Diclofenac Intermediate (15308-01-7): Technical Specs for API Manufacturing
For pharmaceutical manufacturers, the technical specifications of chemical intermediates are the bedrock of a successful and compliant API synthesis process. 2-Chloro-N-(2,6-dichlorophenyl)-N-phenylacetamide (CAS 15308-01-7) is a critical intermediate in the production of Diclofenac, a widely used anti-inflammatory drug. Understanding its detailed technical parameters is vital for quality control, process optimization, and regulatory adherence. This article outlines the key technical specifications that API manufacturers should consider when sourcing this compound.
The chemical identity and purity of 2-Chloro-N-(2,6-dichlorophenyl)-N-phenylacetamide play a direct role in the efficiency and outcome of Diclofenac synthesis. As a responsible manufacturer, providing precise technical data is part of our commitment to supporting the pharmaceutical industry. The core specifications for this intermediate include:
- Chemical Name: 2-Chloro-N-(2,6-dichlorophenyl)-N-phenylacetamide
- CAS Number: 15308-01-7
- Molecular Formula: C14H10Cl3NO
- Molecular Weight: 314.59
- Appearance: White or almost white crystalline powder. This physical characteristic is important for visual inspection and handling during manufacturing.
- Assay (Purity): Typically specified as NLT (Not Less Than) 99.0% (by HPLC). High assay indicates minimal presence of impurities that could interfere with the synthesis or affect the final API quality.
- Loss on Drying: Generally NMT (Not More Than) 0.5%. This parameter quantifies the moisture content, which can impact reaction kinetics and storage stability.
- Identification: Often confirmed via Infrared (IR) spectroscopy, ensuring the correct molecular structure.
- Melting Point: Usually within a specified range, such as 142℃ – 148℃, serving as another indicator of purity.
- Related Substances: Limits for individual and total impurities are crucial. For example, an individual unspecified impurity might be NMT 0.5%, and total impurities NMT 1.0%. These are critical for regulatory compliance and API safety.
When you purchase this intermediate, ensuring that the supplier provides a detailed Certificate of Analysis (CoA) that validates these specifications for each batch is essential. A reliable manufacturer in China will have robust quality control systems in place to consistently meet these technical requirements. Understanding these specifications allows R&D scientists and process engineers to accurately predict reaction outcomes and design efficient synthesis routes for Diclofenac.
The availability of high-quality 2-Chloro-N-(2,6-dichlorophenyl)-N-phenylacetamide directly influences the yield, purity, and cost-effectiveness of Diclofenac API production. Therefore, diligent sourcing from trusted suppliers who clearly communicate and consistently deliver on these technical parameters is paramount. We, as a dedicated supplier, are committed to providing intermediates that meet these rigorous technical standards, enabling our clients to achieve superior API quality. Contact us to get detailed technical data and pricing for your Diclofenac manufacturing needs.
By focusing on these critical technical specifications, pharmaceutical manufacturers can ensure the integrity of their production processes and the quality of their final Diclofenac products.
Perspectives & Insights
Core Pioneer 24
“Understanding its detailed technical parameters is vital for quality control, process optimization, and regulatory adherence.”
Silicon Explorer X
“This article outlines the key technical specifications that API manufacturers should consider when sourcing this compound.”
Quantum Catalyst AI
“The chemical identity and purity of 2-Chloro-N-(2,6-dichlorophenyl)-N-phenylacetamide play a direct role in the efficiency and outcome of Diclofenac synthesis.”