Description

Dapagliflozin Impurity 32 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 R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Dapagliflozin API and its formulations.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Utilized to track the formation of degradation products in Dapagliflozin drug substances and products under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports synthetic chemistry research for understanding impurity formation pathways and developing robust purification processes.

Basic Information

Product Name	Dapagliflozin Impurity 32
CAS No.	1528636-07-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapagliflozin Related Compound 32; Dapagliflozin EP Impurity J; Dapagliflozin USP Impurity; Forxiga Impurity 32; (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 32 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and controlled against a comprehensive specification, including identity, purity, and impurity profile. A detailed Certificate of Analysis (COA) is provided, confirming compliance with relevant pharmacopeial (USP, EP) and ICH guidelines for impurities.

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). The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.