Category
Anlotinib
CAS Number
NA
Molecular Formula
C₂₆H₂₃Cl₂N₃O₅
Molecular Weight
528.38 g/mol
Synonym

2-((4-Chloro-6-methoxyquinolin-7-yl)oxy)-N-(1-(((4-chloro-6-methoxyquinolin-7-yl)oxy)methyl)cyclopropyl)acetamide; 7-[[1-[[(4-chloro-6-methoxyquinolin-7-yl)oxy]methyl]cyclopropyl]methoxy]-4-chloro-6-methoxyquinoline

Keywords
Intermediates
Pharmaceutical Standards
Impurity Standards
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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

The amide impurity in Anlotinib is a potential trace by-product formed during its synthesis, typically due to incomplete reactions or side reactions involving amide bond formation. This impurity is important because even small amounts can impact the drug’s purity, stability, and safety profile. Analytical techniques like HPLC, LC-MS, or NMR are used to detect and quantify the amide impurity, and process optimization is employed to minimize its presence in the final pharmaceutical product.