Injection 99% Pharmaceutical Material USP Standard Abiraterone CAS:154229-19-3
Alias : 17-(3-Pyridyl)androsta-5,16-dien-3beta-ol
Molecular Formula: C24H31NO
Molecular Weight: 349.51
Appearance: White powder
Grade: Pharmaceutical Grade
Storage: Shading, confined preservation
Usage: It is indicated for use in combination with prednisone as a treatment for metastatic castration-resistant prostate
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.
It is indicated for use in combination with prednisone as a treatment for metastatic castration-resistant prostate cancer. 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).
||A White or almost white crystalline powder
||Freely soluble in methylene chloride,acetone and in THF,hardly soluble in n-Heptane
||A).By IR: Positive
|B).By HPLC: Positive
|Residue on ignition
|Loss on drying
|Unspecified impurity: 0.1% max
|Total impurities: 0.5% max
|Methylene chloride: 600ug/g max
|THF: 720ug/g max
|Acetic acid:5000ug/g max
||Preserve in tight,light-resistant contaners,and store at room temperatura.
|Assay (on anhydrous basis)
||98.0% to 102.0%
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Injection 99% Pharmaceutical Material USP Standard Abiraterone CAS 154229-19-3 Images