Description

Lenalidomide Impurity 11 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 quality control and compliance purposes.

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 & Validation: Critical for developing and validating sensitive HPLC, UPLC, or GC methods to monitor impurity profiles.
• 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 testing in pharmaceutical QC laboratories.
• Regulatory Compliance & Filings: Used to support regulatory submissions (e.g., ANDA, NDA) to agencies like the US FDA and EMA by providing impurity characterization data.
• Research & Development: Utilized in synthetic chemistry research to study the formation and fate of this specific impurity during the manufacturing process.

Basic Information

Product Name	Lenalidomide Impurity 11
CAS No.	48103-74-8
Molecular Formula	C13H10N2O4
Molecular Weight	258.23 g/mol
Synonyms	3-(4-Nitro-1-oxoisoindolin-2-yl)piperidine-2,6-dione; 2,6-Piperidinedione, 3-(4-nitro-1-oxo-1,3-dihydro-2H-isoindol-2-yl)-; Lenalidomide Nitro Impurity; Lenalidomide Related Compound; Lenalidomide Nitroso Impurity Intermediate; 4-Nitro-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione; Revlimid Impurity
EINECS	Contact for details

Quality Control

Our Lenalidomide Impurity 11 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, residual solvent analysis, and identity confirmation (IR, MS) to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every 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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	Off-white to yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.