Description

Lenalidomide Impurity 4 is a specified impurity and degradation product of the active pharmaceutical ingredient Lenalidomide. This compound is critical 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, contract research organizations (CROs), and analytical laboratories involved in the production and testing of Lenalidomide drug substances and finished dosage forms to ensure product safety, efficacy, and regulatory compliance.

Application

• As a certified reference standard (CRS) for the identification and quantification of impurities in Lenalidomide API and drug products.
• For analytical method development and validation (HPLC, UPLC, LC-MS) in pharmaceutical quality control laboratories.
• In stability studies to monitor degradation pathways and establish shelf-life for Lenalidomide formulations.
• Used in regulatory submissions (e.g., ANDA, NDA) to fulfill impurity profiling requirements set by agencies like the FDA and EMA.
• For pharmacopoeial testing to comply with monograph specifications in USP, EP, or other pharmacopoeias.
• As a critical reagent in research and development to understand the chemical behavior and synthesis pathways of Lenalidomide.

Basic Information

Product Name	Lenalidomide Impurity 4
CAS No.	1628915-10-5
Molecular Formula	C13H13N3O3
Molecular Weight	259.26 g/mol
Synonyms	Lenalidomide Related Compound 4; 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione; Lenalidomide Impurity D; Lenalidomide EP Impurity D; Lenalidomide USP Impurity D; Lenalidomide Degradation Product; 2-(4-Amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)-4-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione (process-related dimer); Lenalidomide dimer impurity
EINECS	Contact for details

Quality Control

Every batch of Lenalidomide Impurity 4 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, LC-MS, and NMR, to ensure high purity and accurate identification, aligning with ICH Q3A/B guidelines for impurities. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurity profile.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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