Description

Ornidazole Impurity CAS NO 1100750-18-2 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 quality control testing. The availability of this well-characterized impurity is essential for maintaining stringent pharmacopeial standards in the production of anti-infective medications.

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: Essential for developing and validating HPLC, UPLC, and GC methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, DMF) by providing necessary impurity data for health authorities like the US FDA and EMA.
• Stability Studies: Employed to monitor impurity profiles in Ornidazole formulations under various stress conditions to determine shelf life.
• Research & Development: Used in chemical research to study the degradation pathways and metabolism of Ornidazole.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing.

Basic Information

Item	Details
Product Name	Ornidazole Impurity
CAS No.	1100750-18-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ornidazole Related Compound; Ornidazole Specified Impurity; Ornidazole Degradant; 1-(3-Chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole Impurity; (RS)-1-Chloro-3-(2-methyl-5-nitro-1H-imidazol-1-yl)propan-2-ol Impurity; α-(Chloromethyl)-2-methyl-5-nitro-1H-imidazole-1-ethanol Impurity
EINECS	Contact for details

Quality Control

Our Ornidazole Impurity is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay and spectroscopic identification (IR, NMR), to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with ICH Q3A/B guidelines for impurities in new drug substances and products.

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 must be kept in a desiccated environment to maintain stability and purity. The container should be stored in a well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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