Description

Dapagliflozin D4 is a deuterium-labeled analog of the SGLT2 inhibitor dapagliflozin, serving as a critical internal standard for precise quantitative analysis in bioanalytical and pharmacokinetic studies. This high-purity stable isotope-labeled compound is essential for ensuring the accuracy and reliability of mass spectrometry-based assays, particularly in regulated environments. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in drug metabolism and pharmacokinetics (DMPK) research for the development of anti-diabetic therapeutics.

Application

• Primary use as an internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the quantification of dapagliflozin in biological matrices (plasma, serum, urine).
• Critical component in pharmacokinetic (PK) and bioequivalence studies for dapagliflozin and related SGLT2 inhibitor drug formulations.
• Enabling metabolite identification and profiling studies to understand the drug's metabolic pathways.
• Supporting regulated bioanalysis for clinical trials and non-clinical safety assessments, ensuring data integrity for regulatory submissions (FDA, EMA).
• Use in method development and validation to achieve high specificity, accuracy, and precision in analytical procedures.
• Application in doping control analysis in sports to detect potential misuse of SGLT2 inhibitors.

Basic Information

Product Name	Dapagliflozin D4
CAS No.	1224234-25-6
Molecular Formula	C21H21D4ClO6
Molecular Weight	408.89 g/mol (for deuterated form)
Synonyms	(2S,3R,4R,5S,6R)-2-[4-Chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol-d4; BMS-512148-d4; Dapagliflozin (phenyl-d4); Forxiga-d4; Farxiga-d4; Dapagliflozin-d4; SGLT2 Inhibitor-d4
EINECS	Contact for details

Quality Control

Our Dapagliflozin D4 is manufactured under strict quality control protocols to ensure the high chemical and isotopic purity required for analytical applications. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and MS, to confirm identity, purity, and deuterium incorporation. A comprehensive Certificate of Analysis (COA) is provided, detailing specifications for assay, isotopic enrichment, and related substances. We support GMP/GLP-compliant workflows, and material can be supplied with full traceability and stability data.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material 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 solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Enrichment)	≥ 98 atom % D
Chemical Purity (by NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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