Description

Tolvaptan Impurity 25 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of Tolvaptan, a vasopressin receptor antagonist medication, by enabling accurate identification and quantification of related substances. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and regulatory compliance. The availability of this well-characterized impurity supports robust impurity profiling and helps maintain stringent quality standards in drug production.

Application

• Primary use as a certified reference standard for the analytical testing of Tolvaptan active pharmaceutical ingredient (API) and finished dosage forms.
• Critical component in HPLC and LC-MS method development and validation for impurity profiling and assay determination.
• Essential for conducting pharmaceutical stability studies to monitor degradation pathways and establish shelf-life.
• Used in regulatory submissions (e.g., for FDA, EMA) to fulfill requirements for impurity identification and qualification.
• Serves as a system suitability and calibration standard in quality control (QC) laboratories.
• Valuable for academic and industrial research investigating the metabolism and pharmacokinetics of Tolvaptan.

Basic Information

Product Name	Tolvaptan Impurity 25
CAS No.	792931-76-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	7-Chloro-5-hydroxy-1-[2-methyl-4-(2-methylbenzoyl)phenyl]-2-oxo-1,2-dihydro-3H-1,4-benzodiazepine-3-carboxamide; Tolvaptan Related Compound; Tolvaptan Process Impurity; Tolvaptan Degradant; Benzodiazepine Impurity of Tolvaptan; OPC-41061 Impurity; SR 121463 Impurity
EINECS	Contact for details

Quality Control

Every batch of Tolvaptan Impurity 25 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced techniques including HPLC, LC-MS, NMR, and IR spectroscopy. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and other critical specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.