Description

Lenalidomide Impurity 13 is a specified impurity of the active pharmaceutical ingredient (API) Lenalidomide, a critical immunomodulatory drug. This compound is essential for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Lenalidomide drug substances and products.

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: Critical for developing and optimizing chromatographic methods (e.g., HPLC, UPLC) to separate and detect process-related impurities.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity profiles and ensure compliance with stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of degradation products under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Lenalidomide to minimize the formation of this specific impurity.

Basic Information

Product Name	Lenalidomide Impurity 13
CAS No.	874760-71-1
Molecular Formula	C13H13N3O3
Molecular Weight	259.26 g/mol
Synonyms	Lenalidomide Related Compound; 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione; Lenalidomide EP Impurity; Lenalidomide USP Impurity; Lenalidomide Process Impurity; Revlimid Impurity; CC-5013 Impurity
EINECS	Contact for details

Quality Control

Every batch of Lenalidomide Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards and ICH Q3A/B guidelines. 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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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