Impurities are defined in ICH Q6A guideline as “Any component of the drug product that is not the chemical entity defined as the drug substance or an excipient in the drug product. The impurities in drug products can be originated not only in the drug substance or inert ingredients used for formulating a drug product; […]
GxP Compliance & Safety
Titanium dioxide: the use as a food additive of E171
On February 2020 the EU published that titanium dioxide must be classified as carcinogen if inhaled (Carc. 2, H351 (inhalation) in certain powdered forms under the CLP Regulation. Moreover, on May 2021 the European Food Safety Authority (EFSA) published an updated safety assessment of the food additive titanium dioxide (E 171) concluding that titanium dioxide can […]
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