Description

Tolvaptan Impurity 6 is a designated impurity standard used in the pharmaceutical development and quality control of Tolvaptan, a vasopressin receptor antagonist. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of process-related impurities. It is an essential analytical tool for pharmaceutical manufacturers, contract research organizations (CROs), and quality assurance laboratories focused on API synthesis and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analytical method development and validation of Tolvaptan API.
• Quality Control & Assurance: Critical for routine batch release testing to monitor and control impurity levels as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to identify and track the formation of this specific impurity in forced degradation and long-term stability studies of Tolvaptan drug products.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry R&D: Aids chemists in optimizing synthesis pathways to minimize the formation of this impurity during Tolvaptan manufacturing.
• Pharmacopoeial Testing: Supports testing against monograph specifications for Tolvaptan in various pharmacopoeias (e.g., USP, EP).

Basic Information

Product Name	Tolvaptan Impurity 6
CAS No.	1432725-24-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-Desmethyl Tolvaptan; Tolvaptan N-Desmethyl Impurity; Tolvaptan Related Compound 6; 7-Chloro-5-hydroxy-1-[2-methyl-4-(2-methylbenzoyl)amino]benzoyl-2,3,4,5-tetrahydro-1H-1-benzazepine; 1H-1-Benzazepine-5-carboxamide, 7-chloro-2,3,4,5-tetrahydro-5-hydroxy-1-[2-methyl-4-[(2-methylbenzoyl)amino]benzoyl]-; Tolvaptan Impurity F (Potential); Tolvaptan N-Demethylated Impurity
EINECS	Contact for details

Quality Control

Our Tolvaptan Impurity 6 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic methods, to ensure identity, purity, and traceability. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and analytical data, supporting compliance with cGMP and ICH guidelines for pharmaceutical impurities.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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