title: [The modern approaches to the determination of the content of elemental impurities in the pharmaceutical substances with the use of inductively-coupled plasma mass-spectrometry].
abstract: The elemental impurities contained in the composition of the pharmaceutical dose forms are known to be capable of interacting with their active substances and excipients and of catalyzing their degradation; thereby, they alter stability of the drug products and exert toxic effects on the human tissues. The present publication was designed to report the results of the purity tests for ascorbic acid, valine, and galactose substances by inductively-coupled plasma mass-spectrometry (IBP-MS). This method is recommended for use by the US and EU pharmacopoeias and for the replacement of the traditional test for heavy metals with the use of PbS ethanol suspension.
authors: Department of Analytical Chemistry, Chemical Faculty, M.V. Lomonosov Moscow State University, Moscow, Russia, 119899; Institute of Spectroscopy, Russian Academy of Sciences, Moscow, Russia, 142190.
authors: M A
authors: MA
authors: Bol'shov
authors: Department of Analytical Chemistry, Chemical Faculty, M.V. Lomonosov Moscow State University, Moscow, Russia, 119899.
authors: I F
authors: IF
authors: Seregina
authors: Department of Pharmaceutical and Toxicological Chemistry, Medical Institute of the Russian University of People's Friendship, Moscow, Russia, 117198.
authors: E V
authors: EV
authors: Uspenskaya
authors: Department of Pharmaceutical and Toxicological Chemistry, Medical Institute of the Russian University of People's Friendship, Moscow, Russia, 117198.
authors: O V
authors: OV
authors: Titorovich
authors: Department of Pharmaceutical and Toxicological Chemistry, Medical Institute of the Russian University of People's Friendship, Moscow, Russia, 117198.
authors: A V
authors: AV
authors: Syroeshkin
authors: Department of Pharmaceutical and Toxicological Chemistry, Medical Institute of the Russian University of People's Friendship, Moscow, Russia, 117198.
authors: T V
authors: TV
authors: Maksimova
authors: Department of Pharmaceutical and Toxicological Chemistry, Medical Institute of the Russian University of People's Friendship, Moscow, Russia, 117198.
authors: T V
authors: TV
authors: Pletneva
mesh_terms: D004340:Drug Contamination / Q000517:prevention & control / Q000706:statistics & numerical data; D004355:Drug Stability; D053593:Forensic Toxicology / Q000379:methods; D006801:Humans; D013058:Mass Spectrometry / Q000379:methods*; D019216:Metals, Heavy / Q000009:adverse effects / Q000032:analysis*; D004364:Pharmaceutical Preparations / Q000032:analysis*; D010602:Pharmacopoeias as Topic / Q000592:standards
chemical_list: D019216:Metals, Heavy; D004364:Pharmaceutical Preparations