Description

Canagliflozin Impurity 14 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Canagliflozin. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key marker for method development, validation, and routine batch testing within the pharmaceutical supply chain.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Canagliflozin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to accurately identify and quantify this specific impurity.
• Stability Studies: Used to monitor the formation and levels of this impurity during forced degradation and long-term stability testing of Canagliflozin products.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization and control data.
• Research & Development: Utilized in R&D laboratories for studying the degradation pathways and impurity profiles of SGLT2 inhibitor drugs.
• Pharmacopoeial Testing: May be employed to verify compliance with relevant pharmacopoeial monographs (e.g., USP, EP) for Canagliflozin.

Basic Information

Product Name	Canagliflozin Impurity 14
CAS No.	842133-17-9
Molecular Formula	C24H25FO5S
Molecular Weight	444.52 g/mol
Synonyms	(1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol; Canagliflozin Related Compound 14; Canagliflozin EP Impurity J; Canagliflozin USP Related Compound; SGLT2 Inhibitor Impurity; 1-(4-Chloro-3-((4-(((3S)-tetrahydrofuran-3-yl)oxy)benzyl)phenyl)-1,5-anhydro-D-glucitol
EINECS	Contact for details

Quality Control

Every batch of Canagliflozin Impurity 14 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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