Description

Empagliflozin Impurity 6 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the SGLT2 inhibitor, Empagliflozin. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and control during manufacturing. It is an essential material for analytical laboratories, regulatory affairs, and quality assurance departments within pharmaceutical companies and contract research organizations (CROs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of related substances in Empagliflozin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure API and drug product batches comply with stringent ICH guidelines on impurities (ICH Q3A(R2) & Q3B(R2)).
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization data and specifications.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in forced degradation and long-term stability studies of Empagliflozin.
• Research & Development: Facilitates process chemistry research to understand and minimize the formation of this specific impurity during API synthesis.

Basic Information

Product Name	Empagliflozin Impurity 6
CAS No.	1620758-21-5
Molecular Formula	C23H27ClO7
Molecular Weight	474.91 g/mol
Synonyms	Empagliflozin Related Compound 6; (1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol; BI 10773 Impurity 6; Jardiance Impurity 6; (1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-oxolan-3-yl]oxy]phenyl]methyl]phenyl]-D-glucitol
EINECS	Contact for details

Quality Control

Our Empagliflozin Impurity 6 is manufactured and controlled under a strict quality management system. Each batch is subjected to comprehensive analytical testing, including HPLC purity determination, spectroscopic identification (IR, NMR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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