Abiraterone
Псевдонім : 17-(3-Pyridyl)androsta-5,16-dien-3beta-ol
CAS: 154229-19-3
Молекулярна формула: C24H31NO
Молекулярна маса: 349.51
Molecular Structure:
аналіз: 99%
Зовнішній вигляд: Білий порошок
Оцінка: Фармацевтичний клас
Зберігання: Розтушовування, обмежене збереження
Використання: It is indicated for use in combination with prednisone as a treatment for metastatic castration-resistant prostate cancer.
Abiraterone is a drug used in combination with prednisone in metastatic castration-resistant prostate cancer (formerly hormone-resistant or hormone-refractory prostate cancer) -- тобто, 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. Управління з харчових продуктів і медикаментів (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.
It is indicated for use in combination with prednisone as a treatment for metastatic castration-resistant prostate cancer. 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).
Предмети |
Технічні характеристики |
Результати |
Зовнішній вигляд |
A White or almost white crystalline powder |
білий порошок |
Розчинність |
Freely soluble in methylene chloride,acetone and in THF,hardly soluble in n-Heptane |
Відповідати |
Ідентифікація |
А).By IR: Позитивний |
Відповідати |
Б).By HPLC: Позитивний |
Відповідати |
Питома ротація |
-370до -450 |
-420 |
Залишок при розпалюванні |
0.2% макс |
0.07% |
Втрати при висиханні |
1.0% макс |
0.22% |
Важкі метали |
20ppm max |
Відповідати |
Related Substance
(методом ВЕРХ) |
Unspecified impurity: 0.1% макс |
0.08% |
Total impurities: 0.5% макс |
0.33% |
Residual solvents |
Methanol:3000ug/g max |
1160 |
Methylene chloride: 600ug/g max |
Not detected |
THF: 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. |
аналіз (on anhydrous basis) |
98.0% до 102.0% |
99.7% |