Nitrosamine Impurities: Origin, Control and Regulatory Recommendations

نویسندگان

چکیده

The unexpected finding of presence nitrosamine impurities, by USFDA and EMA in year 2018, drugs such as Angiotensin-II Receptor Blockers (ARBs), Ranitidine, Nizatidine Metformin, has triggered the need for a risk assessment strategy evaluation control these probable human carcinogen - pharmaceutical product that are at risk. This leads to voluntarily recall products worldwide. nitrosamines some types drug led FDA other international regulators conduct detailed impurities APIs products. Although have been found only products, regulatory agencies recommended extend analysis chemically synthesized also.

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ژورنال

عنوان ژورنال: International journal of drug regulatory affairs

سال: 2021

ISSN: ['2321-6794', '2321-7162']

DOI: https://doi.org/10.22270/ijdra.v9i2.472