GPC/SEC
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- たみえ いちぞの
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1 GPC/SEC
2 Agilent GPC/SEC / GPC/SEC...24 Q Q Q Q Q 35 GPC/SEC GPC/SEC GPC/SEC GPC 2
3 80 % Polyplasdone Ultra (ISP) Lµtrol micro Kollidon CL-F & CL-SF ( BASF) Swelstar MX 1 ( ) GalenIQ 721 (Palatinit) - Spectrablend HS (Sensient) Prosolv ODT (JRS) Ludiflash (BASF) Aquarius (Ashland) Avicel DG (FMC) Sepitrap (Seppic) Starcap 1500 (Colorcon) - Solutol HS 15 Soluplus Kollicoat Smartseal 30 D ( BASF) Spress B818 Pregelatinized Corn Starch NF (Grain Processing Corporation) ICH M4Q (Quality) 1 () ( ) 1 The Common Technical Document for the Registration of Pharmaceuticals for Human Use:Quality - M4Q(R1) EU 3
4 Quality by Design QbD (Quality by Design) 20 J. M. Juran Juran QbD % QbD QbD (GPC SEC ) GPC/SEC HPLC 2 Pharmaceutical Quality for the 21st Century - A Risk-Based Approach.USFDA 4
5 (PVP ) : PLgel 10 µm MIXED-B 7.5 x 300 mm x 2 ( PL ) : DMF % LiBr : 70 ºC : 1260 Infinity GPC/SEC (RI) (DMF) RI DMF Agilent PLgel 10 µm MIXED-B ( 1) 10 min Agilent PLgel 10 µm MIXED-B 5
6 PVP (DMAc) PLgel 10 µm MIXED-B ( 2) : PLgel 10 µm MIXED-B 7.5 x 300 mm x 3 ( PL ) : DMAc % LiBr : 0.2 % w/v 100 µl : 60 ºC : 1260 Infinity GPC/SEC (RI) 5 3 : Agilent PL aquagel-oh 60 8 µm 7.5 x 300 mm ( PL ) PL aquagel-oh 50 8 µm 7.5 x 300 mm ( PL ) : 0.2 M NaNO M NaH 2 PO 4 ph 3 : 50 ºC : RI Agilent PLgel 10 µm MIXED-B Agilent PL aquagel-oh 6
7 - (Liquid chromatography under critical conditions: LCCC) PEG PEG MW SEC LCCC PEG PEG 4 PEG PEG GPC/SEC PEG 5 SEC ACN/ PEG 22,800 PEG 8,500 PEG 960 SEC 70 % ACN 49 % ACN % ACN 5. SEC 4. ( ) ( ) 7
8 6 PEG : Agilent PLRP-S 100Å 5 µm 4.6 x 150 mm ( PL ) : 49 % : 20 µl : Agilent 1260 Infinity 1 ( PEG ) 2 ( ) 2 PEG 8 % PEG 45 % 47 % SEC (PEG ) PEG HCI PEG- SEC PEG- PEG (8 %) (45 %) (47 %) ( ) ( ) Agilent 1260 Infinity ( ) 1290 Infinity ( ) 8
9 Agilent PL aquagel-oh MIXED-H 8 µm (PEO/PEG 1000 ) (>35,000 /m) PL aquagel-oh MIXED-H 8 µm 2 mg/ml 0.45 µm 7 Mp 1,600,000 Mp 788,000 Mp 212,000 8 : PL aquagel-oh MIXED-H 8 µm 7.5 x 300 mm x 2 ( PL ) : 0.2 M NaNO M NaH 2 PO 4 ph 7 : 50 ºC : RI D C Log M Mp 47,300 Mp 11,800 B Mp 667 A Agilent PL aquagel-oh MIXED-H 8 µm 8. Agilent PL aquagel-oh MIXED 4 Agilent GPC/SEC GPC/SEC Agilent EasiVial Agilent EasiCal Q Q Q Q Q GPC Calibrating GPC Columns - A Guide to Best Practice ( EN : ) 9
10 9 : PL aquagel-oh MIXED-H 8 µm 7.5 x 300 mm x 2 ( PL ) : 0.2 M NaNO M NaH 2 PO 4 ph 7 : 50 ºC : RI A B C D D (Mw/Mn) Mn Mw A 6,520 17, B 21,720 88, C 67, , D 128, , dw/dlogm (Mw/Mn) 2 log M 8 PL aquagel-oh MIXED-H 8 µm
