The pharmaceutical industry operates under strict regulations to ensure the safety and efficacy of medications. For widely used drugs like Amlodipine, a calcium channel blocker, identifying and quantifying related substances and impurities is a critical component of quality assurance. Among these, Dehydro Amlodipine (CAS 113994-41-5), also known as Amlodipine Impurity D, stands out as a key compound for analytical purposes.

Dehydro Amlodipine is an oxidation product or a degradation intermediate that can form during the synthesis or storage of Amlodipine. Its chemical structure differs slightly from Amlodipine, and its presence needs to be carefully monitored. Pharmaceutical manufacturers and quality control laboratories utilize Dehydro Amlodipine in several crucial ways:

  • As a Primary Reference Standard: High-purity Dehydro Amlodipine serves as a benchmark for analytical testing. When purchasing this material, researchers and QC analysts look for suppliers who can guarantee its identity and purity, typically >95% by HPLC. This allows for the accurate calibration of analytical equipment, such as HPLC systems, essential for detecting and quantifying this specific impurity in Amlodipine samples.
  • In Forced Degradation Studies: Understanding how Amlodipine breaks down under stress (heat, light, humidity, acidic or basic conditions) is vital for determining its shelf-life and appropriate handling. Dehydro Amlodipine is often a key degradation product observed in these studies. By using it as a standard, scientists can precisely measure the extent of degradation and assess the stability of various Amlodipine formulations. This information is invaluable for product development and regulatory submissions.
  • For Method Validation: Any analytical method developed to assess Amlodipine's purity must be validated to prove its reliability. Dehydro Amlodipine is used during validation to demonstrate the method's specificity (ability to distinguish the impurity from other components), linearity (response proportional to concentration), accuracy, and precision. Purchasing this standard is a prerequisite for comprehensive method validation.

When seeking to buy Dehydro Amlodipine, it is advisable to partner with manufacturers specializing in pharmaceutical impurities and reference standards. These suppliers often provide detailed technical data, including spectra and chromatographic profiles, to support the use of their products. Engaging with a reliable supplier, potentially from regions like China known for their chemical manufacturing expertise, ensures access to consistent quality and a stable supply for your ongoing needs. Always inquire about batch-to-batch consistency and the availability of custom packaging or bulk quantities if your project demands it.

In essence, Dehydro Amlodipine (CAS 113994-41-5) is an indispensable tool for any entity involved in the production or quality assessment of Amlodipine. Its role in ensuring drug purity and safety cannot be overstated, making it a key component in the pharmaceutical quality control arsenal.