Sourcing Gabapentin Intermediates: A Buyer's Guide to 1,1-Cyclohexanediacetic Acid
For procurement managers and R&D scientists in the pharmaceutical industry, identifying reliable sources for key Active Pharmaceutical Ingredient (API) intermediates is paramount. Among these, 1,1-Cyclohexanediacetic Acid (CAS 4355-11-7) stands out as a critical building block for the synthesis of Gabapentin, a widely prescribed medication for epilepsy and neuropathic pain. Understanding the nuances of sourcing this compound is essential for ensuring product quality, cost-effectiveness, and supply chain stability.
Understanding 1,1-Cyclohexanediacetic Acid (CAS 4355-11-7)
1,1-Cyclohexanediacetic Acid, often abbreviated as CDA, is a dicarboxylic acid characterized by its white crystalline powder appearance. Its chemical formula is C10H16O4, and it plays an indispensable role in the multi-step synthesis of Gabapentin. The demand for high-purity CDA is directly linked to the growing global market for Gabapentin, making it a compound of significant interest for pharmaceutical manufacturers and chemical suppliers alike. When considering where to buy, looking for a reputable manufacturer that guarantees high assay values, typically above 99.5%, is crucial.
Key Considerations for Procurement
When you plan to purchase 1,1-Cyclohexanediacetic Acid, several factors should guide your decision. Firstly, purity is non-negotiable. Impurities in an intermediate can lead to failed batches, regulatory issues, and compromised final drug products. Therefore, seeking out suppliers who provide detailed Certificates of Analysis (CoA) with specified purity levels (e.g., ≥99.5% via GC) is a standard practice.
Secondly, supply chain reliability is vital. Pharmaceutical production requires consistent access to raw materials. Establishing a relationship with a manufacturer or a primary supplier in regions like China, known for its extensive chemical manufacturing capabilities, can offer a stable source. It's advisable to inquire about production capacity and lead times, especially when placing large orders. Working with a direct manufacturer often provides more competitive pricing and better control over the supply chain.
Thirdly, regulatory compliance and documentation are critical. While CDA itself is an intermediate, its journey through the manufacturing process must align with pharmaceutical industry standards. Suppliers should be able to provide necessary documentation to support your regulatory filings. Understanding the storage and handling requirements, such as keeping containers tightly closed in a dry, well-ventilated place, is also important for maintaining product integrity.
Finding a Trusted Supplier/Manufacturer
For businesses looking to buy 1,1-Cyclohexanediacetic Acid, partnering with a manufacturer that demonstrates expertise in fine chemicals and pharmaceutical intermediates is key. Companies that offer comprehensive product databases, competitive pricing, and responsive customer service are usually preferred. When searching for a supplier, using specific keywords like 'buy 1,1-cyclohexanediacetic acid,' 'CAS 4355-11-7 price,' or 'gabapentin intermediate manufacturer China' will help you identify potential partners.
Ultimately, securing a high-quality and dependable supply of 1,1-Cyclohexanediacetic Acid is a strategic decision that impacts the efficiency and success of your Gabapentin production. By focusing on purity, supplier reliability, and comprehensive support, procurement professionals can ensure they are obtaining the best possible intermediate for their pharmaceutical needs.
Perspectives & Insights
Molecule Vision 7
“While CDA itself is an intermediate, its journey through the manufacturing process must align with pharmaceutical industry standards.”
Alpha Origin 24
“Suppliers should be able to provide necessary documentation to support your regulatory filings.”
Future Analyst X
“Understanding the storage and handling requirements, such as keeping containers tightly closed in a dry, well-ventilated place, is also important for maintaining product integrity.”