Description

Lorazepam Related Compound E (25 Mg) (6-Chloro-4-(o-Chlorophenyl)-2-Quinazoline Metha-Nol) is a high-purity analytical reference standard critical for pharmaceutical research and quality control. This compound serves as a specified impurity and degradation product of the active pharmaceutical ingredient Lorazepam, making it essential for ensuring drug safety and efficacy. It is primarily used by analytical chemists, quality assurance laboratories, and R&D departments within the pharmaceutical and contract research organization (CRO) sectors for method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify specified impurities in Lorazepam drug substances and finished products according to ICH Q3A/B guidelines.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC methods for purity and stability-indicating assays.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this related compound during drug stability testing to establish shelf-life and recommended storage conditions.
• Pharmacopoeial Compliance Testing: Essential for testing against monographs in USP (United States Pharmacopeia), EP (European Pharmacopoeia), or other international pharmacopoeias that list this related substance.
• Quality Control and Batch Release: Used in routine QC laboratories to ensure that batches of Lorazepam API and formulations meet stringent purity specifications before release.
• Regulatory Submission Support: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.

Basic Information

Product Name	Lorazepam Related Compound E (25 Mg) (6-Chloro-4-(o-Chlorophenyl)-2-Quinazoline Metha-Nol)
CAS No.	773871-49-1
Molecular Formula	C16H12Cl2N2O
Molecular Weight	319.19 g/mol
Synonyms	6-Chloro-4-(2-chlorophenyl)-2-quinazolinemethanol; Lorazepam Impurity E; Lorazepam Related Substance E; 6-Chloro-4-(o-chlorophenyl)-2-quinazolinemethanol; 2-Quinazolinemethanol, 6-chloro-4-(2-chlorophenyl)-; Lorazepam EP Impurity E; Lorazepam USP Related Compound E
EINECS	Contact for details

Quality Control

Every batch of Lorazepam Related Compound E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods (e.g., HPLC, NMR, MS) to ensure compliance with pharmacopoeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing batch-specific results for purity, related substances, and other critical parameters.

Storage

Preserve in the original, tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive). For long-term storage, consider desiccant use and storage under inert atmosphere to maintain optimal purity and 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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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