10. 化學製藥新藥開發流程
Raw Material
1. Control
2. Specification Raw Material
1. Preparation
2. Control
Drug Substance
1. Analysis
2. Specification
3. Stability
Process
1. Formulation
2. Preparation
3. Control
Drug Substance
1. Analysis
2. Specification
3. Stability
Chemistry, Manufacture and Control
(Quality)
Pharmacology
(Efficacy)
Toxicology
(Safety)
中華醫藥產業股份有限公司,2004
52. 2010/5/30 52
Inductively Coupled Plasma Mass Spectrometry (ICP-MS) Analysis
Features of ICP-MS
• Heavy metal analysis (trace) - low
detection limit
• Simultaneously analyze 70 inorganic
elements
• Isotope analysis
7 Li 57 Fe 93 Nb 139 La 178 Hf
9 Be 59 Co 95 Mo 140 Ce 181 Ta
11 B 60 Ni 101 Ru 141 Pr 182 W
23 Na 63 Cu 103 Rh 146 Nd 185 Re
24 Mg 66 Zn 105 Pd 147 Sm 189 Os
27 Al 69 Ga 107 Ag 151 Eu 193 Ir
29 Si 72 Ge 111 Cd 157 Gd 195 Pt
39 K 75 As 115 In 159 Tb 197 Au
43 Ca 79 Br 118 Sn 163 Dy 202 Hg
45 Sc 82 Se 121 Sb 165 Ho 205 Tl
47 Ti 85 Rb 125 Te 166 Er 208 Pb
51 V 88 Sr 127 I 169 Tm 209 Bi
53 Cr 87 Y 133 Cs 172 Yb 232 Th
55 Mn 90 Zr 137 Ba 175 Lu 238 U