Pitavastatin (3S,5R)-Isomer Calcium Salt is an isomeric impurity in Pitavastatin formulations, formed under specific conditions.

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

It forms under specific synthesis or storage conditions that can lead to isomeric impurity development in Pitavastatin.

Proper storage and careful synthesis control help minimize its formation.

Advanced techniques like GC-MS, LC-MS, and HPLC-MS are employed 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 isomeric impurity as a reference standard to support regulatory compliance and quality control.