Description

Tolvaptan Impurity 3 (DM-4104) is a high-purity reference standard used for the analytical profiling and quality control of Tolvaptan, a vasopressin receptor antagonist. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, monitor degradation pathways, and comply with stringent regulatory requirements for impurity identification. It is an essential material for research and development, method validation, and stability studies in the production of Tolvaptan API and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in quality control laboratories.
• Method Development and Validation: Critical for developing and validating analytical procedures to detect and quantify Tolvaptan-related impurities.
• Stability Indicating Studies: Used to identify and track the formation of this specific impurity during forced degradation and long-term stability studies of Tolvaptan drug substance and product.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data required for drug master files (DMFs) and investigational new drug (IND) applications.
• Research and Development: Serves as a key intermediate or marker in synthetic chemistry research to understand and optimize the Tolvaptan manufacturing process.
• Pharmacopoeial Testing: Potential use as a system suitability component in testing to meet pharmacopoeial monographs (e.g., USP, EP) for Tolvaptan.

Basic Information

Product Name	Tolvaptan Impurity 3 (DM-4104)
CAS No.	1587638-01-4
Molecular Formula	C26H25ClN2O3
Molecular Weight	448.94 g/mol
Synonyms	DM-4104; Tolvaptan Related Compound 3; 7-Chloro-5-hydroxy-1-[2-methyl-4-(2-methylbenzoyl)aminobenzoyl]-2,3,4,5-tetrahydro-1H-1-benzazepine; 7-Chloro-5-hydroxy-1-[2-methyl-4-[(2-methylbenzoyl)amino]benzoyl]-2,3,4,5-tetrahydro-1H-1-benzazepine; UNII-9K8F8P8A4S; 9K8F8P8A4S; Tolvaptan Impurity D; Tolvaptan EP Impurity C
EINECS	Contact for details

Quality Control

Every batch of Tolvaptan Impurity 3 (DM-4104) is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing including identity confirmation (IR, NMR), purity determination by HPLC, and control of related substances and residual solvents to ensure it meets the high standards required for pharmaceutical impurity analysis. A detailed Certificate of Analysis (COA) with batch-specific data is provided for traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant and inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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