Description

Tolvaptan Impurity 4 (DM-4105) 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, contract research organizations (CROs), and analytical laboratories involved in drug development and quality control. The material is supplied with comprehensive analytical data to support method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Tolvaptan Impurity 4 in drug substance and finished product analysis.
• Method Development & Validation: Essential for developing and validating analytical methods, particularly HPLC and LC-MS, to monitor impurities during the manufacturing process.
• Quality Control (QC) Testing: Employed in routine QC laboratories to ensure Tolvaptan batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Used to track the formation and level of this specific impurity in Tolvaptan formulations under various storage conditions over time.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry research and process optimization for Tolvaptan.

Basic Information

Product Name	Tolvaptan Impurity 4 (DM-4105)
CAS No.	1587638-02-5
Molecular Formula	C26H25ClN2O3
Molecular Weight	448.94 g/mol
Synonyms	DM-4105; Tolvaptan Related Compound; 7-Chloro-5-hydroxy-1-[2-methyl-4-(2-methylbenzoyl)aminobenzoyl]-2,3,4,5-tetrahydro-1H-1-benzazepine; Tolvaptan EP Impurity D; Tolvaptan USP Impurity; UNII-6J8U8QN4A4; (5R)-7-Chloro-5-hydroxy-1-[2-methyl-4-[(2-methylbenzoyl)amino]benzoyl]-2,3,4,5-tetrahydro-1H-1-benzazepine
EINECS	Contact for details

Quality Control

Every batch of Tolvaptan Impurity 4 (DM-4105) is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed results for identity, purity, and impurity profile as determined by advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 degradation. 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)	≥ 98.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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