Abiraterone
Псевдоним : 17-(3-Пиридил)androsta-5,16-dien-3beta-ol
КАС: 154229-19-3
Молекулярная формула: C24H31NO
Молекулярный вес: 349.51
Молекулярная структура:
Анализ: 99%
Появление: Белый порошок
Оценка: Фармацевтический класс
Хранилище: Затенение, ограниченное сохранение
Использование: Он показан для использования в сочетании с преднизолоном для лечения метастатического рака простаты, резистентного к кастрации..
Abiraterone is a drug used in combination with prednisone in metastatic castration-resistant prostate cancer (formerly hormone-resistant or hormone-refractory prostate cancer) -- i.e., prostate cancer not responding to androgen deprivation or treatment with antiandrogens. It is formulated as the prodrug abiraterone acetate and marketed under the trade name Zytiga. Cadila Pharmaceuticals has recently started marketing Abiraterone acetate under the trade name Abretone.
After an expedited six-month review, abiraterone was approved by the U.S. Управление по контролю за продуктами и лекарствами (FDA) in April 2011. In Phase III trials, it extended median survival to 14.8 months versus 10.9 months placebo, and the trial was stopped because of the successful outcome.
Он показан для использования в сочетании с преднизолоном для лечения метастатического рака простаты, резистентного к кастрации.. It has received FDA (28 April 2011), EMA (23 September 2011), MHRA (5 September 2011) and TGA (1 March 2012) approval for this indication. In Australia it is covered by the Pharmaceutical Benefits Scheme when being used to treat castration-resistant prostate cancer and given in combination with prednisone/prednisolone (subject to the conditions that the patient is not currently receiving chemotherapy, is either resistant or intolerant of docetaxel, has a WHO performance status of <2, and his disease has not since become progressive since treatment with PBS-subsidised abiraterone has commenced).
| Предметы |
Технические характеристики |
Результаты |
| Появление |
A White or almost white crystalline powder |
белый порошок |
| Растворимость |
Freely soluble in methylene chloride,acetone and in THF,hardly soluble in n-Heptane |
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| Идентификация |
А).By IR: Позитивный |
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| Б).By HPLC: Позитивный |
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| Конкретное вращение |
-370к -450 |
-420 |
| Остаток при зажигании |
0.2% Макс |
0.07% |
| Потери при высыхании |
1.0% Макс |
0.22% |
| Тяжелые металлы |
20ppm max |
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Related Substance
(методом ВЭЖХ) |
Unspecified impurity: 0.1% Макс |
0.08% |
| Всего примесей: 0.5% Макс |
0.33% |
| Остаточные растворители |
Метанол:3000ug/g max |
1160 |
| Methylene chloride: 600ug/g max |
Not detected |
| ТГФ: 720ug/g max |
Not detected |
| Acetic acid:5000ug/g max |
Not detected |
| Storage condition |
Preserve in tight,light-resistant contaners,and store at room temperatura. |
| Анализ (on anhydrous basis) |
98.0% к 102.0% |
99.7% |