Description

Tolvaptan Impurity 9 is a designated impurity of the active pharmaceutical ingredient (API) Tolvaptan, a vasopressin receptor antagonist. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure the purity, safety, and efficacy of Tolvaptan-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Tolvaptan Impurity 9 in drug substances and finished products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the Tolvaptan synthesis pathway to minimize impurity formation.

Basic Information

Product Name	Tolvaptan Impurity 9
CAS No.	1859917-22-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	7-Chloro-5-hydroxy-1-[2-methyl-4-(2-methylbenzoyl)phenyl]-2,3,4,5-tetrahydro-1H-1-benzazepine-3-carboxamide; Tolvaptan Related Compound 9; Tolvaptan EP Impurity I; Tolvaptan USP Impurity; Tolvaptan Process Impurity; Benzazepine Impurity of Tolvaptan
EINECS	Contact for details

Quality Control

Our Tolvaptan Impurity 9 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, identity confirmation (IR, MS), and residual solvent screening, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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