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Day 1 - US Pharmacopeial Convention

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Procedures 1 and 2 (ICP-OES and ICP-MS,<br />

respectively)<br />

• Standards: 2xlimit for a given element and 0.1xlimit for a<br />

given element<br />

• System suitability solution: 1 ppm of elements of<br />

interest<br />

• All solutions matrix-matched<br />

• Follow validation requirements<br />

• Follow manufacturer’s suggestions for program and<br />

wavelength or m/z.<br />

• Calculate results based on original sample size<br />

• Weigh all liquid samples<br />

Bristol Bristol-Myers Myers Squibb Company<br />

Page 10<br />

What about Wet Chemical Methods?<br />

• Some non-instrumental techniques may not be able to<br />

meet the limits for a given element and/or sample<br />

• Limits selected were driven by toxicological information<br />

and developed by a team of toxicologists<br />

• Key is to meet validation requirements<br />

• Demonstrate that whatever method you chose is<br />

appropriate for its intended use<br />

Bristol Bristol-Myers Myers Squibb Company

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