Description

Dapagliflozin Impurity 19 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Dapagliflozin, a leading SGLT2 inhibitor. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Dapagliflozin API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, and LC-MS methods to meet ICH Q3A/B guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels and ensure product specifications are met.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Dapagliflozin formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports synthetic chemistry research, including route scouting and process optimization to minimize impurity formation.

Basic Information

Product Name	Dapagliflozin Impurity 19
CAS No.	1469910-84-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapagliflozin Related Compound 19; Dapagliflozin EP Impurity J; Dapagliflozin USP Impurity; Forxiga Impurity 19; (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol Impurity; SGLT2 Inhibitor Impurity; 1-Chloro-4-(β-D-glucopyranos-1-yl)-2-[4-(ethoxyphenyl)methyl]benzene Impurity
EINECS	Contact for details

Quality Control

Our Dapagliflozin Impurity 19 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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