Androgen Receptor Pathway Inhibitor – Manufacturer and Bulk Supplier in Maharashtra for Prostate Cancer Treatment Formulations
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
Abiraterone (CAS 154229-18-2) is the free-base steroid compound that serves as both an active pharmaceutical ingredient and the biosynthetic precursor to Abiraterone Acetate, the prodrug form used clinically. As a selective irreversible inhibitor of CYP17A1 (17α-hydroxylase/17,20-lyase), abiraterone blocks androgen synthesis in testicular, adrenal, and intratumoral tissues, making it essential in castration-resistant prostate cancer (mCRPC) therapeutics.
Abiraterone free base requires highly specific synthesis control, particularly for the 3β-hydroxyl group stereochemistry and the pyridyl ring regiochemistry, which determine biological activity. Quality buyers specify optical rotation (specific [α]D²⁰ = +54° to +58° in ethanol), confirmed by chiral HPLC, alongside HPLC purity ≥98.5% and strict control of Δ16-abiraterone (a key process impurity) below 0.5%.
Swapnroop manufactures Abiraterone API at our WHO-GMP certified Aurangabad facility using validated stereoselective synthetic routes. Our supply is supported by chiral HPLC purity data, optical rotation confirmation, full impurity profiling, and DMF-level documentation for formulators developing abiraterone-based products or using it as a chemical intermediate in acetate prodrug synthesis.
Abiraterone API is packaged under nitrogen atmosphere in double-sealed amber glass bottles (100g–1 kg) for R&D quantities and in sealed polyethylene-lined fiber drums (5 kg, 25 kg) for bulk commercial supply. Stored at controlled room temperature (15–25°C) away from light and moisture.
Get Bulk QuoteThe CAS number for Abiraterone is 154229-18-2. It is a Androgen Receptor Pathway Inhibitor used in pharmaceutical prostate cancer treatment formulations.
Abiraterone is classified as a Androgen Receptor Pathway Inhibitor. It is used in prostate cancer treatment formulations and is an established API in both domestic Indian and international pharmaceutical markets.
Abiraterone API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC purity ≥98.0–102.0%, complete related substances profiling, and residual solvent analysis per ICH Q3C guidelines.
Minimum order is 1 kg for sampling and 25 kg for commercial bulk supply. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility. Larger volumes may be available from existing stock.
Yes, Swapnroop provides complete DMF-grade documentation for Abiraterone API including Certificate of Analysis (CoA), MSDS, impurity profile, residual solvent certificate, and regulatory filing support for USFDA, EMA, and CDSCO submissions.
Swapnroop Drugs and Pharmaceuticals is a trusted Abiraterone API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Abiraterone API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.
As a Abiraterone API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Abiraterone API pricing, samples, and sourcing support.