Description

Ertugliflozin Impurity 3 is a specified impurity of the antidiabetic pharmaceutical agent Ertugliflozin, identified by CAS No. 1298086-17-5. This compound is critical for ensuring the quality, safety, and efficacy of the final drug product by serving as a reference standard in analytical development and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the research, development, and production of SGLT2 inhibitor therapies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ertugliflozin Impurity 3 in active pharmaceutical ingredient (API) and finished drug product testing.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in pharmaceutical R&D laboratories.
• Quality Control & Batch Release: Employed in routine quality control (QC) testing to monitor impurity levels and ensure batches of Ertugliflozin API comply with International Council for Harmonisation (ICH) guidelines and regulatory specifications.
• Stability Studies: Used as an analytical marker in forced degradation and long-term stability studies to track impurity profiles over time and under various stress conditions.
• Regulatory Submissions: Provides necessary data and structural confirmation for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis and purification stages of Ertugliflozin manufacturing.

Basic Information

Product Name	Ertugliflozin Impurity 3
CAS No.	1298086-17-5
Molecular Formula	C22H25ClO7
Molecular Weight	460.89 g/mol
Synonyms	(1S,2S,3S,4R,5S)-5-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol; Ertugliflozin Related Compound 3; Ertugliflozin EP Impurity C; Ertugliflozin USP Impurity C; PF-04971729 Impurity 3; (1S,2S,3S,4R,5S)-5-[4-Chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol
EINECS	Contact for details

Quality Control

Our high-purity pharmaceutical impurity standards are manufactured and tested under strict quality systems. Each batch of Ertugliflozin Impurity 3 undergoes comprehensive analytical characterization using techniques including HPLC, GC, MS, and NMR to confirm identity and purity, ensuring compliance with current pharmacopeial standards (USP/EP/ICH). A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every product.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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