Description

Tolvaptan Impurity 7 CAS NO 1863916-82-8 is a high-purity chemical reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Tolvaptan. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily required by R&D scientists, QC/QA professionals, and regulatory affairs specialists in the pharmaceutical and biotechnology industries for method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Tolvaptan Impurity 7 in Tolvaptan drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Tolvaptan API and formulations meet stringent pharmacopeial (USP, EP) and internal specification limits for impurities.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing characterized impurity data required for drug approval.
• Research & Development: Aids in process chemistry research to understand and minimize the formation of this impurity during the synthesis and purification of Tolvaptan.

Basic Information

Product Name	Tolvaptan Impurity 7
CAS No.	1863916-82-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-Desmethyl Tolvaptan; Tolvaptan N-Desmethyl Impurity; Tolvaptan Related Compound 7; 5'-Demethyl Tolvaptan; OPC-41061 Impurity; (5R)-5-[(5S,7R)-7-Hydroxy-5-(4-methylbenzoyl)-1,4,5,6,7,8-hexahydro-2H-cyclohepta[b]pyridin-2-yl]-2-methylvaleronitrile; 1,4,5,6,7,8-Hexahydro-2H-cyclohepta[b]pyridin-7-ol, 5-[(1R)-1-cyano-4-methylpentyl]-2,3,4,5-tetrahydro-5-(4-methylbenzoyl)-, (5S,7R)-
EINECS	Contact for details

Quality Control

Every batch of Tolvaptan Impurity 7 is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our products are characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm structure and meet stringent specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines for impurities and reference standards.

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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.