Description

Empagliflozin Impurity 35 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Empagliflozin. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized by professionals in pharmaceutical development, quality assurance (QA), and quality control (QC) for method validation and impurity identification studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material for the identification and quantification of impurities in Empagliflozin API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a benchmark in routine quality control testing to monitor and control impurity levels, ensuring batch-to-batch consistency.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Employed in forced degradation and long-term stability studies of Empagliflozin to understand impurity formation pathways.
• Research & Development (R&D): Used in synthetic chemistry and process research to study the formation and fate of this specific impurity during API synthesis.

Basic Information

Product Name	Empagliflozin Impurity 35
CAS No.	1459754-40-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Empagliflozin Related Compound 35; Empagliflozin EP Impurity G; Empagliflozin USP Impurity; SGLT2 Inhibitor Impurity; (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol Impurity; BI 10773 Impurity 35; Jardiance Impurity
EINECS	Contact for details

Quality Control

Our Empagliflozin Impurity 35 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized and confirmed using advanced techniques including HPLC, MS, and NMR. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with every shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store under inert conditions where appropriate.

Specification

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