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臺灣臺中地方法院97年度訴字第4141號

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       974141                                 9713201 985 1500000000424 985 15西仿958 19974 196 1 Sildenafil2 958 191 1096951115975 151064.63 10,909737,448.4 00000000250 9 951115西95126 SL095F01690-2/2 西21.7ppm Sildenafil西6 1 1 153 - 2,800 1 1 974 1910,9090103- 972 252 - Sildenafil調調5 15010650-20708 調調 159 1 159 5 1 4 159 1 159 4 2 調159 1 使159 1 159 4 使159 1 159 4 976162226 227 - 西西955 17西11151222西西38396941西Sildenafil951115西951222Sildenafil西西Sildenafil西- 343511318 985 15985 159510309511151064.63 10,909737,448.4 1 153 - 2,800 1 1 974 1910,9090103- 調調975 15250 9 010650-20708調調調5155- 3 6 調調2 調1244496063115 122 9713619192 西Sildenafil西Sildenafil- 955 17西 西調21200 700 200 700 466 466 466 466 Acetildenafil 466 460.2 460.2 vardenafil488.604 460.2 230 232 955 8 460.2m/zMS2 SildenafilViagraVardenafilLevitra Tadalafil Cialis460.2m/zMS2 VardenafilMS2 VardenafilVardenafil analogue MSLC-NMR9811139809800044600 174 186 調1930 Sildenafil460.2 LC-NMR西調9195調6465西37 調9511Sildenafil西955 17調7 調1930調95調5 6 Sildenafil調調 95111595126 SL095F01690-2/2 西2 1 1 4 6 SL095F01690-1/2 7 SL095F01690-2/2 246 4 6 SL095F01690-1/2 西5 HPLCHPLC/MS 10100 西西西SL095F01 690-1/2西74 退SL095F01690-2/2 SL095F01690-2/2 75247 951115西SL095F01690-1/2 2 95112195126 95126 SL095F01690-1/2 SL095F01690-2/2 991 160990116 20061121Test Report 95126 1417 951115- SL095F01690-1/2 西Sildenafil95126 SL095F01690-1/2 95126 SL095F01690-2/2 21.7ppm 250 9 171195126 SL095F01690-2/2 Sildenafil西- - 西Sildenafil 調95126 SL095F01690 調31951229SL095F01889 調34 4 7 調31331/2 調246 98102209801022SL095F01690 SL095F01889 SL095F01690 SL095F01889 2 7 95126 SL095F01690-1/2 4 6 調SL095F01690 調31332 SL095F01690-1/2 調SL095F01690 調3133調3133SL095F01690 調調10調調SL095F01690 SL095F01690 SL095F01690-1/2 SL095F01690-2/2 2 SL095F01690-1/2 -1/2SL095F01690 1/1 1/2 2 SL095F01690-2/2 調SL095F01690-2/2 調951115- 西調8 西SL095F01690 1 28使 951222SL095F01889 調343 95126 SL095F01690-2/2 7 - 95122295111595115 - 95126 西西- 西95126 16951222951222西SL095F01889 951115西951222西34調951222調8 調951229調34SL095F01690-2/2 972 18972 25sildenafil351.6 μg/g(ppm) 西981113119 調40調調119 調4076247 972 18Sildenafil351.6 μg/g(ppm)118 122 972 18- 972 25Sildenafil351.6 μg/g(ppm)95126 SL095F01690-2/2 西調調40119 SildenafilN.D.351.6 μg/g(ppm)調調351.6 μg/g(ppm)N.D.