Description

Dapagliflozin-3-o--D-Glucuronide is a major, pharmacologically relevant Phase II metabolite of the SGLT2 inhibitor dapagliflozin. This compound is critical for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics (PK/ADME), and the development of bioanalytical methods. It serves as a vital reference standard for laboratories in the pharmaceutical and biotechnology sectors, enabling accurate quantification and characterization of dapagliflozin and its metabolites in biological matrices.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for quantitative bioanalysis in clinical and non-clinical studies.
• Drug Metabolism and Pharmacokinetics (DMPK): Essential for investigating the metabolic pathways, clearance mechanisms, and excretion profiles of dapagliflozin.
• Bioanalytical Method Development & Validation: Used to calibrate equipment and validate LC-MS/MS, HPLC, and other analytical methods for accurate metabolite detection.
• Toxicology and Safety Assessment: Supports studies assessing the safety profile and potential toxicity of dapagliflozin metabolites.
• Impurity Profiling and Control: Acts as a known impurity or degradation product standard for quality control in active pharmaceutical ingredient (API) manufacturing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) requiring comprehensive metabolite identification and quantification.

Basic Information

Product Name	Dapagliflozin-3-o--D-Glucuronide
CAS No.	1351438-75-9
Molecular Formula	C25H27ClO10
Molecular Weight	522.93 g/mol
Synonyms	Dapagliflozin 3-O-Glucuronide; Dapagliflozin Glucuronide; BMS-512148 Glucuronide; (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol 3-O-β-D-Glucopyranosiduronic Acid; Forxiga Metabolite; Dapagliflozin Metabolite M18.1; BMS-512148-3-O-Glucuronide
EINECS	Contact for details

Quality Control

Our Dapagliflozin-3-o--D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and assay is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity. Allow the vial to equilibrate to room temperature before opening to minimize moisture condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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