Industrial Purity 2,6-Diamino-9-(β-D-Arabinofuranosyl)Purine Grading Standards
- Critical Physical Constants: Melting point at 286 °C and Molar Mass of 282.26 g/mol define identity.
- Storage & Safety: Requires +2 to +8 °C storage; classified under ADR 6.1 III for transport.
- Quality Assurance: HPLC assay ≥98% is the baseline for pharmaceutical intermediate grading.
In the pharmaceutical intermediates sector, the specification of nucleoside analogues demands rigorous adherence to chemical identity and purity profiles. 2,6-Diamino-9-(β-D-arabinofuranosyl)purine, often referenced by its CAS registry number 34079-68-0, serves as a critical building block in the synthesis of antiviral and antineoplastic agents. For procurement officers and process chemists, understanding the grading standards associated with industrial purity is essential to ensure downstream reaction yields and regulatory compliance.
As a premier global manufacturer, NINGBO INNO PHARMCHEM CO.,LTD. maintains strict control over the production parameters of this compound. This article details the technical specifications, quality control metrics, and commercial considerations necessary for sourcing high-grade material.
Technical Specifications and Physical Properties
Accurate identification of the material begins with verifying physical constants against certified data sheets. Deviations in melting point or molecular weight often indicate the presence of solvent residues or isomeric impurities. The following table outlines the standard technical parameters expected for pharmaceutical-grade lots.
| Parameter | Specification | Significance |
|---|---|---|
| CAS Number | 34079-68-0 | Unique chemical identifier |
| Empirical Formula | C10H14N6O4 | Confirms molecular structure |
| Molar Mass | 282.26 g/mol | Stoichiometric calculations |
| Melting Point | 286 °C | Purity indicator (decomposition) |
| Boiling Point | 798.5 °C | Thermal stability limit |
| Storage Temperature | +2 to +8 °C | Prevents degradation |
| Transport Classification | ADR 6.1 III / UN 2811 | Safety and logistics compliance |
Maintaining the integrity of these specifications requires a robust manufacturing process. The melting point, specifically at 286 °C, is a critical quality attribute. Materials exhibiting a lower melting range often contain residual starting materials or incomplete reaction products, which can interfere with subsequent coupling reactions.
Synthesis Route and Impurity Profile
The synthesis route for this purine derivative typically involves the glycosylation of 2,6-diaminopurine with an activated arabinose donor. Controlling the stereoselectivity at the anomeric center is paramount to ensure the correct β-configuration. Process chemists must monitor for the presence of the α-anomer or N7-regioisomers, which are common process-related impurities.
High-performance liquid chromatography (HPLC) is the standard method for quantifying these impurities. For industrial applications, an assay of ≥98% is generally required. However, specific therapeutic applications may demand ≥99% purity. When evaluating suppliers for 2,6-Diamino-9-(β-D-arabinofuranosyl)purine, buyers should request a comprehensive Certificate of Analysis (COA) that details the limits for related substances, heavy metals, and residual solvents.
Key Impurity Controls
- Related Substances: Individual impurities should not exceed 0.10%, with total impurities below 2.0%.
- Residual Solvents: Must comply with ICH Q3C guidelines, particularly for Class 2 solvents used in crystallization.
- Heavy Metals: Typically limited to <10 ppm to ensure biocompatibility in downstream API synthesis.
Commercial Considerations and Bulk Procurement
Procurement strategies for fine chemicals must balance cost efficiency with supply chain reliability. Market analysis indicates significant price variance based on pack quantity. Small-scale research packs (5g to 25g) command a premium per gram due to packaging and handling costs. Conversely, bulk procurement offers substantial economies of scale.
Historical pricing data suggests that bulk price tiers become advantageous at quantities exceeding 100g. For large-scale production, negotiating contracts based on metric ton availability is standard practice. However, buyers must account for the specific storage requirements of this compound. Because the material requires storage between +2 to +8 °C, logistics providers must offer cold chain solutions to prevent thermal degradation during transit, even though the transport temperature classification may allow for ambient conditions over short durations.
Safety and Regulatory Compliance
From a health and safety perspective, this compound is classified as toxic if swallowed (H301). It falls under ADR Class 6.1, Packing Group III, with UN Number 2811. Facilities handling this material must implement appropriate engineering controls to minimize exposure. Proper documentation, including Safety Data Sheets (SDS) and transport declarations, is mandatory for international shipping.
Partnering with NINGBO INNO PHARMCHEM CO.,LTD.
Selecting the right supply partner is critical for maintaining production continuity. NINGBO INNO PHARMCHEM CO.,LTD. stands out as a top-tier manufacturer capable of meeting stringent industrial purity requirements. By leveraging advanced crystallization techniques and rigorous QC protocols, we ensure batch-to-batch consistency essential for GMP environments.
Our commitment to quality extends beyond the final product. We provide full traceability for every lot, ensuring that the COA reflects accurate analytical data derived from validated methods. Whether for clinical trial material or commercial API production, our facility is equipped to handle custom synthesis and large-volume orders.
Conclusion
The successful integration of 2,6-Diamino-9-(β-D-arabinofuranosyl)purine into pharmaceutical workflows relies on strict adherence to grading standards. From verifying the melting point of 286 °C to ensuring proper cold chain logistics, every step impacts the final quality of the active pharmaceutical ingredient. By prioritizing suppliers who demonstrate transparency in their manufacturing process and offer competitive bulk price structures, organizations can secure a reliable supply of this vital intermediate.
For technical inquiries or to request a sample for qualification, contact our sales team to discuss how our production capabilities align with your project timelines.