Description

Flumazenil Impurity 2 is a designated impurity reference standard used in the analytical profiling and quality control of the pharmaceutical agent Flumazenil. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Flumazenil Impurity 2 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC methods to monitor impurities in Flumazenil synthesis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Flumazenil API and formulations meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (light, heat, humidity) to establish product shelf-life.
• Research & Development: Facilitates process chemistry research to understand and minimize the formation of this impurity during Flumazenil synthesis.

Basic Information

Product Name	Flumazenil Impurity 2
CAS No.	162110-24-9
Molecular Formula	C15H12FN3O3
Molecular Weight	301.27 g/mol
Synonyms	Ethyl 8-fluoro-5-methyl-6-oxo-5,6-dihydro-4H-imidazo[1,5-a][1,4]benzodiazepine-3-carboxylate; Flumazenil Related Compound B; Flumazenil EP Impurity B; 4H-Imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic acid, 8-fluoro-5-methyl-6-oxo-5,6-dihydro-, ethyl ester; Ethyl 8-fluoro-5-methyl-6-oxo-4H-imidazo[1,5-a][1,4]benzodiazepine-3-carboxylate
EINECS	Contact for details

Quality Control

Our Flumazenil Impurity 2 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity, and impurity profile by validated methods such as HPLC and NMR. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards.

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 at 2-8°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.