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 studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Ornidazole API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to accurately identify and quantify this specific impurity.
• Stability Studies: Employed to monitor the formation of Ornidazole Impurity 7 in drug products under various stress conditions to establish shelf life.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Research & Development: Used in R&D laboratories to study the degradation pathways and synthesis impurities of Ornidazole.
• Pharmacopoeial Testing: Serves as a reference material for testing against pharmacopoeial monographs (e.g., USP, EP, BP) that specify impurity limits.

Basic Information

Product Name	Ornidazole Impurity 7
CAS No.	1348117-98-5
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; 2-Methyl-5-nitro-1-(3-chloro-2-hydroxypropyl)imidazole
EINECS	Contact for details

Quality Control

Every batch of Ornidazole Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 Solid
Identification (IR)	Conforms to Reference Standard
Identification (HPLC)	Conforms to Reference Standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual Impurity: ≤ 0.5% Total Impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Guidelines

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