Dimetindene Impurities

General Information

Dimetindene Impurities and Dimetindene

Daicel Pharma specializes in offering high-quality impurities for Dimetindene, a crucial active pharmaceutical ingredient. These impurities, including Dimetindene EP Impurity – E, Dimetindene EP Impurity- A, Dimetindene EP Impurity-C, Dimetindene EP Impurity-D, Dimetindene EP Impurity-F, Dimetindene EP Impurity-G, Dimetindene EP impurity-H, and Dimetindene EP impurity-I, play a vital role in assessing the purity, reliability, and safety of Dimetindene. Daicel Pharma also offers a customized synthesis of Dimetindene impurities to cater to clients’ requirements, with worldwide delivery options available.

Dimetindene [CAS: 5636-83-9], an indene compound, acts as an antihistamine. It is a first-generation H1 antagonist. It treats allergic reactions such as urticaria, rhinitis, pruritus, and common cold symptoms.

Dimetindene: Use and Commercial Availability  

Dimetindene, available under the brand name Fenistil treats various disorders. It treats pruritus in eruptive skin diseases such as chickenpox. Additionally, it is effective in relieving pruritus of different origins, except pruritus caused by cholestasis. Dimetindene treats the upper respiratory tract allergies like hay fever and perennial rhinitis, food and drug allergies, and urticaria. It is an adjuvant in managing eczema and other pruritic allergic dermatoses.

Dimetindene Structure and Mechanism of Action 

The chemical name of Dimetindene is N, N-Dimethyl-3-[1-(2-pyridinyl)ethyl]-1H-indene-2-ethanamine. Its chemical formula is C₂₀H₂₄N_2, and its molecular weight is approximately 292.4 g/mol.

Dimetindene inhibits the interaction of histamine with histamine receptors and treats allergies.

Dimetindene Impurities and Synthesis

The formation of impurities in Dimetindene can occur during various stages such as synthesis¹, storage, or degradation processes. Analyzing and controlling these impurities is crucial to ensure the safety and quality of Dimetindene. Impurity analysis helps identify, quantify, and characterize unwanted substances, thus establishing appropriate specifications and limits. Impurities in Dimetindene can be minimized by effective control, ensuring regulatory compliance, maintaining product stability, and other harmful effects.

Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Dimetindene impurity standards, including Dimetindene EP Impurity – E, Dimetindene EP Impurity- A, Dimetindene EP Impurity-C, Dimetindene EP Impurity-D, Dimetindene EP Impurity-F, Dimetindene EP Impurity-G, Dimetindene EP impurity-H and Dimetindene EP impurity-I. They generate from an analytical facility that complies with cGMP standards. The CoA provides a detailed characterization report with data obtained through techniques such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². We give additional data like 13C-DEPT upon request. Daicel Pharma synthesizes unknown Dimetindene impurities or degradation products. Every delivery accompanies a complete characterization report.