Description

Tolvaptan Impurity 7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Tolvaptan, a pharmaceutical active ingredient. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and R&D facilities involved in drug development and quality control.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Tolvaptan Impurity 7 in Tolvaptan drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to monitor batch-to-batch consistency.
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Tolvaptan formulations.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive characterization data for impurity identification as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Research & Development: Used in synthetic chemistry research to study the formation pathway and chemical behavior of this impurity.

Basic Information

Product Name	Tolvaptan Impurity 7
CAS No.	1580889-33-3
Molecular Formula	C26H25ClN2O3
Molecular Weight	448.94 g/mol
Synonyms	7-Chloro-5-hydroxy-1-[2-methyl-4-(2-methylbenzoyl)amino]benzoyl-2,3,4,5-tetrahydro-1H-1-benzazepine; Tolvaptan Related Compound 7; Tolvaptan EP Impurity C; Tolvaptan USP Impurity; UNII-7P8K714K1N; 1H-1-Benzazepine-1-acetamide impurity of Tolvaptan
EINECS	Contact for details

Quality Control

Every batch of Tolvaptan Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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