Description

Metronidazole Impurity 11 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Metronidazole and its related drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing. Utilizing this high-purity impurity standard is essential for compliance with stringent pharmacopeial guidelines.

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 & Batch Release Testing: Essential for routine quality control laboratories to monitor impurity levels against established specifications, ensuring product safety.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, DMF) and audits by providing traceable data for impurity characterization as per ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products in Metronidazole formulations under various stress conditions.
• Research & Development: Used in R&D to understand the degradation pathways and chemical behavior of Metronidazole during synthesis and formulation processes.

Basic Information

Product Name	Metronidazole Impurity 11
CAS No.	138169-63-8
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; Metronidazole Hydroxyethyl Impurity; MNZ Impurity 11
EINECS	Contact for details

Quality Control

Our Metronidazole Impurity 11 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of related substances. A Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with pharmacopeial standards (USP, EP).

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 hygroscopic (moisture-sensitive) and should be handled under inert atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
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.