Abiraterone
Псевдоним : 17-(3-Pyridyl)androsta-5,16-dien-3beta-ol
CAS: 154229-19-3
Молекулярна формула: C24H31NO
Молекулно тегло: 349.51
Molecular Structure:
Анализ: 99%
Външен вид: Бяла пудра
Степен: Фармацевтичен клас
Съхранение: Засенчване, ограничено съхранение
Използване: 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) -- 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. Администрация по храните и лекарствата (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 |
Спецификации |
Резултати |
Външен вид |
A White or almost white crystalline powder |
Бяла пудра |
Разтворимост |
Freely soluble in methylene chloride,acetone and in THF,hardly soluble in n-Heptane |
Съобразете се |
Идентификация |
А).By IR: Положителен |
Съобразете се |
б).By HPLC: Положителен |
Съобразете се |
Специфична ротация |
-370да се -450 |
-420 |
Остатък при запалване |
0.2% макс |
0.07% |
Загуба при сушене |
1.0% макс |
0.22% |
Тежки метали |
20ppm max |
Съобразете се |
Related Substance
(чрез HPLC) |
Unspecified impurity: 0.1% макс |
0.08% |
Общи примеси: 0.5% макс |
0.33% |
Остатъчни разтворители |
Метанол:3000ug/g max |
1160 |
Methylene chloride: 600ug/g max |
Не е открит |
THF: 720ug/g max |
Не е открит |
Acetic acid:5000ug/g max |
Не е открит |
Състояние на съхранение |
Preserve in tight,light-resistant contaners,and store at room temperatura. |
Анализ (on anhydrous basis) |
98.0% да се 102.0% |
99.7% |