Description

Empagliflozin Impurity 42 is a high-purity chemical reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Empagliflozin. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods for Empagliflozin API.
• Quality Control & Assurance: Used in routine HPLC/LC-MS analysis to monitor and control the levels of specified impurities in drug substance batches, ensuring they meet pharmacopeial limits (e.g., USP, EP).
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Stability Studies: Employed to identify and track degradation products that may form in Empagliflozin formulations under various stress conditions (e.g., heat, humidity, light).
• Method Development: A key component in developing and optimizing chromatographic separation methods for the accurate resolution of Empagliflozin and its related impurities.
• Research & Development: Used in synthetic chemistry research to understand impurity formation pathways and to develop robust purification processes for the API.

Basic Information

Product Name	Empagliflozin Impurity 42
CAS No.	2452301-12-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Empagliflozin Related Compound 42; (1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol Impurity; SGLT2 Inhibitor Impurity; BI 10773 Impurity 42; Jardiance Impurity 42
EINECS	Contact for details

Quality Control

Our Empagliflozin Impurity 42 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic identification (NMR, MS), 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 and confirming compliance with specified purity criteria.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store under an inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% 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.