Desloratadine

General Information

Desloratadine Impurities and Desloratadine

Daicel Pharma offers high-quality Desloratadine impurities, Desloratadine Methanone Impurity, and genotoxic NDSRI N-nitroso-desloratadine impurity. They are vital for evaluating Desloratadine quality, stability, and biological safety. Furthermore, Daicel Pharma specializes in the custom synthesis of Desloratadine impurities and ensures their worldwide delivery.

Desloratadine [CAS: 100643-71-8] is a major metabolite of Loratadine. It is an antihistamine to alleviate symptoms associated with allergies such as rhinitis and chronic urticaria. It is a tricyclic H1 inverse agonist.

Desloratadine: Use and Commercial Availability

Desloratadine, a piperidine derivative with prolonged action, exhibits selective H1 antihistaminergic properties. Unlike some antihistamines, Desloratadine does not induce drowsiness as it does not readily penetrate the central nervous system. Its roles include serving as an H1-receptor antagonist, an anti-allergic agent, a cholinergic antagonist, and a drug metabolite. Desloratadine is prescribed to alleviate allergic symptoms. Marketed under the trade name Clarinex, it treats allergies.

Desloratadine Structure and Mechanism of Action

The chemical name of Desloratadine is 8-Chloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine. The chemical formula for Desloratadine is C₁₉H₁₉ClN₂, and its molecular weight is approximately 310.8g/mol.

Desloratadine is a long-acting tricyclic histamine antagonist. It has selective H1-receptor histamine antagonist activity. It inhibits histamine release from human mast cells in vitro.

Desloratadine Impurities and Synthesis

During the synthesis¹ of Desloratadine, meticulous steps can maintain its purity and therapeutic efficacy. Despite these precautions, impurities may occur, affecting the drug’s quality. Advanced purification methods such as chromatography and crystallization can minimize impurities, preserving the integrity of Desloratadine.

Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Desloratadine impurities, which includes Desloratadine Methanone Impurity and genotoxic NDSRI N-nitroso-desloratadine impurity. The CoA is from a cGMP-compliant analytical facility and encompasses complete characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². On request, we give additional data like 13C-DEPT and CHN. Daicel Pharma also prepares any unidentified Desloratadine impurity or degradation product. Furthermore, Daicel Pharma offers highly purified isotope-labeled standards of Desloratadine for bioanalytical research and BA/BE studies. We provide a complete characterization report upon delivery.