The Essential Role of 4-Hydrazinobenzenesulfonamide in API Manufacturing
In the rigorous and highly regulated world of Active Pharmaceutical Ingredient (API) manufacturing, the selection and procurement of high-quality intermediates are critical for success. Among these vital components, 4-Hydrazinobenzenesulfonamide (CAS 4392-54-5) holds a prominent position, particularly due to its indispensable role in the synthesis of Celecoxib. This article explores its significance for API manufacturers and provides insights into sourcing strategies.
4-Hydrazinobenzenesulfonamide: A Lynchpin in Celecoxib Synthesis
The primary function of 4-Hydrazinobenzenesulfonamide in API manufacturing is as a foundational intermediate for Celecoxib. Celecoxib, a well-established nonsteroidal anti-inflammatory drug (NSAID), is synthesized through a multi-step process where 4-Hydrazinobenzenesulfonamide serves as a key building block. Its specific chemical structure enables crucial reactions that lead to the formation of the Celecoxib molecule. For API manufacturers, sourcing this intermediate with guaranteed purity (typically ≥98.0%) is non-negotiable to ensure the efficacy, safety, and regulatory compliance of the final drug product.
Properties and Specifications for Manufacturers
API manufacturers must pay close attention to the detailed specifications of 4-Hydrazinobenzenesulfonamide. The typical physical form is an off-white to light beige powder, which is convenient for industrial handling. Key properties such as melting point (158-159°C) and assay (≥98.0%) are thoroughly vetted. The molecular formula C6H9N3O2S and molecular weight of 187.22 g/mol are also fundamental identifiers. When looking to purchase this chemical, understanding these specifications ensures you are acquiring material suitable for pharmaceutical-grade synthesis.
Finding Reliable Suppliers and Manufacturers
The global supply chain for 4-Hydrazinobenzenesulfonamide is robust, with a significant number of manufacturers located in China, a region known for its extensive chemical production capabilities. API manufacturers seeking a dependable source should focus on suppliers who:
- Demonstrate Quality Assurance: Look for suppliers with established quality control systems and the ability to provide detailed Certificates of Analysis (COAs).
- Offer Competitive Pricing: Engage with manufacturers for price quotes, especially for large-scale production, to secure cost-effective procurement.
- Ensure Supply Chain Stability: Verify the manufacturer's production capacity and their commitment to consistent supply.
- Provide Necessary Documentation: Confirm that they can supply all required regulatory and safety documentation.
For API manufacturers, partnering with a reliable manufacturer for 4-Hydrazinobenzenesulfonamide is crucial. This ensures not only the quality of the intermediate but also supports regulatory submissions and the overall integrity of the drug manufacturing process. When you buy 4-Hydrazinobenzenesulfonamide, you are selecting a critical partner in your API production chain.
In summary, 4-Hydrazinobenzenesulfonamide (CAS 4392-54-5) is a vital intermediate for the synthesis of Celecoxib and other potential APIs. Its precise specifications and reliable sourcing from experienced manufacturers are essential for successful API production. By focusing on quality and supplier reliability, manufacturers can ensure a stable supply chain and maintain the high standards required in the pharmaceutical industry.
Perspectives & Insights
Bio Analyst 88
“0%) is non-negotiable to ensure the efficacy, safety, and regulatory compliance of the final drug product.”
Nano Seeker Pro
“Properties and Specifications for ManufacturersAPI manufacturers must pay close attention to the detailed specifications of 4-Hydrazinobenzenesulfonamide.”
Data Reader 7
“The typical physical form is an off-white to light beige powder, which is convenient for industrial handling.”