Description

Empagliflozin Impurity 5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification and quantification of process-related impurities in the active pharmaceutical ingredient (API) Empagliflozin. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical development and manufacturing, ensuring drug safety and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Primary use as a certified reference standard in analytical methods for impurity identification.
• Method Development and Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for monitoring Empagliflozin purity.
• Quality Control (QC) and Quality Assurance (QA): Serves as a system suitability standard and for routine batch testing in API and finished drug product manufacturing.
• Stability Studies: Employed to track the formation of specific impurities in Empagliflozin formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in synthetic chemistry research to study impurity formation pathways and in metabolic studies.

Basic Information

Product Name	Empagliflozin Impurity 5
CAS No.	1800196-46-6
Molecular Formula	C23H27ClO7
Molecular Weight	474.91 g/mol
Synonyms	Empagliflozin Related Compound 5; (1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol; 1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol; BI 10773 Impurity 5; Jardiance Impurity 5
EINECS	Contact for details

Quality Control

Every batch of Empagliflozin Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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