General Information

Teneligliptin Impurities and Teneligliptin

Daicel Pharma offers a diverse range of exclusive Teneligliptin impurities, such as

1-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazine, Teneligliptin (2R,4R)-Isomer, Teneligliptin (2R,4S)-isomer and Teneligliptin (2S,4R)-isomer. These impurities are significant in assessing the quality, stability, and biological safety of the active pharmaceutical ingredient Teneligliptin. Moreover, Daicel Pharma offers custom synthesis of Teneligliptin impurities and delivers them globally to meet the specific requirements of the clientele.

Teneligliptin [CAS: 760937-92-6] is an orally bioavailable, long-acting pyrrolidine-based dipeptidyl peptidase 4 (DPP-4) inhibitor exhibiting hypoglycemic activity. It manages type 2 diabetes mellitus (T2DM).

Teneligliptin: Use and Commercial Availability  

Teneligliptin treats type 2 diabetes mellitus. As an inhibitor of dipeptidyl peptidase 4 (DPP-4), this drug helps regulate blood glucose levels by increasing the activity of incretin hormones, such as GLP-1 (glucagon-like peptide-1). By inhibiting the degradation of these hormones, Teneligliptin promotes insulin secretion and reduces glucagon release, leading to improved glycemic control.

Teneligliptin is available under Teneria, Tenepure, Teneza, etc., containing the active ingredient Teneligliptin.

Teneligliptin Structure and Mechanism of Action

The chemical name of Teneligliptin is [(2S,4S)-4-[4-(3-Methyl-1-phenyl-1H-pyrazol-5-yl)-1-piperazinyl]-2-pyrrolidinyl]-3-thiazolidinylmethanone. Its chemical formula is C₂₂H₃₀N₆OS, and its molecular weight is approximately 426.6 g/mol.

The mechanism of action of Teneligliptin is not known.

Teneligliptin Impurities and Synthesis

During the synthesis¹ of Teneligliptin, various impurities like related substances, degradation products, and residual solvents can generate. It is vital to carefully monitor and control them to ensure the drug’s safety, efficacy, and overall quality.

Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Teneligliptin impurity standards, 1-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazine, Teneligliptin (2R,4R)-Isomer, Teneligliptin (2R,4S)-isomer and Teneligliptin (2S,4R)-isomer. They are manufactured in compliance with current Good Manufacturing Practices (cGMP). The CoA includes complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². We give additional characterization data, including 13C-DEPT, on request. Daicel Pharma can generate unknown impurities or degradation products of Teneligliptin.