General Information

Bepotastine Impurities and Bepotastine 

Daicel Pharma synthesizes high-quality Bepotastine impurities, including Bepotastine N-Oxide (trifluoroacetate salt), Bepotastine piperidine N-Oxide (Mixture of diastereomers), SBPB (Bepotastine n-Butyl Ester), and SBPI (Bepotastine Isopropyl Ester). These impurities are essential for evaluating the quality, stability, and safety of Bepotastine, which is an active pharmaceutical ingredient. Additionally, Daicel Pharma offers a customized synthesis of Bepotastine impurities for global delivery to meet the specific needs of our customers.

Bepotastine [CAS: 125602-71-3] is a non-sedating, selective histamine (H1) receptor antagonist with topical application. Its benzenesulfonate salt treats itching related to allergic conjunctivitis.

Bepotastine: Use and Commercial Availability  

Bepotastine is an ophthalmic antihistamine that has additional anti-inflammatory and mast cell stabilizing properties. It can inhibit eosinophilic infiltration, IL-5 production, and leukotriene B4 and D4 activity. The drug treats allergic rhinitis and pruritus/itching linked to urticaria and other skin conditions. Bepreve is the trade name under which Bepotastine is available.

Bepotastine Structure and Mechanism of Action

The chemical name of Bepotastine is 4-[(S)-(4-Chlorophenyl)-2-pyridinylmethoxy]-1-piperidinebutanoic acid. Its chemical formula is C₂₁H₂₅ClN₂O₃, and its molecular weight is approximately 388.9 g/mol.

Bepotastine inhibits the release of histamine from mast cells.

Bepotastine Impurities and Synthesis

During the manufacturing¹ of Bepotastine, impurities generate due to various factors such as the starting materials, chemical reactions, and processing conditions. These impurities can affect the drug quality, safety, and efficacy. So, it is necessary to control them to ensure their levels are within acceptable limits. The identification and quantification of impurities, as well as the establishment of appropriate specifications and testing methods, are crucial for ensuring the quality of Bepotastine and minimizing potential risks to patients.

Daicel Pharma provides a Certificate of Analysis (CoA) for Bepotastine impurity standards, including Bepotastine N-Oxide (trifluoroacetate salt), Bepotastine piperidine N-Oxide (Mixture of diastereomers), SBPB (Bepotastine n-Butyl Ester), and SBPI (Bepotastine Isopropyl Ester). The CoA is generated from a cGMP-compliant analytical facility and includes comprehensive characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². We can also give additional characterization data like 13C-DEPT and CHN upon request. Daicel Pharma is capable of creating unknown Bepotastine impurities or degradation products. Each delivery has a complete characterization report.