Description

Dapagliflozin Impurity 20 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Dapagliflozin. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) departments involved in the development and production of SGLT2 inhibitor medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods.
• Method Development & Validation: Essential for developing and validating precise HPLC, UPLC, or LC-MS methods for impurity profiling of Dapagliflozin API.
• Quality Control & Batch Release: Used in routine QC testing to monitor and control the levels of specified impurities in drug substance and drug product batches, ensuring they meet ICH guidelines.
• Stability Studies: Employed to identify and track degradation products that may form under various stress conditions during drug shelf-life studies.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry studies by helping to identify and understand process-related impurities.

Basic Information

Product Name	Dapagliflozin Impurity 20
CAS No.	2040305-09-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapagliflozin Related Compound 20; Dapagliflozin EP Impurity J; Dapagliflozin USP Impurity; Forxiga Impurity 20; (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; BMS-512148 Impurity 20
EINECS	Contact for details

Quality Control

Our Dapagliflozin Impurity 20 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods. We ensure compliance with relevant pharmacopeial standards (USP, EP) and ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under 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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.