Pesticide Residue Testing with USP <561>

In order to meet the safety standards enforced by regulatory authorities, food commodities and botanicals are required to undergo pesticide residue testing. The tests described in the U.S. Pharmacopoeia <561> “Articles of Botanical Origin” and the European SANTE/11813/2017 guidance documents allow for the quantitative and qualitative analysis of these pesticide residues. These analyses are [...]

Nitrosamine Impurities Testing With the Updated FDA Guidance

Nitrosamine impurities have recently become a very important topic in the world of pharmaceuticals. Ever since unacceptable levels of this probable carcinogen were detected in common drugs (including angiotension II receptor blockers, Zantac, metformin), regulatory authorities have recognized the need to reduce this risk and educate others on the matter. At the beginning of [...]

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