Prodrug Ester of Abiraterone for Metastatic Prostate Cancer Tablets
| Parameter | Specification |
|---|---|
| Appearance | White to off-white powder |
| Identification | IR & HPLC compliant |
| Assay | 98.0% – 102.0% (on dried basis) |
| Loss on Drying / Water | As per pharmacopoeia |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.5% |
Typical specification. Exact limits are given in the batch Certificate of Analysis.
Get Bulk Quote for Abiraterone Acetate API
WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries
Abiraterone Acetate (CAS 154229-19-3) is the 3-acetate ester prodrug of abiraterone, an irreversible inhibitor of CYP17A1 (17α-hydroxylase/C17,20-lyase). After oral absorption it is rapidly hydrolysed to abiraterone, which blocks androgen biosynthesis in the testes, adrenal glands and prostate tumour tissue. It is used with prednisone or prednisolone for metastatic castration-resistant (mCRPC) and high-risk castration-sensitive prostate cancer.
Abiraterone Acetate is practically insoluble in water, so particle size (often micronised) and polymorphic form strongly affect bioavailability and food effect. Buyers should check that each batch controls the free abiraterone content, the Δ16-ene and other process-related steroid impurities, and residual solvents, and that the steroid is handled under high-potency containment.
Swapnroop Drugs and Pharmaceuticals supplies Abiraterone Acetate API from our WHO-GMP facility in Chhatrapati Sambhaji Nagar (Aurangabad), Maharashtra with complete documentation — Certificate of Analysis, MSDS, method of analysis and, where required, DMF-grade technical packages. Potent and hormonal APIs are handled under strict containment, with gram-scale samples for development and multi-kilogram lots for commercial supply.
Abiraterone Acetate API is packed in double polyethylene bags inside sealed HDPE containers or fibre drums (100 g, 500 g, 1 kg and 5 kg), labelled with cytotoxic / potent-compound handling instructions, batch number and storage conditions.
Get Bulk QuoteOther products available from Swapnroop Pharma
Abiraterone Acetate (CAS 154229-19-3) is the acetate ester prodrug used in tablets. It converts to abiraterone (CAS 154229-18-2), the active CYP17 inhibitor, after absorption.
The API is practically insoluble in water, so a smaller, controlled particle size improves dissolution and reduces variability in absorption, especially with food.
Each batch is tested for free abiraterone, steroidal process impurities, degradation products and residual solvents per ICH Q3A/Q3C limits.
Every batch is supplied with Certificate of Analysis (CoA), MSDS, and on request method of analysis, stability data and regulatory support documents.
Sample and trial quantities are available. Bulk orders are packed as per customer requirement; contact us on WhatsApp or email for pricing and lead time.
Swapnroop Drugs and Pharmaceuticals is a trusted Abiraterone Acetate API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical companies across India and international markets. Our WHO-GMP certified facility provides consistent Abiraterone Acetate API quality with full documentation, competitive pricing and dependable delivery.
As an exporter of Abiraterone Acetate API from India, Swapnroop supports customers with Certificate of Analysis, MSDS, impurity profiles and regulatory filing assistance. Contact us for Abiraterone Acetate API pricing, samples and sourcing support.