Description

Lenalidomide Impurity 14 is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient, lenalidomide. This compound is critical for pharmaceutical manufacturers and quality control laboratories to ensure the purity, safety, and efficacy of lenalidomide-based drug products. It is primarily utilized in research and development, method validation, and routine batch analysis within the pharmaceutical industry.

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, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Batch Release: Serves as a system suitability and calibration standard in routine QC testing to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry Research: Used to study and control the formation of this impurity during the synthesis and purification stages of lenalidomide manufacturing.

Basic Information

Product Name	Lenalidomide Impurity 14
CAS No.	1198299-72-7
Molecular Formula	C13H13N3O3
Molecular Weight	259.26 g/mol
Synonyms	Lenalidomide Related Compound 14; 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione; 2-(2,6-Dioxopiperidin-3-yl)-4-amino-1H-isoindole-1,3(2H)-dione; 4-Amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione; Lenalidomide Impurity K; Lenalidomide EP Impurity K; Lenalidomide USP Impurity K
EINECS	Contact for details

Quality Control

Every batch of Lenalidomide Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods (e.g., HPLC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 kept in a desiccated environment to maintain stability and purity.

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)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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