General Information

Tolvaptan Impurities and Tolvaptan

Daicel Pharma specializes in synthesizing high-quality Tolvaptan impurities, such as 2-Desmethylbenzaldehyde Tolvaptan, 2-methyl-4-(2-methylbenzamido)benzoic acid, 3-Methyl tolvaptan, 7-chloro-2,3,4,5-tetrahydro-1H-benzo[b]azepin-5-ol, Tolvaptan amide impurity, Tolvaptan Open Ring Hydroxyacid, and more. These impurities analyze the active pharmaceutical ingredient of Tolvaptan, ensuring its integrity, stability, and biological safety. Additionally, Daicel Pharma offers tailored synthesis services for Tolvaptan impurities to meet customers’ specific requirements worldwide and trust for exceptional pharmaceutical solutions.

 Tolvaptan [CAS: 150683-30-0] is a vasopressin₂ receptor antagonist for slowing cyst development progression and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults.

Tolvaptan: Use and Commercial Availability

Tolvaptan slows kidney function failure in adult patients with progressing autosomal dominant polycystic kidney disease (ADPKD). It also treats hyponatremia secondary to the syndrome of inappropriate antidiuretic-hormone secretion (SIADH).

Tolvaptan is available under Jynarque and Samsca, which contain the active ingredient Tolvaptan.

Tolvaptan Structure and Mechanism of Action

The chemical name of Tolvaptan is N-[4-[(7-Chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl)carbonyl]-3-methylphenyl]-2-methylbenzamide. Its chemical formula is C₂₆H₂₅ClN₂O₃, and its molecular weight is approximately 448.9 g/mol.

Tolvaptan inhibits native arginine vasopressin (AVP) stimulated cyst growth in human ADPKD epithelial cells.

Tolvaptan Impurities and Synthesis

Effective management and monitoring of impurities are crucial during the manufacturing¹ of Tolvaptan to maintain its desired efficacy. These impurities can emerge from various sources, including raw materials, intermediates, and chemicals used in the synthesis. Ensuring the optimal quality and safety of the drug requires dynamic control and oversight of these impurities.

Daicel offers a wholesome and integrated Certificate of Analysis (CoA) for Tolvaptan impurities, such as 2-Desmethylbenzaldehyde Tolvaptan, 2-methyl-4-(2-methylbenzamido)benzoic acid, 3-Methyl tolvaptan, 7-chloro-2,3,4,5-tetrahydro-1H-benzo[b]azepin-5-ol, Tolvaptan amide impurity, Tolvaptan Open Ring Hydroxyacid, and more. The Certificate of Analysis (CoA) furnishes comprehensive characterization data, encompassing 1H NMR, 13C NMR, IR, MASS, and HPLC purity². Furthermore, we give a detailed 13C-DEPT analysis upon product delivery. Leveraging advanced technology and expertise, Daicel Pharma can synthesize any unknown Tolvaptan impurity or degradation product.