エンドトキシン測定用試薬 2011/2012 - エンドトキシン試験
Contents
1. Be gt aE 0 001EU mL Pyrochrome 0 001 EU mL FDA U S Licence No 700 MEndospecy ES 50M MEndospecy9 ES 24S CHE Pyrotell8 T MP 962. 10 000 1 10 000 a
3. 8 8255 MSDS
4. PAE 2 Limulus polyphemus 3 18 Tachypleus tridentatus Tachypleus gigas Tachypleus rotundicauda TS 8 G G RES FERNALD TS test solution LAL Limulus amebocyte lysatfe
5. Ot 2 1 100V 30W 50 60Hz 2 500rpm 50Hz 2 0kg NFS as W105 XD130XH160mm 900675 TM 251 30 000 1 AA ae LAL Accessory Products 6 LAL Accessory Products 8 QP ize A TE w EZEZA EA CA Y A 7 anit LPs Ain OS sn sv N 900520 3mL 6 2
6. 1 ES LAL TEL 03 3537 7913 FAX 03 3537 9061 E mail lal seikagaku co jp URL http www seikagakubb co jp 1 TEL 03 3959 1351 FAX 03 3959 9401 E mail info scinics co jp URL http www scinics co jp MP 96 SK603 0 65 4 3 3 EG SV 12
7. AU a a eI SEC moe a ik FCN URES Ase Wa Feo 10
8. 4 1 50 Instrumentation and Software TTT ALB 121 ALB 121 2 zam US 0 1 0 4 C 0 1 200W SKC Ow 7 Bl ig a ca W190 X D280 X H160mm AC100V 50 60Hz 2 5A m R 900481 ALB 121 1 8 230008 10 5mmX45mm 36 ALB 121 12 0mmX45mm 3677 900505 ALB 121 1 98 000 900506 ALB 121 1 141 000 900462 1 23 000 51
9. 100uL 100uL ES 245 EG SV 12 gt e 9 8 5 T 6 2710 ControlStandard Endotoxin ACC 200 1000 LP 1 800810 O SARE SSB
10. 8 200 uL 1000 uL B m a R 900540 200 500 27 000 900545 1000 100 16 000 58 N j O h Q gt O N N U WJ Y lt 9 By aloe E 8 AREA 500798 Associates of Cape Cod Inc 800810 10x75mm 9 000 LP B 96
11. ER ES Part11 SK603 MP 96 ER ES Part1 1 ER ES Part11 ER ES Part 1 1 SK603 MP 96 900604 ER ES Part1 1 e CD ROM 1 e 1 46 Instrumentation and Software 47 SK603 MP 96 EG SV 12 Windows Vista Windows2000 XP Vista I Windows m lt 900606 SK603 MP 96 Vista 1 11 000 900607 EG SV 12 Vista 1 11 000 eCD ROM 1 Instrumen
12. 2 3 m 900620 1000 1 CD ROM 1 e 1 Instrumentation and Software 52 Instrumentation and Software 53
13. 1000 MP 96 SK603 1 3 D A
14. CD eo ee 87 5 LPS RA A 2 ae 1 Se Ol la ik gt TNF 7a NA LAL LAL
15. 2001 3 1999 JP14 2003 EU CH Q4B 2004 2009 10 EP 2010 1 USP 2010 10 JP 2011 4 JIS y g ac ot Ba ENS EN 7 Y gt EI e lt i ve d Y Ey gt SY f A a 8 5 5 EVEN EY lt AS 7 AA yo i be OR a TON gt Fi Y gt A x lt an f la eNOS AC TS TD DN RNA RAI et EN A PI IN SY CESE O f A E lt E e
16. ER ES Part11 EFA FE TS HDF Instrumentation and Software tk RESCH 380 800nm 10nm 2nm 2nm 405nm 492nm 6 gt TE 0 005Abs 60min at0 000Abs 0 01Abs Gt0 000Abs 0 000 3 000Abs 0 000 2 000Abs 2 7 0 005Abs 296 at 0 300Abs Ma VAY Dene ea 3 05 Hat 1 8 RE 2 e Rate e Delta T 1 5 2 10
