Standardization of Thrombaptanib Drug Substance for Residual Organic Solvents
- Авторы: Petukhov A.1,2, Petrykina E.1, Tereshkina O.1, Ramenskaya G.1, Antipova O.3, Turashev A.3, Zav’yalova E.3,4, Golovin A.3,5, Pavlova G.3,6, Kopylov A.3,4
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Учреждения:
- I. M. Sechenov First Moscow State Medical University
- Moscow Narcology Research and Practice Center, Moscow City Department of Health
- APTO-FARM Company
- Department of Chemistry, M. V. Lomonosov Moscow State University
- Department of Bioengineering and Bioinformatics, M. V. Lomonosov Moscow State University
- Institute of Gene Biology, Russian Academy of Sciences
- Выпуск: Том 52, № 4 (2018)
- Страницы: 366-371
- Раздел: Structure of Chemical Compounds, Methods of Analysis and Process Control
- URL: https://journals.rcsi.science/0091-150X/article/view/245188
- DOI: https://doi.org/10.1007/s11094-018-1823-4
- ID: 245188
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Аннотация
Results from experiments conducted for the parameter Residual Organic Solvents during the course of developing a draft regulation for the drug substance of the innovative pharmacological agent thrombaptanib are reported. The structure of the compound is given. Its pharmacological action is described. A list of potential residual organic solvents was compiled by analyzing the synthetic scheme and manufacturing technology. A separate part of the work describes in detail a developed GC-MS procedure for determining residual organic solvents. Validation results of the procedure for Specificity, Linearity, Accuracy, Precision, and Reproducibility are presented. The validation protocol for the procedure at the time of the studies followed domestic guides for validation that were written based on existing international documents because there was no existing GPM for validation in the current edition of the SP RF. A test sample of thrombaptanib was analyzed using the developed procedure for Residual Organic Solvents. The developed procedure was included in the Residual Organic Solvents section of the draft regulation.
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Об авторах
A. Petukhov
I. M. Sechenov First Moscow State Medical University; Moscow Narcology Research and Practice Center, Moscow City Department of Health
Email: a-l-e-x4@yandex.ru
Россия, Moscow, 119991; Moscow, 103390
E. Petrykina
I. M. Sechenov First Moscow State Medical University
Email: a-l-e-x4@yandex.ru
Россия, Moscow, 119991
O. Tereshkina
I. M. Sechenov First Moscow State Medical University
Email: a-l-e-x4@yandex.ru
Россия, Moscow, 119991
G. Ramenskaya
I. M. Sechenov First Moscow State Medical University
Email: a-l-e-x4@yandex.ru
Россия, Moscow, 119991
O. Antipova
APTO-FARM Company
Автор, ответственный за переписку.
Email: a-l-e-x4@yandex.ru
Россия, Moscow, 115230
A. Turashev
APTO-FARM Company
Email: a-l-e-x4@yandex.ru
Россия, Moscow, 115230
E. Zav’yalova
APTO-FARM Company; Department of Chemistry, M. V. Lomonosov Moscow State University
Email: a-l-e-x4@yandex.ru
Россия, Moscow, 115230; Moscow, 119991
A. Golovin
APTO-FARM Company; Department of Bioengineering and Bioinformatics, M. V. Lomonosov Moscow State University
Email: a-l-e-x4@yandex.ru
Россия, Moscow, 115230; Moscow, 119991
G. Pavlova
APTO-FARM Company; Institute of Gene Biology, Russian Academy of Sciences
Email: a-l-e-x4@yandex.ru
Россия, Moscow, 115230; Moscow, 119334
A. Kopylov
APTO-FARM Company; Department of Chemistry, M. V. Lomonosov Moscow State University
Email: a-l-e-x4@yandex.ru
Россия, Moscow, 115230; Moscow, 119991