Selective CDK4/6 Inhibitor for HR-Positive HER2-Negative Advanced Breast Cancer
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
Abemaciclib (CAS 1231929-97-7) is a selective, potent inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6) that disrupts the cell cycle by blocking retinoblastoma protein (Rb) phosphorylation, preventing S-phase entry in HR+/HER2− breast cancer cells. Unlike palbociclib, abemaciclib demonstrates continuous daily dosing capability due to its high oral bioavailability and distinct metabolite profile including active metabolites M2, M18, and M20.
Oncology API sourcing for abemaciclib demands exacting control of genotoxic process impurities, including nitrosamine screening per EMA/CHMP guidelines and ICH M7. HPLC purity must exceed 99% with individual impurity limits ≤0.1% for carcinogenic impurity categories. Particle size control (D90 <50 µm) is critical for absorption in fed-state dosing, and polymorphic form stability (Form I crystalline) must be confirmed by XRPD for each commercial batch.
Swapnroop manufactures Abemaciclib API at our WHO-GMP Aurangabad facility using validated synthetic routes with rigorous nitrosamine risk assessment documentation. We supply oncology manufacturers and CDMO partners with HPLC-characterised, polymorphically confirmed API with complete DMF filing support for USFDA ANDA submissions and EMA CTD dossiers.
Abemaciclib API is packaged in UN-certified double-polyethylene lined aluminium containers (1 kg, 5 kg) with desiccant, nitrogen blanket, and tamper-evident sealing. Oncology API packaging complies with cytotoxic handling guidelines with full labelling per GHS and UN Recommendations.
Get Bulk QuoteThe CAS number for Abemaciclib is 1231929-97-7. It is a selective CDK4/6 inhibitor for HR+/HER2- breast cancer treatment.
Abemaciclib is approved for hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer, used as monotherapy or combined with endocrine therapies (fulvestrant, anastrozole, letrozole).
Yes. Abemaciclib has multiple crystalline polymorphic forms. Swapnroop provides XRPD and DSC characterisation data confirming the specific polymorphic form for each commercial batch to ensure consistent dissolution performance.
Abemaciclib should be protected from light (photolabile) and moisture. Store below 25°C in original sealed packaging. Photostability testing data per ICH Q1B is provided with each batch.
Yes. We supply Abemaciclib API with complete Type II DMF documentation for USFDA ANDA filings, including polymorphic characterisation, genotoxic impurity profiles, stability data, and full analytical packages.
Swapnroop Drugs and Pharmaceuticals is a trusted Abemaciclib API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Abemaciclib API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.
As a Abemaciclib API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Abemaciclib API pricing, samples, and sourcing support.