Description

Lenalidomide Impurity 1 is a high-purity reference standard specifically identified for the quality control of lenalidomide, a critical pharmaceutical active ingredient. This compound is essential for analytical method development, validation, and ensuring the purity and safety of lenalidomide drug substances and products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

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 validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing to ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions.
• Pharmacopoeial Testing: Supports testing to meet the specifications of pharmacopoeias such as USP, EP, and BP.

Basic Information

Product Name	Lenalidomide Impurity 1
CAS No.	874760-72-2
Molecular Formula	C13H13N3O3
Molecular Weight	259.26 g/mol
Synonyms	3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione; Lenalidomide Related Compound A; Lenalidomide EP Impurity A; Lenalidomide USP Impurity A; Lenalidomide Process Impurity; CC-5013 Impurity 1; Revlimid Impurity A
EINECS	Contact for details

Quality Control

Our Lenalidomide Impurity 1 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analysis. We support compliance with ICH guidelines and relevant pharmacopoeial standards for impurity reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

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