Development of a sample preparation method for accurate analysis of 24 elemental impurities in oral drug products by ICP-MS according to USP/ICH guidelines

Abstract

Regulatory requirements for the analysis of 24 elemental impurities (Li, V, Cr, Co, Ni, Cu, As, Se, Mo, Ru, Rh, Pd, Ag, Cd, Sn, Sb, Ba, Os, Ir, Pt, Au,...

Stabilizers for Osmium Isotopes in Microwave-Irradiated Acid Digestion and Inductively Coupled Plasma Mass Spectrometry Analysis

“…Thiourea made a complex with osmium, which stabilized the osmium in solution. [21][22][23] They could obtain good spike recovery values and precision. The crucial issue for obtaining the highly sensitive results is to change the chemical form of the osmium from osmium tetroxide to another stable state.…”

Determination of trace elements in ibuprofen drug products using microwave-assisted acid digestion and inductively coupled plasma-mass spectrometry

“…Trace elements appear in most drugs as catalytic residues, impurity constituents of the active pharmaceutical ingredient (API) or excipients, and/or due to contamination from manufacturing equipment, production processes, or packaging [ [1] , [2] , [3] , [4] , [5] ]. Elemental impurities have no intended therapeutic effect and can be potentially toxic to humans.…”

“…Compared to the analysis of the component substances, analysis of the final dosage increases the sample complexity, and one must carefully evaluate the sample preparation strategy. Wet digestion, direct dissolution, and combustion are popular sample preparation procedures, followed by trace elemental quantification using inductively coupled plasma (ICP) spectrometry methods providing low limits of detection (LOD) [ 1 , 2 , [13] , [14] , [15] ]. Recent studies focus on the application of microwave-assisted acid digestion for sample preparation to evaluate trace elemental impurities in solid pharmaceuticals.…”

“…The elements Li, Sn, Os, Hg, and Tl described in the ICH Q3D(R1) guideline were not included in this study primarily due to analytical challenges associated with both sample preparation and limitations of ICP mass spectrometry i.e., Os requires stabilization of the sample solution to avoid the formation of volatile OsO 4 [ 23 ], Hg demonstrates challenges with carry-over effect during ICP-MS analysis [ 24 ], Li has a high and varying background in ICP-MS [ 25 ], Sn potentially vaporizes as SnCl 4 and/or forms colloidal precipitation in the presence of hydrochloric acid (HCl) [ 26 ]. Previous studies describe methods for measuring all 24 ICH Q3D elements including Li, Sn, Os, Hg, and Tl [ 1 , 7 , 14 ] for toxicological evaluation of pharmaceuticals.…”

Novel Dielectric Barrier Discharge Trap for Arsenic Introduced by Electrothermal Vaporization: Possible Mechanism and Its Application

“…Traditional atomic spectrometric approaches have been applied to As detection in food and water matrices, including inductively coupled plasma mass spectrometry (ICP-MS), − hydride generation atomic fluorescence spectrometry (HG-AFS), and atomic absorption spectrometry (HG-AAS). , Owing to high sensitivity, wide dynamic linear range, and multielemental capability, ICP-MS is the most utilized tool for elemental analysis including arsenic; on the other hand, HG-AFS and HG-AAS demonstrate an adequate detection limit (LOD) and precision for arsenic analysis. However, the above instrumental methods necessitate liquid samples; as a result, complicated and time-consuming digestion renders rapid field As-in-algae analysis impossible.…”