There is a "targetlimit response" of 500 µg of Carbon/L. The true limit is the response ofthe TOC measurement system to a 500 µg Carbon/L (prepared from sucrose)solution, Rs, corrected for the response to reagent water, Rw. ...
TheendotoxinlimitforparenteraldrugsisspecifiedinindividualmonographsinunitssuchasEU/mL,EU/mg,orEU/Unitofbiologicalactivity、 GELCLOTTECHNIQUES ThegelclottechniquesdetectorquantifyendotoxinsbasedonclottingoftheLALReagentinthepresenceofendotoxin、Theconcentrationofendotoxinrequiredtocausethelysatetoclotunderstandardconditions...
23、(MVD) The Maximum Valid Dilution is the maximum allowable dilution of a specimen at which the endotoxin limit can be determined. It applies to injections or to solutions for parenteral administration in the form constituted or diluted for administration, or, where applicable, to the amount of...
is to be carried out when a new batch of lysate is used or when there is any change in the test conditions that may affect the outcome of the test. Prepare standard solutions having at least four concentrations equivalent to 2, , 0.5, and 0.25 by diluting the USP Endotoxin RS with...
The number of significant figures in the labeled calculation value is a function of the use of the standard and the number of significant figures in the acceptance range or limit. Generally, Reference Standards used in assays are labeled with three significant figures and standards used in limit ...
plies with the test if the mean endotoxin concentration of Incubator—Use an incubator capable of maintaining a the replicates of Solution A , after correction for dilution and temperature of 37±1° and a humidified atmosphere of concentration, is less than the endotoxin limit for the 5±1% ...
Table2.PreparationofSolutionsfortheGel-ClotLimitTest表2:凝胶限度检测, 溶液的制备 SolutionEndotoxinConcentration/SolutiontowhichNumberof * 溶液*EndotoxinisAdded内毒素浓度/参加内毒素的溶液Replicates重复次数 ANone/DilutedSampleSolution无/稀释的样品溶液2 B2 2/DilutedSampleSolution2/稀释的样品溶液 C2 2/Waterfor...
endotoxin limit is specified by volume EU mL l the labeled sensitivity in the Gel Clot Technique EU mL or the lowest concentration used in the standard curve for the Turbidimetric Technique or Chromogenic Technique GEL CLOT TECHNIQUE The gel clot technique is used for detecting or quantifying ...
The result with Solution D does not exceed the limit of the blank value required in the description of the lysate reagentemployed, or it is less than the endotoxin detection limit of the lysate reagent employed.Calculate the mean recovery of the added endotoxin by subtracting the mean endotoxin...
giveninthefederalregulations(seeBiologics〈1041〉).Avalidated,equivalentinvitropyrogenorbacterialendotoxintestmaybeusedinplaceoftheinvivorabbit pyrogentest,whereappropriate. APPARATUSANDDILUENTS Renderthesyringes,needles,andglasswarefreefrompyrogensbyheatingat250°forNLT30minorbyanyothersuitablemethod.Treatalldiluentsan...