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 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 [...]
Health Canada recently sent a letter to Market Authorization Holders (MAHs) about nitrosamine testing of impurities in human pharmaceutical products. Nitrosamine are genotoxic compounds that are potentially carcinogenic even at low exposure levels. What the regulators are asking is for the MAHs to perform Nitrosamine testing to evaluate levels of these impurities which include [...]
Over the past week or so, drugs containing Ranitidine have been in the news with provocative headlines like: Drugmaker halts shipments of ranitidine heartburn medication Novartis halts distribution of Zantac drug amid probe into impurities Carcinogen Scare sets of Global Race to Contain Tainted Zantac Health Canada requests that companies stop distributing ranitidine drugs [...]
Elemental impurities (or heavy metals if you will) can be toxic for humans when they are not metabolized by the body and accumulate in the soft tissues. Depending on the elemental impurities in question, toxicity can occur at levels just above naturally occurring background levels. This means that consumption of pharmaceuticals and food supplements [...]
