Methyl 8-(2-Hydroxybenzamido) Octanoate (CAS 2780975-72-4) is a process-related impurity that presents as an esterified octanoate bearing a 2-hydroxybenzamido functionality and can impact drug substance purity and stability. Its combination of moderate lipophilicity and polar hydroxy and amide groups can cause partial coelution with target APIs in reversed phase HPLC, and it exhibits a UV chromophore enabling detection around 230 to 280 nm. It is prone to hydrolytic cleavage under acidic or basic conditions yielding the corresponding acid and methanol, and displays characteristic LC-MS fragmentation and NMR signals useful for identification. Control strategies include optimized purification, stability-indicating HPLC methods, LC-MS confirmation, and specification limits aligned with ICH impurity guidelines.
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