Description

Everolimus Ring-Opening Impurity is a specified impurity and degradation product of the active pharmaceutical ingredient Everolimus, an mTOR inhibitor used as an immunosuppressant and in oncology. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, stability studies, and quality control to ensure the purity and safety of the final drug product. It is primarily utilized by analytical chemists, quality assurance professionals, and researchers in pharmaceutical manufacturing and contract research organizations (CROs) focused on developing and monitoring complex active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the ring-opened impurity in Everolimus drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles during stability studies.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Everolimus API and formulations meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability and Forced Degradation Studies: Acts as a key marker to understand the degradation pathways of Everolimus under various stress conditions (e.g., hydrolytic, oxidative).
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval.
• Process Chemistry Research: Used to optimize synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Everolimus Ring-Opening Impurity
CAS No.	1708118-13-1
Molecular Formula	C53H83NO14
Molecular Weight	958.23 g/mol
Synonyms	42-O-(2-Hydroxyethyl)rapamycin; Everolimus Hydroxyethyl Derivative; Everolimus Impurity F (Ring-Opened); 32,42-Di-O-[(2S)-2-hydroxyethyl]-20,21,22,23-tetradehydrorapamycin; 32,42-Bis-O-(2-hydroxyethyl)everolimus impurity; Afinitor Impurity F; RAD001 Ring-Opening Impurity; Zortress Impurity F
EINECS	Contact for details

Quality Control

Our Everolimus Ring-Opening Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC purity assay, related substance profiling, and structural confirmation (e.g., by NMR and MS). We adhere to ICH Q3A/B guidelines for impurity qualification, and our quality system supports the needs of cGMP-compliant pharmaceutical development.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C, in a dry environment. Due to its hygroscopic (moisture-sensitive) nature, the container should be kept sealed in a desiccator or under an inert atmosphere after opening to prevent moisture uptake and degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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