In the pursuit of pharmaceutical excellence, precise analytical tools and high-purity reference materials are indispensable. Dehydro Amlodipine, identified by CAS 113994-41-5, is one such critical compound. Commonly known as Amlodipine Impurity D, it serves as a vital reference standard in the pharmaceutical industry, particularly for the quality control and stability assessment of Amlodipine-based medications. For research scientists and procurement specialists, understanding its properties and how to source it effectively is key.

Dehydro Amlodipine is primarily used in:

  • Analytical Method Development: As a known impurity of Amlodipine, it is essential for developing and validating chromatographic methods (e.g., HPLC, UPLC) that can accurately separate and quantify it from the parent drug. Researchers often look for established suppliers to purchase this standard to refine their analytical techniques and ensure they meet regulatory requirements.
  • Quality Control Testing: Pharmaceutical manufacturers use Dehydro Amlodipine to establish a baseline for acceptable impurity levels in Amlodipine API and finished products. Regular testing against this reference standard ensures batch-to-batch consistency and compliance with pharmacopoeial standards. Purchasing reliable standards is paramount for maintaining the integrity of QC operations.
  • Stability Studies: This compound is instrumental in identifying potential degradation pathways of Amlodipine. By monitoring its formation under various stress conditions, pharmaceutical companies can optimize formulation and packaging to enhance drug stability and extend shelf life. This makes it a key element in a comprehensive stability program.

When considering the purchase of Dehydro Amlodipine, the choice of supplier is crucial. Manufacturers in China have developed significant expertise in synthesizing and supplying high-quality fine chemicals and pharmaceutical intermediates. They often offer Dehydro Amlodipine with verified purity (>95% by HPLC) and comprehensive characterization data. For those looking to buy, engaging with these suppliers allows for competitive pricing and a reliable supply chain, essential for ongoing R&D or manufacturing needs.

Key factors to consider when evaluating a manufacturer include their adherence to quality management systems, the availability of detailed product specifications, and their capacity to provide consistent product quality. Furthermore, inquiring about bulk purchase options and lead times is advisable for long-term project planning. A responsive supplier will also provide necessary safety data sheets (SDS) and technical support, ensuring a smooth procurement and integration process.

In summary, Dehydro Amlodipine (CAS 113994-41-5) is a critical analytical tool in the pharmaceutical industry. Leveraging the capabilities of experienced manufacturers, particularly those in China, ensures access to a high-quality reference standard that supports rigorous quality control, efficient method development, and robust stability testing for Amlodipine products.