Abiraterone
alias : 17-(3-Pyridyl)androsta-5,16-dien-3beta-ol
CAS: 154229-19-3
Formulae hypotheticae: C24H31NO
M. Pondus: 349.51
M:
Assay: 99%
Aspectus: Pulvis albus
Gradus: Pharmaceutical Grade
Repono: Shading, inclusi conservationem
Usage: Indicatur usus in compositione cum valium pro curatione metastaticae castrationis repugnantis cancer prostatae.
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. Cibus et medicamentis Administration (FDA) in April 2011. In Phase III trials, it extended median survival to 14.8 mensibus versus 10.9 months placebo, and the trial was stopped because of the successful outcome.
Indicatur usus in compositione cum valium pro curatione metastaticae castrationis repugnantis cancer prostatae. 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).
| Items |
Specifications |
Proventus |
| Aspectus |
A White or almost white crystalline powder |
cerussa |
| Solubilitas |
Freely soluble in methylene chloride,acetone and in THF,hardly soluble in n-Heptane |
Conformare |
| Lepidium sativum |
A).per IR: Positivum |
Conformare |
| B).per HPLC: Positivum |
Conformare |
| Imprimis Rotationes |
-370to -450 |
-420 |
| Requiesce in ignitio |
0.2% max |
0.07% |
| Damnum in siccitate |
1.0% max |
0.22% |
| Metalla gravis |
20ppm max |
Conformare |
Substantia cognata
(per HPLC *) |
immunditia non specificata: 0.1% max |
0.08% |
| Summa immunditiae: 0.5% max |
0.33% |
| RELICTUM menstrua |
Methanol:3000ug/g max |
1160 |
| Methylene chloride: 600ug/g max |
Non detectum |
| THF: 720ug/g max |
Non detectum |
| Acetic acid:5000ug/g max |
Non detectum |
| Storage condition |
Stricta in conserva,light-resistant contaners,and store at room temperatura. |
| Assay (in anhydrous basis) |
98.0% to 102.0% |
99.7% |