Description

Lorazepam Impurity D 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 active pharmaceutical ingredient (API) lorazepam by serving as a key marker for impurity profiling and control. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in method development, validation, and quality assurance processes.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Lorazepam API and finished drug products.
• Analytical Method Development & Validation (HPLC/GC): Serves as a critical component for developing, optimizing, and validating chromatographic methods to meet ICH Q2(R1) and USP guidelines.
• Quality Control (QC) & Quality Assurance (QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, JP).
• Stability Studies: Acts as a marker to track degradation pathways and assess the stability of Lorazepam formulations under various storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control strategy.
• Research & Development: Utilized in synthetic chemistry research to study the formation, fate, and purge of process-related impurities.

Basic Information

Product Name	Lorazepam Impurity D
CAS No.	54699-91-1
Molecular Formula	C₁₅H₁₀Cl₂N₂O₂
Molecular Weight	321.16 g/mol
Synonyms	7-Chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one; Lorazepam Related Compound D; 3-Hydroxylorazepam; Lorazepam Impurity 4; Lorazepam EP Impurity D; Lorazepam USP Related Compound D; 2H-1,4-Benzodiazepin-2-one, 7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-
EINECS	Contact for details

Quality Control

Our Lorazepam Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing identity, purity, and impurity profiles. We support compliance with ICH, USP, and EP guidelines.

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 must be kept in a desiccated environment to maintain stability and purity.

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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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