Name | Ribociclib succinate |
CAS number | 1374639-75-4 |
Description | Ribociclib succinate (CAS 1374639-75-4) is the succinate salt form of ribociclib, a selective inhibitor of cyclin-dependent kinases 4 and 6. The compound features a complex molecular architecture centered around a pyrido[2,3-d]pyrimidin-7-one core structure with specific substituents that confer both potency and selectivity. |
Structural formula |  |
Molecular Formula | C27H36N8O5 |
Molecular Weight | 552.64 g/mol |
Appearance | White powder |
Quality Standard | 99% |
Storage Condition | Cool dry place( away from the light) |
Shelf Life | >2 years if stored properly |
Sample package | Aluminium foil bag |
Commercial package | Aluminium Tin, Fiber drum |
Origin | China |
Chemical Profile and Structural Characteristics
Ribociclib succinate (CAS 1374639-75-4) is the succinate salt form of ribociclib, a selective inhibitor of cyclin-dependent kinases 4 and 6. The compound features a complex molecular architecture centered around a pyrido[2,3-d]pyrimidin-7-one core structure with specific substituents that confer both potency and selectivity. The formation of the succinate salt enhances the compound's aqueous solubility and bioavailability while maintaining the pharmacological activity of the parent molecule. It typically presents as a solid with defined crystalline properties and demonstrates favorable stability under recommended storage conditions.
Mechanism of Action and Pharmacological Activity
The compound exerts its therapeutic effect through potent and selective inhibition of cyclin-dependent kinases 4 and 6, which play crucial roles in cell cycle progression from the G1 to S phase. By inhibiting the phosphorylation of the retinoblastoma protein, ribociclib induces G1 phase arrest and suppresses cellular proliferation in estrogen receptor-positive breast cancer cells. The succinate salt form does not alter the fundamental mechanism but improves the pharmacokinetic profile, ensuring adequate systemic exposure and target engagement following oral administration. This targeted approach provides a therapeutic strategy that is particularly effective in hormone receptor-positive malignancies.
Therapeutic Applications and Clinical Uses
Ribociclib succinate is approved for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in combination with endocrine therapy. Clinical protocols typically initiate therapy at 600 mg daily for 21 consecutive days followed by 7 days off, in combination with an aromatase inhibitor or fulvestrant. The compound has demonstrated significant improvement in progression-free survival in multiple phase III clinical trials, establishing its role as a standard of care in this patient population. Dose adjustments are implemented based on individual tolerance and specific adverse effect management.
Formulation Development and Pharmaceutical Considerations
We supply ribociclib succinate active pharmaceutical ingredient suitable for the development of immediate-release oral solid dosage forms, primarily tablets. The compound demonstrates adequate stability in solid state when protected from excessive moisture and light. Formulation strategies focus on ensuring consistent dissolution profiles and maintaining chemical integrity throughout the product shelf life. Our technical data includes comprehensive compatibility information with common pharmaceutical excipients and guidance on manufacturing processes to achieve robust product performance and quality.
Quality Specifications and Analytical Controls
Our ribociclib succinate meets stringent pharmacopeial standards with specifications including identification by spectroscopic methods, assay requirement of 98.0-102.0%, and of related substances and degradation products. Critical quality attributes encompass tests for residual solvents, heavy metals, microbial limits, and specific characterization of the salt form stoichiometry. We employ validated stability-indicating chromatographic methods for precise quantification and impurity profiling, supported by spectroscopic techniques for structural confirmation. Storage recommendations specify protection from light and moisture at controlled room temperature to ensure chemical stability throughout the product lifecycle.
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