Description

Flumazenil Impurity 12 is a designated impurity 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 reference marker in chromatographic analyses. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Primary use as a certified reference standard for the identification and quantification of Flumazenil Impurity 12 in active pharmaceutical ingredients (APIs) and finished drug products.
• Essential component in analytical method development and validation for Flumazenil, supporting regulatory filings and compliance.
• Used in stability studies and forced degradation studies to monitor impurity profiles and establish shelf-life specifications.
• Critical for pharmaceutical quality control (QC) laboratories to ensure batch-to-batch consistency and adherence to pharmacopeial standards (e.g., USP, EP).
• Supports research and development efforts in understanding the degradation pathways and metabolism of Flumazenil.
• Valuable for contract research organizations (CROs) and testing facilities offering analytical services to the pharmaceutical industry.

Basic Information

Product Name	Flumazenil Impurity 12
CAS No.	1248271-71-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Flumazenil Related Compound 12; Flumazenil Specified Impurity 12; 8-Fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic acid ethyl ester impurity; Ethyl 8-fluoro-5-methyl-6-oxo-5,6-dihydro-4H-imidazo[1,5-a][1,4]benzodiazepine-3-carboxylate impurity; Ro 15-1788 Impurity 12; Anexate Impurity 12; Lanexat Impurity 12
EINECS	Contact for details

Quality Control

Our Flumazenil Impurity 12 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with every shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.