Abiraterone
Alias : 17-(3-Pyridyl)androsta-5,16-dien-3beta-ol
CAS: 154229-19-3
Molekulový vzorec: C24H31NO
Molekulová hmotnosť: 349.51
Molekulárna štruktúra:
Skúška: 99%
Vzhľad: Biely prášok
stupňa: Farmaceutická trieda
Skladovanie: Tieňovanie, obmedzené uchovanie
Použitie: Je indikovaný na použitie v kombinácii s prednizónom na liečbu metastatického karcinómu prostaty rezistentného na kastráciu.
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. Food and Drug Administration (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.
Je indikovaný na použitie v kombinácii s prednizónom na liečbu metastatického karcinómu prostaty rezistentného na kastráciu. 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).
| Položky |
Špecifikácie |
Výsledky |
| Vzhľad |
A White or almost white crystalline powder |
biely prášok |
| Rozpustnosť |
Freely soluble in methylene chloride,acetone and in THF,hardly soluble in n-Heptane |
Vyhovovať |
| Identifikácia |
A).IR: Pozitívny |
Vyhovovať |
| B).Pomocou HPLC: Pozitívny |
Vyhovovať |
| Špecifická rotácia |
-370do -450 |
-420 |
| Zvyšky po zapálení |
0.2% max |
0.07% |
| Strata sušením |
1.0% max |
0.22% |
| Ťažké kovy |
20ppm max |
Vyhovovať |
Súvisiaca látka
(pomocou HPLC) |
Nešpecifikovaná nečistota: 0.1% max |
0.08% |
| Celkové nečistoty: 0.5% max |
0.33% |
| Zvyškové rozpúšťadlá |
metanol:3000a/g max |
1160 |
| metylénchlorid: 600a/g max |
Nezistené |
| THF: 720a/g max |
Nezistené |
| Acetic acid:5000a/g max |
Nezistené |
| Storage condition |
Preserve in tight,light-resistant contaners,and store at room temperatura. |
| Skúška (na bezvodom základe) |
98.0% do 102.0% |
99.7% |