Quality Assurance for Famotidine Intermediates: A Supplier's Perspective
For any manufacturer producing Active Pharmaceutical Ingredients (APIs), quality assurance is not just a procedural requirement; it is the bedrock of product efficacy and patient safety. In the synthesis of Famotidine, a critical H2 receptor antagonist, the intermediate N-Sulphamyl-3-chloropropionamidine Hydrochloride (CAS 106649-95-0) plays a pivotal role. As a leading supplier, we understand the stringent quality expectations placed upon this compound and the measures taken to meet them.
Our commitment begins with meticulous sourcing of raw materials and extends through a controlled manufacturing process designed to yield N-Sulphamyl-3-chloropropionamidine Hydrochloride with a high assay, typically exceeding 98.0%. The appearance, a white or off-white powder, is the first visual indicator, but comprehensive quality control involves rigorous analytical testing. Parameters such as melting point (140-145°C), loss on drying (≤1.0%), and residue on ignition (≤1.0%) are closely monitored for each batch.
These specifications are not arbitrary; they directly impact the efficiency and outcome of the downstream synthesis of Famotidine. Impurities, even in trace amounts, can interfere with reaction kinetics, generate unwanted by-products, and necessitate more complex purification steps, ultimately increasing production costs and potentially compromising the final API’s quality. Therefore, robust analytical methods, such as HPLC, are employed to confirm the purity and identity of our N-Sulphamyl-3-chloropropionamidine Hydrochloride.
For our clients in the pharmaceutical industry, including R&D scientists and procurement managers looking to buy this intermediate, we provide detailed Certificates of Analysis (CoAs) with every shipment. These documents serve as a testament to our quality standards and provide the necessary data for their internal quality assurance and regulatory filings. We also offer flexibility in packaging, with standard 25 kg drums or custom solutions to meet specific client needs, ensuring product integrity during transit and handling.
In essence, supplying high-quality N-Sulphamyl-3-chloropropionamidine Hydrochloride is fundamental to our role as a partner in the pharmaceutical supply chain. By adhering to strict quality assurance protocols and maintaining transparency with our clients regarding product specifications and analysis, we aim to be the preferred manufacturer and supplier for this essential chemical intermediate. Our focus on quality ensures that our customers can confidently integrate our product into their Famotidine manufacturing processes.
Perspectives & Insights
Chem Catalyst Pro
“For our clients in the pharmaceutical industry, including R&D scientists and procurement managers looking to buy this intermediate, we provide detailed Certificates of Analysis (CoAs) with every shipment.”
Agile Thinker 7
“These documents serve as a testament to our quality standards and provide the necessary data for their internal quality assurance and regulatory filings.”
Logic Spark 24
“We also offer flexibility in packaging, with standard 25 kg drums or custom solutions to meet specific client needs, ensuring product integrity during transit and handling.”