Description

Lenalidomide Impurity 21 is a specified impurity used in the quality control and analytical research of the active pharmaceutical ingredient lenalidomide. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of lenalidomide drug products. It serves as a key reference standard for method development, validation, and regulatory compliance testing in the pharmaceutical industry.

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 & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor impurity profiles during drug manufacturing.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure lenalidomide products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to establish shelf-life and storage recommendations.
• Regulatory Submissions: Critical for preparing impurity data packages required for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of the active ingredient.

Basic Information

Product Name	Lenalidomide Impurity 21
CAS No.	2089206-55-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lenalidomide Related Compound 21; Lenalidomide EP Impurity 21; Lenalidomide USP Impurity 21; Lenalidomide Process Impurity 21; 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione derivative (specific); Revlimid Impurity 21; CC-5013 Impurity 21
EINECS	Contact for details

Quality Control

Every batch of Lenalidomide Impurity 21 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines.

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 anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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