Description

Ornidazole Impurity 21 is a specified impurity and degradation product of the antimicrobial pharmaceutical agent Ornidazole. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is essential for quality control laboratories, regulatory affairs, and R&D departments within the pharmaceutical industry to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Ornidazole impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used to develop, optimize, and validate chromatographic methods, primarily HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels against ICH Q3A/B guidelines, ensuring product specifications are met.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Ornidazole.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Research & Development: Supports synthetic chemistry research aimed at understanding and minimizing impurity formation during the manufacturing process.

Basic Information

Product Name	Ornidazole Impurity 21
CAS No.	16935-05-0
Molecular Formula	C7H7ClN4O3
Molecular Weight	230.61 g/mol
Synonyms	1-(3-Chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole; 1-(3-Chloro-2-hydroxypropyl)-2-methyl-4-nitroimidazole; Ornidazole EP Impurity B; Ornidazole Related Compound B; Ornidazole Impurity B; 1-(3-Chloro-2-hydroxypropyl)-2-methyl-4(5)-nitroimidazole; α-(Chloromethyl)-2-methyl-5-nitro-1H-imidazole-1-ethanol
EINECS	Contact for details

Quality Control

Our Ornidazole Impurity 21 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

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

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