Description

Empagliflozin Impurity 14 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 Control: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during the manufacturing and quality control of Empagliflozin API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating sensitive HPLC, UPLC, or LC-MS methods to ensure accurate detection and quantification limits.
• Stability Studies and Forced Degradation Testing: Employed as a marker to study the degradation pathways and stability profile of Empagliflozin under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity identification and qualification data.
• Quality Assurance/Quality Control (QA/QC): Used in routine batch release testing to confirm that impurity levels are within the specified International Council for Harmonisation (ICH) guidelines.
• Research and Development (R&D): Supports ongoing research into the synthesis, metabolism, and pharmacokinetics of Empagliflozin and related compounds.

Basic Information

Product Name	Empagliflozin Impurity 14
CAS No.	2137418-13-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Empagliflozin Related Compound 14; Empagliflozin EP Impurity J; Empagliflozin USP Impurity; (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 14; Jardiance Impurity
EINECS	Contact for details

Quality Control

Our Empagliflozin Impurity 14 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and confirmed using advanced techniques such as HPLC, LC-MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

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