Description

Metronidazole-13C2,15N2 is a stable isotope-labeled analog of the widely used nitroimidazole antibiotic, metronidazole. This compound is an essential internal standard for the precise and accurate quantification of metronidazole in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in pharmacokinetic studies, bioequivalence testing, and therapeutic drug monitoring to ensure data integrity and regulatory compliance.

Application

• Internal Standard for Bioanalysis: Serves as a critical reference standard in the quantitative LC-MS/MS analysis of metronidazole in plasma, serum, urine, and tissue homogenates.
• Pharmacokinetic & Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Bioequivalence Testing: Used to validate analytical methods for comparing the bioavailability of generic and innovator drug formulations.
• Therapeutic Drug Monitoring (TDM): Facilitates precise measurement of drug concentrations in patient samples to optimize dosage and efficacy.
• Method Development & Validation: Essential for developing, optimizing, and validating robust analytical methods in compliance with ICH, FDA, and EMA guidelines.
• Quality Control in Manufacturing: Can be employed in impurity profiling and stability-indicating assay methods for metronidazole active pharmaceutical ingredient (API) and finished dosage forms.

Basic Information

Product Name	Metronidazole-13C2,15N2
CAS No.	1173020-03-5
Molecular Formula	C613C2H9N15N2O3
Molecular Weight	174.13 g/mol (approximate)
Synonyms	2-Methyl-5-nitroimidazole-1-ethanol-13C2,15N2; Metronidazole (13C2,15N2); 1-(2-Hydroxyethyl)-2-methyl-5-nitroimidazole-13C2,15N2; Metronidazole Isotopically Labeled; Metronidazole-d0 (13C2,15N2); [13C2,15N2]-Metronidazole; Stable Isotope-Labeled Metronidazole; Internal Standard for Metronidazole
EINECS	Contact for details

Quality Control

Our Metronidazole-13C2,15N2 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic enrichment, chemical purity (by HPLC), and identity confirmation (by NMR and MS). We support GMP/GLP-compliant research and ensure traceability and data integrity for regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive). For long-term storage, consider desiccation and storage under inert atmosphere to maintain stability and isotopic integrity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Enrichment	≥99 atom % 13C; ≥99 atom % 15N
Chemical Purity (by NMR)	Conforms
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.