Description

Flumazenil Impurity is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the pharmaceutical agent Flumazenil by identifying and quantifying related substances. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Flumazenil Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels throughout the manufacturing process.
• Quality Control & Assurance: Essential for routine batch release testing in GMP environments to ensure compliance with ICH Q3A/B guidelines on impurities in new drug substances and products.
• Stability Studies: Employed to track the formation of degradation products in Flumazenil formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and justify specifications.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Flumazenil.

Basic Information

Product Name	Flumazenil Impurity
CAS No.	2700278-14-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Flumazenil Related Compound; Flumazenil Specified Impurity; Ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo[1,5-a][1,4]benzodiazepine-3-carboxylate Impurity; 4H-Imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic acid, 8-fluoro-5,6-dihydro-5-methyl-6-oxo-, ethyl ester, impurity; Anexate Impurity; Romazicon Impurity
EINECS	Contact for details

Quality Control

Our Flumazenil Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), 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.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with individual specification
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.