Description

Lenalidomide Impurity 12 is a specified impurity of the active pharmaceutical ingredient lenalidomide, a critical compound used in pharmaceutical research and development. This impurity is essential for analytical method development, stability studies, and ensuring the quality and safety of lenalidomide-based drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for comprehensive quality control and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in lenalidomide drug substance and finished products.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of lenalidomide.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity profiles and specifications.
• Research & Development: Used in synthetic chemistry research to study the formation and mitigation of this specific impurity during the manufacturing process.

Basic Information

Product Name	Lenalidomide Impurity 12
CAS No.	109444-53-3
Molecular Formula	C13H13N3O3
Molecular Weight	259.26 g/mol
Synonyms	3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione; Lenalidomide Related Compound; Lenalidomide Degradant; Lenalidomide Process Impurity; Revlimid Impurity; CC-5013 Impurity; (S)-3-(4-Amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)piperidine-2,6-dione
EINECS	Contact for details

Quality Control

Every batch of Lenalidomide Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmaceutical reference standard 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). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.