Description

Ornidazole Impurity 15 is a designated impurity standard used in the pharmaceutical development and quality control of the antimicrobial drug Ornidazole. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, validation, and batch release of Ornidazole and its formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ornidazole Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH Q2(R1) and Q3A/B guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC labs to monitor impurity profiles and ensure every batch of Ornidazole complies with strict pharmacopoeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (heat, light, humidity) to establish shelf-life and storage recommendations.
• Regulatory Submissions: Provides necessary 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: Aids in synthetic route optimization and impurity profiling during the process development of Ornidazole.

Basic Information

Product Name	Ornidazole Impurity 15
CAS No.	105687-87-4
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 Chlorohydrin Impurity; Ornidazole Related Compound C; Ornidazole EP Impurity C; Ornidazole Process Impurity; (RS)-1-(3-Chloro-2-hydroxypropyl)-2-methyl-5-nitro-1H-imidazole
EINECS	Contact for details

Quality Control

Our Ornidazole Impurity 15 is manufactured under strict quality management systems. Each batch undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques like HPLC, GC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) are provided, detailing batch-specific results and confirming compliance with relevant guidelines.

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) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
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.