Description

Everolimus Impurity CAS NO 1661009-29-5 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the immunosuppressant drug Everolimus. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for those working with mTOR inhibitors.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Everolimus Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Research: Used in HPLC, UPLC, and LC-MS analysis to identify, characterize, and quantify this specific impurity, ensuring it remains within International Council for Harmonisation (ICH) specified limits.
• Regulatory Compliance & Filings: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity profiles and control strategies as per ICH Q3A and Q3B guidelines.
• Stability Studies: Employed as a marker to monitor the formation of degradation products during forced degradation and long-term stability studies of Everolimus.
• Process Chemistry & Optimization: Helps in identifying the source of the impurity during the synthesis of Everolimus, enabling process chemists to refine manufacturing steps for higher purity yield.

Basic Information

Product Name	Everolimus Impurity
CAS No.	1661009-29-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Everolimus Related Compound; Everolimus Process Impurity; Afinitor Impurity; RAD001 Impurity; 40-O-(2-Hydroxyethyl)rapamycin Impurity; mTOR Inhibitor Impurity; Zortress Impurity; Certican Impurity
EINECS	Contact for details

Quality Control

Every batch of Everolimus Impurity CAS 1661009-29-5 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using advanced techniques like HPLC, LC-MS, and NMR to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with current Good Manufacturing Practice (cGMP) and ICH guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% 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.