Elemental Impurity Analysis in Pharmaceuticals
A method to identify the presence of heavy metals in pharmaceuticals was introduced in the United States Pharmacopeia more than 100 years ago.
Pharmaceutical companies are still using essentially the same method, known as the USP Heavy Metals Limit Test.
This paper will provide an overview of current method limitations, considerations for the new methodology and risk-based assessments being carried out by manufacturers.
see……Filed under: Regulatory Tagged: Elemental Impurity, Elemental Impurity Analysis, heavy metals, Impurity, Pharmaceutical companies, Pharmaceuticals, United States Pharmacopeia
