Abiraterone
エイリアス : 17-(3-ピリジル)androsta-5,16-dien-3beta-ol
CAS: 154229-19-3
分子式: C24H31NO
分子量: 349.51
分子構造:
アッセイ: 99%
外観: 白い粉
学年: 医薬品グレード
ストレージ: シェーディング, 密閉保存
使用法: 転移性去勢抵抗性前立腺がんの治療としてプレドニゾンと併用することが適応となります。.
Abiraterone is a drug used in combination with prednisone in metastatic castration-resistant prostate cancer (formerly hormone-resistant or hormone-refractory prostate cancer) -- つまり, 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. 食品医薬品局 (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.
転移性去勢抵抗性前立腺がんの治療としてプレドニゾンと併用することが適応となります。. 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 |
適合 |
| 識別 |
あ).IRによる: ポジティブ |
適合 |
| B).HPLCによる: ポジティブ |
適合 |
| 特定の回転 |
-370に -450 |
-420 |
| 強熱時の残留物 |
0.2% 最大 |
0.07% |
| 乾燥減量 |
1.0% 最大 |
0.22% |
| 重金属 |
20ppm最大 |
適合 |
関連物質
(HPLCによる) |
不特定の不純物: 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 |
検出されませんでした |
| THF: 720ug/g max |
検出されませんでした |
| Acetic acid:5000ug/g max |
検出されませんでした |
| Storage condition |
Preserve in tight,light-resistant contaners,and store at room temperatura. |
| アッセイ (無水ベースで) |
98.0% に 102.0% |
99.7% |