Description

Canagliflozin Impurity 18 is a high-purity chemical reference standard used in the research, development, and quality control of pharmaceutical products. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Canagliflozin, a medication used in the treatment of type 2 diabetes. It serves as a vital analytical marker for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to monitor and control impurity profiles. The compound is supplied with comprehensive analytical data to support method validation and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quantitative and qualitative analysis of Canagliflozin API and finished drug products.
• Method Development & Validation: Essential for developing and validating sensitive and specific analytical methods, such as HPLC and LC-MS, in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing to establish impurity thresholds, ensure batch-to-batch consistency, and meet pharmacopoeial specifications (USP, EP).
• Stability Studies: Employed to monitor the formation of degradation products in Canagliflozin formulations under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval and market authorization.
• Research & Development: Aids in synthetic route optimization and impurity profiling during the R&D phase of Canagliflozin and related SGLT2 inhibitors.

Basic Information

Product Name	Canagliflozin Impurity 18
CAS No.	1951467-29-0
Molecular Formula	C24H25FO5S
Molecular Weight	444.52 g/mol
Synonyms	(1S)-1,5-Anhydro-1-C-[4-fluoro-3-[(4-fluorophenyl)methyl]phenyl]-D-glucitol 6-(phenylsulfonate); Canagliflozin 6-O-Phenylsulfonate; Canagliflozin 6-O-Phenyl Sulfonate Ester; Canagliflozin Phenyl Sulfonate Impurity; SGLT2 Inhibitor Impurity; 1,5-Anhydro-1-C-[4-fluoro-3-[(4-fluorophenyl)methyl]phenyl]-D-glucitol 6-(benzenesulfonate)
EINECS	Contact for details

Quality Control

Every batch of Canagliflozin Impurity 18 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference standards. Our quality protocols are designed to comply with current Good Manufacturing Practices (cGMP) and relevant ICH guidelines (Q3A, Q3B). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity, related substances, residual solvents, and other specified tests.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C (59-77°F). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccants 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.