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Quality Control Analytical Methods: Physical Quantitative Verification of Nonsterile Compounded Preparations: Individualized Dosage Units

Author(s):  Sidhu Raman

Issue:  Jul/Aug 2015 - Volume 19, Number 4
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Abstract:  United States Pharmacopeia <795> states that to ensure accuracy and completeness, the compounder shall observe the finished preparation. One such verification method described in United States Pharmacopeia <1163> is weight assessment of final nonsterile compounded preparations. This article will focus on this weight-assessment technique and discuss common pitfalls and tools which can be used to better comply with current industry quality-control guidelines.

Related Keywords: Raman Sihu, BSc, United States Pharmacopeia Chapter <795>, USP, quality control, physical testing, weight assessment, theoretical weight, acceptable weight range, drug safety, misdosing, dose errors, medication errors

Related Categories: SUPPORT, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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