Industrial Purity 2',3',5'-Tri-O-Acetyl-2-Fluoroadenosine: Technical Specs and Bulk Procurement
- High-Purity Standard: Manufactured to ≥99.0% HPLC purity suitable for API synthesis.
- Comprehensive Documentation: Full COA, MSDS, and batch traceability available for download.
- Scalable Supply: Optimized synthesis route supports kilogram to ton-scale production.
2',3',5'-Tri-O-acetyl-2-fluoroadenosine (CAS: 15811-32-2) serves as a critical pharmaceutical intermediate in the production of nucleoside analogs, specifically acting as a precursor for Fludarabine phosphate. In the context of large-scale pharmaceutical manufacturing, the consistency of chemical properties and the absence of toxic impurities are paramount. This compound, often referred to technically as 2-Fluoro-2',3',5'-triacetoxyadenosine, requires rigorous control during the acetylation and fluorination steps to ensure the final active pharmaceutical ingredient meets regulatory guidelines.
For procurement managers and process chemists, securing a supply chain that guarantees industrial purity is essential to prevent downstream purification bottlenecks. NINGBO INNO PHARMCHEM CO.,LTD. operates as a premier global manufacturer dedicated to providing high-quality nucleoside derivatives with full regulatory compliance. This article details the technical specifications, synthesis considerations, and quality assurance protocols required for sourcing this material in bulk quantities.
Physicochemical Properties and Specification Sheet
Understanding the molecular structure and physical constants of Adenosine 2-fluoro 2',3',5'-triacetate is the first step in quality verification. The presence of the fluorine atom at the C2 position of the adenine ring significantly alters the electronic properties compared to standard adenosine, influencing both solubility and reactivity during subsequent coupling reactions. The table below outlines the standard specifications expected for industrial-grade material.
| Parameter | Specification | Test Method |
|---|---|---|
| CAS Number | 15811-32-2 | Registry |
| Molecular Formula | C16H18FN5O7 | Calculation |
| Molecular Weight | 411.34 g/mol | Calculation |
| Purity (HPLC) | ≥ 99.0% | Area Normalization |
| Appearance | White to Off-White Crystalline Powder | Visual |
| Loss on Drying | ≤ 0.5% | Karl Fischer / LOD |
| Residual Solvents | Compliant with ICH Q3C | GC Headspace |
Synthesis Route and Manufacturing Process Control
The production of this Fluoroadenosine derivative typically involves the selective fluorination of adenosine followed by protection of the hydroxyl groups via acetylation. Alternatively, the sequence may involve acetylation prior to fluorination depending on the specific regioselectivity required. A robust synthesis route must minimize the formation of regioisomers, such as N6-acetyl impurities or incomplete acetylation byproducts, which can be difficult to remove in later stages.
At NINGBO INNO PHARMCHEM CO.,LTD., the manufacturing process is optimized to maximize reaction yields while maintaining strict control over exothermic parameters during the acetylation step. Critical process parameters include temperature control during the addition of acetic anhydride and the precise stoichiometry of the fluorinating agent. Post-reaction, the crude material undergoes multiple recrystallization steps to achieve the target purity levels. This ensures that the bulk price reflects not just the weight of the material, but the value of reduced downstream processing costs for the client.
When evaluating suppliers for 2',3',5'-Tri-O-acetyl-2-fluoroadenosine, technical verification is paramount. Procurement teams should request batch-specific data to confirm that the fluorination position is correct and that no defluorination has occurred during the acetylation process. Nuclear Magnetic Resonance (NMR) spectroscopy, specifically 19F NMR, is the gold standard for verifying the integrity of the fluoro-adenine moiety.
Quality Assurance: COA and MSDS Documentation
In regulated pharmaceutical environments, documentation is as critical as the chemical itself. A comprehensive Certificate of Analysis (COA) provides the empirical data necessary for quality control units to release the material for production. Key data points on the COA should include chromatograms showing the absence of known impurities, residual solvent profiles, and heavy metal analysis.
Furthermore, safety data sheets (MSDS) must be up-to-date and compliant with global transport regulations. Given the reactive nature of acetylated nucleosides, proper handling instructions regarding moisture sensitivity and storage conditions are vital. Industrial buyers should ensure that their supplier offers fast delivery of these documents alongside the physical shipment to prevent delays in warehouse intake procedures. Digital access to specs sheet downloads allows for rapid integration into Laboratory Information Management Systems (LIMS).
Impurity Profile and Heavy Metals
Strict adherence to GMP standard guidelines requires monitoring for specific impurities. For this intermediate, the primary concerns are:
- Related Substances: Unreacted starting materials or mono/di-acetylated byproducts.
- Heavy Metals: Lead, Arsenic, Cadmium, and Mercury must be below ppm thresholds defined by pharmacopeia.
- Residual Solvents: Class 1 and Class 2 solvents used during synthesis and crystallization must be quantified via Gas Chromatography.
Commercial Scalability and Bulk Procurement
Transitioning from gram-scale research to kilogram or ton-scale production introduces distinct challenges. Heat transfer rates, mixing efficiency, and filtration times change significantly at scale. A reliable partner must demonstrate the capacity for custom synthesis adjustments if specific particle size distributions or packaging requirements are needed for automated processing lines.
Procurement strategies should focus on long-term supply agreements that lock in quality parameters rather than just cost. While bulk price is a factor, the cost of failure due to inconsistent purity far outweighs initial savings. NINGBO INNO PHARMCHEM CO.,LTD. supports clients with flexible quantity options, ensuring that pilot plant trials can be seamlessly scaled to commercial production without re-qualifying the supplier.
Conclusion
2',3',5'-Tri-O-acetyl-2-fluoroadenosine is a high-value intermediate essential for the synthesis of antineoplastic agents. Ensuring the integrity of this molecule requires a supplier with deep technical expertise in nucleoside chemistry and a commitment to industrial purity standards. By prioritizing verified COA data, robust synthesis routes, and scalable manufacturing capabilities, pharmaceutical companies can mitigate supply chain risks.
For organizations seeking a dependable source for this critical intermediate, partnering with an experienced entity ensures regulatory alignment and production continuity. NINGBO INNO PHARMCHEM CO.,LTD. remains committed to delivering superior chemical solutions that accelerate drug development pipelines globally.