Description

Lenalidomide Impurity 12 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 certified reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Lenalidomide-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Lenalidomide API and finished dosage forms.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Lenalidomide products meet stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research & Process Chemistry: Aids in understanding the degradation pathways and synthesis by-products of Lenalidomide, enabling process optimization.

Basic Information

Product Name	Lenalidomide Impurity 12
CAS No.	295357-72-1
Molecular Formula	C13H10N2O4
Molecular Weight	258.23 g/mol
Synonyms	3-(4-Nitro-1-oxoisoindolin-2-yl)piperidine-2,6-dione; Lenalidomide Nitro Impurity; Lenalidomide Related Compound 12; 2,6-Piperidinedione, 3-(4-nitro-1-oxo-1,3-dihydro-2H-isoindol-2-yl)-; 4-Nitro-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione; Lenalidomide Nitroso Impurity Precursor; Lenalidomide Degradant; CC-5013 Impurity 12
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 (HPLC, GC, NMR, MS) to ensure compliance with industry standards for reference materials. 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 material should be handled in a low-humidity environment and desiccated for long-term storage.

Specification

Item	Specification
Appearance	Off-white to yellow 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%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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