Description

Metronidazole Ep Impurity C is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a specified impurity for the validation and monitoring of the active pharmaceutical ingredient Metronidazole, ensuring compliance with stringent pharmacopeial monographs. It is essential for analytical chemists and quality assurance professionals in pharmaceutical development and manufacturing, providing a benchmark for method development, stability studies, and impurity profiling.

Application

• Primary use as a certified reference standard for Metronidazole impurity identification and quantification.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) for pharmaceutical quality control labs.
• Used in stability studies and forced degradation studies to track impurity formation in drug substances and products.
• Essential for pharmacopeial compliance testing against European Pharmacopoeia (EP) and other international standards.
• Supports regulatory filings (e.g., ANDA, NDA) by providing characterized impurity samples for toxicology and qualification studies.
• Utilized in research and development to understand the degradation pathways of Metronidazole.
• Calibration standard for ensuring the accuracy and precision of impurity assays in Good Manufacturing Practice (GMP) environments.

Basic Information

Product Name	Metronidazole Ep Impurity C
CAS No.	5006-69-9
Molecular Formula	C6H9N3O3
Molecular Weight	171.16 g/mol
Synonyms	2-Methyl-5-nitroimidazole-1-ethanol; 1-(2-Hydroxyethyl)-2-methyl-5-nitroimidazole; Metronidazole Impurity C (EP); Metronidazole Related Compound C; Hydroxymethyl Metronidazole; Metronidazole Alcohol; Metronidazole EP Impurity C; 5006-69-9
EINECS	Contact for details

Quality Control

Every batch of Metronidazole Ep Impurity C is manufactured and controlled to meet the highest standards for pharmaceutical reference materials. Our quality system ensures identity, purity, and strength are rigorously verified through advanced analytical techniques including HPLC, GC-MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines. Our commitment to cGMP principles and traceability guarantees the reliability and consistency required for your critical applications.

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 low-humidity 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 structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.