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http://dspace.nuph.edu.ua/handle/123456789/20948| Title: | Сharacterization of a reference standard for qualification of differential scanning calorimetry intended for purity determination in certification of pharmaceutical reference standards |
| Authors: | Leontiev, D. A. Volovyk, N. V. Bevz, O. V. Vashchenko, O. V. Gryzodub, O. I. Леонтьев, Д. А. Леонтьєв, Д. А. Воловик, Н. В. Бевз, О. В. Ващенко, О. В. Гризодуб, О. І. |
| Keywords: | cholesterol;differential scanning calorimetry;equipment qualification;homogeneity;pharmaceutical reference standards;purity |
| Issue Date: | 2018 |
| Bibliographic description (Ukraine): | Сharacterization of a reference standard for qualification of differential scanning calorimetry intended for purity determination in certification of pharmaceutical reference standards / D. A. Leontiev, N. V. Volovyk, O. V. Bevz [et al.] // Journal of Pharmaceutical Sciences and Research. – 2018. – Vol. 10 (11). – P. 2709-2714. |
| Abstract: | To select and characterize a reference standard for equipment qualification suitable for performance verification in the certification of pharmaceutical reference standards by differential scanning calorimetry (DSC) based on the metrological criteria of the State Pharmacopoeia of Ukraine |
| Description: | The metrological criteria for results of purity determination in the certification of pharmaceutical reference standards by DSC used as an alternative method were formulated. A candidate material of cholesterol for performance verification of DSC met the established requirements. For cholesterol, the characteristics of purity, melting point and enthalpy of fusion were certified simultaneously. The further study of intra- and inter-laboratory variation of the results is required to characterize the uncertainty of the purity determination. |
| URI: | http://dspace.nuph.edu.ua/handle/123456789/20948 |
| Appears in Collections: | Наукові публікації кафедри фармацевтичної хімії |
Files in This Item:
| File | Description | Size | Format | |
|---|---|---|---|---|
| jpsr10111805.pdf | 965,37 kB | Adobe PDF | View/Open |
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