Description

Empagliflozin Impurity 82 is a high-purity reference standard used for analytical and research purposes in pharmaceutical development. This specific impurity 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 quality control laboratories, analytical research and development teams, and regulatory affairs departments focused on method validation and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify and quantify this specific impurity in Empagliflozin API and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical standard for developing, optimizing, and validating chromatographic methods to ensure accurate detection and measurement.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release Testing: Essential for routine QC testing of Empagliflozin batches to confirm they meet stringent pharmacopeial (e.g., USP, EP) or internal specification limits.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the impurity profile.
• Research into Degradation Pathways: Aids in research studies to understand the chemical pathways leading to the formation of this impurity.

Basic Information

Product Name	Empagliflozin Impurity 82
CAS No.	2452301-16-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Empagliflozin Related Compound 82; Empagliflozin EP Impurity J; Empagliflozin USP Impurity; BI 10773 Impurity 82; (1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol Impurity; SGLT2 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Empagliflozin Impurity 82 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and related substances. Our quality commitment aligns with the needs of cGMP-compliant environments.

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. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.