Tolvaptan Impurities
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.
References
FAQ's
References
- Ogawa, Hidenori; Miyamoto, Hisashi; Kondo, Kazumi; Yamashita, Hiroshi; Nakaya, Kenji; Komatsu, Hajime; Tanaka, Michinori; Takara, Shinya; Tominaga, Michiaki; Yabuchi, Yoichi, Benzoheterocyclic compounds, Otsuka Pharmaceutical Co., Ltd., Japan, US5258510A, November 2, 1993
- Pei, Qi; Zhang, Bikui; Tan, Hongyi; Liu, Lihua; Peng, Xiangdong; Li, Zuojun; Huang, Panhao; Luo, Mi; Zuo, Xiaocong; Guo, Chengxian; et al, Development and validation of an LC-MS/MS method for the determination of tolvaptan in human plasma and its application to a pharmacokinetic study, Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, Volume: 913-914, Pages: 84-89, 2013
Frequently Asked Questions
Are there particular analytical techniques employed to ensure impurity control in Tolvaptan?
Many validated analytical methods, such as Reversed Phase high-performance liquid chromatography (RP-HPLC) coupled with a UV method, help detect and quantify impurities in Tolvaptan.
What measures help to minimize Tolvaptan impurities during the storage of the drug?
The proper storage conditions, such as temperature control and protection from light and moisture, help to minimize impurity formation.
Which solvent helps in the analysis of Tolvaptan impurities?
Methanol helps in analyzing many impurities in Tolvaptan.
What are the temperature conditions required to store Tolvaptan impurities?
Tolvaptan impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).
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