The Role of 1,1-Cyclohexanediacetic Acid Monoamide in Pharmaceutical Manufacturing
The pharmaceutical industry operates under stringent quality demands, where the integrity of every component is scrutinized. Intermediates, the chemical building blocks for Active Pharmaceutical Ingredients (APIs), are particularly crucial. Among these, 1,1-Cyclohexanediacetic Acid Monoamide (CAS 99189-60-3) stands out for its indispensable role in the synthesis of Gabapentin, a widely utilized medication.
Gabapentin: A Vital Medication and its Intermediate
Gabapentin is a cornerstone in treating epilepsy and managing neuropathic pain. Its efficacy and safety are directly linked to the purity and quality of the API produced. The synthesis of Gabapentin typically involves several chemical steps, and 1,1-Cyclohexanediacetic Acid Monoamide is a key player in this sequence. As a chemical manufacturer specializing in pharmaceutical intermediates, we understand that providing a high-purity version of this compound is paramount for our clients in the pharmaceutical sector.
Ensuring Quality for Pharmaceutical Applications
For pharmaceutical manufacturers looking to buy 1,1-Cyclohexanediacetic Acid Monoamide, several quality aspects are non-negotiable:
- High Assay: A minimum assay of 98.0% is standard, ensuring that the majority of the material is the desired compound, minimizing diluents or unwanted side products.
- Consistent Physical Properties: The appearance as a white powder, along with controlled moisture content (≤0.5%), provides immediate visual confirmation of quality and stability.
- Low Impurity Profile: Beyond the assay, understanding and controlling the levels of specific impurities is critical. Reputable suppliers provide detailed Certificates of Analysis (CoA) that list these parameters.
- Traceability and Documentation: For regulated industries, traceability from raw material to finished intermediate is essential. Manufacturers should be able to provide robust documentation supporting their quality control processes.
The Manufacturer's Commitment to Supply Chain Integrity
As a chemical supplier and manufacturer, our responsibility extends beyond just producing the compound. We are committed to maintaining supply chain integrity. This involves:
- Reliable Production Capacity: Ensuring we can meet the demands for this intermediate, whether for R&D purposes or large-scale commercial production.
- Timely Delivery: Understanding the critical nature of pharmaceutical timelines and ensuring our products reach clients when needed.
- Secure Packaging: Utilizing appropriate packaging (e.g., 25 kg drums) to preserve product quality during transport and storage.
- Responsive Customer Service: Assisting clients with inquiries, providing quotes, and offering technical support.
When procurement professionals and R&D scientists seek a supplier for 1,1-Cyclohexanediacetic Acid Monoamide (CAS 99189-60-3), partnering with experienced pharmaceutical intermediate manufacturers offers significant advantages. This ensures that the foundational materials for life-saving medications are of the highest caliber, contributing to patient safety and treatment efficacy.
Perspectives & Insights
Data Seeker X
“Ensuring Quality for Pharmaceutical Applications For pharmaceutical manufacturers looking to buy 1,1-Cyclohexanediacetic Acid Monoamide, several quality aspects are non-negotiable: High Assay: A minimum assay of 98.”
Chem Reader AI
“0% is standard, ensuring that the majority of the material is the desired compound, minimizing diluents or unwanted side products.”
Agile Vision 2025
“Consistent Physical Properties: The appearance as a white powder, along with controlled moisture content (≤0.”