Tegoprazan Impurities and Tegoprazan
Daicel Pharma offers a diverse range of Tegoprazan impurities, such as
3-(3,5-difluorophenoxy)propan-1-ol,5,7-difluorochroman-4-ol, 5,7-difluorochroman-4-one and Tegoprazan R-Isomer Impurity. Manufacturers can assess the quality, stability, and biological safety of the active pharmaceutical ingredient Tegoprazan based on the presence of these impurities. Daicel Pharma offers a customized synthesis of Tegoprazan impurities, ensuring precise adherence to customer specifications and dependable worldwide delivery.
Tegoprazan [CAS: 942195-55-3] is an innovative potent drug that helps address acid-related gastrointestinal disorders. This medication acts as a highly selective potassium-competitive acid blocker (P-CAB), delivering rapid long-lasting relief and control of gastric pH.
Tegoprazan: Use and Commercial Availability
Tegoprazan, a potent potassium-competitive acid blocker (P-CAB), treats gastrointestinal diseases. It can control gastric pH over an extended period.
Tegoprazan is not available under any brand name in the commercial market.
Tegoprazan Structure and Mechanism of Action
The chemical name of Tegoprazan is 7-[[(4S)-5,7-Difluoro-3,4-dihydro-2H-1-benzopyran-4-yl]oxy]-N, N,2-trimethyl-1H-benzimidazole-5-carboxamide. Its chemical formula is C20H19F2N3O3, and its molecular weight is approximately 387.4 g/mol.
Tegoprazan can directly reversibly inhibit H+/K+‐ATPase. It can remain in the highly acidic canaliculi of gastric parietal cells as it is an acid-resistant weak base.
Tegoprazan Impurities and Synthesis
During the synthesis1 of Tegoprazan, various impurities like related substances, degradation products, and residual solvents generate. It is vital to carefully monitor and control these impurities to ensure the drug’s safety, efficacy, and overall quality.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Tegoprazan impurity standards, which includes 3-(3,5-difluorophenoxy)propan-1-ol,5,7-difluorochroman-4-ol, 5,7-difluorochroman-4-one and Tegoprazan R-Isomer Impurity. These impurities are manufactured in compliance with current Good Manufacturing Practices (cGMP). The CoA provides detailed characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2, offering a thorough understanding of the impurity profile. If required, Daicel can also provide 13C-DEPT data for further characterization.
Moreover, Daicel Pharma possesses the technical expertise to synthesize any unknown impurities or degradation products of Tegoprazan. This capability ensures clients obtain the necessary impurities for their research and development requirements.
- Hanazawa, Takeshi; Koike, Hiroki, Chromane Substituted Benzimidazoles And Their Use As Acid Pump Inhibitors, Pfizer Inc., Japan, RaQualia Pharma Inc., Japan, EP1963311B1, June 16, 2010
Frequently Asked Questions
Tegoprazan impurities can arise from various sources, including starting materials, reagents, or by-products formed during synthesis.
Liquid chromatography/tandem mass spectrometry (LC-MS/MS) can detect impurities effectively in Tegoprazan.
The presence of impurities in Tegoprazan can have implications for patient safety. Different types and levels of impurities can cause adverse effects or compromise the efficacy of the medication.
Acetonitrile is used to achieve optimal solubility and separation of Tegoprazan impurities.
Tegoprazan impurities are stored at a controlled room temperature between 2-8 °C 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.