Description

Dapagliflozin Impurity 38 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the SGLT2 inhibitor, 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 analysis. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Dapagliflozin Impurity 38 in active pharmaceutical ingredient (API) and finished drug product testing.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and LC-MS, to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Dapagliflozin.
• Quality Control & Batch Release: Serves as a system suitability and calibration standard in routine QC testing to ensure every batch of Dapagliflozin API meets stringent purity specifications.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify the control strategy for the drug substance.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during synthesis, helping to optimize manufacturing processes to minimize its generation.

Basic Information

Product Name	Dapagliflozin Impurity 38
CAS No.	2452300-92-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapagliflozin Related Compound 38; Dapagliflozin EP Impurity G; Dapagliflozin USP Impurity; Forxiga Impurity 38; (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol Impurity; SGLT2 Inhibitor Impurity; BMS-512148 Impurity 38
EINECS	Contact for details

Quality Control

Every batch of Dapagliflozin Impurity 38 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and strength, compliant with current industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques. Our quality commitment ensures reliability for your most critical analytical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. Keep the container sealed to protect the material from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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 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.