Description

Metronidazole β-D-Glucuronide is a crucial reference standard and metabolite used in advanced pharmaceutical research and development. This compound is essential for the accurate quantification and metabolic profiling of the parent drug, metronidazole, ensuring precise pharmacokinetic and toxicokinetic studies. It is primarily utilized by analytical laboratories, pharmaceutical manufacturers, and contract research organizations (CROs) engaged in drug development, bioanalytical method validation, and regulatory compliance testing.

Application

• Primary use as a high-purity reference standard for calibrating analytical instruments (HPLC, LC-MS/MS).
• Critical component in bioanalytical method development and validation for quantifying metronidazole and its metabolites in biological matrices.
• Essential for conducting pharmacokinetic (PK) and toxicokinetic (TK) studies during drug development.
• Used in metabolite identification and profiling research to understand drug metabolism pathways.
• Serves as a key material for quality control and assurance in pharmaceutical manufacturing of metronidazole-based products.
• Important for regulatory submission support, providing necessary data for FDA, EMA, and other global health authority filings.

Basic Information

Product Name	Metronidazole β-D-Glucuronide
CAS No.	100495-98-5
Molecular Formula	C15H19N3O9
Molecular Weight	385.33 g/mol
Synonyms	Metronidazole Glucuronide; Metronidazole β-D-Glucopyranosiduronic Acid; 1-(2-Hydroxyethyl)-2-methyl-5-nitroimidazole β-D-Glucuronide; MNZ-G; Metronidazole O-β-D-Glucuronide; 2-Methyl-5-nitro-1H-imidazole-1-ethanol β-D-Glucopyranosiduronic Acid
EINECS	Contact for details

Quality Control

Our Metronidazole β-D-Glucuronide is manufactured under strict quality systems to ensure it meets the exacting requirements for use as a reference standard. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods. A Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment, supporting traceability and compliance with cGMP and ICH guidelines for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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