Elemental impurities in pharmaceutical products adding fuel to the fire

Regulatory Toxicology and Pharmacology : RTP
M MaithaniP Bansal

Abstract

The pharmaceuticals may generate impurities at various stages of development, transportation and storage which make them risky to be administered. Thus, it is essential that these impurities must be detected and quantified. However, their presence as impurities in finished products is virtually unavoidable, even under GMP conditions. Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug products to control based on permitted daily exposures in drug products. Within the pharmaceutical community, there is uncertainty regarding the impact of these changes on manufactures of drug products. This uncertainty is fueled due to lack of publicly available information on elemental impurity levels in common pharmaceutical excipients. The present compilation gives an account of updated information about elemental impurities and reviews the regulatory aspects for such impurities in active pharmaceutical ingredients/drug formulations. In addition, the aim of this article is to review and discuss the currently used quantitative analytical method, which is used for quality control of elemental impurities in pharmaceutical products.

References

Jul 1, 1986·Analytical Chemistry·J M Harnly
Mar 1, 1974·Analytica Chimica Acta·K G Brodie, J P Matousek
Jul 20, 1973·Science·F BakirR A Doherty
Aug 1, 1973·Analytical Chemistry·J P Matousek, K G Brodie
Oct 7, 2000·Journal of Pharmaceutical and Biomedical Analysis·T WangR S Egan
Oct 26, 2000·Biological Trace Element Research·I C ChuangT H Lin
Apr 18, 2003·The New England Journal of Medicine·Richard L CanfieldBruce P Lanphear
Apr 3, 2004·Bulletin of Environmental Contamination and Toxicology·S HaiderP Kakkar
May 13, 2004·Journal of Pharmaceutical and Biomedical Analysis·Matti NiemeläPaavo Perämäki
Jun 15, 2004·Journal of Pharmaceutical and Biomedical Analysis·Nancy LewenThomas Raglione
Feb 4, 2005·Biometals : an International Journal on the Role of Metal Ions in Biology, Biochemistry, and Medicine·Feng HongAihua Zhang
Nov 30, 2005·Journal of Pharmaceutical and Biomedical Analysis·Xiujuan JiaSandra Spencer
Aug 28, 2007·International Journal of Occupational and Environmental Health·James HuffPeter F Infante
Oct 20, 2007·Toxicological Sciences : an Official Journal of the Society of Toxicology·Walter C ProzialeckWilliam D Atchison
Feb 4, 2010·Journal of Pharmaceutical and Biomedical Analysis·Qiang TuVincent Antonucci
Mar 11, 2010·Pharmaceutical Research·Darrell R AbernethyUNKNOWN USP Metal Impurities Advisory Panel
Jun 4, 2015·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Uwe WolleinNicholas Schramek
Apr 11, 2018·Regulatory Toxicology and Pharmacology : RTP·Edgar PintoAgostinho Almeida
Feb 17, 2019·Regulatory Toxicology and Pharmacology : RTP·Marie-Luise BuchholzerWerner Knoess
Apr 15, 2019·Regulatory Toxicology and Pharmacology : RTP·Paul A AndrewsJoseph J DeGeorge
Apr 27, 2019·Regulatory Toxicology and Pharmacology : RTP·Shunto NishikawaNobutaka Shirasaki

❮ Previous
Next ❯

Citations


❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.