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Heavy Metal in The USP
Heavy Metal in The USP
Sources
Deliberately added (e.g., catalysts)
Carried through the process (e.g., starting
materials)
From the process (e.g., leaching from pipes
and other equipment)
Background
120
100
A v erag e % R eco v eries
80
USP Results
60
ICP-MS Results
40
20
0
Pb As Se Sn Sb Cd Pd Pt Ag Bi Mo Ru In Hg
Elements
What Metals to MonitorConsiderations
Route of Administration
Oral
Parenteral
Inhalation
Duration of exposure
Age at Exposure
Preparesample,monitorsolutionandUSPreferencesolutionaccordingtosampleprep.
procedure
PerformanalysisviaICPOESorICPMS
Yes
DidthemonitorandUSP Performanalysisusingelement
referencesolutionrecover specificmethod
towithin20%?
No
Yes
ReportResult
Methodology