Description

Morinidazole Impurity 5 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 a specific impurity in Morinidazole API and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Morinidazole.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used as a marker to track impurity formation during forced degradation and long-term stability studies of Morinidazole formulations.
• Research & Development: Supports research into the synthesis, degradation pathways, and metabolism of Morinidazole and related nitroimidazole antibiotics.

Basic Information

Product Name	Morinidazole Impurity 5
CAS No.	1807608-40-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Morinidazole Related Compound 5; Morinidazole EP Impurity 5; Morinidazole USP Impurity 5; 1-Methyl-2-(4-methyl-1-piperazinyl)-5-nitro-1H-imidazole Impurity; 5-Nitro-1-(2-morpholinoethyl)-2-(4-methylpiperazin-1-yl)-1H-imidazole Impurity; Morinidazole Degradation Product; Morinidazole Process Impurity
EINECS	Contact for details

Quality Control

Our Morinidazole Impurity 5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatographic purity and structure confirmation data, is provided with every shipment.

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. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.