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Universally Applicable Methods for Comprehensive Risk Assessment of Elemental Impurities in Vitamin A and D Preparations
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Background:
Vitamin A and D deficiency in children is a common public health
problem. In China, almost all children are administered vitamin A and D preparations daily and
they should be consumed continuously until the age of 18. Children are sensitive to elemental impurities,
including heavy metals. However, there are no regulatory requirements or reports on the
risk assessment of elemental impurities in marketed vitamin A and D preparations.
Objective:
The aim of this study was to propose an accurate and efficient method suitable for samples
from different manufacturers to detect elemental impurities and conduct risk assessments according
to the ICH Q3D guidelines.
Methods:
We developed a universally applicable digestion method for capsules and an ICP–MS
method for quantitative analysis of 28 elemental impurities in vitamin A and D formulations. These
methods were validated according to the USP 233 guidelines. Elemental impurities in 15 batches
of vitamin A and D products from 10 manufacturers and their capsule shells were determined,
and risk assessment was conducted according to the International Council for Harmonization Q3D
guidelines.
Results:
All elemental impurities of toxicological concern met the Q3D requirements. However,
the concentrations of various elements, including those of lead (not detected to 4.1 μg/g), arsenic
(not detected to 7 μg/g), aluminum (not detected to 888 μg/g), and palladium (not detected to 36
μg/g), varied markedly. Moreover, the lead content in one batch from one manufacturer exceeded
the control threshold.
Conclusion:
In this study, we successfully developed an effective digestion method for processing
capsules containing samples from different sources and a sensitive ICP–MS method for quantitative determination of 28 elemental impurities in vitamin A and D preparations. ICP–MS should be
implemented for the evaluation and control of elemental impurities in vitamin A and D preparations. This will ensure safe long-term vitamin A and D supplementation in children
Title: Universally Applicable Methods for Comprehensive Risk Assessment of Elemental Impurities in Vitamin A and D Preparations
Description:
Background:
Vitamin A and D deficiency in children is a common public health
problem.
In China, almost all children are administered vitamin A and D preparations daily and
they should be consumed continuously until the age of 18.
Children are sensitive to elemental impurities,
including heavy metals.
However, there are no regulatory requirements or reports on the
risk assessment of elemental impurities in marketed vitamin A and D preparations.
Objective:
The aim of this study was to propose an accurate and efficient method suitable for samples
from different manufacturers to detect elemental impurities and conduct risk assessments according
to the ICH Q3D guidelines.
Methods:
We developed a universally applicable digestion method for capsules and an ICP–MS
method for quantitative analysis of 28 elemental impurities in vitamin A and D formulations.
These
methods were validated according to the USP 233 guidelines.
Elemental impurities in 15 batches
of vitamin A and D products from 10 manufacturers and their capsule shells were determined,
and risk assessment was conducted according to the International Council for Harmonization Q3D
guidelines.
Results:
All elemental impurities of toxicological concern met the Q3D requirements.
However,
the concentrations of various elements, including those of lead (not detected to 4.
1 μg/g), arsenic
(not detected to 7 μg/g), aluminum (not detected to 888 μg/g), and palladium (not detected to 36
μg/g), varied markedly.
Moreover, the lead content in one batch from one manufacturer exceeded
the control threshold.
Conclusion:
In this study, we successfully developed an effective digestion method for processing
capsules containing samples from different sources and a sensitive ICP–MS method for quantitative determination of 28 elemental impurities in vitamin A and D preparations.
ICP–MS should be
implemented for the evaluation and control of elemental impurities in vitamin A and D preparations.
This will ensure safe long-term vitamin A and D supplementation in children.
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