11 N- 2 GPC/SEC Mw 2 Agilent PL aquagel-oh MIXED-H 8 µm 3 ph 0.5 M PL aquagel-oh MIXED 8 µm 7 (9 ) 3 (Mw) 10 ( /) RI : PL aquagel-oh MIXED-H 8 µm 7.5 x 300 mm x 2 ( PL ) : 0.5 M NaNO M NaH 2 PO 4 ph 2 : 50 ºC : RI A (Mw 367,600) B (Mw 385,800) C (Mw 449,350) 5 20 RI HPLC GC 11
12 2 PL aquagel-oh SEC : PL aquagel-oh 60 8 µm 7.5 x 300 mm ( PL ) PL aquagel-oh 40 8 µm 7.5 x 300 mm ( PL ) : 0.05 M NaH 2 PO M NaCl ph 7 : 50 ºC : RI dw/dlogm A B (cps) ,000 6,000 Mn 131, ,000 Mw 369,000 1,023,000 Mz 691,000 1,884, log M Agilent PL aquagel-oh 2 12
13 1 PL aquagel-oh MIXED-H 8 µm 0.1 M NaOH ph 1.0 mg/ml Mp 186, mg/ml Mp dn/dc dn/dc dn/dc 90º 15º Mw RI LS SEC Mw 174,000 (90º) 189,850 (15º) 184,800 (SEC) 90º 15º RI RI : PL aquagel-oh MIXED-H 8 µm 7.5 x 300 mm x 2 ( PL ) : M NaNO M NaH 2 PO 4 ph 7 : 1260 Infinity GPC/SEC RI 18 (mv) 12 RI 90º 15º Agilent PL aquagel-oh MIXED-H 2 90º 15º 13
14 : PLgel 10 µm MIXED-B 7.5 x 300 mm x 3 ( PL ) : DMAc % LiBr : 0.2 % w/v 100 µl : 60 ºC : 1260 Infinity GPC/SEC (RI) 15 min Agilent PLgel 10 µm MIXED-B Agilent 1260 Infinity GPC/SEC 14
15 (CMC) Agilent PL aquagel-oh 40 8 µm PL aquagel-oh 60 8 µm CMC (>35,000 /m) PL aquagel-oh 14 3 : PL aquagel-oh 60 8 µm 7.5 x 300 mm ( PL ) PL aquagel-oh 40 8 µm 1.5 x 300 mm ( PL ) : 0.5 M Na 2 SO 4 : RI 0.3 dw/dlogm log M Mw Agilent PL aquagel-oh 15
16 - HPLC (CD) CD HPLC UV RI (ELSD) HPLC ELSD 1260 Infinity 1 Agilent ELSD : C18 5 µm 4.6 x 150 mm A : B : : 20 µl : % B : 1260 Infinity ( = 30 ºC = 50 ºC = 1.0 SLM) Agilent ELSD UV 221 nm 15. Agilent ELS () 15 ELSD 16
17 Agilent ELSD ºC 50 ºC Agilent ELSD 1 Agilent ELSD UV UV HPLC ELSD ESLD HPLC : C18 5 µm 4.6 x 150 mm A : B : : 20 µl : % B : 1260 Infinity ( = 30 ºC = 50 ºC = 1.0 SLM) ºC 30 ºC Agilent ELSD 17
18 in vitro 17 2 Agilent PLgel 5 µm MIXED-C THF 80, : PLgel 5 µm MIXED-C 7.5 x 300 mm x 2 ( PL ) : THF ( ) : 200 µl : RI ~ Agilent PLgel MIXED-C ( ) 18
19 () - (GPEC) GPEC GPEC GPEC LC HPLC (GPEC ) ( ) / ( HPLC ) /
20 99 % % 99 % : Agilent PLRP-S 100Å 5 µm 4.6 x 150 mm ( PL ) : THF : 20 µl : : Agilent 1260 Infinity : 1260 Infinity (%) (%) 50 (%) log Mn 5.0 log Mn 0 % R 2 = % 7.5 Rt/min % % % GPEC GPEC 20
21 / (HEC) HEC GPC (DMF) PLgel 5 µm MIXED-C LiBr ( 21) DMF PEO/PEG Mn Mw Mp (Mw/Mn) A 27, ,000 80, B 30, , , C 39, , , : PLgel 5 µm MIXED-C 7.5 x 300 mm ( PL ) : DMF % LiBr : 50 ºC : RI B A dw/dlogm 1K 10M 21. Agilent PLgel 5 µm MIXED-C 3 3 C 21
