Description

Empagliflozin Impurity CAS NO 2444010-96-0 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 research laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is essential for professionals engaged in method development, stability studies, and batch release testing within the pharmaceutical and analytical chemistry sectors.

Application

• Primary use as a certified reference standard for the identification and quantification of related substances in Empagliflozin API.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for impurity profiling.
• Used in pharmaceutical stability studies to monitor degradation pathways and establish shelf-life.
• Essential for quality control (QC) and quality assurance (QA) laboratories to meet ICH, USP, and EP guidelines.
• Serves as a key material in regulatory submissions (e.g., for FDA, EMA) to demonstrate comprehensive impurity control.
• Valuable for research and development of generic formulations and process chemistry optimization.

Basic Information

Product Name	Empagliflozin Impurity
CAS No.	2444010-96-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Empagliflozin Related Compound; Empagliflozin Process Impurity; SGLT2 Inhibitor Impurity; (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol Impurity; BI 10773 Impurity; Jardiance Impurity
EINECS	Contact for details

Quality Control

Our Empagliflozin Impurity is manufactured under strict quality systems to ensure the highest standards of purity and consistency. Each batch is subjected to comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to confirm identity and purity. A Certificate of Analysis (COA) detailing all test results is provided with every shipment, ensuring full traceability and compliance with current Good Manufacturing Practice (cGMP) and ICH Q3A/B guidelines for impurities in new drug substances.

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. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

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)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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