For pharmaceutical companies, the consistent and reliable supply of high-quality intermediates is not just a matter of efficiency, but of patient safety and regulatory compliance. Ethyl (2R,4S)-4-Amino-5-(biphenyl-4-yl)-2-methylpentanoate Hydrochloride (CAS 149690-12-0) is one such critical intermediate, essential for the synthesis of important therapeutic agents like LCZ696. Sourcing this compound requires a strategic approach to identify and partner with dependable manufacturers. This guide outlines key considerations for procurement professionals seeking to secure their supply chain for this vital pharmaceutical building block.

The Criticality of Ethyl (2R,4S)-4-Amino-5-(biphenyl-4-yl)-2-methylpentanoate Hydrochloride

This chiral molecule serves as a precursor in the complex synthetic pathway for Sacubitril, an integral component of LCZ696, a drug widely used in managing heart failure. The precise stereochemistry and high purity of CAS 149690-12-0 are paramount, as any deviations can compromise the efficacy and safety of the final drug product. Therefore, when you decide to buy this intermediate, a minimum purity of 99.0% is a standard requirement, alongside well-defined impurity profiles. Manufacturers who specialize in chiral synthesis and adhere to stringent quality control measures are preferred.

Evaluating Potential Manufacturers and Suppliers

When looking to purchase Ethyl (2R,4S)-4-Amino-5-(biphenyl-4-yl)-2-methylpentanoate Hydrochloride, prospective buyers should perform thorough due diligence on potential manufacturing partners. Key aspects to evaluate include:

  • Technical Expertise and Production Capacity: Does the manufacturer possess the advanced synthetic capabilities, particularly in chiral chemistry, to consistently produce this complex molecule? What is their production capacity to meet your current and future volume needs?
  • Quality Management Systems: Look for evidence of robust quality control processes, such as ISO certifications. While intermediates may not always require full GMP compliance, a strong commitment to quality management is a strong indicator of reliability.
  • Traceability and Documentation: A reputable supplier will provide comprehensive documentation, including Certificates of Analysis (CoA) for each batch, detailing purity, enantiomeric excess, and impurity levels. This transparency is vital for regulatory filings and internal quality assurance.
  • Supply Chain Reliability and Lead Times: Understanding the manufacturer's lead times for production and delivery is crucial for effective inventory management and production planning. Proximity and efficient logistics from their base, such as in China, can also be advantageous.
  • Competitive Pricing and Commercial Terms: While quality is paramount, cost is a significant factor for procurement. Engaging in open discussions about pricing structures for different volumes is essential.

Building a Strong Partnership

Establishing a direct relationship with a trusted manufacturer is often the most effective way to secure a stable supply of Ethyl (2R,4S)-4-Amino-5-(biphenyl-4-yl)-2-methylpentanoate Hydrochloride. Suppliers who offer technical support, are responsive to inquiries, and can provide samples for validation purposes are ideal partners. By carefully selecting your supplier, you can ensure a consistent flow of high-quality materials, thereby safeguarding your production processes and ultimately contributing to the reliable availability of essential medicines.

As a dedicated manufacturer and supplier of critical pharmaceutical intermediates, we are committed to providing the quality and reliability you need. Contact us to discuss your requirements for Ethyl (2R,4S)-4-Amino-5-(biphenyl-4-yl)-2-methylpentanoate Hydrochloride.