Description

Dapagliflozin-D5 is a high-purity, deuterium-labeled internal standard of the SGLT2 inhibitor dapagliflozin, specifically designed for advanced analytical applications. This stable isotope-labeled compound is essential for ensuring the accuracy, precision, and reliability of quantitative bioanalytical methods, particularly in pharmacokinetic and metabolism studies. It is a critical tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control units requiring definitive analytical standards for method development and validation.

Application

• Quantitative Bioanalysis: Serves as a stable isotope internal standard for the precise quantification of dapagliflozin in biological matrices (plasma, serum, urine) using LC-MS/MS.
• Pharmacokinetic (PK) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Metabolite Identification & Profiling: Aids in the detection and structural elucidation of dapagliflozin metabolites in complex biological samples.
• Method Development & Validation: Critical for developing robust, sensitive, and selective analytical methods compliant with GLP and ICH guidelines.
• Drug Impurity & Degradation Studies: Used as a reference standard in stability-indicating assays to monitor drug purity and stability.
• Regulatory Submissions: Supports data packages submitted to regulatory bodies (FDA, EMA) by providing traceable and reliable analytical data.

Basic Information

Product Name	Dapagliflozin-D5
CAS No.	1204219-80-6
Molecular Formula	C21H20D5ClO6
Molecular Weight	414.88 g/mol
Synonyms	(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-D-glucitol-2,3,4,5,6-pentadeuterio; Dapagliflozin (D5); Dapagliflozin-d5; BMS-512148-d5; Forxiga-d5; Farxiga-d5; (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol-2,3,4,5,6-d5
EINECS	Contact for details

Quality Control

Our Dapagliflozin-D5 is manufactured under strict quality systems to ensure the highest standards of purity and isotopic enrichment required for analytical applications. Each batch undergoes comprehensive testing, including HPLC purity, NMR, and MS analysis to confirm chemical and isotopic identity. Certificates of Analysis (COA) detailing batch-specific results for assay, chemical purity, isotopic purity, and residual solvents are provided and are traceable to certified reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled under dry, inert conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (by MS)	≥ 98.0 atom % D
Chemical Purity (by NMR)	Conforms
Residual Solvents (GC)	Meets ICH limits

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