Development and Validation of a Procedure for Subvisible Particles Determination in Water for Injections by the Coulter Principle (Electrical Sensing Zone Method)
Water for injections is one of the most popular diluents used for preparation of parenteral dosage forms. The European Pharmacopoeia recommends two methods for the determination of subvisible particulate matter: Light Obscuration Particle Count Test and Microscopic Particle Count Test. The Russia...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-06-01
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| Series: | Биопрепараты: Профилактика, диагностика, лечение |
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| Online Access: | https://www.biopreparations.ru/jour/article/view/136 |
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| author | A. A. Voropaev O. V. Fadeikina T. N. Ermolaeva D. S. Davydov R. A. Volkova D. V. Shvedov |
| author_facet | A. A. Voropaev O. V. Fadeikina T. N. Ermolaeva D. S. Davydov R. A. Volkova D. V. Shvedov |
| author_sort | A. A. Voropaev |
| collection | DOAJ |
| description | Water for injections is one of the most popular diluents used for preparation of parenteral dosage forms. The European Pharmacopoeia recommends two methods for the determination of subvisible particulate matter: Light Obscuration Particle Count Test and Microscopic Particle Count Test. The Russian Pharmacopoeia, 13th ed., additionally allows for the use of the Coulter principle (Electrical Sensing Zone method). Thus, a procedure had to be developed for subvisible particles determination in water for injections based on the Coulter principle (hereinafter — procedure). The article presents the results of development and validation of the procedure, i.e. the characteristics of accuracy, dilutional linearity, ruggedness in terms of the time factor, and repeatability for particles more than 10 μm in size. The results of subvisible particles determination obtained with the help of the developed procedure based on the Coulter principle were compared to the results obtained with the help of the light obscuration particle count test. The accuracy of the developed procedure was supported by the statistical insignificance of the differences between the obtained results. The values of ruggedness in terms of the time factor (NMT 14 %) and repeatability (NMT 15 %) did not exceed the established acceptance criterion which is equal to the acceptable limit of the instrument error for particle count in the tested samples (20 %). The dilutional linearity of the procedure was demonstrated (coefficient of determination R2 = 0.999). The results obtained during the validation studies support the possibility of using the Coulter principle for the assessment of subvisible particles in water for injections. |
| first_indexed | 2024-03-08T21:44:32Z |
| format | Article |
| id | doaj.art-dfac6cc514a2403f9bd2aba75b819761 |
| institution | Directory Open Access Journal |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| last_indexed | 2024-04-24T19:12:18Z |
| publishDate | 2018-06-01 |
| publisher | Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Биопрепараты: Профилактика, диагностика, лечение |
| spelling | doaj.art-dfac6cc514a2403f9bd2aba75b8197612024-03-26T09:10:52ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562018-06-011829810510.30895/2221-996X-2018-18-2-98-105127Development and Validation of a Procedure for Subvisible Particles Determination in Water for Injections by the Coulter Principle (Electrical Sensing Zone Method)A. A. Voropaev0O. V. Fadeikina1T. N. Ermolaeva2D. S. Davydov3R. A. Volkova4D. V. Shvedov5Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsWater for injections is one of the most popular diluents used for preparation of parenteral dosage forms. The European Pharmacopoeia recommends two methods for the determination of subvisible particulate matter: Light Obscuration Particle Count Test and Microscopic Particle Count Test. The Russian Pharmacopoeia, 13th ed., additionally allows for the use of the Coulter principle (Electrical Sensing Zone method). Thus, a procedure had to be developed for subvisible particles determination in water for injections based on the Coulter principle (hereinafter — procedure). The article presents the results of development and validation of the procedure, i.e. the characteristics of accuracy, dilutional linearity, ruggedness in terms of the time factor, and repeatability for particles more than 10 μm in size. The results of subvisible particles determination obtained with the help of the developed procedure based on the Coulter principle were compared to the results obtained with the help of the light obscuration particle count test. The accuracy of the developed procedure was supported by the statistical insignificance of the differences between the obtained results. The values of ruggedness in terms of the time factor (NMT 14 %) and repeatability (NMT 15 %) did not exceed the established acceptance criterion which is equal to the acceptable limit of the instrument error for particle count in the tested samples (20 %). The dilutional linearity of the procedure was demonstrated (coefficient of determination R2 = 0.999). The results obtained during the validation studies support the possibility of using the Coulter principle for the assessment of subvisible particles in water for injections.https://www.biopreparations.ru/jour/article/view/136water for injectionssubvisible particulate mattercoulter principle (electrical sensing zone method)light obscuration particle count test |
| spellingShingle | A. A. Voropaev O. V. Fadeikina T. N. Ermolaeva D. S. Davydov R. A. Volkova D. V. Shvedov Development and Validation of a Procedure for Subvisible Particles Determination in Water for Injections by the Coulter Principle (Electrical Sensing Zone Method) Биопрепараты: Профилактика, диагностика, лечение water for injections subvisible particulate matter coulter principle (electrical sensing zone method) light obscuration particle count test |
| title | Development and Validation of a Procedure for Subvisible Particles Determination in Water for Injections by the Coulter Principle (Electrical Sensing Zone Method) |
| title_full | Development and Validation of a Procedure for Subvisible Particles Determination in Water for Injections by the Coulter Principle (Electrical Sensing Zone Method) |
| title_fullStr | Development and Validation of a Procedure for Subvisible Particles Determination in Water for Injections by the Coulter Principle (Electrical Sensing Zone Method) |
| title_full_unstemmed | Development and Validation of a Procedure for Subvisible Particles Determination in Water for Injections by the Coulter Principle (Electrical Sensing Zone Method) |
| title_short | Development and Validation of a Procedure for Subvisible Particles Determination in Water for Injections by the Coulter Principle (Electrical Sensing Zone Method) |
| title_sort | development and validation of a procedure for subvisible particles determination in water for injections by the coulter principle electrical sensing zone method |
| topic | water for injections subvisible particulate matter coulter principle (electrical sensing zone method) light obscuration particle count test |
| url | https://www.biopreparations.ru/jour/article/view/136 |
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