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製品名 Abiraterone Acetate
CAS番号. 154229-18-2
分子式 C26H33NO2
分子量 391.55
純度 99%
外観 白色または白色に近い粉末

Androgen antagonists.Abiraterone acetate (宿, ウーサン, 禁止, JAN) (brand names Zytiga, Abiratas, Abretone, Abirapro) is a steroidal antiandrogen, specifically an androgen synthesis inhibitor, used in combination with in metastatic castration-resistant prostate cancer (previously called hormone-resistant or hormone-refractory prostate cancer) - つまり, prostate cancer not responding to androgen deprivation or treatment with androgen receptor antagonists. It is a prodrug to the active agent abiraterone, and is marketed by Janssen Biotech under the trade name Zytiga. 加えて, Intas Pharmaceuticals markets the drug under the trade name Abiratas, Cadila Pharmaceuticals markets the drug as Abretone, and Glenmark Pharmaceuticals as Abirapro.

Abiraterone acetate was approved by the United States Food and Drug Administration on April 28, 2011. The FDA press release made reference to a phase III clinical trial in which abiraterone use was associated with a median survival of 14.8 months versus 10.9 months with placebo; the study was stopped early because of the successful outcome.

Use in Cancer Abiraterone acetate is approved to be used with to treat Prostate cancer that has metastasized (spread to other parts of the body). It is used in patients whose disease has not gotten better with other hormone therapy.
Abiraterone is also being studied in the treatment of other types of cancer.

アイテム 規格 結果
外観 White or off-white solid powder 準拠
識別 IRによる 準拠
By HPLC 準拠
溶解性 Soluble in DMF, sparingly soluble in THF, slightly soluble in meth anol and aceto nitrile, very sightly soluble in ethanol and dichloro met hane, insoluble in water 準拠
Polymorphic Form Polymorphic form 1 準拠
融点 211ºC~216ºC 212.8ºC~214.9ºC
水分含有量 ≤ 0.50% 0.10%
重金属 ≤ 20ppm 準拠
強熱時の残留物 ≤ 0.20% 0.09%
Related Substance Any single impurity: ≤0.10% 0.06%
総不純物: ≤1.00% 0.16%
アッセイ (on the anhydrous basis) 98.0%~102.0% 99.94%
粒子サイズ D90: ≤100µm 準拠
Reference Standard In-house Standard
結論 The product complied to In-house standard.
ストレージ Preserve in tight,light-resistant containers in a cool

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