Description

Ornidazole Impurity 17 is a designated chemical reference standard used in the pharmaceutical development and quality control of the antimicrobial drug Ornidazole. This high-purity impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of process-related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Ornidazole Impurity 17 in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Facilitates studies on the synthesis pathway, degradation mechanisms, and metabolic profiling of Ornidazole.

Basic Information

Product Name	Ornidazole Impurity 17
CAS No.	95881-05-3
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-nitro-1H-imidazole; Ornidazole Related Compound; Ornidazole EP Impurity C; Ornidazole USP Related Compound; α-(Chloromethyl)-2-methyl-5-nitro-1H-imidazole-1-ethanol; 1H-Imidazole-1-ethanol, α-(chloromethyl)-2-methyl-5-nitro-
EINECS	Contact for details

Quality Control

Every batch of Ornidazole Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical parameters.

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 matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
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.