Description

Tolvaptan Impurity 10 CAS NO 1859917-54-6 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 the active pharmaceutical ingredient (API) Tolvaptan, a vasopressin receptor antagonist. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and contract research organizations (CROs) involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during Tolvaptan API manufacturing and stability studies.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accurate detection and quantification limits.
• Quality Control and Release Testing: Employed in routine QC testing of Tolvaptan drug substance and finished dosage forms to verify compliance with ICH Q3A/B guidelines on impurities.
• Stability Studies: Used to assess the formation and levels of this impurity under various stress conditions (heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Reference Standard: Acts as a pure standard for academic and industrial research into the metabolism, degradation pathways, and toxicology of Tolvaptan-related compounds.

Basic Information

Product Name	Tolvaptan Impurity 10
CAS No.	1859917-54-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tolvaptan Related Compound 10; Tolvaptan Impurity; Tolvaptan EP Impurity 10; Tolvaptan USP Impurity; 1859917-54-6; (2R,4S)-5-(5'-Chloro-2'-hydroxy-3'-nitro-[1,1'-biphenyl]-4-carbonyl)-2-methyl-2,3,4,5-tetrahydro-1H-1-benzazepine-4-carboxamide; Biphenyl derivative of Tolvaptan; Tolvaptan Degradation Product
EINECS	Contact for details

Quality Control

Our Tolvaptan Impurity 10 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and supporting data, aligning with ICH guidelines and current Good Manufacturing Practice (cGMP) principles 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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

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