Features of the Development of Reference Materials of Pharmaceutical Substances
The article considers the features of developing reference materials of pharmaceutical substances using the example of thiamine hydrochloride. It describes the procedure for developing a reference material, which includes preliminary authentication of the main substance of a certified pharmaceutical...
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| Veröffentlicht in: | Measurement techniques 2022-12, Vol.65 (9), p.686-694 |
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| creator | Medvedevskikh, M. Yu Sergeeva, A. S. Shokhina, O. S. Krasheninina, M. P. |
| description | The article considers the features of developing reference materials of pharmaceutical substances using the example of thiamine hydrochloride. It describes the procedure for developing a reference material, which includes preliminary authentication of the main substance of a certified pharmaceutical substance, determination of mass fraction of the main substance by direct (titrimetry) and indirect (mass balance) methods, verification of the feasibility of methods for assessing all impurities, provision of the certified value traceability. The results of infrared Fourier spectrometry confirm the authenticity of the analysed substance of thiamine hydrochloride. The mass fractions of the main substance were measured using acid- base titration in an aqueous-alcoholic medium, as well as the mass balance method taking into account the contents of sulphate ash, water, related impurities, and residual organic solvents. The expanded uncertainty of the results of measuring the mass fraction of the main substance and groups of impurities was assessed, and the full uncertainty budget was compiled. It has been established that the results of measuring the mass fraction of the main substance in the thiamine hydrochloride substance, determined by the titrimetric method (97.36 ± 0.40)% and the mass balance method (97.37 ± 0.08)%, are consistent with each other within the specified uncertainties. The metrological traceability of the certified value of reference material to the units of quantities reproduced by state primary measurement standards (State primary measurement standard for the unit of mass (kilogram) GET 3-2020, State primary measurement standard for units of mass fraction and mass (molar) concentration of water in solid and liquid substances and materials GET 173-2017, State primary measurement standard for units of mass (molar, atomic) fraction and mass (molar) concentration of components in liquid and solid substances and materials based on coulometry GET 176-2019, State primary measurement standard for units of mass (molar) fraction and mass (molar) concentration of organic components in liquid and solid substances and materials based on liquid and gas chromatography-mass spectrometry with isotope dilution and gravimetry GET 208-2019) was ensured. The results obtained are relevant for ensuring the measurements uniformity in the quality control of medicines. |
| doi_str_mv | 10.1007/s11018-023-02140-w |
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Yu ; Sergeeva, A. S. ; Shokhina, O. S. ; Krasheninina, M. P.</creator><creatorcontrib>Medvedevskikh, M. Yu ; Sergeeva, A. S. ; Shokhina, O. S. ; Krasheninina, M. P.</creatorcontrib><description>The article considers the features of developing reference materials of pharmaceutical substances using the example of thiamine hydrochloride. It describes the procedure for developing a reference material, which includes preliminary authentication of the main substance of a certified pharmaceutical substance, determination of mass fraction of the main substance by direct (titrimetry) and indirect (mass balance) methods, verification of the feasibility of methods for assessing all impurities, provision of the certified value traceability. The results of infrared Fourier spectrometry confirm the authenticity of the analysed substance of thiamine hydrochloride. The mass fractions of the main substance were measured using acid- base titration in an aqueous-alcoholic medium, as well as the mass balance method taking into account the contents of sulphate ash, water, related impurities, and residual organic solvents. The expanded uncertainty of the results of measuring the mass fraction of the main substance and groups of impurities was assessed, and the full uncertainty budget was compiled. It has been established that the results of measuring the mass fraction of the main substance in the thiamine hydrochloride substance, determined