22 3 PL aquagel-oh Mn Mw Mz (cps) A 60, , , B 413, ,000 1,552, C 914,000 2,016,000 3,422,000 1,500 2,500 : PL aquagel-oh 60 8 µm 7.5 x 300 mm ( PL ) PL aquagel-oh 40 8 µm 7.5 x 300 mm ( PL ) : 0.05 M NaH 2 PO M NaCl ph 7 : 50 ºC : RI 0.5 A B C HEC PL aquagel-oh 40 PL aquagel-oh 60 8 µm PL aquagel-oh 23 HEC A HEC B A : : PL aquagel-oh 60 8 µm 7.5 x 300 mm ( PL ) PL aquagel-oh 40 8 µm 7.5 x 300 mm ( PL ) : 0.05 M NaH 2 PO M NaCl ph 7 : 50 ºC : RI 0.4 B A dw/dlogm dw/dlogm log M Agilent PL aquagel-oh
23 NMR FTIR HPLC GC/MS SEC GC/MS UV-Vis GPC-FTIR (GPC) (FTIR) 2 1 GC/MS (GC) / (GC/MS) GC GC/MS LC LC/MS ( ) Agilent 6100 Agilent 6200 Accurate-Mass TOF LC/MS Easy Access Agilent 6500 Accurate-Mass Q-TOF LC/MS MassHunter Agilent Poroshell 120 LC 2 µm LC Poroshell LC LC/MS ICP-MS Agilent 7700x ICP-MS (HMI) ORS3 () x Apparatus Agilent 708-DS Apparatus 3 Agilent BIO-DIS Apparatus 7 Agilent 400-DS Apparatus 7 Agilent 400-DS Agilent Poroshell
24 GPC/SEC (5 7) Agilent 1260 Infinity GPC/SEC 5. Agilent 1260 Infinity GPC/SEC ( ) G1310B G1322A G1316A G1329B Agilent 1260 Infinity 1260 Infinity 1260 Infinity 1260 Infinity G1328C 1260 Infinity GPC/SEC GPC 80 ºC mm GPC GPC/SEC µl (PEG) (PEG) (HPMC) (PVAP) (CMC) * * * (HEC) * 24
25 6. Agilent 1260 Infinity GPC/SEC ( ) * G1362A G1314F G7850AA G7854AA 1260 Agilent 1260 Infinity Agilent GPC/SEC Agilent GPC/SEC G1365D Agilent 1260 Infinity 8 µl LAN GPC (PEG) (PEG) (HPMC) (PVAP) (CMC) (HEC) * 1 (G1362A G1314F G1365D ) HPLC LC LC/MS HPLC GC CrossLab CrossLab Bruker/Varian CTC PerkinElmerThermo/Dionex Waters CrossLab
26 Agilent 1260 Infinity GPC/SEC 7. Agilent 1260 Infinity GPC/SEC ( ) G1310B G1322A G1316A G1329B G7800A Agilent 1260 Infinity 1260 Infinity * Infinity 1260 Infinity 1260 Infinity G1328C 1260 Infinity GPC/SEC GPC 80 ºC x 300 mm GPC GPC/SEC µl (PEG) (PEG) (HPMC) (PVAP) (CMC) * 2 * 2 * 2 (HEC) * 1 * 2 * 3 1 (G7801A G7802A G7803A ) * Infinity MDS (G7801A) * Infinity MDS /1260 Infinity MDS 26
27 G7801A* 3 G7802A* 3 G7803A* 3 G1314F* 4 G7850AA G7852AA G7854AA 1260 Infinity MDS 1260 Infinity MDS 1260 Infinity MDS Agilent 1260 Infinity G1365D* 4 Agilent 1260 Infinity Agilent GPC/SEC Agilent GPC/SEC * 5 Agilent GPC/SEC GPC 15º 90º Mw 1 GPC GPC Agilent GPC/SEC 27
28 agilent.com/chem/navigator LC 4 Q Q Q Q - LC - - USP : : Agilent EasiVial Agilent EasiCal GPC Calibrating GPC Columns - A Guide to Best Practice ( EN ) _japan@agilent.com Agilent Technologies, Inc Published in Japan, March 14, JAJP
SEC (SEC) SEC SEC SEC 2
SEC (SEC) SEC SEC SEC 2 SEC ( 1) 1: SEC www.agilent.com/chem/jp 3 ( ) ( 2) ICH (Q6B) 3 lgg 8 7 6 5 4 1. 2. 3. 4. 5. Agilent AdvanceBio SEC 3 Å 7.8 x 3 mm 2.7 µm (p/n PL118-531) Agilent 126 Infinity LC
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