17. MP 96 SK603 EG EG SV 12 Part 11 FDA 1997 ER ES 21 11 ER ES 2005 ER ES Electronic Records and Electronic Signature 1995 3 1 158 GMP IO 0Q 0 00 0 DO Design Qualification 1Q Installation Qualification OQ Operational Qualification PO
18. FDA FDA Method Qualification EZRA mM KORE ROD i 160 250 C C 30 2 Peace 250 30 MVD Maximum Valid Dilution LAL
19. Windows 9 RS 232C PC e EG SV 12 1 e CD ROM 2 1 9 1 1 3 2 1 8 1 43 Instrumentation and Software 400 660nm OS Windows 2000 XP FSA JA 405nm 492nm 2nm HEE Inmo nm CPU 600MHz 2 KUNA HDD 100MB 1000 256MB 2 99 800X600 oe PP RS 232C DSUB 9 TEF 1 2 0Ps
20. padeau WO te CORPORATION Wellreader MP MP 96 LAL Pyrochrome with Glucashild Buffer MP 96 900625 MP 96 1 700 000 MP 96 1 DOS V 1 e CD ROM 1 e 1 3 2 1 e 1 4 Windows Reader for Windows
21. C 3 8 Db G Associates of Cape Cod Inc mL 50 800810 FDA 4 a 4 010210 0 03EU mL 1 18 000 010215 0 06EU mL 1 17 500 010220 0 125EU mL 1 17 000 Associates of Cape Cod Inc 1 0 2mL 800807 C G FDA R 010230 0 03EU m
22. Dn MSDS RY MSDS CONTENTS RG SR ee ASA ee A S 2 3 3 4 5 Pyrochrome 6 7 LAL Giese
23. y A gt A OO _ 2 LS em Smm rr cinc A Ts
24. 1 Instrumentation and Software 38 Instrumentation and Software 8 i 39 Instrumentation and Software MP 96 MP 96 1 3 8 D MP 96 MP 96 9 Windows 9 ft RS 232C PC 40 Instrumentation and Software MP 96
25. LAL human agnostic use itage insert for 03 OVERVIEW OF 2 C dlc Limulus polyphemus LAL Limulus Amebocyte Lysate Chapter lt 85 gt USP BRINSE EA chapter 2 6 14 EP 4 01 JP 1980 USP 1988 JP11 1996 JP13
26. X8 59 X1 66 8 X16 20 D X1 X1 50 4 X1 10 X1 LAL Reagents Colorimetric Method mm 27 EN a pa p 6 PY of E RS ENS y LAL Disso ER Exp po no LAL Reagents Colorimetric Method ES 50M 1 3 D G MP 96 0 001EU mL 0 002 0 1EU mL
27. RS5232C 9 Reader for Windows Windows 2000 XP 5 232 77 DSUB 9 10 27 C RH70 W333XD422 XH163mm AC90 130V 50 60Hz 200W 15Kqg lt 42 Instrumentation and Software EG SV 12 EG SV 12 12 4 4 48
28. 0 001EU mL MPyrotell9 T 0 001 EU mL FDA 1 U S Licence No 700 180 Pyrotell 0 03EU mL Pyrotell 0 03 0 06 0 125 EU mL FDA U S Licence No 700 Pyrotell 0 03 0 06 0 125 EU mL FDA U S Licence No 700 MP 96 O EcG SV 12 ZE 2111611118 11 0 05mL 0 2mL LAL 2 50 0 05 1 ell ESO 82 1R0 05mL 0 2mL 0 05mL Fi OS
29. 8X12 0 3mL BM 900570 31 000 LAL Accessory Products 60 LAL Accessory Products PZA J DS E 50x50mm 250 2 E 800804 SET ISSA 1 5008 PER 14X18mm 250 2 ES 24S5 800807 9 ES 50M LS 50M R 800817 26mm 9 1 3 500 6
30. B 1 3 1 6 1 4 3 8 D 1 3 8 D E coli 0113 H10 EU 1EU 1 IU LU E coli UKT B JPRSE The Japanese Pharmaco 00613 Reference Standard Endotoxin WHO 1 10 000 25 000EU
