Description

Metronidazole Impurity 9 is a high-purity chemical reference standard, specifically identified as an impurity of the antibiotic Metronidazole. This compound is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of related substances in active pharmaceutical ingredients (APIs) and finished drug products. It is an essential tool for quality assurance and regulatory compliance in the pharmaceutical industry, particularly for manufacturers and analytical laboratories focused on antibiotic production and quality control.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Metronidazole and its related substances.
• Method Development and Validation: Critical for developing and validating analytical methods, such as HPLC and UPLC, to ensure specificity and accuracy in impurity profiling.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor and control impurity levels in Metronidazole API batches to meet pharmacopeial standards (e.g., USP, EP, BP).
• Stability Studies: Employed to identify and track degradation products formed during the stability testing of Metronidazole drug products.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Research and Development: Facilitates research into the synthesis, degradation pathways, and metabolism of Metronidazole.

Basic Information

Product Name	Metronidazole Impurity 9
CAS No.	87009-72-1
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 C (EP); Metronidazole Related Compound C (USP); Metronidazole Hydroxy Impurity; MNZ Impurity 9; 87009-72-1
EINECS	Contact for details

Quality Control

Every batch of Metronidazole Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure compliance with pharmacopeial and in-house specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results—including HPLC purity, related substance data, and spectroscopic identification—is provided with each shipment to support your quality and regulatory requirements.

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 (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown 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.