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Subject: Positive Product Control (PPC, Spike) Recovery pharm. Пожалуйста, очень важно! как перевести название раздела:Validation of Analytical Procedures Endotoxin 4.0 EVALUATION OF TEST PARAMETERS 4.1 Positive Product Control (PPC, Spike) Recovery Prior to routine testing using the kinetic chromogenic assay, three separate lots of sample must be shown not to inhibit or enhance the sensitivity of the method using the chosen test parameters (PPC recovery 50% to 200% for three separate lots). To demonstrate this, an initial screen assay was performed using one batch of DS to establish a non-interfering dilution for routine DS and DP testing. This dilution was then used in a confirmation assay on a further two lots of DP sample. A range of dilutions (1:5, 1:10, 1:100, 1:1000) of Batch WPU3030001 of DS was assayed using kinetic chromogenic methodology to establish a non-interfering dilution. Each dilution was tested both unspiked and spiked to give an endotoxin level of 0.5 EU/mL (positive product controls, PPCs, or spikes). |
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