Description

Metronidazole Impurity (1-Methyl-4-Nitro-1H-Imidazole) is a critical reference standard and impurity used in the analytical profiling of the antibiotic drug Metronidazole. This compound is essential for pharmaceutical quality control laboratories to ensure drug safety and efficacy by accurately identifying and quantifying related substances. It is primarily required by manufacturers of active pharmaceutical ingredients (APIs), contract research organizations (CROs), and regulatory testing facilities for method development, validation, and compliance with pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Metronidazole API and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and GC methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance: Critical for routine batch release testing of Metronidazole to ensure compliance with ICH Q3A/B, USP, and EP impurity guidelines.
• Stability Studies: Employed to monitor the formation of degradation products in Metronidazole under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Metronidazole.

Basic Information

Product Name	Metronidazole Impurity (1-Methyl-4-Nitro-1H-Imidazole)
CAS No.	143508-97-8
Molecular Formula	C4H5N3O2
Molecular Weight	127.10 g/mol
Synonyms	1-Methyl-4-nitro-1H-imidazole; 4-Nitro-1-methylimidazole; 1-Methyl-4-nitroimidazole; MNZ Impurity; Metronidazole Related Compound; 1-Methyl-4-nitro-1H-imidazole (Metronidazole Impurity); 1-Methyl-4-nitroimidazole
EINECS	Contact for details

Quality Control

Every batch of our Metronidazole Impurity (1-Methyl-4-Nitro-1H-Imidazole) is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with ICH, 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. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	Off-white to pale yellow solid
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 ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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