Abiraterone
Alias : 17-(3-piridilo)androsta-5,16-dien-3beta-ol
CAS: 154229-19-3
Fórmula molecular: C24H31NO
Peso molecular: 349.51
Estructura molecular:
Ensayo: 99%
Apariencia: polvo blanco
Calificación: Grado farmacéutico
Almacenamiento: Sombreado, preservación confinada
Uso: Está indicado para su uso en combinación con prednisona como tratamiento del cáncer de próstata metastásico resistente a la castración..
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. Administración de Alimentos y Medicamentos (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.
Está indicado para su uso en combinación con prednisona como tratamiento del cáncer de próstata metastásico resistente a la castración.. 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).
| Elementos |
Presupuesto |
Resultados |
| Apariencia |
A White or almost white crystalline powder |
polvo blanco |
| Solubilidad |
Freely soluble in methylene chloride,acetone and in THF,hardly soluble in n-Heptane |
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| Identificación |
A).By IR: Positivo |
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| B).By HPLC: Positivo |
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| Rotación específica |
-370a -450 |
-420 |
| Residuo de ignición |
0.2% máximo |
0.07% |
| Pérdida por secado |
1.0% máximo |
0.22% |
| metales pesados |
20ppm máx. |
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Sustancia relacionada
(por HPLC) |
Unspecified impurity: 0.1% máximo |
0.08% |
| Impurezas totales: 0.5% máximo |
0.33% |
| Solventes residuales |
Metanol:3000ug/g max |
1160 |
| Methylene chloride: 600ug/g max |
Not detected |
| THF: 720ug/g max |
Not detected |
| Acetic acid:5000ug/g max |
Not detected |
| Condición de almacenamiento |
Preservar firmemente,light-resistant contaners,and store at room temperatura. |
| Ensayo (en base anhidra) |
98.0% a 102.0% |
99.7% |