Description

Ornidazole Impurity 16 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the antimicrobial drug Ornidazole. It is primarily utilized by researchers, analytical laboratories, and quality assurance departments within the pharmaceutical industry to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development and validation in HPLC, LC-MS, and other chromatographic techniques.
• Quality Control & Assurance: Used for the identification, quantification, and monitoring of impurity profiles in Ornidazole Active Pharmaceutical Ingredient (API) and finished drug products.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Employed in stability studies, degradation pathway elucidation, and forced degradation studies of Ornidazole.
• Analytical Method Calibration: Acts as a calibrant to ensure the accuracy and precision of analytical instruments and procedures.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP, BP) that specify impurity limits.

Basic Information

Product Name	Ornidazole Impurity 16
CAS No.	1565482-62-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-(3-Chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole; Ornidazole Related Compound; Ornidazole EP Impurity; Ornidazole USP Impurity; Ornidazole Process Impurity; (RS)-1-(3-Chloro-2-hydroxypropyl)-2-methyl-5-nitro-1H-imidazole
EINECS	Contact for details

Quality Control

Every batch of Ornidazole Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each 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 structure
Identification (HPLC)	Conforms to reference retention time
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 1.0%

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