeneity of Dosing Forms Page 2
Quality-Control Analytical Methods: Homogeneity of Dosing Forms Page 3
Quality-Control Analytical Methods: Homogeneity of Dosing Forms Page 4

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Abstract:  Content uniformity is the degree of consistency in the amount of the drug substance among dosage units. There are two ways to determine content uniformity according to United States Pharmacopeial Chapter <905>; by means of Content Uniformity or Weight Variation methods. It is essential that compounding pharmacists know the different methods, how they work, and when to use each method to determine the content uniformity of their individual dosages.

Related Keywords: Thomas C. Kupiec, PhD, Nicole Vu, PhD, David Bransum, content uniformity, quality control, United States Pharmacopeia, USP Chapter <905>, quality assurance, standards, weight variation, dosage forms

Related Categories: QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, DOSAGE FORMS/DRUG CARRIERS

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