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 Res
Petukhov A. E. Aleksej Evgenyevich 1985-
Petry'kina E. A. Elena Anatolyevna 1959-
Tereshkina O. I. Ol`ga Ivanovna 1955-
Ramenskaya G. V. Galina Vladislavovna 1972-
Antipova O. M.
Turashev A. D.
Zav’yalova E. G.
Golovin A. V. Andrej Viktorovich 1975-
Pavlova G. V. Galina Valerievna 1967-
Kopylov A. M.
Петухов А. Е. Алексей Евгеньевич 1985-
Петрыкина Е. А. Елена Анатольевна 1959-
Терешкина О. И. Ольга Ивановна 1955-
Раменская Г. В. Галина Владиславовна 1972-
Антипова О. М.
Тюрашев А. Д.
Зав’ялова Е. Г.
Головин А. В. Андрей Викторович 1975-
Павлова Г. В. Галина Валериевна 1967-
Копyлов А. М.
Standardization of Thrombaptanib Drug Substance for Residual Organic Solvents
Текст визуальный непосредственный
Pharmaceutical Chemistry Journal
Springer New York Consultants Bureau
Vol.52, Issue4 P. 366-371
2018
Статья
GC-MS determination procedure residual organic solvents standardization thrombaptanib validation
chemical compound organic solvent thrombaptanib thrombin inhibitor unclassified drug accuracy Article drug analysis drug mechanism drug specificity multiple sclerosis process control reproducibility standardization
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 Res