Description

Empagliflozin Impurity 10 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) Empagliflozin, a leading SGLT2 inhibitor. It is an essential material for pharmaceutical manufacturers, quality control laboratories, and research institutions involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference standard for the identification and quantification of specific impurities in Empagliflozin API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for stability-indicating assays.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation and behavior of this impurity under various stress conditions (thermal, photolytic, hydrolytic) as part of forced degradation studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity characterization and control strategies.
• Research and Development: Facilitates chemical and pharmacological research into the degradation pathways and properties of SGLT2 inhibitors.

Basic Information

Product Name	Empagliflozin Impurity 10
CAS No.	2069942-68-1
Molecular Formula	C23H27ClO7
Molecular Weight	450.91 g/mol
Synonyms	Empagliflozin Related Compound 10; BI 10773 Impurity 10; (1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol Impurity; Empagliflozin EP Impurity J; Empagliflozin USP Impurity J; SGLT2 Inhibitor Impurity; 1-(4-Chloro-3-((4-(((3S)-tetrahydrofuran-3-yl)oxy)benzyl)phenyl)-1,5-anhydro-D-glucitol Impurity
EINECS	Contact for details

Quality Control

Our Empagliflozin Impurity 10 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, LC-MS, NMR, and other orthogonal techniques. We ensure compliance with relevant ICH guidelines and can support qualification to pharmacopeial standards (USP, EP) upon request.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
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.