Description

Metronidazole Impurity 3 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Metronidazole by enabling the accurate identification, quantification, and control of related substances. It is an essential tool for analytical chemists and quality assurance professionals in pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Metronidazole and its related products.
• Method Development and Validation: Critical for developing and validating analytical methods, such as HPLC, UPLC, and GC, to monitor impurities in drug substances and finished dosage forms.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Metronidazole API and formulations comply with stringent pharmacopeial standards (e.g., USP, EP, JP) for impurity profiles.
• Stability Studies: Employed to identify and track degradation products that may form during the stability testing of Metronidazole under various storage conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports impurity profiling, route scouting, and process chemistry optimization during the synthesis of Metronidazole.

Basic Information

Product Name	Metronidazole Impurity 3
CAS No.	5006-79-1
Molecular Formula	C6H9N3O3
Molecular Weight	171.16 g/mol
Synonyms	2-Methyl-5-nitroimidazole-1-ethanol; 1-(2-Hydroxyethyl)-2-methyl-5-nitroimidazole; Hydroxymethyl Metronidazole; Metronidazole Hydroxy Impurity; Metronidazole EP Impurity C; Metronidazole Related Compound C; MNZ Impurity C; 1H-Imidazole-1-ethanol, 2-methyl-5-nitro-
EINECS	Contact for details

Quality Control

Every batch of Metronidazole Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques to ensure compliance with pharmacopeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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