Description

Everolimus Related Compound 3 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity marker and analytical standard in the quality control of the active pharmaceutical ingredient (API) Everolimus, an important immunosuppressant and anticancer drug. It is essential for analytical chemists and quality assurance professionals in pharmaceutical manufacturing and contract research organizations (CROs) to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Everolimus API batches during stability studies and release testing.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and LC-MS/MS methods for Everolimus analysis.
• Quality Control & Assurance (QC/QA): Employed as a system suitability standard and for preparing calibration curves to ensure the accuracy and precision of analytical instruments in GMP/GLP laboratories.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH guidelines.
• Stability-Indicating Studies: Helps in monitoring the degradation pathways of Everolimus under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2) requirements.
• Academic & Biomedical Research: Utilized in metabolic and pharmacokinetic studies to understand the biotransformation and clearance of Everolimus in biological systems.

Basic Information

Product Name	Everolimus Related Compound 3
CAS No.	147438-30-0
Molecular Formula	C53H83NO14
Molecular Weight	958.23 g/mol
Synonyms	42-O-(2-Hydroxyethyl)rapamycin; 42-O-(2-Hydroxyethyl) Sirolimus; Everolimus Impurity 3; Everolimus EP Impurity C; Everolimus Related Substance 3; RAD001 Related Compound 3; Afinitor Impurity 3; Zortress Impurity 3
EINECS	Contact for details

Quality Control

Every batch of Everolimus Related Compound 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with ICH Q3A, Q3B, and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chromatographic purity, water content, and residual solvents, is provided with each shipment to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. The product is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere or in a controlled humidity environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.