Description

Dapagliflozin Impurity 10 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 related substances. It is primarily utilized by professionals in pharmaceutical development, quality assurance, and regulatory affairs who require reliable and well-characterized impurities for method validation and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Dapagliflozin Impurity 10 in API and finished drug product testing.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS, in compliance with ICH guidelines.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of dapagliflozin formulations.
• Quality Control (QC) and Quality Assurance (QA): Provides a benchmark for in-process control and release testing to ensure impurity profiles meet stringent pharmacopeial specifications (e.g., USP, EP).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive characterization data for specified impurities.
• Research and Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes for the API.

Basic Information

Product Name	Dapagliflozin Impurity 10
CAS No.	461432-27-9
Molecular Formula	C21H25ClO6
Molecular Weight	408.87 g/mol
Synonyms	(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-D-glucitol; Dapagliflozin Related Compound; Dapagliflozin EP Impurity; Dapagliflozin USP Impurity; Forxiga Impurity; (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-D-glucitol; BMS-512148 Impurity
EINECS	Contact for details

Quality Control

Our Dapagliflozin Impurity 10 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every 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). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to maintain stability and purity.

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)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
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.