Description

Morinidazole Impurity 4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Morinidazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Morinidazole API and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for quality control testing.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation and degradation pathways of Morinidazole.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Quality Control (QC) Testing: Used as a system suitability and identification standard in routine QC release testing of pharmaceutical batches.
• Research & Development: Supports synthetic chemistry research, including route scouting and process optimization, by providing a benchmark for impurity identification.

Basic Information

Product Name	Morinidazole Impurity 4
CAS No.	1782143-94-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Morinidazole Related Compound 4; Morinidazole EP Impurity D; Morinidazole USP Impurity; 1-Methyl-2-(4-nitrophenyl)-5-nitro-1H-imidazole Impurity; 5-Nitro-1-(4-nitrophenyl)methyl-1H-imidazole Impurity; Morinidazole Nitro Impurity; Morinidazole Degradant
EINECS	Contact for details

Quality Control

Our Morinidazole Impurity 4 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material 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)	Single unspecified impurity ≤ 1.0% 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.