Description

Everolimus Hydrolized Impurity is a critical pharmaceutical reference standard used for the analytical characterization and quality control of the active pharmaceutical ingredient (API) Everolimus. This impurity is essential for ensuring the purity, safety, and efficacy of the final drug product, particularly in complex therapeutic areas like oncology and immunosuppression. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of hydrolytic degradation products in Everolimus API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical system suitability component for HPLC, UPLC, and LC-MS methods to ensure accurate impurity detection.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels against ICH Q3A/B guidelines, ensuring product consistency and compliance.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., hydrolytic stress) to establish product shelf life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Facilitates research into the degradation pathways and stability of Everolimus and related mTOR inhibitors.

Basic Information

Item	Detail
Product Name	Everolimus Hydrolized Impurity
CAS No.	769905-89-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Everolimus Hydrolyzed Impurity; Everolimus Hydrolysis Product; 42-O-(2-Hydroxyethyl)rapamycin Hydrolyzed Derivative; Afinitor Impurity (Hydrolyzed); Zortress Impurity (Hydrolyzed); mTOR Inhibitor Impurity; (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 (Hydrolyzed Form)
EINECS	Contact for details

Quality Control

Our Everolimus Hydrolized Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), 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, supporting compliance with cGMP and ICH guidelines.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed 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%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% 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.