31. MP 96 ALB 121 O O TM 251 O O O O O 1 8 2 LAL LAL Reagents han o Pr ti a sti pus 10 LAL Reagents Colorimetric Method LAL Reagents Colorimetric Method Pyrochrome with Glucashield Buffer Pyrochrome FDA Limulus polyphemus LAL Limulus Amebocyte Lysate TU Pyrochrome with Glucashield Buffer l4 Limulus polyphemus LAL
32. ie dica ois SE ety lo Sle oe ae CACA TA A 1 1 eta EAN A AR A A AAA A A 19 OT JUE RA AENA e AAA A E Rw A RA A 21 LAL St Rie ee ee A RO e eS Se RRR 9 9 25 aw oo we eS a a 29 OZ ERRE AAA AAA AAA 31 E a eo res aa rare aora 35 dE A A A A e RA A 39 Oy 7 45 EA A AR A RAR ARAS ARAS 48 A EA ARANA 50 A A e e A RA AR A AAA 5 bere tor Sin Ge GRE ee a ee ee Ge es ee GR ee a ad a ee eS E 57 63 INDEX Coe HEEREHES CERNE RRS So 6S BED R RRS CREED RSS OK EEE RR ESS 65 a A i 0 66 http www seikagakubb co jp lalweb PULL SUPPORT
33. ES 50M C m a 5 Sn a 1 020150 ES 50M 50 28 000H 2 8mLX1 LAL C 1 Et 2 8mLX1 LS 50M C E 123 8 D G MP96 0 001EU mL 0 002 0 1EU mL LS 50M E a 020130 LS 50M 1 210008 50 i 2 8mLX1
34. Glucashield CAE Pyrochrome with Glucashield Buffer 1 3 8 D 0 001 EU mL 0 005 EU mL LAL Reagents Colorimetric Method LRA SRE RE Pyrochrome l amp 0 001 10EU mL 0 005 50EU mL 2 a hs Stucan tnHIBITING BF LAL Pyrochrome LAL Glucashield pH
35. RS 232C PC El 0 000 2 000 0D 2 0 ae 7 2 2 12X65mm In PID n 37 0 5 15 C 35 C RH45 80 Milla ERRE AC100V 109 50 60Hz 2A 200W ee 3 85 O fs HE A S W180XD303 x H270mm Tp Y GT YEAS 96 6 At lt 44 Instrumentation and Software 45 Instrumentation and Software UR URA OE SK603 MP 96
36. T 0 2M pH7 4 pH pH a 010271 DH 5 5mL 5 10 000 010272 DH 55mL 1 10 800 LRW LAL Reagent Water Associates of Cape Cod Inc T ACC CSE a8 010290 LRW 10 10 000 5 5mLx10 Associates of Cape Cod Inc T G
37. Glucashield 1 3 B D LAL aia CERT Pyrochrome 2 8 8 Pyrochrome FDA U S License No 700 Associates of Cape Cod Inc C a 1 010265 Pyrochrome with Glucashield Buffer 60 23 000H eLAL 1 Glucashield8 5 5mLx1 LAL Reagents Colorimetric Method Pyrochrome e 37 405nm 492nm ERRE 0 00550EU mL 60 90 oa a a a 916 8666 86688 88 7 X2
38. 28 log 00 1 1 1 ES 245 96 REA Rate Delta T Dat
39. 558 1 Fie sms SPR Rees i LAL Accessory Products HD 4 7 HDF ERARE I gt 800826 22 000 62 63 A WI 5 8 8 8 E E AE Endotoxin oo Pee Pyrogen
40. N ad ae 57 4 es 10 200 0 5 10uL 0 01 es 100 200 10 lt 100uL 0 1uL es 200 200 20 200uL 1 uL es 1000 1000 100 1000uL 1 a 900513 10 1 25 000 900515 100 1 25 000 900516 200 1 25 000 900517 1000 1 25 000
