Description

Tolvaptan Impurity 7 CAS NO 1432725-23-9 is a high-purity chemical reference standard used for the identification, qualification, and quantification of a specific process-related impurity in Tolvaptan active pharmaceutical ingredient (API) and finished drug products. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance during development and quality control. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) departments.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for analytical method development, validation, and verification in accordance with ICH guidelines.
• Quality Control & Assurance: Used for routine batch testing of Tolvaptan API and drug products to monitor and control impurity levels, ensuring they remain within specified safety thresholds.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Stability Studies: Employed to identify and track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Tolvaptan synthesis pathway to minimize the formation of this impurity.
• Contract Research Organizations (CROs): Used by analytical service providers to offer impurity testing and characterization services to pharmaceutical clients.

Basic Information

Product Name	Tolvaptan Impurity 7
CAS No.	1432725-23-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-Desethyl Tolvaptan; Tolvaptan N-Desethyl Impurity; Tolvaptan Related Compound 7; 5-Demethyl Tolvaptan; 4'-[(7-Chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl)carbonyl]-o-toluamide derivative; UNII-Contact for details; Tolvaptan Metabolite M1 (referential); Tolvaptan EP Impurity C
EINECS	Contact for details

Quality Control

Every batch of Tolvaptan Impurity 7 is manufactured and handled under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical quality attributes.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 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.