Quizartinib is a small-molecule targeted anticancer active pharmaceutical ingredient belonging to the class of FLT3 tyrosine kinase inhibitors. The pharmaceutical drug substance is used as quizartinib dihydrochloride, an orally active inhibitor of FLT3 signaling. FDA substance records identify quizartinib dihydrochloride under CAS 1132827-21-4 and UNII WK7Q6ZIZ10.
The active moiety, quizartinib, has CAS 950769-58-1, molecular formula C₂₉H₃₂N₆O₄S, and molecular weight 560.67 g/mol. The dihydrochloride salt has molecular formula C₂₉H₃₄Cl₂N₆O₄S and molecular weight 633.59 g/mol.
Quizartinib is a potent and selective second-generation FLT3 inhibitor. It inhibits wild-type and mutant FLT3 kinase activity and has been developed for the treatment of FLT3-mutated acute myeloid leukemia (AML).
The free base is identified as CAS 950769-58-1, while the pharmaceutical dihydrochloride salt is CAS 1132827-21-4. FDA GSRS confirms the dihydrochloride as the relevant pharmaceutical substance identity.
| Parameter | Details |
|---|---|
| Product Name | Quizartinib |
| Pharmaceutical Form | Quizartinib Dihydrochloride |
| API CAS Number | 1132827-21-4 |
| Active Moiety CAS | 950769-58-1 |
| Molecular Formula | C₂₉H₃₄Cl₂N₆O₄S |
| Molecular Weight | 633.59 g/mol |
| Active Moiety Formula | C₂₉H₃₂N₆O₄S |
| Active Moiety MW | 560.67 g/mol |
| FDA UNII | WK7Q6ZIZ10 |
| Drug Class | FLT3 Tyrosine Kinase Inhibitor |
| Therapeutic Area | Oncology |
| Primary Application | FLT3-mutated AML |
| Stereochemistry | Achiral |
| Physical Form | Solid |
FDA's GSRS record specifically describes Quizartinib Dihydrochloride as achiral and gives the formula and salt relationship.
Quizartinib is used as a targeted oncology API for pharmaceutical development involving FLT3-driven malignancies. It inhibits FLT3 signaling, including mutant FLT3 forms associated with AML.
Its pharmaceutical-development applications include:
Quizartinib dihydrochloride has demonstrated potent inhibition of mutant FLT3 and related receptor tyrosine kinases.
Quizartinib dihydrochloride can be characterized using HPLC, LC-MS, NMR, IR and other chromatographic and spectroscopic techniques.
Commercial analytical materials report high chromatographic purity. MedChemExpress currently reports a selected batch at 99.98% purity/assay, while other commercial sources report >98% HPLC purity. These are commercial/reference-batch results and should not be treated as universal pharmacopoeial API limits.
An Axon certificate reports 98.1% chemical purity, confirms the molecular structure by NMR and mass spectrometry, and reports an observed melting/decomposition event above 232°C for its specific hydrated batch.
Quizartinib API manufacturing requires controlled synthesis, purification and salt formation to obtain consistent quizartinib dihydrochloride quality.
Critical quality considerations include:
Quizartinib dihydrochloride should be protected from moisture and stored in tightly closed pharmaceutical packaging under validated conditions.
Commercial analytical materials commonly recommend sealed storage away from moisture, with some references specifying approximately 4°C for solid material.
For pharmaceutical API storage, the final temperature and shelf-life conditions should be established from validated stability data.
Quizartinib API documentation may include:
A reliable Quizartinib API manufacturing program should provide consistent dihydrochloride salt quality, controlled chromatographic purity, validated analytical testing and complete batch documentation. Particular attention should be given to hydration state and solid-state characteristics because commercial analytical batches can exhibit different degrees of hydration. An Axon certificate, for example, identifies a specific batch as a 3.5-hydrate with a batch molecular weight of 696.64 g/mol, even though the nominal dihydrochloride molecular weight is 633.59 g/mol.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.5 – 6.5 |