Description

Empagliflozin Impurity 17 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Empagliflozin. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential material for method development, validation, and routine testing in the production of SGLT2 inhibitor class diabetes medications.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Empagliflozin API.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for pharmaceutical quality control laboratories.
• Used in stability studies and forced degradation studies to monitor impurity profiles over time.
• Essential for regulatory submissions (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Serves as a research tool in pharmacokinetic and metabolic studies of SGLT2 inhibitors.
• Supports pharmacopoeial testing to meet standards set by USP, EP, or other international bodies.

Basic Information

Product Name	Empagliflozin Impurity 17
CAS No.	2452301-27-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Empagliflozin Related Compound 17; Empagliflozin EP Impurity J; 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 17; Jardiance Impurity
EINECS	Contact for details

Quality Control

Every batch of Empagliflozin Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopoeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles. We support compliance with cGMP, ICH Q3A/B guidelines, and other relevant regulatory frameworks.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store under inert conditions if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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