Description

Metronidazole Impurity 13 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) Metronidazole. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is fundamental for maintaining stringent pharmacopeial standards and product integrity.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Metronidazole API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to monitor batch-to-batch consistency.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies (ICH Q3A/B).
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of pharmaceutical formulations.
• Research & Development: Used in R&D to study the degradation pathways, synthesis impurities, and metabolic profiles related to Metronidazole.

Basic Information

Product Name	Metronidazole Impurity 13
CAS No.	110578-73-9
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; Metronidazole Impurity F; Metronidazole Related Compound F; Metronidazole EP Impurity F; Metronidazole USP Related Compound F; 1H-Imidazole-1-ethanol, 2-methyl-5-nitro-
EINECS	Contact for details

Quality Control

Every batch of Metronidazole Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH guidelines). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and storage recommendations.

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); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to Off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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