Global Manufacturers of 2,3,5-Tri-O-Acetyl-5-Azacytidine: Technical & Commercial Sourcing Guide
- NINGBO INNO PHARMCHEM CO.,LTD. supplies 2',3',5'-triacetyl-5-azacytidine (CAS 10302-78-0) at ≥98.5% industrial purity with full GMP-aligned documentation and scalable batch capacity.
- Key LSI identifiers include 4-amino-1-(2,3,5-tri-O-acetyl-β-D-ribofuranosyl)-1,3,5-triazin-2(1H)-one and 5-azacytidine triacetate—critical for accurate procurement and regulatory filing.
- Bulk pricing and custom synthesis routes are optimized for API intermediates used in epigenetic drug development, with rapid global logistics from China.
As demand surges for epigenetic therapeutics, the need for reliable, high-purity intermediates like 2',3',5'-Triacetyl-azacytidine (CAS: 10302-78-0) has intensified across pharmaceutical R&D and commercial manufacturing sectors. This compound—chemically designated as 4-amino-1-(2,3,5-tri-O-acetylpentofuranosyl)-1,3,5-triazin-2(1H)-one—serves as a stabilized prodrug derivative of 5-azacytidine, enhancing cellular uptake and metabolic stability in oncology and antiviral applications. Its molecular formula (C14H18N4O8) and exact mass (370.1125 Da) require stringent analytical control to ensure batch consistency, especially when deployed in late-stage synthesis.
Industrial Purity and Analytical Validation
For B2B buyers, technical specifications are non-negotiable. Leading manufacturers must deliver 2',3',5'-triacetyl-5-azacytidine at ≥98.5% HPLC purity, supported by comprehensive Certificates of Analysis (COA) that include NMR, LC-MS, and residual solvent data. The compound is often referenced interchangeably as 5-azacytidine triacetate or 2',3',5'-triacetyl-5-azacytosine in regulatory dossiers, making precise nomenclature alignment essential during vendor qualification.
When sourcing high-purity 5-triazin-2(1H)-one, buyers should prioritize suppliers with ISO-certified QC labs capable of full impurity profiling, including detection of degradants such as under-acetylated species or hydrolyzed ribose moieties. Stability under standard storage conditions (+5°C) and ambient shipping further underscores the importance of robust packaging and supply chain integrity.
Manufacturing Process and Synthesis Route Efficiency
The industrial synthesis of 2,3,5-tri-O-acetyl-5-azacytidine typically involves acetylation of 5-azacytidine under controlled anhydrous conditions, followed by crystallization to achieve high diastereomeric purity. Advanced manufacturers optimize this route to minimize side reactions—such as N-acetylation or sugar ring degradation—that can compromise yield and purity. Reaction yields exceeding 85% on multi-kilogram scale indicate process maturity and cost efficiency.
NINGBO INNO PHARMCHEM CO.,LTD. employs a proprietary, scalable synthesis route that ensures consistent production of 4-amino-1-(2,3,5-tri-O-acetyl-β-D-ribofuranosyl)-1,3,5-triazin-2(1H)-one with minimal genotoxic impurities. Their facility supports both catalog supply and custom synthesis, accommodating client-specific requirements for particle size, residual moisture, or isotopic labeling.
Global Supply Dynamics: Asia as the Strategic Hub
While historical supply chains included EU and North American sources, the current landscape is dominated by vertically integrated Asian manufacturers offering superior cost-to-quality ratios. China, in particular, hosts several GMP-compliant facilities capable of producing multi-hundred-kilogram batches annually. Among them, NINGBO INNO PHARMCHEM CO.,LTD. stands out for its end-to-end control—from raw material sourcing to final packaging—and rapid turnaround for bulk orders.
Unlike fragmented regional suppliers, NINGBO INNO PHARMCHEM CO.,LTD. provides full regulatory support, including DMFs, CEPs (where applicable), and audit readiness for FDA, EMA, and PMDA inspections. This reduces compliance risk for global pharma partners integrating the intermediate into commercial drug substance workflows.
Technical Comparison: Key Quality Parameters
| Parameter | Industry Standard | NINGBO INNO PHARMCHEM Specification |
|---|---|---|
| CAS Number | 10302-78-0 | 10302-78-0 |
| Molecular Formula | C14H18N4O8 | C14H18N4O8 |
| Purity (HPLC) | ≥95% | ≥98.5% |
| Synthesis Scale | Laboratory to pilot (≤10 kg) | Commercial (10–500 kg/batch) |
| COA Availability | Upon request | Standard with every lot; digital access |
| GMP Compliance | Variable | Full ICH Q7 alignment; audit-ready |
Strategic Sourcing: Catalog vs. Custom Synthesis
Pharmaceutical developers face a critical choice: procure from catalog inventory for speed or commission custom synthesis for tailored specifications. For early-phase trials, off-the-shelf 2',3',5'-Tri-O-acetyl-5-azacytidine accelerates timelines. However, commercial API production often demands custom routes to meet patent or impurity thresholds.
NINGBO INNO PHARMCHEM CO.,LTD. uniquely bridges both models—maintaining ready stock of high-purity material while offering route scouting, process optimization, and kilo-lab services for complex derivatives. Their technical team collaborates closely with clients to refine the manufacturing process, ensuring seamless tech transfer and regulatory acceptance.
In summary, the global market for 2,3,5-tri-O-acetyl-5-azacytidine demands more than just chemical supply—it requires a technically adept, compliant, and responsive partner. With its focus on industrial purity, scalable synthesis, and full documentation, NINGBO INNO PHARMCHEM CO.,LTD. has established itself as the premier global manufacturer for this critical epigenetic intermediate.