Description

Tolvaptan Impurity 35 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, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Tolvaptan drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and final release testing of Tolvaptan batches to meet pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation and level of this impurity during forced degradation and long-term stability studies of Tolvaptan formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and justify specifications.
• Research & Development: Used in R&D to study the degradation pathways and metabolism of Tolvaptan.

Basic Information

Product Name	Tolvaptan Impurity 35
CAS No.	1316312-24-9
Molecular Formula	C26H25ClN2O3
Molecular Weight	448.94 g/mol
Synonyms	N-Desmethyl Tolvaptan; Tolvaptan N-Desmethyl Impurity; 5'-Demethyl Tolvaptan; 7-Chloro-5-hydroxy-1-[2-methyl-4-(2-methylbenzoyl)amino]benzoyl-2,3,4,5-tetrahydro-1H-1-benzazepine; UNII-7V3F8J2Q4R; Tolvaptan Related Compound 35; Tolvaptan Metabolite; OPC-41061 Related Substance
EINECS	Contact for details

Quality Control

Our Tolvaptan Impurity 35 is manufactured under strict quality control conditions to ensure it meets the stringent requirements for pharmaceutical reference standards. Each batch is characterized and tested using advanced analytical techniques, including HPLC, LC-MS, and NMR, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines.

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 must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

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%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Assay (HPLC)	90.0% - 110.0% on dried basis

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