For professionals involved in pharmaceutical synthesis, understanding the precise technical specifications and quality control parameters of key intermediates is fundamental. 5,6-Dimethoxy-1-indanone (CAS: 2107-69-9) is a vital chemical building block, particularly recognized for its role in the synthesis of Donepezil hydrochloride. Ensuring the quality and consistency of this intermediate is paramount for successful drug manufacturing. This article delves into the critical technical aspects and quality control measures associated with 5,6-Dimethoxy-1-indanone, offering insights for those looking to buy or use this compound.

Key Technical Specifications of 5,6-Dimethoxy-1-indanone

When procuring 5,6-Dimethoxy-1-indanone, buyers should pay close attention to the following specifications provided by manufacturers and suppliers:

  • Appearance: Typically described as an off-white to pale yellow crystalline powder. Deviations from this can indicate potential impurities or degradation.
  • Assay (Purity): This is a critical parameter, usually specified as ≥98.0% or ≥98.5% by methods like Gas Chromatography (GC) or High-Performance Liquid Chromatography (HPLC). Higher purity directly translates to cleaner reactions and a purer final product.
  • Melting Point: A narrow melting point range is indicative of high purity. For 5,6-Dimethoxy-1-indanone, this is often cited between 118-122°C, with specific batches sometimes showing tighter ranges like 120.5-122.0°C.
  • Loss on Drying (LOD): This measures the volatile content (typically water or residual solvents) and is usually limited to ≤1.0% or ≤0.5%. Low LOD ensures a concentrated product.
  • Residue on Ignition (ROI): Also known as sulfated ash, this indicates the level of inorganic impurities. A low ROI, often ≤0.1%, is desirable.
  • Single Impurity: Limits on individual known or unknown impurities are crucial. Typically, a single impurity is specified at ≤0.5% or ≤0.2%.
  • Total Impurities: An overall limit on all impurities is also provided, often ≤1.0% or ≤0.5%.

Quality Control Processes in Manufacturing

Reputable manufacturers employ stringent quality control (QC) measures throughout the production of 5,6-Dimethoxy-1-indanone. These typically include:

  • Raw Material Testing: Ensuring the quality of incoming raw materials used in the synthesis.
  • In-Process Controls (IPCs): Monitoring critical process parameters and intermediate purities at various stages of synthesis.
  • Finished Product Testing: Comprehensive analysis of the final 5,6-Dimethoxy-1-indanone batch against all specifications using validated analytical methods.
  • Stability Studies: Assessing the shelf-life and storage conditions required to maintain product quality over time.
  • Documentation: Maintaining detailed batch records, analytical reports, and providing robust Certificates of Analysis (CoA) and Material Safety Data Sheets (MSDS).

Procuring High-Quality 5,6-Dimethoxy-1-indanone

When you decide to buy 5,6-Dimethoxy-1-indanone, engage with manufacturers and suppliers who are transparent about their QC processes and specifications. Requesting samples for your own verification is a standard practice in the industry. Understanding these technical details empowers you to make informed purchasing decisions, ensuring you procure a reliable intermediate that meets your exacting pharmaceutical synthesis requirements.

Conclusion

The quality of pharmaceutical intermediates like 5,6-Dimethoxy-1-indanone directly impacts the safety and efficacy of the final drug product. By thoroughly understanding its technical specifications and the quality control measures employed by manufacturers, researchers and procurement managers can confidently source this critical compound, thereby ensuring the integrity of their synthesis processes.