Description

Dapagliflozin Impurity 165 is a high-purity chemical reference standard used in the development and quality control of the active pharmaceutical ingredient (API) dapagliflozin. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and contract research organizations (CROs) focused on SGLT2 inhibitor therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments (HPLC, LC-MS) in method development and validation.
• API Impurity Profiling: Used to identify, monitor, and control the levels of this specific impurity during the synthesis and purification of Dapagliflozin API.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed as a marker to track impurity formation in drug substance and drug product stability testing under various ICH conditions.
• Quality Control Testing: A key component in the routine batch release testing of Dapagliflozin to ensure it meets pharmacopeial (e.g., USP, EP) or internal specification limits.
• Research & Development: Utilized in synthetic route optimization and process chemistry to understand and minimize the formation of this impurity.

Basic Information

Product Name	Dapagliflozin Impurity 165
CAS No.	342043-51-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapagliflozin Related Compound 165; Dapagliflozin EP Impurity I; Dapagliflozin USP Impurity; Forxiga Impurity 165; (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 165 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) are provided, detailing batch-specific results and confirming compliance with relevant specifications. Our quality commitment supports your needs for GMP-aligned materials and reliable regulatory documentation.

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 product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed 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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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 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.