Pregabalin Intermediates Supply

Product Description

Pregabalin is a widely prescribed pharmaceutical agent for the treatment of neuropathic pain and epilepsy, with its therapeutic efficacy attributed to the (S)-enantiomer's specific interaction with calcium channel subunits. The industrial synthesis of Pregabalin relies on chiral intermediates to establish the correct stereochemistry at the α-carbon, as conventional resolution of racemic precursors limits theoretical yield to 50%. Cosperpharm supplies three key intermediates that constitute the critical synthetic pathway for Pregabalin manufacturing: 3-Isobutylglutarimide (CAS 916982-10-0), 3-Carbamoymethyl-5-methylhexanoic acid (CAS 181289-15-6), and (R)-(-)-3-Carbamoymethyl-5-methylhexanoic acid (CAS 181289-33-8). These intermediates represent distinct stages from scaffold construction to enantioselective synthesis, enabling manufacturers to optimize yields and reduce reliance on traditional chiral resolution methods.

Why Cosperpharm?

Cosperpharm provides a complete suite of Pregabalin intermediates spanning the synthetic route from cyclic imide scaffold to enantiopure chiral precursor. Our portfolio enables pharmaceutical manufacturers to source multiple critical building blocks from a single qualified supplier, simplifying supply chain management and ensuring consistent quality across production campaigns. Each intermediate is supplied with comprehensive analytical documentation, including HPLC purity data and, where applicable, chiral purity verification. Our technical team offers process development support, including guidance on enzymatic versus chemical ring-opening strategies and asymmetric synthesis approaches that can achieve theoretical 100% atom utilization.

Product Advantages

Complete Synthetic Pathway Coverage. Cosperpharm offers three intermediates representing consecutive stages in Pregabalin synthesis: 3-Isobutylglutarimide as the cyclic imide scaffold, 3-Carbamoymethyl-5-methylhexanoic acid as the racemic ring-opened precursor, and (R)-(-)-3-Carbamoymethyl-5-methylhexanoic acid as the enantiopure chiral intermediate directly convertible to the API via Hofmann rearrangement.

Enantioselective Synthesis Compatibility. The chiral intermediate (R)-(-)-3-Carbamoymethyl-5-methylhexanoic acid is designed to support modern asymmetric synthesis routes. Recent advances in D-hydantoinase-catalyzed desymmetrization of 3-isobutylglutarimide have demonstrated enantiomeric excess values exceeding 97%, enabling theoretical 100% atom economy compared to traditional resolution methods limited to 50% yield.

Regulatory Compliance Support. 3-Isobutylglutarimide serves dual roles as both a key intermediate and an official impurity reference standard (Pregabalin Impurity 5 and Impurity 13), making it indispensable for analytical method development, forced degradation studies, and regulatory submissions including ANDA and DMF filings.

Contact Us

For inquiries regarding Pregabalin intermediates, including pricing, analytical documentation, or technical specifications, please contact the Cosperpharm sales team. We provide customized supply solutions for process development, impurity reference standard procurement, and commercial-scale manufacturing.