Abiraterone
エイリアス : 17-(3-Pyridyl)androsta-5,16-dien-3beta-ol
CAS: 154229-19-3
分子式: C24H31NO
分子量: 349.51
Molecular Structure:
アッセイ: 99%
外観: 白い粉
学年: 医薬品グレード
保管所: シェーディング, 密閉保存
使用法: 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. Food and Drug Administration (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).
アイテム |
仕様 |
結果 |
外観 |
A White or almost white crystalline powder |
白い粉 |
溶解性 |
Freely soluble in methylene chloride,acetone and in THF,hardly soluble in n-Heptane |
Conform |
識別 |
あ).By IR: Positive |
Conform |
B).By HPLC: Positive |
Conform |
Specific Rotation |
-370に -450 |
-420 |
着火残留物 |
0.2% 最大 |
0.07% |
乾燥減量 |
1.0% 最大 |
0.22% |
ヘビーメタル |
20ppm max |
Conform |
Related Substance
(HPLCによる) |
Unspecified impurity: 0.1% 最大 |
0.08% |
総不純物: 0.5% 最大 |
0.33% |
残留溶剤 |
メタノール:3000ug/g max |
1160 |
Methylene chloride: 600ug/g max |
見つかりませんでした |
THF: 720ug/g max |
見つかりませんでした |
Acetic acid:5000ug/g max |
見つかりませんでした |
Storage condition |
しっかりと保存する,light-resistant contaners,and store at room temperatura. |
アッセイ (on anhydrous basis) |
98.0% に 102.0% |
99.7% |