Description

Lenalidomide Impurity 16 is a specified impurity used as a reference standard in the analytical profiling and quality control of the active pharmaceutical ingredient (API) lenalidomide. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily required for method development, validation, and routine testing in the production of lenalidomide-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in lenalidomide API and finished dosage forms.
• Analytical Method Development: Used to develop and optimize chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Essential for routine batch release testing to monitor and control impurity levels as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products in lenalidomide formulations under various stress conditions.
• Research & Development: Used in R&D laboratories for studying the degradation pathways and chemical behavior of lenalidomide.

Basic Information

Product Name	Lenalidomide Impurity 16
CAS No.	1198299-53-4
Molecular Formula	C13H10N2O4
Molecular Weight	258.23 g/mol
Synonyms	Lenalidomide Related Compound 16; Lenalidomide EP Impurity 16; Lenalidomide USP Impurity 16; 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione impurity; Lenalidomide Degradant; Lenalidomide Process Impurity; Revlimid Impurity 16
EINECS	Contact for details

Quality Control

Every batch of Lenalidomide Impurity 16 is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our products are characterized using advanced techniques including HPLC, GC, MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results against stringent in-house specifications. We support compliance with pharmacopeial standards (USP, EP) and ICH 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 in a desiccated environment to maintain stability and purity. Handle and store under inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.