Description

Lenalidomide Impurity 3 is a high-purity reference standard used in the analytical characterization and quality control of the active pharmaceutical ingredient lenalidomide. This compound is critical for ensuring the safety and efficacy of lenalidomide-based drug products by enabling the accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods.
• Quality Control & Assurance (QC/QA): Used in the routine batch release testing of lenalidomide API to monitor and control impurity levels as per ICH guidelines.
• Method Development and Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods for lenalidomide.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity identity and qualification data.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in pharmaceutical R&D to understand the degradation pathways and impurity profile of lenalidomide.

Basic Information

Product Name	Lenalidomide Impurity 3
CAS No.	295357-66-3
Molecular Formula	C13H13N3O3
Molecular Weight	259.26 g/mol
Synonyms	3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione; Lenalidomide Related Compound C; Lenalidomide EP Impurity C; Lenalidomide USP Impurity C; CC-5013 Impurity 3; Revlimid Impurity 3; 2-(4-Amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)-4-(2,6-dioxopiperidin-3-yl)butanedinitrile (related); Lenalidomide Degradant
EINECS	Contact for details

Quality Control

Every batch of Lenalidomide Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming conformity to client specifications or relevant guidelines (USP, EP, ICH).

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 under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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