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Academic Journal
X-Ray powder diffraction. The practical application of the method in the pharmaceutical expertise
V. S. Kuzmin, V. V. Chernyshev, V. A. Yashkir, V. A. Merkulov
Регуляторные исследования и экспертиза лекарственных средств, Vol 0, Iss 2, Pp 13-16 (2018)
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| Title | X-Ray powder diffraction. The practical application of the method in the pharmaceutical expertise |
|---|---|
| Authors | V. S. Kuzmin, V. V. Chernyshev, V. A. Yashkir, V. A. Merkulov |
| Publication Year |
2018
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| Source |
Регуляторные исследования и экспертиза лекарственных средств, Vol 0, Iss 2, Pp 13-16 (2018)
|
| 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".
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| Document Type |
article
|
| Language |
Russian
|
| Publisher Information |
Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’), 2018.
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| Subject Terms | |
