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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.

Manufacturing Facilities

NINGBO INNO PHARMCHEM CO.,LTD. was established in 2007. It is committed to the R&D, production and sales of raw materials, pharmaceutical intermediates and fine chemicals. We striving to create a high-efficiency and high-quality integrated chemical service platform to better serve domestic and foreign customers.

Professional Export Experience

to Global Customers

WHY CHOSE US?

1. 20 years of R&D, manufacturing and sales experience, serving customers in 60 countries and regions around the world;

2. Own R&D laboratory, pilot platform and large-scale production workshop, which can meet the audit requirements of global customers;

3. We can satisfy customers' perfect transition from small scale lab requirements (gram level) to commercialization requirements (hundred tons level).

FAQ

  • A: We don't have Minimum Order Quantity, exact quantity should be provided before quotation for us to calculate the exact cost.

  • A: We don't provide free samples due to lots of request and expensive international courier's cost, we can deduct the sample charge after commercial order placed.

  • A: Our payment terms: Small or sample order: T/T IN ADVANCE. Commercial order: First order should be by T/T IN ADVANCE or L/C at sight, and following orders T/T 30~90days is acceptable subject to approval of credit application.

CONTACT US
Should you need to contact us; you may call during regular business hours, Monday through Friday, 8am – 6 pm.
NINGBO INNO PHARMCHEM CO.,LTD.
Address: No.163 Ruiqing Rd.,Ningbo 315000 China
Phone: 86-574-87319282
Fax: 86-574-27912196
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