We are a professional Chinese plant integrating steroid raw material extraction & full chemical synthesis. Our Abiraterone Acetate 99% industrial synthesis route uses an optimized Negishi coupling green process without high-toxic triflate reagents, full closed-loop impurity removal production line, independent 100,000-class purification workshop, and strictly separated synthesis, crystallization, drying & packaging areas to prevent cross-contamination of impurities.
Our product is the premium pharmaceutical API grade for industrial mass production:
Appearance: Uniform fine white crystalline powder, no agglomeration, no visible colored impurities, high fineness for direct tablet pressing formulation;
Main fixed specifications: 99.0% HPLC (our industrial standard, higher than common market 98% grade), single unknown impurity ≤0.05%, total related substances ≤0.15%.
Product Strength
Chemical Advantage
Adopt proprietary two-stage gradient cooling recrystallization process, remove steroidal degradation impurities and pyridine by-products generated during Suzuki coupling reaction. Total impurities controlled within 0.15%, which greatly improves finished generic drug pass rate, reduces downstream pharmaceutical factories' secondary purification costs, shortens drug synthesis cycle by 15-20% compared with ordinary 98% raw materials. Stable chiral structure ensures consistent CYP17 enzyme inhibition activity after oral absorption of finished tablets, eliminating efficacy fluctuation risks caused by low chiral purity raw materials.
Physical processing advantages
Our 99% grade fine crystalline powder has uniform particle size distribution, good fluidity and compressibility, can be directly mixed with lactose, microcrystalline cellulose and other excipients for tablet pressing without micronization secondary processing, saving pharmaceutical factory grinding energy consumption and production time. Excellent solubility in pharmaceutical-grade DMSO and ethanol solvents, fully compatible with all mainstream solid preparation synthesis processes for prostate cancer oral drugs.
Full ICH Q3D heavy metal zero-compliance risk
Independent heavy metal purification workshop, whole-process closed production to avoid metal equipment pollution. Each batch comes with third-party ICP-MS heavy metal full inspection report, all heavy metal indicators meet FDA, EMA, EU pharmaceutical export standards. No need for downstream enterprises to conduct secondary heavy metal testing, simplifying overseas drug registration audit procedures.
Batch consistency & large-scale industrial scalability
Monthly stable production capacity of 500kg, automated continuous synthesis production line, all critical process parameters controlled by QbD quality design system. Core purity, impurity, heavy metal indicators of different batches fluctuate ≤0.1%, solving the common industry pain point of unstable finished drug quality caused by raw material batch difference. Support long-term annual exclusive bulk supply cooperation for large generic drug factories.
Product Applications
Generic Oncology Drug Mass Production
Key synthetic raw material of oral Abiraterone Acetate 250mg/500mg tablets, used by global pharmaceutical factories to produce drugs for metastatic castration-resistant prostate cancer (mCRPC) and high-risk metastatic hormone-sensitive prostate cancer (mHSPC). In vivo converted to active Abiraterone to inhibit CYP17 androgen synthesis enzyme, block tumor androgen supply. Our 99% high-purity grade is the designated raw material for EU/US registered generic drug manufacturers.
Pharmaceutical Standard Reference Substance Production
99% high-purity batch products can be used as primary reference standards for third-party pharmaceutical testing laboratories.
Customized New Steroidal Anti-tumor Drug Derivative Synthesis
Provide high-purity raw material support for pharmaceutical R&D enterprises developing modified long-acting Abiraterone derivatives, support laboratory small-batch trial synthesis and pilot scale-up production.
Customer case
European Medium-Sized Generic Drug Factory 3-Year Exclusive Supply Case
Long-term supply of 99% Abiraterone Acetate bulk raw materials to a Germany-based oncology pharmaceutical manufacturer, monthly fixed order 80-120kg. Our product's low heavy metal and ultra-low impurity indicators fully pass EMA drug registration audit, helping the customer complete 2 specifications of Abiraterone tablets EU marketing authorization, finished product qualification rate increased by 12% after switching our raw materials.
Thailand pharmaceutical factory Case
Provide free test samples for a Thailand pharmaceutical factory, after verifying purity and formulation adaptability, sign an annual bulk supply framework agreement, and support sea freight door-to-door delivery with complete customs clearance certification documents.
FAQ
Q: What are the storage and transportation requirements of Abiraterone Acetate 99%?
A: Sealed, dry, dark environment storage at -20℃, avoid high temperature and moisture, shelf life 24 months under standard storage. During international transportation, use moisture-proof aluminum drum packaging with ice box low-temperature cold chain transportation to prevent molecular hydrolysis degradation caused by temperature rise. MSDS safety operation guide will be provided with each shipment.
Q: What is the MOQ for bulk industrial orders?
A: Industrial mass production bulk orders MOQ is 1kg, monthly stable supply capacity up to 500kg, support annual long-term exclusive supply framework agreements with customized preferential prices.
Q: Are your Abiraterone Acetate 99% raw materials compliant with USP/EP international pharmacopoeia standards?
A: 100% compliant. All production indicators are formulated strictly referring to USP 49-NF44 and EP 11 monographs, impurity limits, heavy metal control, identification test methods fully consistent with pharmacopoeia requirements. Third-party CNAS laboratory regular sampling inspection can provide pharmacopoeia standard comparison test reports for customer drug registration use.
Q: What is your delivery cycle and available global logistics methods?
A: We maintain spot inventory of 200kg+ 99% high-purity grade, spot orders delivered within 3-5 working days after payment; customized large batches over 100kg delivered within 7-12 working days. Support DHL/FedEx international express for small samples, air freight for 1-50kg batches, sea freight for ton-level bulk orders, complete customs clearance documents to ensure smooth customs clearance in Europe, America, Southeast Asia and other regions.
Q: What is the palladium catalyst residue control standard of your product, will it affect finished drug registration?
A: Palladium residual limit ≤0.5ppm, far lower than ICH Q3D oral drug 10ppm limit standard. Independent palladium removal purification process is added in the production line, each batch has special heavy metal detection data for palladium, will not cause non-compliance risks in finished drug overseas registration audit.
Our Certification
We are certified ISO9001, HACCP, Kosher, Halal, and EU NOP Organic Certification.
Customer feedback
Our commitment to purity and potency speaks for itself. With outstanding feedback internationally, our product is a verified choice for businesses seeking reliability and excellence.
Payment And Shipping
We accept the payment by T/T, PayPal ,Western Union,Trade Assurance or Escrow.
Beton is your trusted partner, dedicated to listening to customers, solving every problem, and providing quick responses. For any questions or assistance regarding products, feel free to contact us.
Email: dh@betonnutrition.com
WeChat: +86 13096987266
WhatsApp: +86 18792880979
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