41. DH 55mL vial LRW LAL CSE L LS 50M ES 50M ES 24S 11 6x65mm 26mm 9 I EG II EG S I EG I EG P HD 1 1 1 1 150 50 1 1 1 1 1 10 10 10 1 1 5 5 1 10 5 1 1 1 1 1 100 1 100 50 1 50 50 50 7 000 7 000 52 000 24 000 10 000 28 000 10 000 24 000 18 000 17 500 17 000 12 000 10 000 10 000 18 000 23 000 10 000 10 000 10 600 10 000 15 000 50 000 10 000 21 000 28 000 33 000 11 000 1 500 9 600 9
42. lt Wa Ms http www seikagakubb co jp lalweb index html HP Box 6 1 Box 2 Box 9 CSE e HP 66 104 0033 17 24 Telephone 03 3537 7913 Facsimile 03 3537 9061 E mail lal seikagakubb co jp URL http www seikagakubb co jp 2011 8 1 3T MP
43. LAL CAs C ze a abe G AT kA MK 1 3 8 D 8 C G aka C G C 1 3 8 D G 1 3 8 D 1 3 D
44. Performance Qualification HDF Hemo Dialysis Filtration HD A Aiko AC a Windows Excel Word Micros
45. 1 3 D lt 010291 e 5 5mLX5 32 Other Reagents Other Reagents 35 Glucatell 1 3 8 p 1 3 8 p 55 MP 96 T Associates of Cape Cod Inc G E e 1 1 1 3 8 D 1 e 1 9
46. E ey il de JJ E 200 1000 LP 1 A 1 gs 7i FARAILE O MP 96 EG SV 12 ALB 121 O8 TM 251 Control Standard Endotoxin ACC 2 3 4 5 CO N 8 MP 96 ES 245
47. 85 71 7 EUT 1 1 FDA Endotoxin Unit 5EU kg WHO 1EU 1 U JP The Japanese Pharmacopoeia USP The United States Pharmacopeia EP European Pharmacopoeia DR PDG Pharmacopoeial Discussion Group CBER FDA Center for Biologics Evaluation and Research FDA ICH EU The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use DEX ICH Q4b ICH Q4b EWG 2
48. LAL 1 OR BK Et 2 8mLX1 16 LAL Reagents Colorimetric Method LAL Reagents Colorimetric Method ES 24S 1 3 8 D G EG SV 12 0 001EU mL EE 0 002 0 1EU mL ES 24S C A a 68 TE 8 1 020170 ES 24S 24 33 000 Pir 2 8mLX4 LAL C 24 Et 2 8mLx
49. SEIKAGAKU BIOBUSINESS ENDOTOXIN 2011 2012 ENDOTOXIN INTRODUCTION 2011 7 1 2011 7 1 a
50. 1 1884 Christian Gram LPS Dei nog 4 LPS Lipopolysaccharide 0 R A 10 FATA ERAN amp
51. DIA60 STV Hydrochloric HCI solution Sodium nitrite 4 8mgx3 3 N 1 Naphthyl ethylenediamine dihydrochloride 8 4mgx3 DIA150 MP Associates of Cape Cod Inc DIA150 MP ES 50M LS 50M 010145 VP VRE DIA150 MP Hydrochloric HCI solution M Sodium nitrite 1 65mgX2 2 Ammonium sulfamate 12mgx2 3 N 1 Naphthyl ethylenediamine dihydrochloride 2 8mgx2 BA N Methyl 2 pyrrolidone solution 4 0mLx2 30 LAL Related Reagents Other Reagents Associates OF CAPE COD IM 15 Saint Jean Dr East Falmai RECONSTITUTION BY PYROSOL BINS Tris hydroxymethy ride 0 2M pH 7 4 at 37 pee package insert for use 31 LAL Related Reagents Other Reagents my Associates of Cape Cod Inc
