Description

Dapagliflozin Impurity 8 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Dapagliflozin. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential material for method development, validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Dapagliflozin Impurity 8 in API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles during manufacturing.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Dapagliflozin meets stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (thermal, humidity, light) to establish shelf-life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Dapagliflozin to minimize the formation of this impurity.

Basic Information

Product Name	Dapagliflozin Impurity 8
CAS No.	2305949-33-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapagliflozin Related Compound 8; Dapagliflozin EP Impurity 8; Dapagliflozin USP Impurity 8; Forxiga Impurity 8; Farxiga Impurity 8; (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol Impurity 8; SGLT2 Inhibitor Impurity; BMS-512148 Impurity 8
EINECS	Contact for details

Quality Control

Our Dapagliflozin Impurity 8 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and qualified using advanced techniques including HPLC, LC-MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

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 under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.