Industrial Synthesis Route Of Sodium Aminosalicylate
- Optimized Synthesis: Advanced manufacturing process ensures high reaction yields and minimal by-products.
- Quality Assurance: Rigorous testing guarantees industrial purity compliant with global pharmacopoeia standards.
- Bulk Supply: Reliable sourcing from a top-tier global manufacturer for large-scale pharmaceutical production.
Sodium aminosalicylate, chemically known as Sodium 4-amino-2-hydroxybenzoate, is a critical pharmaceutical intermediate and active ingredient primarily utilized in the treatment of tuberculosis. As a bacteriostatic agent, it inhibits the growth of Mycobacterium tuberculosis by interfering with folic acid synthesis. For pharmaceutical companies and chemical procurement managers, understanding the technical nuances of the synthesis route is essential for ensuring consistent supply chain quality and regulatory compliance. At NINGBO INNO PHARMCHEM CO.,LTD., we prioritize technical transparency and process optimization to deliver superior chemical solutions.
Chemical Identification and Physical Properties
Accurate chemical identification is the foundation of quality control in bulk procurement. The following table outlines the key physicochemical properties derived from standard technical data sheets. These parameters are critical for verifying the identity and quality of Sodium aminosalicylate during incoming goods inspection.
| Property | Specification |
| Chemical Name | Sodium 4-amino-2-hydroxybenzoate |
| CAS Number | 8031-28-5 |
| Molecular Formula | C7H6NNaO3 |
| Molecular Weight | 175.117 g/mol |
| Density | 1.491 g/cm³ |
| Melting Point | 150-151ºC (with effervescence) |
| Flash Point | 184.1ºC |
| HS Code | 2918219000 |
Key Reaction Parameters for Scalable Production
The manufacturing process for this compound involves precise control over reaction conditions to maximize yield and minimize impurities. Industrial scale-up requires careful management of temperature, pH, and solvent systems. Based on established synthetic methodologies, the production often begins with precursor intermediates such as m-nitrophenol or m-nitroaniline derivatives.
Critical process parameters include strict temperature regulation during diazonium salt formation and subsequent hydrolysis. For instance, maintaining reaction temperatures below -5ºC during acid addition prevents premature decomposition. Subsequent heating phases, typically between 85-90ºC, facilitate the conversion of intermediate salts into the desired phenolic structures. Solvent washing steps utilizing methanol, acetone, or ether are employed to remove organic impurities, ensuring the final product meets stringent industrial purity requirements.
Optimizing Yield and Purity in Bulk Manufacturing Processes
Achieving high reaction yields is paramount for cost-effective bulk production. The synthesis pathway often involves a reduction step followed by salification with sodium hydroxide or carbonate. Recrystallization from acid solutions, such as dilute nitric acid or acetic acid, is a standard purification technique to enhance crystal quality and remove residual starting materials.
Quality control protocols must verify the absence of hazardous by-products. Comprehensive testing includes High-Performance Liquid Chromatography (HPLC) for assay determination and Gas Chromatography-Mass Spectrometry (GC-MS) for related impurities. A valid Certificate of Analysis (COA) should accompany every batch, detailing parameters such as loss on drying, heavy metals, and assay percentage. This level of documentation is vital for regulatory filings and audit readiness.
Commercial Procurement and Global Supply
Securing a reliable supply chain for pharmaceutical intermediates requires partnering with a verified global manufacturer. Market dynamics indicate that bulk pricing is influenced by raw material availability, energy costs, and regulatory compliance overheads. Buyers should prioritize suppliers who demonstrate capacity for large-volume production without compromising on quality standards.
When sourcing high-purity Aminosalicylate Sodium, buyers should evaluate the supplier's ability to provide consistent batch-to-b reproducibility. Technical support regarding storage conditions is also essential; the compound should be kept in a cool, dry place to prevent degradation. Furthermore, understanding the HS Code (2918219000) facilitates smoother customs clearance and tariff assessment during international logistics.
Conclusion
The industrial production of Sodium p-aminosalicylate demands a sophisticated approach to chemical synthesis and quality assurance. By focusing on optimized reaction conditions and rigorous testing, manufacturers can deliver products that meet the exacting standards of the pharmaceutical industry. NINGBO INNO PHARMCHEM CO.,LTD. stands ready to support your procurement needs with technically superior intermediates and reliable bulk supply capabilities. Partnering with an experienced manufacturer ensures that your production timelines are met without sacrificing the integrity of your final medicinal products.