In the complex landscape of pharmaceutical manufacturing, maintaining the highest standards of product purity and quality is non-negotiable. For medications like Amlodipine, a widely used cardiovascular drug, the precise identification and quantification of impurities are crucial. Dehydro Amlodipine, also known as Amlodipine Impurity D and bearing the CAS number 113994-41-5, serves as a fundamental reference standard in this regard.

As a recognized impurity of Amlodipine, Dehydro Amlodipine plays a multifaceted role in pharmaceutical quality control (QC) and research and development (R&D). Its primary applications include:

  • As a Pharmaceutical Reference Standard: Dehydro Amlodipine is indispensable for validating analytical methods used to assess the purity of Amlodipine. When purchasing this compound, researchers prioritize high purity (typically >95% by HPLC) and reliable characterization data. This standard allows for the accurate calibration of chromatographic systems and ensures the specificity of analytical tests designed to detect and quantify related substances in Amlodipine APIs and finished products.
  • In Forced Degradation Studies: Pharmaceutical stability testing aims to understand how a drug degrades over time and under various environmental conditions. Dehydro Amlodipine is often identified as a degradation product of Amlodipine, particularly under oxidative or photolytic stress. Using it as a reference allows for the precise measurement of degradation rates, informing formulation design and shelf-life determination.
  • For Method Development and Validation: Developing sensitive and specific analytical methods for impurity detection requires well-characterized standards. Dehydro Amlodipine is used to optimize chromatographic separation parameters, establish limits of detection (LOD) and quantification (LOQ), and demonstrate the overall reliability of analytical procedures. Purchasing this standard is a necessary step for validating any new or existing method for Amlodipine analysis.

For pharmaceutical companies seeking to purchase Dehydro Amlodipine, sourcing from established manufacturers, particularly in China, offers a strategic advantage. These suppliers are adept at producing complex chemical entities with stringent quality controls, ensuring the high purity and consistency required for reference standards. When evaluating potential suppliers, it's vital to look for those who provide comprehensive product documentation, including Certificates of Analysis (CoA) and Safety Data Sheets (SDS), and who can offer competitive pricing and reliable delivery, especially for bulk orders.

In essence, Dehydro Amlodipine (CAS 113994-41-5) is a critical component in the pharmaceutical quality assurance framework. Its availability from reputable manufacturers ensures that drug developers and manufacturers can maintain the integrity and safety of Amlodipine products through rigorous analytical testing and control.