Description

Midazolam Ep Impurity J is a specified impurity and reference standard used in the analytical profiling of the pharmaceutical compound Midazolam. This compound is critical for ensuring the purity, safety, and efficacy of Midazolam drug substances and products in compliance with stringent pharmacopoeial guidelines. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in method development, stability studies, and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Midazolam Ep Impurity J in Midazolam Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) or Ultra-High-Performance Liquid Chromatography (UPLC) methods to monitor impurities.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure drug substance and product batches meet European Pharmacopoeia (EP), United States Pharmacopeia (USP), or other international purity specifications.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory filings (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and process impurity profiling during API manufacturing.

Basic Information

Product Name	Midazolam Ep Impurity J
CAS No.	59469-08-8
Molecular Formula	C₁₈H₁₃ClFN₃
Molecular Weight	325.77 g/mol
Synonyms	8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine; Midazolam Impurity J; Midazolam Related Compound J; 1-Methyl-8-chloro-6-(2-fluorophenyl)-4H-imidazo[1,5-a][1,4]benzodiazepine; Midazolam EP Impurity J; Midazolam USP Impurity J; Midazolam Process Impurity; Midazolam Degradant
EINECS	Contact for details

Quality Control

Every batch of Midazolam Ep Impurity J is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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