Description

Tolvaptan Impurity 11 CAS NO 150683-27-5 is a designated impurity standard used in the pharmaceutical development and quality control of Tolvaptan, a vasopressin receptor antagonist. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference marker in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Tolvaptan Impurity 11 in drug substance and drug product analysis.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities.
• Quality Control and Batch Release: A critical component in the quality control laboratory for testing Tolvaptan API and finished dosage forms against ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization and control data in Common Technical Documents (CTD).
• Research and Development: Used in R&D to understand the degradation pathways and synthesis by-products of Tolvaptan.

Basic Information

Product Name	Tolvaptan Impurity 11
CAS No.	150683-27-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tolvaptan Related Compound 11; Tolvaptan EP Impurity J; Tolvaptan USP Impurity; 7-Chloro-5-hydroxy-1-[2-methyl-4-(2-methylbenzoyl)amino]benzoyl-2,3,4,5-tetrahydro-1H-1-benzazepine; (5R)-7-Chloro-5-hydroxy-1-[2-methyl-4-[(2-methylbenzoyl)amino]benzoyl]-2,3,4,5-tetrahydro-1H-1-benzazepine; Benzazepine impurity of Tolvaptan; Degradation product of Tolvaptan
EINECS	Contact for details

Quality Control

Our Tolvaptan Impurity 11 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with current pharmacopeial expectations (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity assay, related substances, and identification tests (IR, MS).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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