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Quality-Control Analytical Methods: Selecting an Analytical Method

Author(s):  Allen Loyd V Jr

Issue:  Jan/Feb 2004 - Androgen Deficiency in Women
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Abstract:  The author distinguishes between relatively simple analytical methods that can be conducted inhouse (weight and volumetric measurements; pH; density/specific gravity; refractive index; and, in some cases, sterility testing and endotoxin testing) and those that can be outsourced to a contract laboratory (various methods of chromatography). He then discusses considerations in selecting an analytical method and types of analytical methods. Tables provide a classification of analytical methods and suggested analytical methods for various dosage forms, depending upon the active drug. In summary, analytical testing will probably become a more important part of pharmaceutical compounding as the public and regulatory agencies demand more and more documentation of the quality of compounded preparations. Compounding pharmacists must decide on the types and degree of testing that will be included in their quality-control program and on what testing will be done inhouse. The author concludes that analytical testing is like pharmaceutical compounding in that it should only be performed by those trained and validated in its operation.

Related Keywords: Allen, Jr, Loyd V., PhD, RPh, Analytical methods, quality control, Analytical methods, selection of, Quality control, and analytical methods

Related Categories: BUSINESS, SUPPORT, QUALITY CONTROL

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