Romidepsin API is a synthetic cyclic depsipeptide and a potent histone deacetylase (HDAC) inhibitor. It is an antineoplastic pharmaceutical active ingredient used in oncology for the treatment of certain T-cell lymphomas. Romidepsin is also known by the development names FK228 and FR-901228.
Romidepsin is a structurally complex sulfur-containing cyclodepsipeptide with a defined stereochemical configuration. The API is characterized by a molecular formula of C24H36N4O6S2 and a molecular weight of 540.71 g/mol. FDA's CMC review identifies CAS 128517-07-7 for romidepsin.
Romidepsin is a cyclic depsipeptide containing peptide-like amide and ester functionalities together with a disulfide linkage. Its complex molecular structure and stereochemistry are important characteristics of the pharmaceutical substance.
PubChem identifies romidepsin as a cyclodepsipeptide and organic disulfide, with four hydrogen-bond donors, eight hydrogen-bond acceptors and a calculated molecular weight of approximately 540.7 g/mol.
Romidepsin API is used in pharmaceutical formulations for oncology applications. FDA records identify approved use in:
Romidepsin is administered as an intravenous pharmaceutical product following appropriate formulation and dilution.
Romidepsin is a histone deacetylase inhibitor. HDAC enzymes remove acetyl groups from acetylated lysine residues on histones and other proteins. Inhibition of HDAC activity by romidepsin alters histone acetylation and gene-expression regulation, contributing to its antineoplastic activity.
Quality control of Romidepsin API requires careful assessment of identity, assay, purity, related substances, residual solvents, water content and other applicable quality attributes.
Because romidepsin is a complex cyclic peptide-like molecule containing a disulfide linkage and multiple stereochemical elements, analytical characterization should also appropriately address structural identity and integrity.
Typical quality-control testing may include chromatographic purity, spectroscopic identification, impurity profiling, residual-solvent analysis and physicochemical characterization. Numerical release limits should be taken from the applicable validated API specification rather than assumed as universal compendial values.
Romidepsin is produced through a controlled synthetic/biochemical manufacturing process appropriate for its complex cyclic depsipeptide structure. Manufacturing controls are designed to maintain the required molecular structure, stereochemical integrity and purity profile.
The manufacturing process should include appropriate control of starting materials, intermediates, critical process parameters, purification and final isolation, followed by validated analytical testing.
Romidepsin is a complex sulfur-containing cyclic depsipeptide.
Key properties:
Romidepsin API should be packaged in suitable pharmaceutical-grade containers designed to protect the material from contamination and environmental exposure.
Storage conditions should follow the validated stability data and approved API specification. The material should be maintained in appropriately closed containers under controlled pharmaceutical storage conditions.
A qualified Romidepsin API manufacturer can provide appropriate technical and quality documentation, including:
A qualified Romidepsin API manufacturer in India can support pharmaceutical and oncology-product development with controlled manufacturing, analytical characterization and batch-specific quality documentation.
Important quality considerations for Romidepsin include structural identity, stereochemical integrity, purity, impurity control and appropriate handling of the sulfur-containing cyclic structure.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |