WitrynaOxacillin sodium Impurity 11: Synonyms: (3S,7R)-2,2-dimethyl-5-(5-methyl-3-phenylisoxazol-4-yl)-2,3,7,7a-tetrahydroimidazo[5,1-b]thiazole-3,7-dicarboxylic acid: … WitrynaHe gave a high-level review regarding the source of impurities (Drug substance process impurity and Drug substance/Drug product degradation products), as well as the current ICH guidelines (i.e., ICH Q3A[R2], Q3B[R2], Q3C[R7], Q3D[R1], M7[R1], and S9) for the safety testing of impurities, residual solvents, heavy metals, and mutagenic ...
Optimization of Ultrafiltration/Diafiltration Processes for Partially ...
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Impurities: Residual Solvents ICH: Q3C - USP–NF
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