R-Amlodipine Besylate is a chiral impurity in Amlodipine formulations, formed due to specific synthesis conditions.

Monitoring this chiral impurity is essential to ensure the safety and efficacy of Amlodipine formulations, as required by regulatory bodies.

It forms during chiral synthesis or specific storage conditions that can lead to chiral impurity development in Amlodipine.

Proper chiral control during synthesis and appropriate storage can help minimize its formation.

Advanced chiral detection techniques like chiral HPLC and LC-MS are used for accurate detection.

Chemicea supplies COA, H-NMR, MASS, HPLC, and TGA reports, with additional documentation available upon request.

Yes, Chemicea’s documentation meets the standards required by USFDA, EMA, ANVISA, PMDA, and others.

It is stable for shipping at room temperature, with specific storage conditions provided in the COA.

Yes, Chemicea offers both standard and customized pack sizes based on client requirements.

Chemicea provides this chiral impurity as a reference standard to support regulatory compliance and quality control.