Abiraterone
Takma ad : 17-(3-Piridil)androsta-5,16-dien-3beta-ol
CAS: 154229-19-3
Moleküler Formül: C24H31NO
Molekül Ağırlığı: 349.51
Moleküler Yapı:
tahlil: 99%
Dış görünüş: Beyaz toz
Seviye: Farmasötik Sınıf
Depolamak: Gölgeleme, sınırlı koruma
Kullanım: Metastatik kastrasyona dirençli prostat kanseri tedavisinde prednizon ile kombinasyon halinde kullanılması endikedir..
Abiraterone is a drug used in combination with prednisone in metastatic castration-resistant prostate cancer (formerly hormone-resistant or hormone-refractory prostate cancer) -- yani., 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. Gıda ve İlaç İdaresi (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.
Metastatik kastrasyona dirençli prostat kanseri tedavisinde prednizon ile kombinasyon halinde kullanılması endikedir.. 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).
| Öğeler |
Özellikler |
Sonuçlar |
| Dış görünüş |
A White or almost white crystalline powder |
beyaz toz |
| çözünürlük |
Freely soluble in methylene chloride,acetone and in THF,hardly soluble in n-Heptane |
Uygun |
| Tanılama |
A).IR tarafından: Olumlu |
Uygun |
| B).HPLC'ye göre: Olumlu |
Uygun |
| Spesifik Rotasyon |
-370ile -450 |
-420 |
| Ateşlemede kalıntı |
0.2% maksimum |
0.07% |
| Kurutma kaybı |
1.0% maksimum |
0.22% |
| Ağır metaller |
20maksimum sayfa/dakika |
Uygun |
İlgili Madde
(by HPLC) |
Unspecified impurity: 0.1% maksimum |
0.08% |
| Toplam safsızlıklar: 0.5% maksimum |
0.33% |
| Artık solventler |
Metanol:3000ug/g max |
1160 |
| Methylene chloride: 600ug/g max |
Algılanmadı |
| THF: 720ug/g max |
Algılanmadı |
| Acetic acid:5000ug/g max |
Algılanmadı |
| Storage condition |
Sıkıca saklayın,light-resistant contaners,and store at room temperatura. |
| tahlil (susuz bazda) |
98.0% ile 102.0% |
99.7% |