Description

Metronidazole Impurity 10 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critically important for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of Metronidazole-based drug products. It is primarily required by professionals in pharmaceutical development, quality assurance (QA), and regulatory affairs for method validation, impurity profiling, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Metronidazole Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC), UPLC, and other chromatographic methods in QC laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required in ICH guidelines Q3A(R2) and Q3B(R2).
• Stability Studies & Forced Degradation: Employed in stability-indicating assay methods to monitor impurity levels in drug substances and products under various stress conditions.
• Research & Development: Serves as a key intermediate or impurity marker in the chemical synthesis and process optimization of Metronidazole and related nitroimidazole antibiotics.
• Quality Control Testing: Acts as a system suitability standard and a quantitative benchmark in routine batch release testing of pharmaceutical raw materials.

Basic Information

Product Name	Metronidazole Impurity 10
CAS No.	56750-04-0
Molecular Formula	C6H9N3O3
Molecular Weight	171.16 g/mol
Synonyms	1-(2-Hydroxyethyl)-2-methyl-5-nitroimidazole; 2-Methyl-5-nitro-1H-imidazole-1-ethanol; Hydroxymethyl Metronidazole; Metronidazole Hydroxy Impurity; Metronidazole EP Impurity C; Metronidazole Related Compound C; Metronidazole Metabolite Hydroxy Derivative; MNZ Impurity 10
EINECS	Contact for details

Quality Control

Every batch of Metronidazole Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods (e.g., HPLC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material 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 matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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