Description

Dapagliflozin Impurity 48 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 material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments engaged in method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Dapagliflozin Impurity 48 in API and finished drug product batches.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing and validating stability-indicating chromatographic methods to monitor impurity levels throughout the drug product lifecycle.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies & Forced Degradation: Used as an analytical marker in stress testing studies to understand the degradation pathways of Dapagliflozin and establish appropriate storage conditions.
• Quality Control & Batch Release Testing: Enables in-house QC laboratories to perform accurate impurity profiling to ensure every batch of Dapagliflozin API meets stringent pharmacopeial (USP, EP) specifications.
• Research on Impurity Formation & Control: Facilitates process chemistry research to identify the root cause of impurity formation during synthesis and develop effective purification strategies.

Basic Information

Product Name	Dapagliflozin Impurity 48
CAS No.	2069934-29-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapagliflozin Related Compound 48; DAPA Impurity 48; (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 48; Farxiga Impurity 48; SGLT2 Inhibitor Impurity; BMS-512148 Impurity 48
EINECS	Contact for details

Quality Control

Our Dapagliflozin Impurity 48 is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical characterization using advanced techniques like HPLC, LC-MS, and NMR to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment aligns with ICH guidelines and supports compliance in cGMP environments for pharmaceutical development.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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