Description

Ornidazole Isomer (Impurity) is a defined chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Ornidazole by serving as a marker for process-related impurities. It is an essential tool for analytical chemists and quality assurance professionals working in pharmaceutical R&D, quality control laboratories, and regulatory affairs. The precise characterization of such impurities is fundamental to meeting stringent global regulatory requirements for drug substances.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Ornidazole API batches.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor and control impurity levels, ensuring compliance with pharmacopoeial specifications (e.g., USP, EP).
• Stability Studies: Acts as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Ornidazole formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA) to demonstrate control over the manufacturing process.
• Research & Development: Used in synthetic chemistry research to study the formation pathways of isomers and to develop purer synthesis routes for the API.

Basic Information

Product Name	Ornidazole Isomer (Impurity)
CAS No.	14419-11-5
Molecular Formula	C7H10ClN3O3
Molecular Weight	219.63 g/mol
Synonyms	1-(3-Chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole; Ornidazole Related Compound; Ornidazole Impurity; α-(2-Methyl-5-nitro-1H-imidazol-1-yl)-3-chloro-2-propanol; 1H-Imidazole-1-ethanol, α-(chloromethyl)-2-methyl-5-nitro-; Ornidazole Isomer; Ornidazole EP Impurity; Ornidazole USP Impurity
EINECS	Contact for details

Quality Control

Every batch of our Ornidazole Isomer (Impurity) is manufactured and handled under strict quality management systems. The product undergoes rigorous identity confirmation and purity analysis using advanced techniques including HPLC, GC, NMR, and mass spectrometry to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use in cGMP and ISO 17025 accredited environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The container should be kept in a desiccator to protect from moisture, as the compound may be hygroscopic.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Heavy Metals	≤ 20 ppm

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