Description

[2H4]-Metronidazol Hydrochloride is a deuterium-labeled isotopologue of the widely used nitroimidazole antibiotic, metronidazole hydrochloride. This high-purity stable isotope-labeled compound is essential for use as an internal standard in quantitative mass spectrometry-based analytical methods, ensuring unparalleled accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions focused on drug metabolism, bioanalytical method development, and regulatory compliance.

Application

• Internal Standard for LC-MS/MS: Primary application as a quantitative internal standard in liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the precise measurement of metronidazole and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK): Enables accurate tracing and quantification in ADME (Absorption, Distribution, Metabolism, and Excretion) studies to support drug development.
• Bioanalytical Method Development & Validation: Used to develop, optimize, and validate robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Clinical and Preclinical Research: Facilitates reliable therapeutic drug monitoring and toxicokinetic assessments in both human and animal studies.
• Pharmaceutical Quality Control: Supports impurity profiling and stability-indicating assays for metronidazole-containing drug products.
• Isotope Dilution Mass Spectrometry (IDMS): Serves as a spike in IDMS protocols for achieving high metrological accuracy in reference material characterization.

Basic Information

Product Name	[2H4]-Metronidazol Hydrochloride
CAS No.	1261397-74-3
Molecular Formula	C6H5D4N3O3·HCl
Molecular Weight	196.62 g/mol (for free base C6H5D4N3O3)
Synonyms	Metronidazole-d4 Hydrochloride; 2-Methyl-5-nitro-1H-imidazole-1-ethanol-d4 Hydrochloride; Deuterated Metronidazole HCl; 1-(2-Hydroxyethyl)-2-methyl-5-nitroimidazole-d4 Hydrochloride; [²H₄]-Metronidazole Hydrochloride; Flagyl-d4 Hydrochloride; Metronidazole (phenyl-d4) Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of [2H4]-Metronidazol Hydrochloride is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity, with comprehensive testing including HPLC for chemical purity, NMR and MS for structural and isotopic confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality commitment supports compliance with cGMP and ICH Q7 guidelines for active pharmaceutical ingredients (APIs) and reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0% (chemical purity)
Isotopic Purity (MS)	≥98.0 atom % D
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH limits

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