Description

Tolvaptan Impurity 11 is a designated process-related impurity and degradation product of the pharmaceutical agent Tolvaptan. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs professionals involved in the development and quality control of Tolvaptan-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Tolvaptan Impurity 11 in active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities during the manufacturing process.
• Stability Indicating Studies: Employed in forced degradation studies to understand the degradation pathways of Tolvaptan and to establish shelf-life specifications.
• Quality Control and Batch Release: Serves as a system suitability standard in routine QC testing to ensure the impurity profile of Tolvaptan API meets pharmacopeial (USP, EP) or internal specifications.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., ANDA, NDA) to demonstrate control over potential impurities.
• Research and Development: Used in R&D to study the chemical behavior, synthesis pathways, and purification processes related to Tolvaptan.

Basic Information

Product Name	Tolvaptan Impurity 11
CAS No.	331947-69-4
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 B; Tolvaptan EP Impurity B; Tolvaptan USP Impurity B; 1-[4-[(2-Methyl-4-benzoyl)amino]benzoyl]-7-chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepine; UNII-8KQ3HZ2B8P; 8KQ3HZ2B8P
EINECS	Contact for details

Quality Control

Every batch of Tolvaptan Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. 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 at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive); ensure the container is kept in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
Assay (HPLC)	97.0% - 103.0% (on anhydrous basis)

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