52. gt 2 MVNONUNSI 4 ASSOCIATES OF Stains 1 65 mg lyophaat s gt reconstitute add la ycrochloric Acid Set _ use instructions contains 12 mg lyophiliz od h Recon fr 29 LAL Related Reagents Diazo Coupling Reagents DIA p ARE 545nhm 545nm 630nm DIA60 STV Associates of Cape Cod Inc DIA60 STV WES 24SM 010045
53. 000 3 500 13 000 14 000 22 000 25 25 27 29 29 21 21 21 21 21 21 19 11 31 31 31 31 31 35 27 15 15 17 59 61 61 59 61 62 900461 900482 900505 900506 900510 900513 900515 900516 900517 900520 900540 900545 900560 900570 900604 900606 900607 900620 900625 900630 900636 900637 900638 900639 900640 900641 900642 900643 900645 900646 900647 900648 900649 900651 900652 900653 900654 900656 900675 ALB 121 10 5mmX45mm 3671 ALB 121 12 0mmX45mm 367 ALB 121 ALB 121 10 0 5 10AL 100 10 100AL 200 20 200AL 1000 100 1000uL a 3 0mL 8 200 1000 96F LP MP 96 SK603 ER ES Part1 1 SK6
54. 03 MP 96 Vista EG SV 12 Vista 1000 MP 96 EG SV 12 SV 12 ND ND ND SK603 450nm 570nm 660nm OCP2000 IQ 0Q IQ 0Q 405nm 492nm 545nm 630nm MP 96 SK603 TM 251 1 1 1 1 1 1 1 1 1 50 500 100 50 50 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 23 000 23 000 98 000 141 000 33 000 25 000 25 000 25 000 25 000 26 000 2
55. 0645 OPC2000 160 000 e 1 e 1 e ec 1 METI is 1 se 1 HR a 900646 1 180008 900647 1 15 000 EG SV 12 ND _ 900637 ND NUS 120 000 O ND 4 NDT 70 NDT 50 NDT 25 TA 1 ERE He 9 od 1 8 e 1 a 900638 1 15 000 900639 ND 1 15 000 IOQ 0Q a 900648 IQ OQ 150 000 900649 IQ OQ 240 000 Instrumentation and Software
56. 2 SS Miro XRD Ary 7 EL CRUE 71240 7 2800807 18 LAL Reagents Turbidimetric Method E ONE cane WS aMEBOCYTE LYS ta PYROTELE T 5 4 Steg ai st Sore rons LAL Reagents Turbidimetric Method T FDA U S Licence No 700 T LAL C 1 3 8 p G 5mL vial 50 MP 96 0 001EU mL T Associates of Cape Cod Inc C G FDA m a TEn 1 010250 T 50 18 000 LAL 1 20 LAL Reagents Gel clot Method 21 LAL Reagents Gel clot Method FDA U S License No 700 LAL
57. 7 000 16 000 31 000 31 000 1 200 000 11 000 11 000 9 600 000 1 700 000 980 000 12 000 120 000 15 000 15 000 2 000 000 60 000 60 000 60 000 160 000 15 000 15 000 150 000 240 000 45 000 45 000 45 000 45 000 15 000 30 000 21 21 21 21 57 58 58 58 58 Sm 58 58 59 45 47 47 52 39 43 48 49 49 49 48 48 48 49 49 49 49 49 48 48 48 48 48 53 ESO a ON LAL Tel 03 3537 7913 Fax 03 3537 9061 E mail lal seikagakubb co jp http www seikagakubb co jp lalweb index html ESTO ER OPA IEA E Te Eo http www seikagakubb co jp lalweb index html Tel 03 3537 7912 Fax 03 3537 9060 Ree et Sse lo uve a PA 7 x Lar z 1 ROL a CON DEO
