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Oncology API / Pharmaceutical technical profile

Nintedanib

methyl 2-hydroxy-3-[N-[4-[methyl-[2-(4-methylpiperazin-1-yl)acetyl]amino]phenyl]-C-phenylcarbonimidoyl]-1H-indole-6-carboxylate

Category: Oncology APICAS No.: 656247-17-5Formula: C31H33N5O4
Chemical structure of Nintedanib
Swati Industries portfolio

Chemical & technical profile

Product nameNintedanib
CategoryOncology API
CAS No.656247-17-5
Molecular formulaC31H33N5O4
Molecular weight539.6 g/mol
PubChem CID135423438
01

Description

Nintedanib is listed in the oncology-focused API portfolio. The page is a technical overview only; clinical, regulatory and commercial status must be established from approved product documentation.

02

Research & Development

Impurity identification and fate mapping; genotoxic-impurity risk assessment where relevant; robust assay/related-substances methods; solid-state characterization; stability and packaging studies.

03

Analytical testing

Identity by IR/LC-MS/NMR; assay and related substances by HPLC/UPLC; residual solvents by GC; water content; XRPD/DSC and particle-size testing where specification-relevant.

Verified chemical reference

methyl 2-hydroxy-3-[N-[4-[methyl-[2-(4-methylpiperazin-1-yl)acetyl]amino]phenyl]-C-phenylcarbonimidoyl]-1H-indole-6-carboxylate

Open PubChem reference ↗

Technical overview only; not a validated manufacturing process or a claim of company capability. Confirm chemical form, CAS No., grade and specifications from the approved specification and batch COA.