Description

Canagliflozin Impurity 17 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Canagliflozin. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance. It serves as a key marker for method development, validation, and stability studies in the production of SGLT2 inhibitor-based therapeutics.

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 (HPLC/LC-MS): Essential for developing and validating precise chromatographic methods to identify and quantify related substances.
• Stability Indicating Studies: Used to monitor the formation of degradation products in Canagliflozin under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research & Development: Utilized in metabolic studies, pharmacokinetic research, and impurity pathway investigation for next-generation SGLT2 inhibitors.
• Contract Research & Testing Laboratories (CROs/CTLs): A vital reagent for third-party labs offering analytical testing and quality assurance services to the pharmaceutical industry.

Basic Information

Product Name	Canagliflozin Impurity 17
CAS No.	1951467-28-9
Molecular Formula	C24H25FO5S
Molecular Weight	444.52 g/mol
Synonyms	Canagliflozin Related Compound 17; Canagliflozin EP Impurity J; Canagliflozin USP Impurity; 1-(β-D-Glucopyranosyl)-4-methyl-3-[5-[4-fluoro-2-(methylsulfanyl)phenyl]phenyl]benzene; SGLT2 Inhibitor Impurity; Canagliflozin Degradant; INVOKANA Impurity 17
EINECS	Contact for details

Quality Control

Every batch of Canagliflozin Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.2%

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