Analytical approach of elemental impurities in pharmaceutical products: A worldwide review

Atomic spectrometry update – a review of advances in environmental analysis

“…Ibourki et al 96 (224 references) discussed similar topics but also featured LIBS and NAA. Aleluia et al 97 (152 references) included herbal medicines and medicinal plants in their review of analytical approaches for the determination of trace element impurities in pharmaceutical products.…”

Atomic spectrometry update: review of advances in the analysis of clinical and biological materials, foods and beverages

“…Methods for the evaluation of elemental impurities in medicines, required by regulatory authorities, were reviewed by Aleluia et al 21 (Section 7). In addition, Lindenmayer et al 22 discussed the use of atomic spectrometry to support national and international regulations related to the presence of trace elements in seaweeds (Section 8.2.6).…”

“…Since the introduction of the regulations, an abundance of papers have been published on the various approaches for the analysis of the elemental impurities. Aleluia et al 21 have reviewed the many papers on this topic. One of the key observations, perhaps unsurprisingly was that ICP-MS and ICP-OES are the analytical methods of choice for performing ICH-Q3D type studies and they also suggested that in the future, in-line analysis and greener methodologies should be considered.…”

Development and Validation of Analytical Procedure for Elemental Impurities in Rosuvastatin Calcium Tablets by ICP-MS and Microwave Digestion

“…According to USP general chapter 232, risk assessment for Cd, Pb, As, Hg, Co, V, and Ni that were listed in class 1 and class 2A was required, which should be focused on assessing the levels of elemental impurities in tablets in relation to the permissible daily exposures (PDEs) presented in USP 232 and ICH Q3D [ 4 , 5 ]. V was considered to be a human carcinogen that was of genetic toxicity but not mutagenic; multiple oral doses of Co could cause human erythrocytosis; exposure to Pb resulted in harmful effects on the central nervous system, reproductive system, and immune system; and Hg absorbed via the respiratory system would damage the brain [ 6 – 10 ]. Thus, a mature analytical procedure for the 7 elemental impurities is indispensable.…”