by the titrimetric method (97.36 ± 0.40)% and the mass balance method (97.37 ± 0.08)%, are consistent with each other within the specified uncertainties. The metrological traceability of the certified value of reference material to the units of quantities reproduced by state primary measurement standards (State primary measurement standard for the unit of mass (kilogram) GET 3-2020, State primary measurement standard for units of mass fraction and mass (molar) concentration of water in solid and liquid substances and materials GET 173-2017, State primary measurement standard for units of mass (molar, atomic) fraction and mass (molar) concentration of components in liquid and solid substances and materials based on coulometry GET 176-2019, State primary measurement standard for units of mass (molar) fraction and mass (molar) concentration of organic components in liquid and solid substances and materials based on liquid and gas chromatography-mass spectrometry with isotope dilution and gravimetry GET 208-2019) was ensured. The results obtained are relevant for ensuring the measurements uniformity in the quality control of medicines.</description><identifier>ISSN: 0543-1972</identifier><identifier>EISSN: 1573-8906</identifier><identifier>DOI: 10.1007/s11018-023-02140-w</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Analytical Chemistry ; Atomic properties ; Characterization and Evaluation of Materials ; Chromatography ; Dilution ; Gas chromatography ; Impurities ; Infrared analysis ; Mass balance ; Mass spectrometry ; Measurement Science and Instrumentation ; Pharmaceuticals ; Physical and Chemical Measurements ; Physical Chemistry ; Physics ; Physics and Astronomy ; Quality control ; Reference materials ; Scientific imaging ; Substance abuse ; Thiamine ; Titration ; Uncertainty ; Vitamin B</subject><ispartof>Measurement techniques, 2022-12, Vol.65 (9), p.686-694</ispartof><rights>Springer Science+Business Media, LLC, part of Springer Nature 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>COPYRIGHT 2022 Springer</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c371t-cba8b31aec03bb093896747349ffbb09fc7ba0af7e9eac8eedff2ffda7d6d13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s11018-023-02140-w$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s11018-023-02140-w$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>315,781,785,27926,27927,41490,42559,51321</link.rule.ids></links><search><creatorcontrib>Medvedevskikh, M. Yu</creatorcontrib><creatorcontrib>Sergeeva, A. S.</creatorcontrib><creatorcontrib>Shokhina, O. S.</creatorcontrib><creatorcontrib>Krasheninina, M. P.</creatorcontrib><title>Features of the Development of Reference Materials of Pharmaceutical Substances</title><title>Measurement techniques</title><addtitle>Meas Tech</addtitle><description>The article considers the features of developing reference materials of pharmaceutical substances using the example of thiamine hydrochloride. It describes the procedure for developing a reference material, which includes preliminary authentication of the main substance of a certified pharmaceutical substance, determination of mass fraction of the main substance by direct (titrimetry) and indirect (mass balance) methods, verification of the feasibility of methods for assessing all impurities, provision of the certified value traceability. The results of infrared Fourier spectrometry confirm the authenticity of the analysed substance of thiamine hydrochloride. The mass fractions of the main substance were measured using acid- base titration in an aqueous-alcoholic medium, as well as the mass balance method taking into account the contents of sulphate ash, water, related impurities, and residual organic solvents. The expanded uncertainty of the results of measuring the mass fraction of the main substance and groups of impurities was assessed, and the full uncertainty budget was compiled. It has been established that the results of measuring the mass fraction of the main substance in the thiamine hydrochloride substance, determined by the titrimetric method (97.36 ± 0.40)% and the mass balance method (97.37 ± 0.08)%, are consistent with each other within the specified uncertainties. The metrological traceability of the certified value of reference material to the units of quantities reproduced by state primary measurement standards (State primary measurement standard for the unit of mass (kilogram) GET 3-2020, State primary measurement standard for units of mass fraction and mass (molar) concentration of water in solid and liquid substances and materials GET 173-2017, State primary measurement standard for units of mass (molar, atomic) fraction and mass (molar) concentration of components in liquid and solid substances and materials based on coulometry GET 176-2019, State primary measurement standard for units of mass (molar) fraction and mass (molar) concentration of organic components in liquid and solid substances and materials based on liquid and gas chromatography-mass spectrometry with isotope dilution and gravimetry GET 208-2019) was ensured. The results obtained are relevant for ensuring the measurements uniformity in the quality control of medicines.