Transcription of ICH Q3D EWG - jpma.or.jp
1 ich q3d ICHQ3 DEWG ICH M7 Q3D 4 27 4 7 Pb 2 ICP ICP Q3D USP Phr Eu Q3D H He Li Be B C N O F Ne Na Mg Al Si P S Cl Ar K Ca Sc Ti V Cr Mn Fe Co Ni Cu Zn Ga Ge As Se Br Kr Rb Sr Y Zr Nb Mo Tc Ru Rh Pd Ag Cd In Sn Sb Te I Xe Cs Ba La Hf Ta W Re Os Ir Pt Au Hg TI Pb Bi Po At Rn Fr Ra Ac Rf Db Sg Bh Hs Mt A B 3 5
2 * GMP ** PhEur,JP,USP) * PDG 2014 11 USP <233> Elemental Impurities-Procedures, EP Determination of metal catalyst or metal reagent residues USP 2015 3 <233> Pharmacopeial Forum 40(2)
3 EU 18 9 USP <233> Elemental Impurities - Procedures Second Supplement to USP 35-NF30 2 ICP-AES ICP-MS Pharmacopeial Forum 40(2) Metal Impurities CP: USP 1 ICP-AES) and 2(ICP-MS) , , +5mL +10mL 1 ICP-AES) 1 2J 2 : : 2J.
4 ICP 1 20% 60 2(ICP-MS) ICP-AES : 1 2 80% 1 2 1 3 15% 2 1 6 RSD20% 50~150% 70~150% RSD20% , : : , J.
5 , 10 g/day ICP-MS g/g g/g ICP-MS ng/mL mg/mL 100 J 5 ng 15 ng/mL a national metrology institute (NMI) (CRM) NMI CRM NMI the National Institute of Standards and Technology Appendix * 60ppm 20ppm CFR2 10ppm * NF 15ppm 15ppm 30ppm 50ppm 50ppm USP 10ppm * 15.
6 30ppm 30ppm Cd522Se15080130Pb555Ag150107As15152Pt100 101Hg3031 3Li55025025 2 ACo5053Sb12009020V100101Ba1400700300Ni20 0205Mo3000150010 2 BTl888Cu300030030Au1001001Sn600060060Pd1 00101Cr1100011003Ir100101Os100101Rh10010 1Ru1001012 4 1 PDE 1 g/day) 10 10 PDE Table PD E 1 PDE( g/day) PDE( g/day) 5 1 2A 1 2A 3 GMP
7 ( USP ) ( ) 60ppm 10ppm 1ppm ) 5ppm 20ppm ( 10ppm 4ppm 10ppm 10ppm 50ppm 10ppm) ( 50ppm) 50ppm 2ppm 40ppm, 5ppm ) ( 50ppm USP 10ppm 20ppm 10ppm Cd 3ppm, Ni 5ppm) 20ppm USP U S P, EP 10ppm PDE 5 g/day 3ppm PDE 5 g/day 5ppm PDE 200 g/day 1 10g 5 g/day 10(g)/day 200 g/day 10(g)
8 /day 20ppm 2a 5 g/day /10ppm PDE 5 g/day /3ppm PDE 1% (%) 50g PDE JP16 25 5 2012 11 ( ) 30 ppm ( ) 10ppm ( ) 30 ppm Cr 3 : PDE 11000 g/day Cr 3 10ppm 3 3 =3 g/day 6 Q3D 6 WHO Q3D USP <232> Elemental Impurities Limits <233> ELEMENTAL IMPURITIES PROCEDURES Parmacopoeial Forum 39(1) 2014 5 1 ich q3d Step2 <232> <233> Pharmacopeial Forum 40(2)
9 2014 10 <232> <233> the ich q3d Step 4 2014 11 2014 12 <232> <233> 2015 6 The Second Supplement to USP 38-NF33 <231>Heavy Metals 2015 12 1 2015 1 2018 1 1 <232> <233> <231> 16 2014 7 the Committee for Medicinal Products for Human Use (CHMP) EMA Guideline on the specification limits for residues of metal catalysts or metal reagents 2014 9 1 Metal catalyst or metal reagent residues Q3D ICH 2015 1 9th edition 2017 1 1 (3 Q3D 17 Q3D Q3C Q3C 17 Q3D 36 PDG Q3D Q3D)
