Description

Everolimus Related Compound 2 is a designated impurity and reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Everolimus. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical products containing Everolimus. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development, production, and regulatory compliance of oncology and immunosuppressant therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Everolimus API and finished drug products according to ICH guidelines.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in GMP environments to monitor and control impurity levels, ensuring product consistency and compliance with regulatory specifications.
• Stability Studies: Employed to track the formation of degradation products in Everolimus formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Supports synthetic chemistry research, metabolic studies, and the investigation of Everolimus degradation pathways.

Basic Information

Product Name	Everolimus Related Compound 2
CAS No.	1062122-63-7
Molecular Formula	C53H83NO14
Molecular Weight	958.23 g/mol
Synonyms	Everolimus Impurity 2; 42-O-[2-Hydroxyethyl]rapamycin; 42-O-(2-Hydroxyethyl)rapamycin; 42-Hydroxyethyl Rapamycin; Afinitor Impurity 2; RAD001 Related Compound 2; Zortress Impurity 2; Certican Impurity 2
EINECS	Contact for details

Quality Control

Our Everolimus Related Compound 2 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We support compliance with ICH Q3A, Q3B, and Q6A guidelines, and our quality management system is designed to meet the needs of GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Water Content (KF)	≤ 2.0%
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.