N-Desmethyl Rosuvastatin Disodium Salt Monohydrate is a demethylation-related impurity encountered during synthesis and storage of rosuvastatin that requires targeted control as a critical quality attribute; robust impurity profiling using reversed phase HPLC with UV detection, orthogonal confirmation by LC-MS and NMR, and validated stability-indicating methods are essential. Formation pathways typically involve oxidative or base-catalyzed demethylation and can impact assay and degradant profiles. Process controls, solvent and reagent selection, in-process monitoring, and specification limits aligned with ICH Q3A and Q3B expectations mitigate risk. Routine stability testing and LOQ-validated methods ensure reliable detection and regulatory compliance.
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