Description

Dapagliflozin-D7 CAS NO 1204219-51-1 is a high-purity, deuterium-labeled analog of the SGLT2 inhibitor Dapagliflozin, specifically designed for use as an internal standard in quantitative bioanalytical studies. This stable isotope-labeled compound is essential for ensuring the accuracy, precision, and reliability of pharmacokinetic and metabolism data in pharmaceutical research and development. It is a critical tool for analytical scientists and researchers in pharmaceutical companies, contract research organizations (CROs), and academic institutions focused on developing and validating robust LC-MS/MS methods for drug quantification.

Application

• Internal Standard for LC-MS/MS Analysis: Primary use as a stable, non-interfering internal standard for the precise quantification of Dapagliflozin and its metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic (PK) and Toxicokinetic (TK) Studies: Enables accurate measurement of drug concentration over time to determine absorption, distribution, metabolism, and excretion (ADME) profiles.
• Bioanalytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating GLP/GCP-compliant analytical methods for clinical and non-clinical trials.
• Drug Metabolism Studies: Used in mass spectrometry to differentiate between the drug and its metabolites, facilitating detailed metabolic pathway identification.
• Quality Control in Manufacturing: Potential application in in-process testing or stability-indicating assays for Dapagliflozin active pharmaceutical ingredient (API) manufacturing.
• Reference Material for Regulatory Submissions: Provides the traceability and consistency required for data packages submitted to regulatory agencies like the FDA and EMA.

Basic Information

Product Name	Dapagliflozin-D7
CAS No.	1204219-51-1
Molecular Formula	C21H18D7ClO6
Molecular Weight	424.90 g/mol (for deuterated form)
Synonyms	(2S,3R,4R,5S,6R)-2-[4-Chloro-3-[(4-ethoxyphenyl)methyl-d7]phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin (d7); Dapagliflozin-d7; BMS-512148-d7; Forxiga-d7; Farxiga-d7; Deuterated Dapagliflozin; Dapagliflozin Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Dapagliflozin-D7 is manufactured and analyzed under strict quality systems to ensure it meets the exacting standards required for use as an analytical reference standard. We provide comprehensive Certificates of Analysis (COA) that detail purity, isotopic enrichment, and confirm identity and purity through multiple orthogonal techniques. Our quality commitment aligns with the needs of GMP/GLP-compliant research environments, ensuring data integrity and reliability for regulatory submissions.

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 product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and storage under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Enrichment)	≥ 98.0 atom % D
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.