Description

Tolvaptan Impurity 30 CAS NO 1310357-40-4 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 quality control testing. The availability of this well-characterized impurity is essential for maintaining stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Tolvaptan Impurity 30 in drug substance and finished product analysis.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods for Tolvaptan and related products.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring product safety and efficacy per ICH guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filings: A necessary component for compiling regulatory documentation (e.g., ANDA, NDA) to demonstrate comprehensive impurity profiling.
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis routes for Tolvaptan.

Basic Information

Product Name	Tolvaptan Impurity 30
CAS No.	1310357-40-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-Chloro-2-methyl-N-[4-(5H-pyrrolo[2,1-c][1,4]benzodiazepin-10(11H)-ylcarbonyl)-3-chlorophenyl]benzamide; Tolvaptan Related Compound 30; Tolvaptan EP Impurity G; Tolvaptan Process Impurity; UNII-7V7F6S8Q3U; Benzamide, 5-chloro-2-methyl-N-[4-[(10,11-dihydro-5H-pyrrolo[2,1-c][1,4]benzodiazepin-10-yl)carbonyl]-3-chlorophenyl]-
EINECS	Contact for details

Quality Control

Our Tolvaptan Impurity 30 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, impurity profile, and analytical results. Our quality system is designed to support compliance with ICH Q3A/B, USP, and EP guidelines for 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 desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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