Methods of quality standardization for diumancal parent substance and related medicinal forms
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Methods for the standardization of the parent substance of the original domestic antiischemic drug diumancal and its medicinal forms have been developed. Taking into account the high level of basic requirements on analytical methods and their validation for suitability in the pharmaceutical analysis of medical products, it is suggested to include HPLC, IR, and 13C NMR spectroscopy techniques into the “Identity,” “Extraneous Impurities,” and “Quantitative Determination” articles together with the well-known conventional methods. In order to ensure the reliability and specificity of determination of the content of the parent substance, the State Reference Sample (SRS) of diumancal is created and the retention times of possible impurities in diumancal are established using mixtures of 7-oxy-2-H-1-benzopyran-2-one and 7-(2-bromoethyleneoxy)-2-H-1-benzopyran-2-one. The total content of these impurities must not exceed 0.5 %. Experimental data on the analysis of impurities in diumancal are presented and optimum conditions for determining diumancal in the parent substance and related medicinal forms are established. The rated parameters of the “Identity,” “Extraneous Impurities,” and “Quantitative Determination” articles for these preparations are established, which can be used for both research and the production quality control purposes.
KeywordsParent Substance Medicinal Form Measuring Flask Asymmetry Coefficient Nujol Mull
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