Description

Dapagliflozin Impurity B is a specified impurity of the active pharmaceutical ingredient Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor. This high-purity reference standard is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is an essential material for research and quality assurance laboratories in the global pharmaceutical and biotechnology industries, ensuring the safety and efficacy of final drug products.

Application

• Primary use as a certified reference standard for the identification and quantification of Dapagliflozin Impurity B in active pharmaceutical ingredient (API) batches.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for Dapagliflozin drug substance and finished dosage forms.
• Used in stability studies and forced degradation studies to monitor impurity profiles and ensure product shelf-life.
• Essential for pharmaceutical quality control (QC) and quality assurance (QA) laboratories to comply with ICH guidelines.
• Serves as a research tool in pharmacokinetic and metabolic studies of Dapagliflozin.
• Supports regulatory filings (e.g., ANDA, NDA) by providing impurity data for submission to agencies like the FDA and EMA.

Basic Information

Product Name	Dapagliflozin Impurity B
CAS No.	1469910-83-5
Molecular Formula	C21H25ClO6
Molecular Weight	408.87 g/mol
Synonyms	Dapagliflozin Related Compound B; (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol; BMS-512148 Impurity B; Forxiga Impurity B; Farxiga Impurity B; Dapagliflozin EP Impurity B; Dapagliflozin USP Impurity B
EINECS	Contact for details

Quality Control

Every batch of Dapagliflozin Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmaceutical reference standard requirements. 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 at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use.

Specification

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

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