Alternatives to amino acid analysis for the purity control of pharmaceutical grade L-alanine
โ Scribed by Ulrike Holzgrabe; Cees-Jan Nap; Tanja Beyer; Stefan Almeling
- Book ID
- 102441620
- Publisher
- John Wiley and Sons
- Year
- 2010
- Tongue
- English
- Weight
- 305 KB
- Volume
- 33
- Category
- Article
- ISSN
- 1615-9306
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โฆ Synopsis
Abstract
The quality control of drugs is important for safety of patients and consumers. International pharmacopoeias mostly employed HPLC with UV detection for this purpose. This is always a problem when the drugs, such as most amino acids, are lacking a chromophor. Instead of UV detection, the impurity control of alanine was performed using charged aerosol detector, evaporative lightโscattering detector, nano quantity analyte detector, MS detector, and as an orthogonal method, quantitative NMR spectroscopy. The charged aerosol detector, MS detector, and quantitative NMR spectroscopy provided similar and precise results, whereas the evaporative lightโscattering detector and nano quantity analyte detector revealed some problems regarding sensitivity, linearity, and robustness.
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Solvent extraction, a clean-up method for samples for the determination of amino acids by gas chromatography, was investigated and compared with a conventional ion-exchange purification. Amino acids were esterified with isopropanol and extracted with various organic solvents. The solubilities of the