Description

Ornidazole Impurity J 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 (API) Ornidazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies. The precise characterization of this impurity is essential for maintaining the highest standards in pharmaceutical production and quality control.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ornidazole Impurity J in drug substances and finished products.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods in quality control laboratories.
• Impurity Profiling & Characterization: Supports structural elucidation and toxicological assessment of degradation products and process-related impurities in Ornidazole API.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to establish impurity limits as per ICH Q3A and Q3B guidelines.
• Stability Studies: Employed in forced degradation studies to understand the degradation pathways of Ornidazole under various stress conditions.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and process optimization for manufacturing Ornidazole.

Basic Information

Product Name	Ornidazole Impurity J
CAS No.	742020-47-9
Molecular Formula	C7H7ClN4O2
Molecular Weight	214.61 g/mol
Synonyms	1-(3-Chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole; 1-(3-Chloro-2-hydroxypropyl)-2-methyl-4-nitroimidazole; Ornidazole EP Impurity J; Ornidazole Related Compound J; Ornidazole Impurity 4; (RS)-1-(3-Chloro-2-hydroxypropyl)-2-methyl-5-nitro-1H-imidazole; Ornidazole Chlorohydrin Impurity
EINECS	Contact for details

Quality Control

Every batch of Ornidazole Impurity J is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, NMR), to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and can supply materials suitable for use in regulatory filings.

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 material is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

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 ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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