Description

Tolvaptan Impurity 9 CAS NO 1580889-25-3 is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and regulatory compliance of Tolvaptan, a vasopressin receptor antagonist medication. It is essential for analytical chemists and quality assurance professionals in pharmaceutical companies and contract research organizations (CROs) to ensure drug safety, efficacy, and adherence to stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Tolvaptan Impurity 9 in active pharmaceutical ingredient (API) and finished drug product batches.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies of Tolvaptan to understand degradation pathways and establish shelf-life.
• Quality Control (QC) Testing: Serves as a system suitability standard and for routine QC release testing to ensure Tolvaptan meets specified purity criteria.
• Research and Development: Used in synthetic chemistry R&D to study the formation and fate of this impurity during the Tolvaptan manufacturing process.

Basic Information

Product Name	Tolvaptan Impurity 9
CAS No.	1580889-25-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-Desmethyl Tolvaptan; Tolvaptan N-Desmethyl Impurity; Tolvaptan Related Compound 9; 7-Chloro-5-hydroxy-1-[2-methyl-4-(2-methylbenzoyl)amino]benzoyl-2,3,4,5-tetrahydro-1H-1-benzazepine; UNII-Contact for details; Tolvaptan Metabolite; OPC-41061 Related Substance 9
EINECS	Contact for details

Quality Control

Our Tolvaptan Impurity 9 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance with ICH Q3A/B 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 product 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 corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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