調調972 25 調972 18西調68調972 18Sildenafil調8 973 12Sildenafil 使GC/MS UVLC/MS/MSNMR 97136156使3941 972 25- 972 270970008606973 120970003866Sildenafil西973 120970003866調1314 - Sildenafil95126 SL095F01690-2/2 972 18Sildenafil351.6ppm972 25119 - Sildenafil973 1295126 SL095F01690-2/2 972 25Sildenafil3 38 974 21974 28sildenafilViagra使HPLC 西調38使HPLC調38MDL SildenafilSildenafil 9西西西7879 LC-NMRLC-MS/MSLC-MS HPLCHPLCLC-MS HPLC1 HPLCLC-MS/MSLC-MS LC-MS 466 LC-MS/MS466 LC-NMRLC-MS/MSLC-MS/MS使LC-NMRLC1 NMR LC-NMRX-RAY IR231 974 28Sildenafil西HPLC981113000031187 189 974 28Sildenafil使HPLCHPLC-MS HPLC-MS/MSHPLC-NMRSildenafil0.6mg/g 600 μg/g 1g =1000mg1mg=1000μg<ppm>1 μg=1000ng< ppb>189 HPLC600ppmSildenafil972 25使LC/MS/MS100ng/g 0.0001mg/gSildenafil351.6 μg/g 使972 25600 μg/g Sildenafil95126 Sildenafil21.7ppm 調972 25西西974 使95126 972 25Sildenafil西974 28- 便使 調974 21西Sildenafil調8 調974 28西調68 SildenafilFDA 調3067 使76 使78 95126 SL095F01690-2/2 972 25使Journal of food and drug analysis,Vol.10,No.2,2002,P112-119 使NLFD-3-P5-3010使SildenafilFDA 西38 調- 西調6667 調調6-1 3 3 西4344 SildenafilThiosildenafilSildenafilThiosildenafilSildenafilThiosildenafil40 SildenafilThiosildenafilSildenafilThiosildenafilSildenafilThiosildenafil43 退42西西西SildenafilThiosildenafil7273 971 150960024365Acetildenafil SildenafilAcetildenafil Acetildenafil 83 971 150960024365SildenafilAcetildenafil 85 SildenafilHPLC/MS/MSSildenafilHydroxyhomosildenafil Homosildenafil193 J00 0000000 J000000000 J000000000 J000000 000 J000000000 J000000000 J000000000 J000000000 J000000000 J000000000 J000000000 J000000000 J000000000 J00 0000000 J000000000 19 3 224 西SildenafilSildenafilHydroxyhomosildenafil Homosildenafil西HPC-MS/MS 西194 使6 201 826872Sildenafil6 1 PDR BNF CPS MIMSAnnu al 992 1 FDA 09900016292533- Sildenafil西西Sildenafil201 西Sildenafil- 西40Sildenafil西6 1 6 3 6 3 383969 821 831 951115Sildenafil西951115SL095F0169-2/2Sildenafil西9511151090902 87 821 831 87831 87831 942 2 957 1 56使95107939374686Sildenafil西92946 9 972 西964 242 1 3 7 2 1 1 3 4 821 1 6 3 1 12964 240103- 791 8 9 9227180405- 調- - - 3 調9 06西Sildenafil- 0708 - 西SildenafilThiosildenafil821 87821 831 87831 26 972 25- 972 270970008606973 120970003866Sildenafil西西Thiosildenafil3 3 977 9 1 1 西Thiosildenafil44973 12097000386698116 0980023722調13145461- 西SildenafilThiosildenafil6 1 3 ThiosildenafilSildenafilSildenafil6 3 992 1 FDA 099000162925 SildenafilThiosildenafilSildenafilThiosildenafilSildenafilThiosildenafil西40- 西西- 6 1 Sildenafil使Thiosildenafil6 3 Thiosildenafil- - Thiosildenafil- Sildenafil6 1 Thiosildenafil- 6 3 972 1517972 252 29972 270970008733972 2509731388000 調7880- Thiosildenafil使Thiosildenafil 退 9812773 216 5 978 11Sibutramine Phenolphthalein 西7.5 VIA BEAUTYBeautyLifeSmoothBeautiful 401 800 1,400 162,000 164 165 9714174 959710SildenafilPiperidenafilAcetildenafil Sildenafil 西50-2231 Sildenafil analogue Piperidenafil Acetildenafil225 226 Sildenafil- 9812773 Sibutramine Phenolphthalein 西VIA BEAUTYBeautyLifeSmoothBeautiful 9714174 SildenafilPiperidenafil Acetildenafil 西西西西使西退 調95126 SL095F01690 972 25使 299 1 821 831 8711552 1 3 7 99 5 31 10滿20 99 5 31 01 - 1 02 - 1 03 - 1 04 27 05 3 06 1 07 1 08 1 82 83 調 87