Description

Ertugliflozin Impurity 2 is a specified impurity and degradation product associated with the active pharmaceutical ingredient Ertugliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Ertugliflozin-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Ertugliflozin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Crucial for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Used in routine batch release testing to ensure API and drug products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and long-term stability programs.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Ertugliflozin to minimize the formation of this impurity.

Basic Information

Product Name	Ertugliflozin Impurity 2
CAS No.	1500090-85-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ertugliflozin Related Compound 2; Ertugliflozin EP Impurity 2; Ertugliflozin USP Impurity 2; Ertugliflozin Degradation Product; (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 (probable structure); PF-04971729 Impurity 2; SGLT2 Inhibitor Impurity.
EINECS	Contact for details

Quality Control

Our Ertugliflozin Impurity 2 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including characterization by NMR, MS, and HPLC to confirm identity and purity. We provide comprehensive Certificates of Analysis (COA) that detail purity, impurity profiles, and analytical results, ensuring compliance with the standards required for pharmaceutical reference materials. Our quality commitment supports your needs for reliable and traceable impurities in regulatory applications.

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 under inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.