Description

Ornidazole Impurity 5 is a designated impurity standard used in the analytical profiling of the pharmaceutical compound Ornidazole. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in quality control laboratories. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and regulatory testing facilities for method development, validation, and routine batch analysis.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ornidazole Impurity 5 in active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurities during stability studies.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Ornidazole API and formulations meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Acts as a marker to track the formation of degradation products under various stress conditions (light, heat, humidity).
• Research & Development: Utilized in R&D to understand the degradation pathways and impurity profile of Ornidazole during synthesis and formulation processes.

Basic Information

Product Name	Ornidazole Impurity 5
CAS No.	16773-51-6
Molecular Formula	C7H5ClN4O2
Molecular Weight	212.59 g/mol
Synonyms	1-(3-Chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole; 1-(3-Chloro-2-hydroxypropyl)-2-methyl-4-nitroimidazole; Ornidazole Related Compound B; Ornidazole EP Impurity B; Ornidazole Impurity B; α-(Chloromethyl)-2-methyl-5-nitro-1H-imidazole-1-ethanol; 1-(3-Chloro-2-hydroxypropyl)-2-methyl-4(5)-nitroimidazole
EINECS	Contact for details

Quality Control

Our Ornidazole Impurity 5 is manufactured and tested under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. Certificates of Analysis (COA) are provided, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. The material is suitable for use as a pharmaceutical reference standard.

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 sealed tightly after each use to prevent exposure to atmospheric moisture.

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 individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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