Description

Canagliflozin Related Impurity 10 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Canagliflozin, a leading SGLT2 inhibitor. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and control during manufacturing. It is an essential material for analytical laboratories, regulatory affairs, and quality assurance departments within pharmaceutical and biotechnology companies focused on metabolic disease therapeutics.

Application

• Primary use as a pharmaceutical reference standard for the analytical method development and validation of Canagliflozin API and finished dosage forms.
• Critical component in stability studies and impurity profiling to monitor degradation pathways and establish shelf-life specifications.
• Used for regulatory compliance and filing, providing essential data for ICH guidelines (Q3A, Q3B) in submissions to agencies like the FDA and EMA.
• Essential for quality control (QC) testing in pharmaceutical manufacturing to ensure batch-to-batch consistency and purity of Canagliflozin.
• Serves as a research tool in pharmacokinetic and metabolic studies to understand the fate of related substances in biological systems.
• Used by contract research organizations (CROs) and testing laboratories offering analytical services to the pharmaceutical industry.

Basic Information

Product Name	Canagliflozin Related Impurity 10
CAS No.	1799552-91-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Canagliflozin Impurity 10; Canagliflozin EP Impurity J; Canagliflozin Related Compound J; SGLT2 Inhibitor Impurity; (2S,3R,4R,5S,6R)-2-(4-Chloro-3-((4-ethoxyphenyl)methyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol Related Substance; Canagliflozin Process Impurity; Canagliflozin Degradant; Canagliflozin Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Canagliflozin Related Impurity 10 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming suitability for use as a reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. The container should be stored in a desiccator if necessary.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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