Description

Empagliflozin Impurity CAS NO 2253771-11-6 is a high-purity chemical reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Empagliflozin. This compound is critical for pharmaceutical quality control and regulatory compliance, enabling the accurate identification and quantification of process-related impurities during drug development and manufacturing. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and production facilities.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of specific impurities in Empagliflozin API batches.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, in compliance with ICH Q2(R1) guidelines.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity levels and ensure the final drug product meets stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed as a marker to track impurity profiles in forced degradation and long-term stability studies of Empagliflozin formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways by identifying and controlling the formation of this specific impurity.

Basic Information

Item	Detail
Product Name	Empagliflozin Impurity
CAS No.	2253771-11-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Empagliflozin Related Compound; Empagliflozin Process Impurity; SGLT2 Inhibitor Impurity; BI 10773 Impurity; (1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol Impurity; 2253771-11-6; Empagliflozin Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Empagliflozin Impurity (CAS 2253771-11-6) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using advanced techniques like HPLC, GC-MS, and NMR to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which could affect stability and purity. For long-term storage, consider using desiccants.

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%

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