Description

Lenalidomide Impurity 7 is a specified impurity of the active pharmaceutical ingredient Lenalidomide, a critical immunomodulatory drug. This compound is essential for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Lenalidomide drug substances and products.

Application

• As a certified reference standard for the identification and quantification of impurities in Lenalidomide API and finished dosage forms.
• For analytical method development and validation (HPLC, UPLC, LC-MS) in quality control laboratories.
• In stability studies to monitor impurity profiles and degradation pathways of Lenalidomide formulations.
• For regulatory compliance and submission, providing necessary data for ICH guidelines (Q3A, Q3B) on impurities.
• Used in pharmacopoeial testing to meet standards set by USP, EP, or other pharmacopoeias.
• As a critical material in research and development of Lenalidomide synthesis and purification processes.

Basic Information

Product Name	Lenalidomide Impurity 7
CAS No.	2197414-55-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lenalidomide Related Compound 7; Lenalidomide Impurity C; 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione derivative; Lenalidomide Process Impurity; Lenalidomide Degradant; Revlimid Impurity 7; CC-5013 Impurity 7
EINECS	Contact for details

Quality Control

Our Lenalidomide Impurity 7 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR, MS), and residual solvent analysis to ensure it meets the stringent requirements for a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH and cGMP guidelines for impurity standards.

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 must be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown 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.