Description

Everolimus Impurity 1 is a designated impurity of the active pharmaceutical ingredient Everolimus, a critical immunosuppressant and anticancer agent. This reference standard is essential for pharmaceutical research and development, enabling the accurate identification, quantification, and control of this specific impurity during drug manufacturing. It is primarily used by analytical chemists, quality control laboratories, and regulatory affairs professionals within the pharmaceutical and biotechnology sectors to ensure product safety, efficacy, and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the qualitative and quantitative analysis of Everolimus Impurity 1 in drug substances and finished products.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control and Assurance: Used in routine QC testing to monitor impurity levels against established specifications, ensuring batch-to-batch consistency.
• Regulatory Submission and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Employed to track the formation and growth of this impurity under various stress and long-term storage conditions.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during synthesis, helping to optimize manufacturing processes for higher purity.

Basic Information

Product Name	Everolimus Impurity 1
CAS No.	745779-75-3
Molecular Formula	C53H83NO14
Molecular Weight	958.23 g/mol
Synonyms	42-O-(2-Hydroxyethyl)rapamycin; 42-O-(2-Hydroxyethyl) Sirolimus; Everolimus Related Compound A; (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
EINECS	Contact for details

Quality Control

Our Everolimus Impurity 1 is manufactured under strict quality systems to ensure the highest standards of purity and consistency, suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques including HPLC, LC-MS, and NMR for structural confirmation and purity assessment. We adhere to relevant ICH guidelines for impurity characterization. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent 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%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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