Description

Empagliflozin Impurity 62 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 primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during the manufacturing and quality control of Empagliflozin API.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to ensure accurate detection and quantification limits.
• Stability Studies and Forced Degradation Testing: Employed to track the formation and behavior of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life and packaging requirements.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed characterization and control of known and potential impurities as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Batch Release Testing: Used in routine QC laboratories to confirm that Empagliflozin drug substance and drug product batches meet stringent purity specifications before release to the market.
• Research and Development: Supports R&D efforts in understanding the synthetic pathway, degradation mechanisms, and purification processes related to Empagliflozin and its related substances.

Basic Information

Product Name	Empagliflozin Impurity 62
CAS No.	1620758-30-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Empagliflozin Related Compound 62; BI 10773 Impurity 62; SGLT2 Inhibitor Impurity; (1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol Impurity; Empagliflozin EP Impurity G; Empagliflozin USP Impurity; 1620758-30-6
EINECS	Contact for details

Quality Control

Every batch of Empagliflozin Impurity 62 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards (e.g., USP, EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatographic purity and assigned structure confirmation, is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material under appropriate laboratory conditions to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.