USP34-细菌内毒素《85》_原创文档.pdf,REAGENTS AND TEST SOLUTIONS 试剂和测试溶液 Amoebocyte Lysate— A lyophilized product obtained from the lysate of amoebocytes (white blood cells) from the horseshoe crab (Limulus polyphemus or Tachypleus tridentatus ).
92〈85〉 Bacterial Endotoxins Test / Biological Tests USP 3550% to 200% of the known added endotoxin concentration Three tests are described (i.e., the Agar Diffusion Test , the after subtraction of any endotoxin detected in the solution Direct Contact Test , and the Elution Test ).* ...
In the event of doubt or dispute, the final decision is made based upon the gel-clot limit test unless otherwiseGeneral ChaptersUSP 40 Biological Tests / á85ñ Bacterial Endotoxins Test 163Official from May 1, 2017Copyright (c) 2016 The United States Pharmacopeial Convention. All rights ...
Test for Interfering Factors — Usually prepare solutions (A –D) as shown in Table 1, and perform the inhibition/enhancement test on the Sample Solutions at a dilution less than Page 1 of 5 © 2010 USPC Official 5/1/11 - 7/31/11 General Chapters: <85> BACTERIAL ENDO...2014-4-...
] Water for Bacterial Endotoxins Test (BET)— Use Water for Injection or water produced by other procedures that shows no reaction with the lysate employed, at the detection limit of the reagent. 细菌内毒素检测 BET 用水 — 使用注射用水或用其他方式制得的不会与鲎试剂检测限对应浓度的溶菌液...
Printedfrom:https://online.uspnf/uspnf/document/GUID-F9D9BFA5-099F-452C-9711-47674B37C1CC_2_en-US?highlight=85 ©2019USPC 〈85〉BACTERIALENDOTOXINSTEST PortionsofthisgeneralchapterhavebeenharmonizedwiththecorrespondingtextsoftheEuropeanPharmacopoeiaand/ortheJapanesePharmacopoeia.Those portionsthatarenot...
BACTERIAL ENDOTOXINS TEST(细菌内毒素检验)USP40.pdf,Accessed from 10.6.1.1 by belmont7 on Tue Nov 01 10:28:09 EDT 2016 USP 40 Biological Tests / á85ñ Bacterial Endotoxins Test 163 ment can be a serious source of bias. In general, the rejection of meas
85 BACTERIAL ENDOTOXINS TEST Portions of this general chapter have been harmonized with the corresponding texts of the European Pharmacopoeia and or the Japanese Pharmacopoeia Those portions that are not harmonized are marked with symbols to specify this fact The Bacterial Endotoxins Test BET is a ...
Bacterial Endotoxins Test 167 INTERPRETATION The test is considered valid when both replicates of Solutions B and C are positive and those of Solution D are negative. When a negative result is found for both replicates of Solution A, the preparation under test complies with the test. When a ...
注射剂通则-USP-药典.pdf,Accessed from by brunswick20 on Tue Feb 21 01:04:24 EST 2017 USP 40 General Requirements / á1ñ Injections and Implanted Drug Products 67 General Chapters General Tests and Assays General Requirements for Tests and Assays á1