Description

Ornidazole Impurity 7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Ornidazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ornidazole API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine quality control testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in Ornidazole formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA) to meet FDA, EMA, and other global health authority requirements.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Ornidazole.

Basic Information

Item	Details
Product Name	Ornidazole Impurity 7
CAS No.	109620-80-6
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 Degradant; 1-(3-Chloro-2-hydroxypropyl)-2-methyl-4-nitro-1H-imidazole; α-(Chloromethyl)-2-methyl-5-nitro-1H-imidazole-1-ethanol
EINECS	Contact for details

Quality Control

Our Ornidazole Impurity 7 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and determination of residual solvents. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results and confirming compliance with in-house specifications aligned with ICH guidelines. Certificates are available upon request.

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 prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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