The successful synthesis of Entecavir, a vital antiviral medication, hinges on the quality of its precursor materials. Entecavir Intermediate V (CAS 142217-78-5) is a complex organic compound that demands stringent quality control from manufacturers and thorough verification by buyers. Understanding the key specifications is paramount for ensuring its suitability for pharmaceutical applications.

At the forefront of quality is chemical purity. For Entecavir Intermediate V, purity levels typically need to be exceptionally high, often exceeding 99%. This is usually determined through analytical techniques such as High-Performance Liquid Chromatography (HPLC). Buyers should always request a Certificate of Analysis (CoA) that clearly states the purity percentage and the methods used for its determination. Consistent purity across batches is a hallmark of a reliable manufacturer.

Stereochemical integrity is another critical specification. The precise (2R,3S,5S) configuration of the cyclopentanol ring is essential for the correct biological activity of the final Entecavir molecule. Manufacturers must employ stereoselective synthesis methods to achieve this. Analytical techniques like Nuclear Magnetic Resonance (NMR) spectroscopy or chiral HPLC are often used to confirm the stereochemistry and detect any unwanted stereoisomers.

Impurities profile is also a significant consideration. While achieving 100% purity is challenging, manufacturers must control and quantify known and unknown impurities. The CoA should list specific impurities that may arise during synthesis and their acceptable limits. This is vital for regulatory compliance and the safety of the final drug product. Buyers seeking to purchase Entecavir Intermediate V should inquire about the identification and control of process-related impurities.

Physical characteristics, such as appearance, also serve as initial quality indicators. Entecavir Intermediate V is typically described as a white to off-white solid. Any significant deviation in color or form might suggest degradation or contamination, warranting further investigation by the supplier and buyer.

For manufacturers and researchers aiming to buy Entecavir Intermediate V, a close collaboration with suppliers is beneficial. Discussing specific quality requirements and ensuring that the manufacturer's specifications align with the intended downstream synthesis and regulatory needs is crucial. A reputable supplier will provide comprehensive documentation and be transparent about their quality assurance processes.

By adhering to these key specifications, pharmaceutical professionals can confidently source Entecavir Intermediate V that meets the high standards required for the production of effective and safe antiviral therapies. This meticulous attention to quality from both the manufacturer and the buyer ensures the integrity of the entire pharmaceutical supply chain.