Description

Tofisopam Impurity CAS NO 37952-09-3 is a high-purity reference standard used in the analytical profiling and quality control of the anxiolytic pharmaceutical, Tofisopam. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) by enabling the accurate identification, quantification, and control of specific impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams focused on method development, validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for calibrating analytical instruments and validating testing methods in compliance with ICH Q3A/B guidelines.
• Impurity Identification and Profiling: Used in HPLC, LC-MS, and GC-MS analyses to identify and characterize the specific impurity in Tofisopam drug substance and finished products.
• Method Development and Validation: A critical component in developing and validating stability-indicating assay methods for Tofisopam and related substances.
• Quality Control and Batch Release: Employed in routine QA/QC testing to monitor impurity levels and ensure every batch of Tofisopam API meets predefined specification limits.
• Regulatory Submission and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity control strategies.
• Stability Studies: Used as a marker to track impurity formation and degradation pathways of Tofisopam under various stress conditions (e.g., heat, light, humidity).

Basic Information

Product Name	Tofisopam Impurity
CAS No.	37952-09-3
Molecular Formula	C22H26N2O4
Molecular Weight	382.46 g/mol
Synonyms	1-(3,4-Dimethoxyphenyl)-4-methyl-5-ethyl-7,8-dimethoxy-5H-2,3-benzodiazepine; Tofisopam Related Compound; Grandaxin Impurity; 2,3-Benzodiazepine derivative; Tofizopam Impurity; 5-Ethyl-1-(3,4-dimethoxyphenyl)-7,8-dimethoxy-4-methyl-5H-2,3-benzodiazepine
EINECS	Contact for details

Quality Control

Our Tofisopam Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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