Our manufactures 99% Ibrutinib API via self-developed 3-stage low-temperature chiral synthesis process. All core intermediates are self-produced in-house to eliminate impurity contamination from outsourced raw materials:
Core pyrimidine mother nucleus: Self-synthesized 3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-4-amine with ≥99.8% purity from independent cyclization workshop;
Chiral split fragment: High-purity (R)-3-aminopiperidine dihydrochloride processed by dedicated chiral separation equipment, S-stereoisomer strictly controlled ≤0.1%;
Capping reagent: Electronic-grade acryloyl chloride with minimal hydrolytic impurities under precise temperature-controlled acylation reaction;
Purification technology: Multi-stage recrystallization with ethanol-isopropanol composite solvent system. Unlike single-solvent refining widely adopted in the industry, this technology stabilizes final purity above 99.0% with batch purity fluctuation controlled within ±0.3%.
Annual production capacity reaches 1200kg for BTK-targeted APIs. We operate independent synthesis workshops and Class D 10,000-level clean purification workshops with fully closed negative-pressure production lines to prevent cross-contamination of heavy metals.
Product strength
1.High-purity single R-enantiomer covalently binds irreversibly to Cys481 site of BTK protein, delivering consistent in-vitro cellular test results free from impurity interference.
2.Strictly controlled impurity profiles minimize confounding variables in preclinical toxicology studies and accelerate ANDA/IND application timelines for generic and novel drug developers.
3.Stable physicochemical properties maintain consistent purity for 3 years at -20℃ sealed storage, ideal for long-term CRO research on pharmacokinetics, drug resistance mechanisms and combination therapy trials.
Products Applications
Generic Pharmaceutical Formulation Manufacturing
Oral capsule & tablet raw material for therapies of Chronic Lymphocytic Leukemia (CLL), Mantle Cell Lymphoma (MCL), Waldenström's Macroglobulinemia (WM);
Oral suspension API for pediatric chronic graft-versus-host disease (cGVHD) formulation development;
Active pharmaceutical ingredient for compound targeted anti-tumor drug co-formulation research.
Biomedical CRO & Academic Laboratory Research
In-vitro BTK kinase inhibitory activity screening and B-cell tumor cellular model pharmacological testing;
Research on drug-resistant BTK mutation mechanisms and comparative trials for second-generation BTK inhibitors;
Preclinical pharmacokinetic (PK) and toxicology animal model experiments;
Fundamental anti-tumor small molecule research for university pharmacy schools and life science research institutes.
Custom Fine Chemical Development
Custom synthesis of Ibrutinib derivative intermediates;
Production of isotope-labeled Ibrutinib (¹³C / ¹⁴C labeled) for tracer studies;
Custom preparation of high-purity impurity reference standards (S-Ibrutinib, acrylamide degradation impurities).
Client Cases
Mid-Size European Generic Pharmaceutical Enterprise (Annual Purchase Volume: 320 kg)
Client Requirement: EP-standard 99% Ibrutinib API with rigorous heavy metal control for EU blood cancer oral capsule registration.
Cooperation Outcome: Stable monthly supply of 30 kg. SGS heavy metal certificates and complete batch COAs are delivered alongside each shipment. Our API directly passed EDQM impurity audits in Europe. The client eliminated secondary purification workflows, reducing per-batch formulation production costs by 18%. A long-term framework supply agreement has been signed covering 2024–2026.
US Biomedical CRO Laboratory
Client Requirement: 10–100 g high-purity trial samples with minimal chiral impurities for in-vitro cellular experiments on BTK drug resistance.
Cooperation Outcome: Free 5 g test samples provided with only courier fees covered by the client. Split small-batch spot delivery is available. Low-impurity raw materials eliminate distorted lab data, supporting continuous procurement over 3 years for raw materials used in multiple SCI pharmacological research papers.
Our service
Flexible Batch Supply Solutions
Lab small orders: 10 g–1 kg in stock for same-day dispatch, DHL/FedEx delivery takes 3–7 working days to Europe & North America;
Industrial bulk orders: 5 kg–1000 kg annual framework contracts with locked long-term unit pricing and priority production during peak demand seasons;
Custom specifications: Isotope-labeled raw materials, impurity reference standards, customized sterile foil bags or vacuum light-proof packaging on demand.
Complete Free Regulatory Documentation Package
All shipments include permanent free access to full filing documents: Batch COA, SDS safety data sheet, SGS heavy metal report, GMP factory certification, synthetic process flow chart, full impurity profile and ICH residual solvent test data. All documents support FDA, EMA and NMPA regulatory audits globally.
Stable Storage & Multi-Channel Logistics
Constant-temperature light-shielded raw material warehouse in-house with 150 kg 99% Ibrutinib spot inventory year-round. Air freight and sea freight shipping channels are both available to balance cost and delivery speed for different order volumes.
FAQ
Q: What purity guarantee do you offer for your 99% Ibrutinib API?
A: Our factory strictly enforces HPLC assay ≥99.0% with S-stereoisomer ≤0.1%. Every batch comes with chiral HPLC chromatograms and SGS heavy metal reports. If independent re-testing by clients fails to meet stated standards, we offer full refunds and complimentary re-shipping of qualified goods.
Q: How do you achieve much lower heavy metal content than other suppliers?
A: We operate fully closed negative-pressure synthesis lines to eliminate contamination from metal reaction equipment. All self-produced starting intermediates undergo pre heavy metal screening. Multi-stage recrystallization removes residual metal ions, resulting in total heavy metal content below 0.1 ppm, far exceeding EP and USP threshold requirements.
Q: What storage conditions are required for 99% Ibrutinib crystalline powder?
A: Store hermetically sealed at -20℃ away from light and moisture for a maximum 36-month shelf life. Under sealed dry room-temperature storage, purity remains stable for 24 months without obvious degradation. Repeated temperature fluctuations must be avoided.
Q: Is your Ibrutinib API suitable for oral solid pharmaceutical mass production?
A: Absolutely. Our 80–120 mesh uniform crystalline powder delivers excellent flowability with moisture content controlled ≤0.2% and zero agglomeration. It works seamlessly on high-speed capsule filling and tablet pressing production lines without equipment blockages during continuous manufacturing.
Q: What advantages does your mixed-solvent recrystallization have over single ethanol refining used by competitors?
A: Single ethanol refining cannot fully remove chiral stereoisomers and trace heavy metal residues. Our ethanol-isopropanol composite recrystallization technology cuts single unknown impurities by 60% and restricts chiral impurities below 0.1%, allowing downstream pharmaceutical factories to eliminate secondary purification steps and reduce overall manufacturing costs.
Q: Do you support long-term annual or quarterly framework supply contracts?
A: Yes. We offer fixed-price annual and quarterly framework agreements for pharmaceutical manufacturers, locking unit prices throughout the contract term, guaranteeing fixed monthly supply volumes, and prioritizing production scheduling during industry peak demand cycles.
Q: What solvents are applied in production, and do they comply with ICH residual solvent guidelines?
A: Primary production solvents are ethanol and isopropanol, both classified as low-toxicity Class 3 solvents per ICH standards. Residual solvent test results for all batches remain below 1000 ppm, fully compliant with ICH Q3C rules for oral pharmaceutical active raw materials.
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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