Description

Canagliflozin Impurity 16 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Canagliflozin. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It serves as a key marker for method development, validation, and routine batch testing within the pharmaceutical industry, particularly for antidiabetic drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Canagliflozin Impurity 16 in API and finished drug product batches.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods (HPLC, UPLC) for impurity profiling of Canagliflozin.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed as a benchmark to track the formation and growth of this specific impurity under various stress and storage conditions.
• Research & Development: Utilized in pharmaceutical R&D for impurity synthesis pathway studies and degradation product investigation.

Basic Information

Product Name	Canagliflozin Impurity 16
CAS No.	1807632-93-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Canagliflozin Related Compound 16; Canagliflozin EP Impurity J; Canagliflozin USP Impurity; SGLT2 Inhibitor Impurity; (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol Impurity; Canagliflozin Degradation Product; Canagliflozin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Canagliflozin Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your regulatory and quality requirements.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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