Description

Dapagliflozin Impurity 19 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) dapagliflozin. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is primarily utilized by professionals in pharmaceutical development, quality assurance (QA), and quality control (QC) laboratories.

Application

• Primary use as a certified reference standard for the identification and quantification of Dapagliflozin Impurity 19 in API batches.
• Critical component in method development and validation for HPLC, UPLC, and other chromatographic techniques.
• Essential for stability studies and impurity profiling to monitor degradation pathways in dapagliflozin formulations.
• Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Used in pharmaceutical research to study the synthesis pathways and metabolism of dapagliflozin.
• Serves as a system suitability standard in routine quality control testing to ensure analytical instrument performance.

Basic Information

Product Name	Dapagliflozin Impurity 19
CAS No.	2133407-73-3
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

Every batch of Dapagliflozin Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic methods, to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) are provided, detailing purity, identity, and impurity profiles. We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

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 individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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