</description><subject>Analytical Chemistry</subject><subject>Atomic properties</subject><subject>Characterization and Evaluation of Materials</subject><subject>Chromatography</subject><subject>Dilution</subject><subject>Gas chromatography</subject><subject>Impurities</subject><subject>Infrared analysis</subject><subject>Mass balance</subject><subject>Mass spectrometry</subject><subject>Measurement Science and Instrumentation</subject><subject>Pharmaceuticals</subject><subject>Physical and Chemical Measurements</subject><subject>Physical Chemistry</subject><subject>Physics</subject><subject>Physics and Astronomy</subject><subject>Quality control</subject><subject>Reference materials</subject><subject>Scientific imaging</subject><subject>Substance abuse</subject><subject>Thiamine</subject><subject>Titration</subject><subject>Uncertainty</subject><subject>Vitamin B</subject><issn>0543-1972</issn><issn>1573-8906</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNp9kdtKxDAQhoMouB5ewKuCV15UJ023SS_FMyiK632YppO1sm3XJPXw9mZ3hWVBJIQww_clTH7GjjiccgB55jkHrlLIRNw8h_Rzi434WIpUlVBssxGMc5HyUma7bM_7NwAQsihH7PGaMAyOfNLbJLxSckkfNOvnLXVh0XomS446Q8kDBnINzpbk0yu6Fg0NoTE4SyZD5QNGyh-wHRsZOvw999nk-url4ja9f7y5uzi_T42QPKSmQlUJjmRAVBWUQpWFzKXIS2sXtTWyQkArqSQ0iqi2NrO2RlkXNRf77Hh169z17wP5oN_6wXXxQZ0pKONf5LJYU1OckW462weHpm280ecyV5CNx0pF6vQPKq6a2sb0Hdkm9jeEkw0hMoG-whQH7_Xd5HmTzVascb33jqyeu6ZF96056EVyepWcjsnpZXL6M0piJfkId1Ny6-n-sX4AYYKbog</recordid><startdate>20221201</startdate><enddate>20221201</enddate><creator>Medvedevskikh, M. 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The results of infrared Fourier spectrometry confirm the authenticity of the analysed substance of thiamine hydrochloride. The mass fractions of the main substance were measured using acid- base titration in an aqueous-alcoholic medium, as well as the mass balance method taking into account the contents of sulphate ash, water, related impurities, and residual organic solvents. The expanded uncertainty of the results of measuring the mass fraction of the main substance and groups of impurities was assessed, and the full uncertainty budget was compiled. It has been established that the results of measuring the mass fraction of the main substance in the thiamine hydrochloride substance, determined by the titrimetric method (97.36 ± 0.40)% and the mass balance method (97.37 ± 0.08)%, are consistent with each other within the specified uncertainties. The metrological traceability of the certified value of reference material to the units of quantities reproduced by state primary measurement standards (State primary measurement standard for the unit of mass (kilogram) GET 3-2020, State primary measurement standard for units of mass fraction and mass (molar) concentration of water in solid and liquid substances and materials GET 173-2017, State primary measurement standard for units of mass (molar, atomic) fraction and mass (molar) concentration of components in liquid and solid substances and materials based on coulometry GET 176-2019, State primary measurement standard for units of mass (molar) fraction and mass (molar) concentration of organic components in liquid and solid substances and materials based on liquid and gas chromatography-mass spectrometry with isotope dilution and gravimetry GET 208-2019) was ensured. 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| subjects | Analytical Chemistry Atomic properties Characterization and Evaluation of Materials Chromatography Dilution Gas chromatography Impurities Infrared analysis Mass balance Mass spectrometry Measurement Science and Instrumentation Pharmaceuticals Physical and Chemical Measurements Physical Chemistry Physics Physics and Astronomy Quality control Reference materials Scientific imaging Substance abuse Thiamine Titration Uncertainty Vitamin B |
| title | Features of the Development of Reference Materials of Pharmaceutical Substances |
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