Description

Dapagliflozin Impurity 9 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 analytical testing. 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: Primary use as a certified reference material for the identification and quantification of Dapagliflozin Impurity 9 in API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Stability Studies: Used in routine batch release testing and long-term stability studies to monitor impurity levels and ensure product shelf-life.
• Regulatory Compliance & Filings: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis and purification of dapagliflozin.
• Pharmacopoeial Standards: Serves as a potential candidate for official pharmacopoeial monographs (e.g., USP, EP) for dapagliflozin.

Basic Information

Product Name	Dapagliflozin Impurity 9
CAS No.	2305949-36-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2S,3R,4R,5S,6R)-2-[4-Chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol Impurity 9; Dapagliflozin Related Compound 9; Forxiga Impurity 9; Farxiga Impurity 9; SGLT2 Inhibitor Impurity; BMS-512148 Impurity 9
EINECS	Contact for details

Quality Control

Our Dapagliflozin Impurity 9 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant ICH guidelines.

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. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment 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)	≥ 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%

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