Description

Metronidazole Impurity 20 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 Metronidazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Metronidazole API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity data required by pharmacopeial standards (USP, EP, ICH).
• Stability Studies: Employed to monitor impurity levels in drug substances and products under various stability testing conditions.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry and metabolic pathway research related to nitroimidazole antibiotics.
• Quality Assurance/Control (QA/QC): Acts as a primary standard for routine batch release testing to ensure pharmaceutical products meet stringent purity specifications.

Basic Information

Item	Detail
Product Name	Metronidazole Impurity 20
CAS No.	113385-77-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-(2-Hydroxyethyl)-2-methyl-5-nitroimidazole; Metronidazole Related Compound; Metronidazole EP Impurity; Metronidazole USP Impurity; 2-Methyl-5-nitro-1H-imidazole-1-ethanol; Metronidazole Hydroxyethyl Impurity; Metronidazole Impurity C (EP); Metronidazole Metabolite Derivative
EINECS	Contact for details

Quality Control

Our Metronidazole Impurity 20 is manufactured under strict quality systems. Each batch is rigorously tested to ensure identity, purity, and consistency, meeting the requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided, detailing results from advanced analytical techniques such as HPLC, NMR, and MS. We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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