Description

Jardiance Impurity C CAS NO 1620758-32-8 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the active pharmaceutical ingredient Empagliflozin. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is primarily used by research institutions, analytical laboratories, and pharmaceutical companies involved in the development and production of SGLT2 inhibitor therapies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Jardiance (Empagliflozin) impurities.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor impurity profiles and degradation pathways of Empagliflozin under various storage conditions.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data.
• Quality Control & Batch Release: Serves as a system suitability and calibration standard for routine QC testing of active pharmaceutical ingredients (APIs).
• Research & Development: Used in synthetic chemistry research to study impurity formation mechanisms and optimize purification processes.

Basic Information

Product Name	Jardiance Impurity C
CAS No.	1620758-32-8
Molecular Formula	C23H27ClO7
Molecular Weight	474.91 g/mol
Synonyms	Empagliflozin Impurity C; (1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol; BI 10773 Impurity C; (1S)-1,5-anhydro-1-[4-chloro-3-[[4-[[(3S)-oxolan-3-yl]oxy]phenyl]methyl]phenyl]-D-glucitol
EINECS	Contact for details

Quality Control

Every batch of Jardiance Impurity C is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with each shipment.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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