Abiraterone
Alias : 17-(3-Piridile)androsta-5,16-dien-3beta-ol
CAS: 154229-19-3
Formula molecolare: C24H31NO
Peso Molecolare: 349.51
Struttura molecolare:
Analisi: 99%
Aspetto: Polvere bianca
Grado: Grado farmaceutico
Magazzinaggio: Ombreggiatura, conservazione confinata
Utilizzo: È indicato per l'uso in combinazione con prednisone come trattamento per il cancro alla prostata metastatico resistente alla castrazione.
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. Amministrazione degli alimenti e dei farmaci (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.
È indicato per l'uso in combinazione con prednisone come trattamento per il cancro alla prostata metastatico resistente alla castrazione. 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).
| Elementi |
Specifiche |
Risultati |
| Aspetto |
A White or almost white crystalline powder |
polvere bianca |
| Solubilità |
Freely soluble in methylene chloride,acetone and in THF,hardly soluble in n-Heptane |
Conformarsi |
| Identificazione |
UN).By IR: Positivo |
Conformarsi |
| B).By HPLC: Positivo |
Conformarsi |
| Rotazione specifica |
-370A -450 |
-420 |
| Residuo alla combustione |
0.2% massimo |
0.07% |
| Perdita all'essiccazione |
1.0% massimo |
0.22% |
| Metalli pesanti |
20ppm massimo |
Conformarsi |
Related Substance
(mediante HPLC) |
Unspecified impurity: 0.1% massimo |
0.08% |
| Impurità totali: 0.5% massimo |
0.33% |
| Solventi residui |
Metanolo:3000ug/g max |
1160 |
| Methylene chloride: 600ug/g max |
Non rilevato |
| THF: 720ug/g max |
Non rilevato |
| Acetic acid:5000ug/g max |
Non rilevato |
| Storage condition |
Preserve in tight,light-resistant contaners,and store at room temperatura. |
| Analisi (on anhydrous basis) |
98.0% A 102.0% |
99.7% |