Development of an obidoxime chloride reference material: a metrological approach to the determination of chromatographic purity |
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Authors: | Ilana Schumacher Paul Gorenbein Arthur Raskin Ilya Kuselman |
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Institution: | (1) Research & Quality Control Laboratory, Medical Corps, Mil., Israel Defense Forces (IDF), P.O.Box 02149, Jerusalem, Israel;(2) The National Physical Laboratory of Israel (INPL), Danciger “A” Bldg, Givat Ram, Jerusalem, 91904, Israel |
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Abstract: | A metrological approach to determination of the chromatographic purity of obidoxime chloride and the corresponding obidoxime
chloride reference material (RM) with a certified chromatographic purity value have been developed. This value was defined
as the ratio of the sum of peak areas of obidoxime chloride isomers to the total peak area of detected substances including
impurities (%) under specified HPLC–UV conditions. The RM homogeneity and stability were studied using HPLC with UV detection
and evaluated as satisfactory. The certified value calculated from the results of an interlaboratory trial was equal to 99.9%
with the expanded uncertainty of 0.6% at the level of confidence 0.95 and the coverage factor 2. The RM certified value, like
other results of chromatographic purity determination traceable to the reference measurement procedure, is not traceable directly
to the SI mole. However, the results are comparable in metrologically traceable environments, i.e. when relevant measuring
laboratory instruments are calibrated with traceability chains to the corresponding SI units. Therefore, the RM can be used
as a measurement standard (calibrator) for analytical instruments and as a control sample for quality control of HPLC obidoxime
chloride assay results. |
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Keywords: | Obidoxime chloride Reference material Chromatographic purity Metrological approach HPLC |
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