Application of Raman spectroscopy in the quality control of injectable medicines
This paper presents the results of the identification procedure certification and subsequent quantitative determination of the active ingredients of two-component injectable medicines (active ingredient and solvent) using Raman spectroscopy. The main objective of the research was to select approache...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | Russian |
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Ural Research Institute of Metrology
2019-07-01
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| Series: | Standartnye Obrazcy |
| Subjects: | |
| Online Access: | https://www.rmjournal.ru/jour/article/view/191 |
| _version_ | 1819298555600306176 |
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| author | M. P. Krasheninina M. Yu. Medvedevskikh E. V. Galeeva R. R. Galeev |
| author_facet | M. P. Krasheninina M. Yu. Medvedevskikh E. V. Galeeva R. R. Galeev |
| author_sort | M. P. Krasheninina |
| collection | DOAJ |
| description | This paper presents the results of the identification procedure certification and subsequent quantitative determination of the active ingredients of two-component injectable medicines (active ingredient and solvent) using Raman spectroscopy. The main objective of the research was to select approaches for estimating the metrological characteristics of the measurement procedure, which include consideration of the methodological parameters and provide the metrological traceability of measurement results to SI units. According to this purpose, the GVET 176‑1‑2010 State Secondary Measurement Standard for units of mass fraction, mass (molar) concentration of components in solid and liquid substances and materials based on volumetric titration was used. The following substances were chosen as the research objects for estimating the metrological characteristics of the measurement procedure: ascorbic acid, novocaine and sodium thiosulphate. The authors of the work have demonstrated the measurement-procedure certification results, whose accurate determination was confirmed by the results of interlaboratory comparisons. The obtained results confirmed the accuracy of the identification procedure and subsequent quantitative determination, which proves its applicability for the determination of the active ingredients in two-component injectable medicines. In addition, the possibility of developing reference materials based on the medicines under study is indicated. Further development of this study may be directed at the development of an identification procedure and its certification, with subsequent quantitative determination of the active ingredients of injectable medicines having three components as well as those having a more complex composition. |
| first_indexed | 2024-12-24T05:31:46Z |
| format | Article |
| id | doaj.art-65b1b2b55a5e42918fe39806ee29fc59 |
| institution | Directory Open Access Journal |
| issn | 2077-1177 |
| language | Russian |
| last_indexed | 2024-12-24T05:31:46Z |
| publishDate | 2019-07-01 |
| publisher | Ural Research Institute of Metrology |
| record_format | Article |
| series | Standartnye Obrazcy |
| spelling | doaj.art-65b1b2b55a5e42918fe39806ee29fc592022-12-21T17:13:09ZrusUral Research Institute of MetrologyStandartnye Obrazcy2077-11772019-07-01151395310.20915/2077-1177-2019-15-1-39-53170Application of Raman spectroscopy in the quality control of injectable medicinesM. P. Krasheninina0M. Yu. Medvedevskikh1E. V. Galeeva2R. R. Galeev3Ural Research Institute for Metrology (UNIIM)Ural Research Institute for Metrology (UNIIM)Information and Methodological Center for Expert Evaluation, Recording and Analysis of Circulation of Medical Products of RoszdravnadzorInformation and Methodological Center for Expert Evaluation, Recording and Analysis of Circulation of Medical Products of RoszdravnadzorThis paper presents the results of the identification procedure certification and subsequent quantitative determination of the active ingredients of two-component injectable medicines (active ingredient and solvent) using Raman spectroscopy. The main objective of the research was to select approaches for estimating the metrological characteristics of the measurement procedure, which include consideration of the methodological parameters and provide the metrological traceability of measurement results to SI units. According to this purpose, the GVET 176‑1‑2010 State Secondary Measurement Standard for units of mass fraction, mass (molar) concentration of components in solid and liquid substances and materials based on volumetric titration was used. The following substances were chosen as the research objects for estimating the metrological characteristics of the measurement procedure: ascorbic acid, novocaine and sodium thiosulphate. The authors of the work have demonstrated the measurement-procedure certification results, whose accurate determination was confirmed by the results of interlaboratory comparisons. The obtained results confirmed the accuracy of the identification procedure and subsequent quantitative determination, which proves its applicability for the determination of the active ingredients in two-component injectable medicines. In addition, the possibility of developing reference materials based on the medicines under study is indicated. Further development of this study may be directed at the development of an identification procedure and its certification, with subsequent quantitative determination of the active ingredients of injectable medicines having three components as well as those having a more complex composition.https://www.rmjournal.ru/jour/article/view/191raman spectroscopyidentification and authentication of medicinesmeasurement procedure certification |
| spellingShingle | M. P. Krasheninina M. Yu. Medvedevskikh E. V. Galeeva R. R. Galeev Application of Raman spectroscopy in the quality control of injectable medicines Standartnye Obrazcy raman spectroscopy identification and authentication of medicines measurement procedure certification |
| title | Application of Raman spectroscopy in the quality control of injectable medicines |
| title_full | Application of Raman spectroscopy in the quality control of injectable medicines |
| title_fullStr | Application of Raman spectroscopy in the quality control of injectable medicines |
| title_full_unstemmed | Application of Raman spectroscopy in the quality control of injectable medicines |
| title_short | Application of Raman spectroscopy in the quality control of injectable medicines |
| title_sort | application of raman spectroscopy in the quality control of injectable medicines |
| topic | raman spectroscopy identification and authentication of medicines measurement procedure certification |
| url | https://www.rmjournal.ru/jour/article/view/191 |
| work_keys_str_mv | AT mpkrasheninina applicationoframanspectroscopyinthequalitycontrolofinjectablemedicines AT myumedvedevskikh applicationoframanspectroscopyinthequalitycontrolofinjectablemedicines AT evgaleeva applicationoframanspectroscopyinthequalitycontrolofinjectablemedicines AT rrgaleev applicationoframanspectroscopyinthequalitycontrolofinjectablemedicines |