Linagliptin N,N’-Methylene Dimer is an impurity that may form in Linagliptin formulations due to specific synthesis or storage conditions.

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

It forms under specific synthesis or storage conditions, leading to impurity development in Linagliptin.

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

Detection is achieved using advanced techniques like GC-MS, LC-MS, and HPLC-MS.

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

Yes, Chemicea’s documentation meets standards required by USFDA, EMA, ANVISA, PMDA, and other regulatory agencies.

Stable for shipping at room temperature, with specific storage guidelines provided in the COA.

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

Chemicea provides this impurity as a reference standard, supporting regulatory compliance and quality control efforts.