X-Ray powder diffraction. The practical application of the method in the pharmaceutical expertise
Method of X-ray phase analysis based on obtaining and analyzing the diffraction pattern resulting from the diffraction of x-rays scattered by electrons of the atoms of the irradiated polycrystalline sample. Using this method in the framework of a pre-registration examination the study of pharmaceuti...
Saved in:
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2018-02-01
|
| Series: | Регуляторные исследования и экспертиза лекарственных средств |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/33 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849395066931511296 |
|---|---|
| author | V. S. Kuzmin V. V. Chernyshev V. A. Yashkir V. A. Merkulov |
| author_facet | V. S. Kuzmin V. V. Chernyshev V. A. Yashkir V. A. Merkulov |
| author_sort | V. S. Kuzmin |
| collection | DOAJ |
| description | Method of X-ray phase analysis based on obtaining and analyzing the diffraction pattern resulting from the diffraction of x-rays scattered by electrons of the atoms of the irradiated polycrystalline sample. Using this method in the framework of a pre-registration examination the study of pharmaceutical substances temosolomide, form I of valacyclovir hydrochloride monohydrate and quetiapine fumarate (form I) to confirm their authenticity. The results obtained allowed to conclude that the claimant substance temosolomide is not primary, and the substance of valacyclovir does not meet the stated requirements in terms of "Authenticity". |
| format | Article |
| id | doaj-art-e90cab8eb1c444e889b4e70567726db3 |
| institution | Kabale University |
| issn | 3034-3062 3034-3453 |
| language | Russian |
| publishDate | 2018-02-01 |
| publisher | Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) |
| record_format | Article |
| series | Регуляторные исследования и экспертиза лекарственных средств |
| spelling | doaj-art-e90cab8eb1c444e889b4e70567726db32025-08-20T03:39:45ZrusFederal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)Регуляторные исследования и экспертиза лекарственных средств3034-30623034-34532018-02-0102131631X-Ray powder diffraction. The practical application of the method in the pharmaceutical expertiseV. S. Kuzmin0V. V. Chernyshev1V. A. Yashkir2V. A. Merkulov3Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationM.V. Lomonosov Moscow State UniversityFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationMethod of X-ray phase analysis based on obtaining and analyzing the diffraction pattern resulting from the diffraction of x-rays scattered by electrons of the atoms of the irradiated polycrystalline sample. Using this method in the framework of a pre-registration examination the study of pharmaceutical substances temosolomide, form I of valacyclovir hydrochloride monohydrate and quetiapine fumarate (form I) to confirm their authenticity. The results obtained allowed to conclude that the claimant substance temosolomide is not primary, and the substance of valacyclovir does not meet the stated requirements in terms of "Authenticity".https://www.vedomostincesmp.ru/jour/article/view/33x-ray powder diffractionx-ray analysissubstances of medicinesindex «identity»рентгеновская порошковая дифрактометриярентгенофазовый анализсубстанции лекарственных средствпоказатель «подлинность» |
| spellingShingle | V. S. Kuzmin V. V. Chernyshev V. A. Yashkir V. A. Merkulov X-Ray powder diffraction. The practical application of the method in the pharmaceutical expertise Регуляторные исследования и экспертиза лекарственных средств x-ray powder diffraction x-ray analysis substances of medicines index «identity» рентгеновская порошковая дифрактометрия рентгенофазовый анализ субстанции лекарственных средств показатель «подлинность» |
| title | X-Ray powder diffraction. The practical application of the method in the pharmaceutical expertise |
| title_full | X-Ray powder diffraction. The practical application of the method in the pharmaceutical expertise |
| title_fullStr | X-Ray powder diffraction. The practical application of the method in the pharmaceutical expertise |
| title_full_unstemmed | X-Ray powder diffraction. The practical application of the method in the pharmaceutical expertise |
| title_short | X-Ray powder diffraction. The practical application of the method in the pharmaceutical expertise |
| title_sort | x ray powder diffraction the practical application of the method in the pharmaceutical expertise |
| topic | x-ray powder diffraction x-ray analysis substances of medicines index «identity» рентгеновская порошковая дифрактометрия рентгенофазовый анализ субстанции лекарственных средств показатель «подлинность» |
| url | https://www.vedomostincesmp.ru/jour/article/view/33 |
| work_keys_str_mv | AT vskuzmin xraypowderdiffractionthepracticalapplicationofthemethodinthepharmaceuticalexpertise AT vvchernyshev xraypowderdiffractionthepracticalapplicationofthemethodinthepharmaceuticalexpertise AT vayashkir xraypowderdiffractionthepracticalapplicationofthemethodinthepharmaceuticalexpertise AT vamerkulov xraypowderdiffractionthepracticalapplicationofthemethodinthepharmaceuticalexpertise |