Day 1 - US Pharmacopeial Convention

Methodology - Strategy
� Provide acceptance criteria for methods as
limits and quantitative tests
� SSample l preparation ti
– Solid/neat samples
– Dilute and shoot
– Closed-vessel digestion
� Analysis
– ICP-OES ICP OES
– ICP-MS
� Other methods meeting the acceptance
criteria are acceptable
Acceptance Criteria – Limits Test
� Accuracy – Spiked test samples give
responses equal to or greater than their
controls
� Precision
– Instrumental methods – RSD for six
measurements NMT 20%
– Non-instrumental methods – meet LoD
requirements
� SSpecificity ifi it - Th The procedure d must t be b able bl to t
unequivocally assess each Target Element in
the presence of components that may be
expected to be present, including other
Target Elements and matrix components
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