Product Overview
Lenalidomide is a controlled drug active ingredient. It is an immunomodulatory drug.
It is manufactured in the form of a thalidomide derivative.
Lenalidomide in its natural form is a white to off-white crystalline powder.
The API shall not be administered directly to humans or animals.
It should be formulated into a final drug by legally qualified pharmaceutical manufacturers.
The molecular formula is C13H13N3O3.
The molecular weight is 259.26 g/mol. When stored appropriately, the API is stable.
API retains quality when transported under controlled transport.
Its value lies in how it can affect immune system function, regulate inflammation, and suppress the growth of some types of cells.
Lenalidomide was created as an improved thalidomide analogue with reduced risk.
It is more targeted in action and less risky when made into drugs.
In its pure state, it is valued for high quality, reliable performance in manufacturing, and well-defined chemical properties.
These attributes make it ideal for reproducible large-scale manufacture.
Therapeutic Applications
Raw API Lenalidomide is a controlled drug used as an intermediate for regulated production.
It is not used to treat animals or humans in its raw API state.
Its value lies in its established chemical structure and the ways in which it can be used to influence specific biological processes.
This renders it a useful instrument for research into the immune system, management of blood vessel development, and control of cell development.
The API is supplied to only licensed plants that conduct their operations under strict safety and quality control.
Its reliability and uniform quality make it suitable for large-scale processes.
It is a useful raw material for R&D work in immunology and cancer-related studies.
Specification Parameters
Lenalidomide API is prepared following the principles of the full Good Manufacturing Practices.
Its specifications conform to international regulations like USP, EP or in-house standards.
Each lot is inspected by viable means to ensure conformance with specifications.
Every lot is shipped with a certificate of analysis (CoA). Representative test values are:
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Appearance: White to off white crystalline powder
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Identification: This has been established by IR spectroscopy and HPLC retention time
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Assay (Purity): ≥ 99.0% by HPLC
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Water Content: ≤ 0.5% (Karl Fischer)
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Specific Optical Rotation: Within specified ranges
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Related Substances: Individual impurities ≤ 0.1%, total ≤ 0.5%
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Residual Solvents: Below ICH Q3C levels
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Heavy Metals: ≤ 10 ppm
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Melting Point: Around 269–271°C
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Particle Size: Regulated for uniform application in processing
Packaging & Storage
The Lenalidomide API is sensitive to heat, light, and moisture. It is safely packaged in sealed containers to safeguard it during transit and storage.
Typical Packaging
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Double bags of polyethylene heat-sealed in HDPE jars or fibre drums
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Standard package sizes: 1 kg, 5 kg, 10 kg (special sizes available)
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Product name, batch number, date of manufacture, date of expiry, and storage recommendation on labels
Storage Conditions:
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Store away from light in a cool, dry location
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Optimal temperature: 2°C to 8°C
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Avoid humidity and temperature changes
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Close the container tightly when not in use
Transport:
Whenever necessary, it is shipped in temperature-controlled systems.
Packaging is made to accommodate normal transportation without degrading quality.
Stability data reflect that the API maintains the integrity of its full shelf life under the proper storage regulations.
Why Choose Us
Actiza Industry is a reliable provider of Lenalidomide API for regulated research and production.
We work following GMP and ISO-certified procedures so that every batch meets strict safety and quality standards.
Our production is checked for quality at all levels.
That begins with raw material purchasing, goes up to packaging and transport.
We deliver full documents with each order.
They include Certificates of Analysis (CoA), Safety Data Sheets (SDS), and stability reports.
These help clients show compliance with local and global regulations.
We supply Lenalidomide API with a minimum purity of 99%. Impurity percentage is minimal.
Our packaging and shipping disallow light, heat, and moisture from accessing the material.
This ensures it is stable until it arrives at the purchaser.
Our supply chain is secure, and delivery is prompt across the globe.
Our technical assistance includes regulatory documentation and formulation planning guidance.
By coupling firm quality control, secure storage, and support, Actiza Industry makes our Lenalidomide API available for research and regulated production.
