Description

Canagliflozin D4 is a stable isotope-labeled analog of the active pharmaceutical ingredient canagliflozin, where four hydrogen atoms are replaced by deuterium. This high-purity reference standard is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods. It is primarily used by pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments for applications in drug metabolism and pharmacokinetics (DMPK) studies.

Application

• Internal Standard for LC-MS/MS Analysis: Serves as a critical internal standard for the precise quantification of canagliflozin in biological matrices (e.g., plasma, serum, urine) using liquid chromatography-tandem mass spectrometry.
• Drug Metabolism Studies (DMPK): Used as a tracer to investigate the absorption, distribution, metabolism, and excretion (ADME) profile of canagliflozin in preclinical and clinical research.
• Pharmacokinetic (PK) and Bioequivalence Testing: Enables accurate measurement of drug concentration over time, supporting bioavailability and bioequivalence studies for generic drug development.
• Method Development and Validation: A key component in developing, optimizing, and validating robust analytical methods in compliance with regulatory guidelines (e.g., FDA, EMA).
• Quality Control and Assurance: Acts as a reference material for in-house quality control testing of canagliflozin API and finished dosage forms to ensure batch-to-batch consistency.

Basic Information

Product Name	Canagliflozin D4
CAS No.	1997338-61-0
Molecular Formula	C24H21D4FO5S
Molecular Weight	464.53 g/mol
Synonyms	(1S)-1,5-Anhydro-1-C-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol-1,1,6,6-d4; Canagliflozin-d4; Canagliflozin (tetradeuterated); 1-(β-D-Glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene-d4; JNJ 28431754-d4; Invokana D4
EINECS	Contact for details

Quality Control

Our Canagliflozin D4 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including NMR and mass spectrometry for isotopic enrichment verification and high-performance liquid chromatography (HPLC) for chemical and isomeric purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results to ensure compliance with your research and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). For long-term stability, store desiccated at -20°C. The product is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Isotopic Purity (Deuterium Content)	≥ 98 atom % D
Chemical Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Any single unknown impurity	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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