Description

Canagliflozin Peroxide Impurity is a high-purity chemical reference standard used for analytical and research purposes. This specific impurity is critical for the quality control and regulatory compliance of the active pharmaceutical ingredient (API) Canagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) involved in method development, validation, and stability studies.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify and quantify the peroxide-related degradation product in Canagliflozin drug substance and finished dosage forms.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical standard for developing, optimizing, and validating stability-indicating analytical methods to monitor impurity levels throughout the drug lifecycle.
• Stability Studies and Forced Degradation Testing: Employed in accelerated and long-term stability studies to understand the degradation pathways of Canagliflozin and establish appropriate shelf-life and storage conditions.
• Regulatory Submission and Compliance: Essential for preparing documentation for regulatory agencies (e.g., FDA, EMA) to demonstrate thorough impurity identification and control as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Batch Release Testing: Used as a system suitability standard and for quantifying the impurity in routine QA/QC testing of Canagliflozin API to ensure it meets stringent pharmacopeial specifications.
• Research on Degradation Mechanisms: Supports academic and industrial research aimed at elucidating the oxidative degradation mechanism of SGLT2 inhibitor类药物.

Basic Information

Product Name	Canagliflozin Peroxide Impurity
CAS No.	2247196-28-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Canagliflozin Peroxide Degradant; Canagliflozin Oxidative Impurity; Canagliflozin Peroxide Related Compound; (1S)-1,5-Anhydro-1-C-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol Peroxide Derivative; SGLT2 Inhibitor Peroxide Impurity; Invokana Peroxide Impurity; JNJ-28431754 Peroxide Impurity
EINECS	Contact for details

Quality Control

Every batch of Canagliflozin Peroxide Impurity CAS 2247196-28-5 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature or as indicated on the label or COA. For long-term storage, keep desiccated under inert atmosphere to prevent degradation. Handle in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report and comply with client requirements
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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