Article

Development and Validation of Analytical Methods for the Quantification and Identification of N-Nitroso Trimetazidine, a Nitrosamine Impurity, in Drug Substance and Drug Product.

2025-02-11

Abstract excerpt

RATIONALE In the manufacturing process of Trimetazidine hydrochloride (TMZ), N Nitroso trimetazidine (NTMZ) generate, final purification of active pharmaceutical ingredient (API) done in the presence of the charcoal, which has been identified as a possible source of nitrite. Secondary amine is present in TMZ, due to the favorable condition for nitrosamine & NDSRIs, NTMZ is generated in TMZ. Significant genotoxic a...

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Literature Corpus work: 6bd993c6-2f62-5d3a-814f-edd4f74f55f6
DOI: 10.22541/au.173924857.76644661/v1

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