Abstract
Calcium carbonate which is extracted from the Earth in combination with other mineral impurities, is largely used in preparations for pediatric supplements. Elemental impurities in drug products pose toxicological concerns without therapeutic benefits. Thus, it is very urgent to assess the safety of chronic exposure to elements that may be present in trace amounts. In the present study, we developed high throughput ICP-MS method for the quantitative determination of 62 elemental impurities in high matric calcium carbonate samples and validated according to USP 233. Calcium carbonate preparations which state clearly used for child (including neonates, infants, toddlers and children) from 9 manufactures and two types of raw materials (light calcium carbonate and ground calcium carbonate) were investigated in terms of the content and variability of 62 elemental impurities. According to the results, ground calcium carbonate was more suitable to be used in pediatric preparations concerning elemental impurities. Parts of elemental impurities in CaCO3 preparations which are derived from the raw materials and the preparation process, may cause potential risks for children. These results indicate that it is necessary to establish a modern instrumental analysis method to evaluate and control elemental impurities in CaCO3 raw materials and preparations.
Highlights
Toddlers, and infants, calcium in food often does not meet the needs of the body in this stage of rapid growth and development; since insufficient calcium intake will affect growth and development, potentially leading to diseases such as osteomalacia and rickets (Baker et al, 1999; Lee and Jiang, 2008; Pu et al, 2016), calcium supplement preparations are suggested to meet the body’s demand.Because of its high calcium content and low price, calcium carbonate is currently recognized as the main calcium source with the highest performance-price ratio in China and other countries, and is the preferred raw material for calcium supplement preparations
Light calcium carbonate is produced by a chemical processing method, and generally uses limestone and shells as raw materials, Elemental Impurities in Pediatric Preparations whereas ground calcium carbonate is produced by crushing natural calcite directly by a mechanical method
A high-throughput method was established for the analysis of 62 elemental impurities in calcium carbonate preparations using different digestion methods
Summary
Toddlers, and infants, calcium in food often does not meet the needs of the body in this stage of rapid growth and development; since insufficient calcium intake will affect growth and development, potentially leading to diseases such as osteomalacia and rickets (Baker et al, 1999; Lee and Jiang, 2008; Pu et al, 2016), calcium supplement preparations are suggested to meet the body’s demand.Because of its high calcium content and low price, calcium carbonate is currently recognized as the main calcium source with the highest performance-price ratio in China and other countries, and is the preferred raw material for calcium supplement preparations. Light calcium carbonate is produced by a chemical processing method, and generally uses limestone and shells as raw materials, Elemental Impurities in Pediatric Preparations whereas ground calcium carbonate is produced by crushing natural calcite directly by a mechanical method. Children may be sensitive to the toxic effects of these metals because they tend to absorb a relatively higher fraction of an oral dose than adults. These harmful consequences for children include developmental delays, neurocognitive disorders, behavioral disorders, respiratory problems, cancer, and cardiovascular diseases (Olympio et al, 2009; Brandão and Gontijo, 2012; Al Osman et al, 2019; Jurowski et al, 2019)
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