Bepotastine

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Bepotastine N-Oxide (trifluoro acetate salt)

  • CAT NUMBER DCTI-C-2404
  • CAS NUMBER NA
  • MOLECULAR FORMULA C21H25ClN2O4 (Free Acid); C23H26ClF3N2O6 (TFA Salt)
  • MOLECULAR WEIGHT 404.89 (Free Acid); 518.91 (TFA Salt)

Bepotastine piperidine N-Oxide (Mixture of diastereomers)

  • CAT NUMBER DCTI-C-2405
  • CAS NUMBER NA
  • MOLECULAR FORMULA C21H25ClN2O4
  • MOLECULAR WEIGHT 404.89

SBPB (Bepotastine n-Butyl Ester)

  • CAT NUMBER DCTI-C-2402
  • CAS NUMBER 1807606-59-2
  • MOLECULAR FORMULA C25H33ClN2O3
  • MOLECULAR WEIGHT 445

SBPI (Bepotastine Isopropyl Ester)

  • CAT NUMBER DCTI-C-2403
  • CAS NUMBER 1807607-93-7
  • MOLECULAR FORMULA C24H31ClN2O3
  • MOLECULAR WEIGHT 430.97

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 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.

References
FAQ's

Frequently Asked Questions

The formation of Bepotastine impurities can be minimized by optimizing the synthetic process, selecting the proper starting materials, and implementing appropriate storage conditions.

Impurities in Bepotastine are identified through various analytical techniques, such as HPLC and LC-MS, which identify and quantify impurities in the drug substance or product.

Methanol is a solvent used in analyzing many impurities in Bepotastine.

Bepotastine impurities are stored at a controlled room temperature between 2-8 ⁰C or as indicated on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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