Description

Lenalidomide (Hemihydrate) is a potent immunomodulatory and antiangiogenic agent, specifically the hemihydrate form of the active pharmaceutical ingredient. This high-purity compound is critical for the development and manufacture of targeted cancer therapies, particularly for hematological malignancies. Pharmaceutical manufacturers and advanced research institutions rely on this material for its proven efficacy in specific oncological applications, ensuring the production of consistent and effective final drug products.

Application

• Active Pharmaceutical Ingredient (API) for the formulation of oral oncology drugs.
• Reference Standard for quality control and analytical method development in pharmaceutical laboratories.
• Research & Development of novel therapeutic agents targeting multiple myeloma and myelodysplastic syndromes.
• Clinical Trial Material supply for investigational new drug (IND) applications and studies.
• Generic Drug Manufacturing for bioequivalent pharmaceutical products post-patent expiry.
• Biochemical Research into mechanisms of immunomodulation, cereblon binding, and protein degradation.

Basic Information

Product Name	Lenalidomide (Hemihydrate)
CAS No.	847871-99-2
Molecular Formula	C13H13N3O3 • ½H2O
Molecular Weight	259.27 g/mol (anhydrous basis)
Synonyms	CC-5013; Revlimid (brand name); 3-(4-Amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)piperidine-2,6-dione hemihydrate; IMiD1; Immunomodulatory drug 1; (RS)-3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione hemihydrate
EINECS	Contact for details

Quality Control

Our Lenalidomide (Hemihydrate) is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical use. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We ensure compliance with relevant ICH guidelines and can supply material aligned with pharmacopeial standards (e.g., USP monographs) upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	1.5% - 3.5%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	< 20 ppm
Specific Rotation	Contact for details

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