Description

Canagliflozin Impurity 49 is a high-purity reference standard specifically identified for pharmaceutical analysis and quality control. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) canagliflozin by enabling accurate identification and quantification of related substances. It is an essential material for analytical laboratories and manufacturers engaged in the development, production, and regulatory compliance of SGLT2 inhibitor medications. The use of this well-characterized impurity standard is fundamental to meeting stringent pharmacopeial requirements and maintaining batch-to-batch consistency.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Canagliflozin Impurity 49 in drug substance and drug product testing.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS).
• Quality Control (QC) Testing: Used in routine QC release and stability testing of canagliflozin API to monitor impurity profiles and ensure compliance with ICH guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Research and Development: Facilitates process chemistry research aimed at understanding impurity formation pathways and optimizing synthesis routes to minimize related substances.

Basic Information

Product Name	Canagliflozin Impurity 49
CAS No.	2243132-56-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Canagliflozin Related Compound 49; Canagliflozin EP Impurity I; Canagliflozin USP Impurity; 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 Impurity; Canagliflozin Process Impurity; Canagliflozin Degradant; Canagliflozin Specified Impurity
EINECS	Contact for details

Quality Control

Our Canagliflozin Impurity 49 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with current industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests such as HPLC purity, related substances, and identification (IR, MS). We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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