Description

Empagliflozin Impurity 97 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This specific impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Empagliflozin, a leading SGLT2 inhibitor. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory affairs departments for method validation, stability studies, and batch release testing. The compound is supplied with comprehensive analytical data to support rigorous quality assurance protocols.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quantitative and qualitative analysis of Empagliflozin API and finished drug products.
• Method Development and Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to accurately detect and quantify this specific impurity.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor impurity profiles and ensure drug product shelf-life.
• Quality Control & Batch Release: A critical component in the QC testing of Empagliflozin batches to confirm they meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions: Provides necessary data and material for regulatory filings (e.g., FDA, EMA) to establish impurity identification, qualification, and control strategies.
• Research and Development: Used in R&D to study the formation, fate, and purge of this impurity during the synthetic process of Empagliflozin.

Basic Information

Product Name	Empagliflozin Impurity 97
CAS No.	2262435-19-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Empagliflozin Related Compound 97; BI 10773 Impurity 97; (1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol Impurity; SGLT2 Inhibitor Impurity; Jardiance Impurity; 1-(4-Chloro-3-((4-(((3S)-tetrahydrofuran-3-yl)oxy)benzyl)phenyl)-1,5-anhydro-D-glucitol Impurity 97
EINECS	Contact for details

Quality Control

Every batch of Empagliflozin Impurity 97 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with industry and regulatory standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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