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System suitability and validation for chiral purity assays of drug substances

Article Abstract:

The importance of chiral purity measurement in establishing quality control for drug substances that exhibit regions of axial asymmetry is discussed. Chiral purity methods are generally validated through the evaluation of specificity, linearity, precision, accuracy, analyte stability, and range. Standards that can be followed in maintaining system suitability are also presented.

Author: Wrezel, P.W., Chion, I., Pakula, R., Weissmueller, D.W.
Publisher: Advanstar Communications, Inc.
Publication Name: LCGC Asia Pacific
Subject: Science and technology
ISSN:
Year: 2006
United States, Product standards, safety, & recalls, Product quality, Standards, Measurement, Quality management, Chirality

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Membrane- assisted liquid-liquid extraction trace analysis of pharmaceutical compounds in aquatic environments

Article Abstract:

The significance of membrane-assisted extraction methods in separating polar pharmaceutical substances from biofluids is discussed.

Author: Moeder, Monika, Lange, Franziska
Publisher: Advanstar Communications, Inc.
Publication Name: LCGC Asia Pacific
Subject: Science and technology
ISSN:
Year: 2007
Capacity, Methods, Evaluation, Fluids, Membrane separation

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Method reproducibility- a case study

Article Abstract:

The measures to be taken to prevent excess variability in liquid chromatography during isolation of drugs are presented.

Author: Dolan, John W., Sigari, Nastaran
Publisher: Advanstar Communications, Inc.
Publication Name: LCGC Asia Pacific
Subject: Science and technology
ISSN:
Year: 2007
Analysis, Usage, Liquid chromatography, Case study

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Subjects list: Drugs
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