Copanlisib Dihydrochloride is a pharmaceutical active ingredient belonging to the phosphoinositide 3-kinase (PI3K) inhibitor class. Copanlisib has inhibitory activity predominantly against the PI3K-alpha (PI3K-α) and PI3K-delta (PI3K-δ) isoforms and is used in oncology applications.
Copanlisib Dihydrochloride is the dihydrochloride salt form of copanlisib. The compound is identified by CAS No. 1402152-13-9 and has the molecular formula C₂₃H₂₈N₈O₄·2HCl, with an anhydrous molecular weight of approximately 553.45 g/mol.
Copanlisib is also known by its development code BAY 80-6946. The free-base form of copanlisib has CAS No. 1032568-63-0, while the dihydrochloride salt used as the active pharmaceutical ingredient has CAS No. 1402152-13-9.
Copanlisib is a PI3K inhibitor with activity predominantly against PI3K-alpha and PI3K-delta. The FDA-approved product has been indicated for adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.
Copanlisib Dihydrochloride API can be supplied for pharmaceutical development, formulation and manufacturing applications, subject to applicable quality specifications and regulatory requirements.
Product documentation, analytical specifications and batch-specific quality information can be provided according to the applicable approved product specification.
Quality testing for Copanlisib Dihydrochloride may include identity, assay, related substances, water content, residual solvents, elemental impurities and other applicable pharmaceutical quality attributes.
Important: Final acceptance criteria should be based on the applicable approved specification and validated analytical methods. Numerical limits should not be represented as official specifications unless supported by the relevant specification or COA.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Melting Point | 150°C – 154°C |