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  • Specifications
  • depictio producti
  • Product Syntaxis
  • COA
Product nomen Abiraterone Acetate
CAS No. 154229-18-2
Formulae hypotheticae C26H33NO2
M. pondus 391.55
Puritas 99%
Aspectus Alba vel fere cerussa

Androgen antagonists.Abiraterone acetate (TABERNA, USAN, BAN, JAN) (brand names Zytiga, Abiratas, Abretone, Abirapro) is a steroidal antiandrogen, specifically an androgen synthesis inhibitor, used in combination with in metastatic castration-resistant prostate cancer (previously called hormone-resistant or hormone-refractory prostate cancer) - i.e., prostate cancer not responding to androgen deprivation or treatment with androgen receptor antagonists. It is a prodrug to the active agent abiraterone, and is marketed by Janssen Biotech under the trade name Zytiga. Autem, Intas Pharmaceuticals markets the drug under the trade name Abiratas, Cadila Pharmaceuticals markets the drug as Abretone, and Glenmark Pharmaceuticals as Abirapro.

Abiraterone acetate was approved by the United States Food and Drug Administration on April 28, 2011. The FDA press release made reference to a phase III clinical trial in which abiraterone use was associated with a median survival of 14.8 months versus 10.9 months with placebo; the study was stopped early because of the successful outcome.

Use in Cancer Abiraterone acetate is approved to be used with to treat Prostate cancer that has metastasized (spread to other parts of the body). It is used in patients whose disease has not gotten better with other hormone therapy.
Abiraterone is also being studied in the treatment of other types of cancer.

Items Standards Results
Aspectus White or off-white solid powder Complies
Lepidium sativum By IR Complies
By HPLC Complies
Solubilitas Soluble in DMF, sparingly soluble in THF, slightly soluble in meth anol and aceto nitrile, very sightly soluble in ethanol and dichloro met hane, insolubilem aquam Complies
Polymorphic Form Polymorphic form 1 Complies
Liquescens punctum 211ºC~216ºC 212.8ºC~214.9ºC
Aqua Content ≤ 0.50% 0.10%
Heavy Metals ≤ 20ppm Complies
Residue on Ignition ≤ 0.20% 0.09%
Related Substance Any single impurity: ≤0.10% 0.06%
Total Impurities: ≤1.00% 0.16%
Assay (on the anhydrous basis) 98.0%~102.0% 99.94%
Magnitudo particula D90: ≤100µm Complies
Reference Standard In-house Standard
conclusio The product complied to In-house standard.
Repono Preserve in tight,light-resistant containers in a cool

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