Nilotinib Hydrochloride

Nilotinib Hydrochloride (AMN107 hydrochloride) is a second-generation Bcr-Abl tyrosine kinase inhibitor with antineoplastic activity, approved for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). Nilotinib Hydrochloride binds to and stabilizes the inactive conformation of the kinase domain of the Abl protein of the Bcr-Abl fusion protein, resulting in the inhibition of Bcr-Abl-mediated proliferation of Ph+ CML cells. As an API, Nilotinib Hydrochloride is manufactured under strict quality controls to ensure consistent therapeutic efficacy. In pharmaceutical quality control, Nilotinib Hydrochloride reference standards are essential for analytical method development and impurity profiling. The hydrochloride salt form of Nilotinib Hydrochloride provides the active pharmaceutical ingredient in the marketed formulation.

 

Product Parameters

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Parameter	Specification
Product Name	Nilotinib Hydrochloride
CAS Number	923288-95-3
Molecular Formula	C₂₈H₂₃ClF₃N₇O
Molecular Weight	565.98 g/mol
Physical Form	Solid
Storage Condition	Store at –20 °C

 

Application

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Nilotinib hydrochloride (nilotinib), marketed under the brand name Tasigna, is an ABL tyrosine kinase inhibitor developed by Novartis AG in Switzerland. It was approved by the U.S. FDA in October 2007 for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic or accelerated phase who are resistant to prior therapies or intolerant to them.

 

Why Cosperpharm?

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When your CML API manufacturing or ANDA filing for nilotinib requires high-quality Nilotinib Hydrochloride, Cosperpharm delivers with the analytical rigor, documentation depth, and supply flexibility that pharmaceutical customers demand. Nilotinib Hydrochloride is a critical API for generic manufacturers entering the CML treatment market. Our analytical release protocol includes HPLC purity verification, solubility testing, and identity confirmation. Every reference-grade shipment includes a Certificate of Analysis (COA) with batch-specific purity data and chromatographic traceability. Cosperpharm supplies Nilotinib Hydrochloride across all development stages — from R&D quantities to bulk commercial manufacturing. DMF-ready documentation, stability summaries, and custom quality agreements are available upon request. R&D samples ship within 5–7 business days.

 

FAQ

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Q1: What is Nilotinib Hydrochloride used for?

A: Nilotinib Hydrochloride is a second-generation Bcr-Abl tyrosine kinase inhibitor approved for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).

 

Q2: How does Nilotinib Hydrochloride differ from imatinib?

A: Nilotinib Hydrochloride was designed to overcome imatinib resistance by binding to and stabilizing the inactive conformation of the Bcr-Abl kinase domain.

 

Contact Us

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Need a trusted partner for Nilotinib Hydrochloride supply? Cosperpharm is ready to support your API manufacturing or analytical development program. Contact our team today for a quote.