Description

Everolimus o-Ethyl Impurity is a designated process-related impurity and reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Everolimus. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and manufacturers involved in the synthesis and production of Everolimus and its formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of the o-Ethyl impurity in Everolimus API and drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards.
• Stability Studies: Utilized to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) to establish shelf-life.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Everolimus to minimize the formation of this impurity.

Basic Information

Product Name	Everolimus o-Ethyl Impurity
CAS No.	1704711-12-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Everolimus Related Compound o-Ethyl; o-Ethyl Everolimus; Everolimus Impurity o-Ethyl; Everolimus EP Impurity o-Ethyl; Everolimus USP Impurity o-Ethyl; (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy-12-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone (o-Ethyl derivative); Afinitor Impurity o-Ethyl; RAD001 Impurity o-Ethyl
EINECS	Contact for details

Quality Control

Our Everolimus o-Ethyl Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the high standards required for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for identity, purity, and impurities. Our quality systems support compliance with cGMP and relevant ICH guidelines for impurities in new drug substances (Q3A(R2)).

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 dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
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 Q3C

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