Author: Li, Wenkui; Gong, Jiawei; Wang, Chuan; Lin, Zhongping John; Flarakos, Jimmy
Title: ICP-MS determination of serum aluminum in monkeys subcutaneously administered an alhydrogel-formulated drug candidate. Cord-id: s8s9doys Document date: 2017_1_1
ID: s8s9doys
Snippet: AIM To develop and validate an inductively coupled plasma-mass spectrometry method for quantitative bioanalysis of aluminum (Al) in monkey serum in support of a GLP TOX study with alhydrogel-formulated drug candidate. METHODS & RESULTS The method was linear over a dynamic range of 10-1000 ng/ml using a 50-μl sample volume. The intra-/inter-run precision (%CV) of the quality control sample results were ≤7.9% (CV) and the accuracy (%bias) within ±11.0% across all quality control concentrations
Document: AIM To develop and validate an inductively coupled plasma-mass spectrometry method for quantitative bioanalysis of aluminum (Al) in monkey serum in support of a GLP TOX study with alhydrogel-formulated drug candidate. METHODS & RESULTS The method was linear over a dynamic range of 10-1000 ng/ml using a 50-μl sample volume. The intra-/inter-run precision (%CV) of the quality control sample results were ≤7.9% (CV) and the accuracy (%bias) within ±11.0% across all quality control concentrations evaluated. Other validation parameters, including stability under various conditions, extraction recovery and matrix effect, all met the acceptance criteria. CONCLUSION The validated method was successfully implemented for the quantitative analysis of Al in monkey serum to assess the systemic exposure to Al.
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