Description

Canagliflozin Impurity 27 is a high-purity 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 safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential material for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Canagliflozin API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and other chromatographic methods for impurity detection.
• Stability Studies & Forced Degradation: Employed to identify and monitor degradation products in Canagliflozin under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic pathway research and process chemistry optimization for Canagliflozin.
• Quality Assurance/Quality Control (QA/QC): Integral for routine batch release testing to confirm that impurity levels are within specified pharmacopeial limits (e.g., ICH Q3A/B guidelines).

Basic Information

Product Name	Canagliflozin Impurity 27
CAS No.	2265214-89-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Canagliflozin Related Compound 27; Canagliflozin EP Impurity G; 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; INVOKANA Impurity
EINECS	Contact for details

Quality Control

Our Canagliflozin Impurity 27 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

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 ≤ 5.0%
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.