Recent advances in the determination of elemental impurities in pharmaceuticals–Status, challenges and moving frontiers

V Balaram - Trac trends in Analytical chemistry, 2016 - Elsevier
Elemental impurities have been regulated in pharmaceutical products for many decades.
Metal impurities such as As, Cd, Cu, Pb, Hg, V and Pt in pharmaceuticals and drugs are …

Impact of residual impurities and contaminants on protein stability

W Wang, AA Ignatius, SV Thakkar - Journal of pharmaceutical sciences, 2014 - Elsevier
Production of recombinant proteins generates a variety of process-related impurities. The
multistep manufacturing processes may introduce many potential contaminants into the final …

Physicochemical and biological impact of metal-catalyzed oxidation of IgG1 monoclonal antibodies and antibody-drug conjugates via reactive oxygen species

ZK Glover, A Wecksler, B Aryal, S Mehta, M Pegues… - Mabs, 2022 - Taylor & Francis
Biotherapeutics are exposed to common transition metal ions such as Cu (II) and Fe (II)
during manufacturing processes and storage. IgG1 biotherapeutics are vulnerable to …

The use of atomic spectroscopy in the pharmaceutical industry for the determination of trace elements in pharmaceuticals

N Lewen - Journal of pharmaceutical and biomedical analysis, 2011 - Elsevier
The subject of the analysis of various elements, including metals and metalloids, in the
pharmaceutical industry has seen increasing importance in the last 10–15 years, as modern …

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

ACM Aleluia, M de Souza Nascimento… - … Acta Part B: Atomic …, 2023 - Elsevier
Elemental impurities may occur in pharmaceutical products under different conditions.
Impurity composition includes many types of species: metals and non-metals, which can be …

Leachables from plastic materials in contact with drugs. State of the art and review of current analytical approaches

L Cuadros-Rodríguez, M Lazúen-Muros… - International Journal of …, 2020 - Elsevier
The plastics used in drug packaging systems and medical devices are composed of
homologous polymers and generally contain additives such as antioxidants, plasticizers and …

[HTML][HTML] Comprehensive stability study of vitamin D3 in aqueous solutions and liquid commercial products

Ž Temova Rakuša, M Pišlar, A Kristl, R Roškar - Pharmaceutics, 2021 - mdpi.com
Vitamin D3 has numerous beneficial effects, such as musculoskeletal, immunomodulatory,
and neuroprotective. However, its instability is the main obstacle to formulating quality …

[HTML][HTML] An update on the use of natural pigments and pigment nanoparticle adducts for metal detection based on colour response

RD Mulyaningsih, R Pratiwi, AN Hasanah - Biosensors, 2023 - mdpi.com
Natural pigments occur in plants as secondary metabolites and have been used as safe
colourants in food. Studies have reported that their unstable colour intensity might be related …

An overview of sample preparation procedures for determination of elemental impurities in medicines

FC Pinheiro, JA Nobrega - Microchemical Journal, 2022 - Elsevier
Elemental impurities determination in pharmaceuticals has become an emerging topic in the
last years due to the revision of the Chapter 231 from the United States Pharmacopeia by …

Screening for multiple weight loss and related drugs in dietary supplement materials by flow injection tandem mass spectrometry and their confirmation by liquid …

F Song, D Monroe, A El-Demerdash… - Journal of Pharmaceutical …, 2014 - Elsevier
A new method has been developed using flow injection tandem mass spectrometry to semi-
quantitatively screen for weight loss drugs, including sibutramine, N-desmethylsibutramine …