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- Dictionarydisregard/ˌdɪsrɪˈɡɑːd/
verb
- 1. pay no attention to; ignore: "the body of evidence is too substantial to disregard"
noun
- 1. the action or state of paying no attention to something: "blatant disregard for the law"
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Oct 18, 2004 · — impurity with relative retention at about 1.23: maximum 0.2 per cent, — any other impurity: maximum 0.1 per cent, — total: maximum 1.2 per cent, — disregard limit: 0.05 per cent. Should I disregard all the peaks below 0,05% including those specified (A, B,…I) and report them as “not detectedâ ...
Aug 11, 2014 · Re: Disregard limit in EP. by dlbenach » Tue Aug 12, 2014 12:08 pm. The isopulegol in Ref B is present at 0.01 uL/mL. Your test solution concentration is 20 uL/mL. 0.05% of 20 is 0.01. It is saying that you do not have to worry about any peaks less than 0.05% the concentration of your major peak.
May 23, 2013 · Measured values should be reported to the same number of significant figures as the limits. Therefore, 0.048% would be rounded to 0.05% and thus equal to an LOQ of 0.05% (note that 0.054% would also round to 0.05% and be reported the same way). If the LOQ had been stated as 0.050%, then 0.048% would not be rounded and would be reported as less ...
by ant_k » Wed Dec 04, 2013 10:15 am. Could you please advice in respect to an impurities calculation issue. We have developed / validated a method where impurities are calculated by the known formula: %imp= (Atest/Aref)* limit. Comparison of the % percentage for an unknown imp. with specific rrt with the %area presented in the chromatogram ...
Nov 9, 2007 · Disregard limit & Method Validation. Milosh. Posts: 4. Joined: Fri Nov 09, 2007 7:08 pm. by Milosh » Tue Mar 18, 2008 8:48 pm. Hi! I am validating analytical methods onto HPLC and UPLC, and I have one question. I validate Pharmacopeiae HPLC method for impurities in which solution for disregard limit is given.
Aug 11, 2005 · Our normal procedure is that if the sample has an unknown peak at a particular RT and the placebo chromatogram also shows a peak at that same RT±10%, we subtract the area due to the placebo from the area of the unknown peak in the sample chromatogram. Often we run a placebo at the begining and end of a sequence of runs and work with the mean ...
Aug 2, 2005 · by Hfranz » Wed Apr 22, 2009 8:55 am. The Rise Time parameter (also referred to as Response) is a measure of how quickly the detector responds to a change in signal. The rise time is defined as the time it takes the detector's output signal to rise from 10% of its final value to 90% of its final value. The measured value is postulated to (in ...
Jun 7, 2017 · In short a failure of SST means that you have demonstrated that the instrument (HPLC, GC, CE...) is not capable of performing the required analysis and that ANY results are not valid and should not be reported. In addition, a CAPA should be issued and the method should be examined for validation per ICH Q2 (r1).
Aug 12, 2011 · Dear Majorel, For impurity determination methods (RS), generally Resolution will be sufficient as a system suitability to check the column performance. However, to check the precision, replicate injections of the diluted standard solution is good enough. Keeping the diluted standard concentration of 10 ppm or less, % RSD of 5 is acceptable.
Aug 30, 2004 · The ChemStation help options should be able to fill in any missing details. 1) Define your internal standard in the calibration table (there is a column labelled ISTD). I already do this. 2) Where you specify the reporting options, in the Quantitative results section (top right) change Calculate: to ISTD.
