Description

Dapagliflozin Impurity D CAS NO 2133407-75-5 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 tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Characterization: Primary use as a certified reference standard for identifying and quantifying Dapagliflozin Impurity D in API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for quality control laboratories.
• Stability Studies and Forced Degradation Testing: Used to monitor the formation of this specific impurity under various stress conditions to establish product shelf-life.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing a characterized impurity standard for specification setting.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure Dapagliflozin API and drug products meet stringent pharmacopeial (USP, EP) purity specifications.
• Research and Development: Used in R&D to study the metabolic pathways, synthesis pathways, and degradation mechanisms of Dapagliflozin.

Basic Information

Item	Details
Product Name	Dapagliflozin Impurity D
CAS No.	2133407-75-5
Molecular Formula	C21H25ClO6
Molecular Weight	408.87 g/mol
Synonyms	Dapagliflozin Related Compound D; (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol Impurity D; BMS-512148 Impurity D; Forxiga Impurity D; Farxiga Impurity D; (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-D-glucitol Impurity D
EINECS	Contact for details

Quality Control

Every batch of Dapagliflozin Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with the highest standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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