58. EA Es K NAS S Ta Y OY OO 827 Sag A me LAL Factor C Activated Activated Factor C Factor G Activated Proclotting enzyme Clotting enzyme Boc Leu Gly Arg pNA H Gly Leu Gly Arg Lys Arg Gly Ser OH 16 17 18 19 46 4 175 Coagulogen Boc Leu Gly Arg OH H Gly Leu Gly Arg OH Gly Ser OH nn a 1 16 17 18 47 175 Azodye 545nm 405nm S S 2 Coagulin Gel 04 OVERVIEW OF
59. L 10 12 000 010240 0 125EU mL 10 10 000 010245 0 25EU mL 10 10 000H 22 LAL LAL Related Reagents LAL Related Reagents Standard Endotoxin EOD ESA MONT N Why i AN E y Mp Y 2 hy 25 L LAL Related Reagents Standard Endotoxin CSE ACC CSE CSE CSE E coli O113 H10 ps pa a o Ps Coe Control Standard Endotoxin 382 Associates of Cape Cod Inc 010020 Control Standard Endotoxin 7 000 10ng vial 1 TYR AEST REE lt a 010022 Control Standard Endotoxin 7 000 e0 5ug vial 1 26 LAL Related Reagents Standard Endotoxin 27 D ans 7 lt lt TOXIN 10 000 5 Endotoxin is pyrogenic Han Ne mination This material co ge isp r l contains 10 000 US ite terial Endotoxins 1 Al iener the vial in 5 M i Chapte
60. mi 0 2mL 2 2 2 0 00 2LAL LAL 0 05mL 37 C PRE ORE Bran re 20s 1 0 05mL 1 0 5mL 2 0 05mL 2 0 5mL 3 0 05mL 3 0 5mL 1 Pyrochrome 0 005 50EU mL 2 0 2mL 06 0 OVERVIEW OF lt TF 5 DS WES 50M WLS 50M WES 24S Control Standard Endotoxin ACC CSE L 0 P USP2 EP DIA150 MP DIA60 STV
61. oft 64 65 INDEX 010020 010022 010023 010045 010095 010096 010097 010145 010210 010215 010220 010230 010240 010245 010250 010265 010270 010271 010272 010290 010291 010310 020055 020130 020150 020170 800798 800804 800807 800810 800817 800820 800821 800826 E coli 0113 10ng vial E coli 0113 USP DIA60 STV G MK G MK G MK DIA150 MP 0 03EU mL 0 06EU mL 0 125EU mL 0 03EU mL 0 125EU mL 0 25EU mL T 0 001EU mL pH 5 5mL vial pH 5 5mL vial
62. r lt 85 gt 4 NO Unopened vial all 1235503 USP LAL Related Reagents Standard Endotoxin E coli O113 H10 USP du RSE 10 000EU USP Reference Standard Endotoxin lt a 010023 USP Reference Standard Endotoxin 52 000H 10 000EU vial 1 CSE Eco 7O113 H10 PR OES TA LS 50M Et 8 0 1EU mL CSE L 020055 CSE L 10 0004 ORBK Et 2 8mLx6 OE ME coli 0113 H10 3 28 __SOCIATES OF capea 4 Nard E Saint Jean Dr l st Fal 1 1 SODIUM NITRITE he
63. tation and Software MP 96 SK603 EG SV 12 m a 900656 MP 96 SK603 1 15 000 900636 SV 12 1 12 000 MP 96 SK603 EG SV 12 WET MP 96 SK603 EG SV 12 AR R 900651 405nm 1 45 000 900652 492nm 1 45 000 900653 545nm 1 45 000 900654 630nm 1 45 000 900641 450nm 1 60 000 900642 570nm 1 60 000 900643 660nm 1 60 000 48 Instrumentation and Software MP 96 SK603 OPC2000 90
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