Industrial Grade 3-Hydroxy-2-Nitropyridine: Purity Standards and COA Verification
- CAS 15128-82-2: Critical intermediate for pharmaceutical and agrochemical synthesis routes.
- Purity Standards: Industrial grades typically exceed 98.0% (GC/HPLC) with strict impurity controls.
- Procurement: Bulk supply requires verified COA and consistent manufacturing process validation.
In the realm of fine chemical manufacturing, consistency and molecular integrity are paramount. 3-Hydroxy-2-nitropyridine (CAS 15128-82-2), also known synonymously as 2-Nitro-3-pyridinol, serves as a vital building block in complex organic synthesis. This pyridine derivative is extensively utilized as a pesticide intermediate and pharmaceutical precursor, notably in the production of kinase inhibitors. For procurement managers and process chemists, securing a reliable supply chain with documented industrial purity is essential to maintain downstream reaction yields.
As a premier global manufacturer, NINGBO INNO PHARMCHEM CO.,LTD. specializes in scaling these production capabilities to meet international bulk demands. Understanding the technical specifications and verification protocols for this compound ensures that your production lines remain efficient and compliant.
Assay Specification Analysis
When evaluating suppliers, the assay value is the primary indicator of quality. While laboratory-grade reagents often sit at 97% purity, industrial applications typically require specifications exceeding 98.0% or 99.0% as determined by Gas Chromatography (GC) or High-Performance Liquid Chromatography (HPLC). The physical appearance of high-quality material should be a consistent yellow crystalline powder with a melting point range of 69-71 °C.
Deviation in melting point or color intensity often signals the presence of oxidation byproducts or residual starting materials. For critical applications, such as the synthesis of Crizotinib impurities or novel sulfonates, even minor deviations can impact catalytic efficiency. When sourcing high-purity 3-Hydroxy-2-nitropyridine, buyers should request chromatograms alongside the standard Certificate of Analysis to verify peak separation and absence of closely eluting impurities.
Typical Physical and Chemical Properties
| Property | Specification |
|---|---|
| CAS Number | 15128-82-2 |
| Molecular Formula | C5H4N2O3 |
| Molecular Weight | 140.10 g/mol |
| Appearance | Yellow Crystalline Powder |
| Melting Point | 69-71 °C |
| Purity (GC/HPLC) | ≥ 98.0% (Industrial Grade) |
| Storage Conditions | Inert atmosphere, Room Temperature |
Impurity Control Measures
The manufacturing process for this nitropyridine derivative typically involves the nitration of 3-hydroxypyridine using nitrating agents such as potassium nitrate in the presence of acetic anhydride. A well-optimized route achieves yields around 81%, but the challenge lies in purification. Common impurities include unreacted 3-hydroxypyridine, over-nitrated species, and tars formed during the exothermic reaction phase.
Effective impurity control requires rigorous work-up procedures, including pH adjustment to neutrality, multiple extraction cycles with ethyl acetate, and activated carbon treatment to remove colored byproducts. Residual solvents must also be monitored according to ICH Q3C guidelines. At NINGBO INNO PHARMCHEM CO.,LTD., advanced distillation and recrystallization techniques are employed to ensure that heavy metals and residual solvents remain below ppm thresholds suitable for pharmaceutical intermediates.
For bulk buyers, understanding the bulk price structure is often correlated with the level of purification required. Higher purity grades command a premium but reduce downstream processing costs. Ensuring the supplier has robust quality control measures in place prevents batch-to-batch variability that could halt production.
COA Verification Steps
The Certificate of Analysis (COA) is the contractual document guaranteeing product quality. However, not all COAs are created equal. A comprehensive COA for CAS 15128-82-2 should include more than just the final assay percentage. Procurement teams should verify the following data points:
- Method of Analysis: Ensure the test method (e.g., HPLC-UV, GC-FID) is specified and validated.
- Impurity Profile: Look for a breakdown of known impurities rather than a generic "unknown impurities" total.
- Physical Constants: Verify that melting point and loss on drying (LOD) match the specification sheet.
- Batch Number: Confirm traceability to specific production runs for consistency.
Reliable suppliers will provide batch-specific COAs upon request. This transparency is critical for regulatory compliance, especially when the material is used as a pharmaceutical intermediate or in regulated agrochemical formulations. Discrepancies in the COA data compared to internal QC testing should be flagged immediately.
Quality Assurance Comparison
| Parameter | Lab Grade | Industrial Grade |
|---|---|---|
| Purity | 97% - 98% | ≥ 98.0% - 99.0% |
| Packaging | 25g - 100g Bottles | 25kg - 200kg Drums |
| Documentation | Standard COA | Full COA + MSDS + Stability Data |
| Lead Time | Immediate | Production Schedule Dependent |
Conclusion
Securing a stable supply of 3-Hydroxy-2-nitropyridine requires a partner who understands the nuances of chemical manufacturing and quality assurance. From optimizing the synthesis route to delivering verified COA documentation, every step impacts the success of your final product. By prioritizing industrial purity and transparent communication, manufacturers can mitigate risks associated with raw material variability.
For organizations seeking a dependable source for this critical intermediate, NINGBO INNO PHARMCHEM CO.,LTD. offers scalable solutions tailored to global market needs. With a focus on technical excellence and competitive bulk pricing, we ensure your supply chain remains robust and compliant.