Description

Tolvaptan Impurity 26 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Tolvaptan, a vasopressin receptor antagonist. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analytical testing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and contract research organizations (CROs) focused on method validation and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Tolvaptan Impurity 26 in active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Crucial for developing, optimizing, and validating chromatographic methods to monitor this specific impurity.
• Stability Studies and Forced Degradation Testing: Used to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release Testing: Employed in routine QA/QC testing to ensure Tolvaptan batches meet stringent purity specifications as per ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Tolvaptan during synthesis and storage.

Basic Information

Product Name	Tolvaptan Impurity 26
CAS No.	1580889-36-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	7-Chloro-5-hydroxy-1-[2-methyl-4-(2-methylbenzoyl)amino]benzoyl-2,3,4,5-tetrahydro-1H-1-benzazepine; Tolvaptan Related Compound 26; Tolvaptan EP Impurity J; Tolvaptan Process Impurity; 1H-1-Benzazepine-1-acetamide, 7-chloro-2,3,4,5-tetrahydro-5-hydroxy-1-[2-methyl-4-[(2-methylbenzoyl)amino]benzoyl]-; UNII-9F8W7V3K1R
EINECS	Contact for details

Quality Control

Every batch of Tolvaptan Impurity 26 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with industry standards and customer specifications for use as a reference standard. Certificates of Analysis (COA) providing detailed results for identity, purity, and impurity profile are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 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.