Description

Lenalidomide Impurity 15 is a specified impurity associated with the active pharmaceutical ingredient lenalidomide. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of lenalidomide-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in lenalidomide API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure compliance with stringent pharmacopeial (USP, EP) and ICH guidelines for impurity profiles.
• Stability Studies: Used to track the formation and levels of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control.
• Process Chemistry Research: Aids in understanding and optimizing the lenalidomide synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Lenalidomide Impurity 15
CAS No.	1240215-76-2
Molecular Formula	C13H13N3O3
Molecular Weight	259.26 g/mol
Synonyms	Lenalidomide Related Compound 15; 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione; Lenalidomide EP Impurity J; Lenalidomide USP Related Compound A (Check specific correlation); Lenalidomide Degradant; 2-(2,6-Dioxopiperidin-3-yl)-4-aminoisoindoline-1,3-dione; CC-5013 Impurity; Revlimid Impurity
EINECS	Contact for details

Quality Control

Every batch of Lenalidomide Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each 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). Due to its hygroscopic nature, the container must be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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