Day 1 - US Pharmacopeial Convention
Day 1 - US Pharmacopeial Convention
Day 1 - US Pharmacopeial Convention
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Elements – <strong>US</strong>P Draft Chapter <br />
� Elements in the environment<br />
– As, Pb, Cd, Hg<br />
�� Elements in EMEA Catalyst Guidance<br />
– Exclude zinc and iron, which are not toxic at levels<br />
relevant in pharmaceuticals<br />
� Need to control in drug products if presence is<br />
possible<br />
– Deliberately added (catalyst)<br />
– Possible supply-chain contaminant or adulterant<br />
– Process issue (equipment)<br />
� Excipients and APIs – Levels sufficiently low that<br />
drug product meets permissible daily dose<br />
requirements, except for Large Volume Parenterals<br />
Impurities and Limits – Current Panel<br />
Recommendations<br />
Oral Daily Parenteral Large Large-Volume Volume<br />
Element l<br />
Dose PDE<br />
(µg/day)<br />
Daily Dose<br />
Dose<br />
PDE (µg/day)<br />
Parenteral<br />
Component<br />
Limit (µg/g)<br />
Arsenic 15 (EPA) 1.5 0.15<br />
Cadmium 5 (ATSDR) 0.5 0.05<br />
Lead 10 (FDA) 1 0.1<br />
Mercury Mercuryy 15 (EPA) ( )<br />
1.5 0.15<br />
11/23/2010<br />
8
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