The development and manufacturing of pharmaceuticals require meticulous attention to detail, particularly regarding the purity of drug substances. For Amlodipine, a widely prescribed medication for cardiovascular conditions, understanding and controlling its impurities is a regulatory and quality imperative. Dehydro Amlodipine, also known as Amlodipine Impurity D and identified by CAS 113994-41-5, is a significant compound in this context, serving as a critical reference standard for analytical and quality assurance purposes.

Dehydro Amlodipine is recognized as a process impurity or a degradation product that can arise during the synthesis or storage of Amlodipine. Its presence must be carefully monitored and controlled to ensure the safety and efficacy of the final drug product. Pharmaceutical companies leverage Dehydro Amlodipine for several key applications:

  • As an Analytical Reference: High-purity Dehydro Amlodipine is used as a standard to calibrate analytical instruments and validate testing methods, such as High-Performance Liquid Chromatography (HPLC). This allows laboratories to accurately identify and quantify the impurity in Amlodipine batches. When sourcing this material, it's crucial to buy from manufacturers who provide a Certificate of Analysis (CoA) confirming its purity and identity, often greater than 95% via HPLC.
  • In Stability Testing Protocols: Understanding the degradation kinetics of Amlodipine is crucial for determining its shelf-life and storage requirements. Dehydro Amlodipine is frequently a degradation product formed under oxidative or light-induced stress. Its use as a standard in stability studies helps researchers assess the stability of Amlodipine formulations and develop appropriate protective measures.
  • For Impurity Profiling and Method Development: Establishing a complete impurity profile is a regulatory requirement. Dehydro Amlodipine is essential for developing and validating specific analytical procedures that can reliably detect and quantify its presence. This enables manufacturers to implement process controls to minimize its formation during synthesis.

For pharmaceutical companies looking to purchase Dehydro Amlodipine, partnering with experienced manufacturers, especially those based in China, can offer significant advantages. These suppliers often possess advanced synthesis capabilities, stringent quality control measures, and competitive pricing. When selecting a supplier, it is essential to inquire about their production capacity, adherence to quality standards (e.g., ISO certification), and the availability of comprehensive documentation like CoAs and Safety Data Sheets (SDS). Reliable manufacturers also offer technical support to assist with product integration into existing analytical workflows.

In summary, Dehydro Amlodipine (CAS 113994-41-5) is a pivotal impurity reference standard for Amlodipine. Its accurate quantification is vital for ensuring drug quality, safety, and regulatory compliance. By strategically sourcing from reputable manufacturers, pharmaceutical professionals can obtain the high-purity material necessary for robust analytical testing and effective drug development.