Description

Everolimus Ep Impurity E is a designated impurity reference standard used in the analytical profiling of the active pharmaceutical ingredient Everolimus. This compound is critical for ensuring the quality, safety, and efficacy of Everolimus-based drug products by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine quality control testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Everolimus API and finished drug products.
• Analytical Method Development: Essential for developing and optimizing HPLC, UPLC, or LC-MS methods to separate and detect process-related impurities.
• Quality Control & Assurance: Serves as a system suitability standard and a calibrant in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., EP, USP).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Employed to monitor the formation of degradation products in Everolimus formulations under various stress conditions.
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of Everolimus.

Basic Information

Product Name	Everolimus Ep Impurity E
CAS No.	1237826-25-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Everolimus Related Compound E; Everolimus Impurity E; 42-O-(2-Hydroxyethyl)rapamycin derivative; Afinitor Impurity E; Zortress Impurity E; RAD001 Impurity E; (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(2R)-1-[(1S,3R,4R)-4-(2-Hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-17-(2-methylprop-1-en-1-yl)-11,28-dioxa-4-azatricyclo[22.3.1.0⁴,⁹]octacos-18-ene-2,3,10,16-tetrone
EINECS	Contact for details

Quality Control

Our Everolimus Ep Impurity E is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, identity confirmation (by IR and/or MS), and residual solvent screening, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

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)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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