Tibremciclib, also known by its development code BPI-16350, is a synthetic small-molecule cyclin-dependent kinase inhibitor. It has been investigated for its antineoplastic activity, with CDK4 identified as a principal pharmacological target. Tibremciclib has the molecular formula C₂₈H₃₂F₂N₈ and a molecular weight of approximately 518.60 g/mol. Its CAS Number is 2397678-18-9.
Tibremciclib is a chemically defined, chiral small molecule belonging to the CDK inhibitor class. The compound is designed to interfere with cyclin-dependent kinase activity involved in cell-cycle regulation. Its molecular structure contains fluorinated heterocyclic and pyrimidine-based structural elements together with a substituted piperazine group.
Chemical Name: N-[5-[(4-ethylpiperazin-1-yl)methyl]-2-pyridinyl]-5-fluoro-4-[(1R)-6-fluoro-1-methyl-1,2,3,4-tetrahydropyrido[1,2-a]benzimidazol-8-yl]pyrimidin-2-amine
Molecular Formula: C₂₈H₃₂F₂N₈
Molecular Weight: 518.60 g/mol
CAS Number: 2397678-18-9
Synonym: BPI-16350
Tibremciclib contains one defined stereocenter and is represented in databases as the (1R) stereoisomer.
Tibremciclib is described as a CDK4 inhibitor. Cyclin-dependent kinases play an important role in regulating progression through the cell cycle. Inhibition of CDK4 can interfere with cell-cycle signaling and represents a targeted approach being investigated in oncology.
Tibremciclib has been developed as an antineoplastic compound and investigated for applications involving aberrant cell-cycle regulation. Its activity as a CDK4 inhibitor makes it relevant to pharmaceutical research and targeted oncology development.
Its regulatory status and permitted applications can differ between countries and should be evaluated against the applicable regulatory framework before use in pharmaceutical development.
Tibremciclib API quality can be evaluated using validated analytical techniques appropriate for a chiral small-molecule drug substance. Typical analytical controls may include HPLC assay, related-substance profiling, identity testing by spectroscopic techniques, chiral purity, residual solvents, water content, elemental impurities and other process-related impurities.
Because Tibremciclib does not have a publicly established universal USP/BP/Ph. Eur. API monograph specifying acceptance limits for all of these parameters, numerical release specifications should be established according to the applicable regulatory dossier, validated analytical methods and customer-approved specifications.
Swapnroop Drugs and Pharmaceuticals provides pharmaceutical API solutions supported by quality-focused analytical testing and technical documentation. Tibremciclib can be positioned as a specialized oncology and CDK inhibitor API for pharmaceutical research and development requirements.
The API profile can be supported with appropriate analytical documentation, batch-specific quality information and technical documentation according to the applicable product specification.
Tibremciclib should be packaged in suitable, well-closed containers that protect the material from moisture, contamination and inappropriate environmental exposure. Storage conditions should follow the approved product specification and Certificate of Analysis.
For long-term storage, the validated stability and packaging requirements applicable to the specific API batch should be followed.
Technical documentation for Tibremciclib may include:
Swapnroop focuses on quality-oriented pharmaceutical API manufacturing and documentation practices. Tibremciclib is a specialized CDK4 inhibitor requiring appropriate control of identity, assay, related substances and stereochemical purity. A specification-driven analytical approach helps support consistent quality for pharmaceutical development and approved applications.
Tibremciclib API from Swapnroop is positioned for customers seeking a technically documented and quality-focused source of this specialized oncology API.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |