Description

Empagliflozin Impurity 32 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 an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Empagliflozin Impurity 32 in drug substances and products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Empagliflozin API and formulations.
• Quality Control & Assurance: Used in routine QC testing to ensure batch-to-batch consistency and that impurity levels remain within ICH Q3A/B regulatory thresholds.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research & Synthesis: Serves as a building block or intermediate for chemical researchers studying the degradation pathways or synthesizing related analogs of Empagliflozin.

Basic Information

Product Name	Empagliflozin Impurity 32
CAS No.	1620758-25-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Empagliflozin Related Compound 32; Empagliflozin EP Impurity J; BI 10773 Impurity 32; (1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol Impurity; SGLT2 Inhibitor Impurity; 1-(4-Chloro-3-((4-(((3S)-tetrahydrofuran-3-yl)oxy)benzyl)phenyl)glucitol Impurity
EINECS	Contact for details

Quality Control

Our Empagliflozin Impurity 32 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.