Description

Dapagliflozin Impurity CAS NO 1807632-95-6 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the SGLT2 inhibitor, Dapagliflozin. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of process-related substances. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of specific impurities in Dapagliflozin API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels throughout the manufacturing process.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure drug substance and product purity complies with ICH Q3A/B guidelines and regulatory filings.
• Stability Studies: Employed to track the formation and growth of degradation products under various stress conditions (heat, light, humidity) as per ICH stability protocols.
• Regulatory Submission Support: Provides essential data for impurity characterization reports required by agencies like the FDA, EMA, and PMDA.
• Research & Development: Supports process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Dapagliflozin Impurity
CAS No.	1807632-95-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapagliflozin Related Compound; Dapagliflozin Process Impurity; Dapagliflozin Specified Impurity; (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol Impurity; Forxiga Impurity; Farxiga Impurity; SGLT2 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Dapagliflozin Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC, MS, and NMR to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, related substances, and residual solvents, ensuring compliance with ICH guidelines and supporting your regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment to prevent moisture absorption. For long-term storage, consider conditions recommended for high-purity pharmaceutical reference standards.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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