As per USP, "data from six replicate injections are used if the relative standard deviation requirement is more than 2.0%". What material can be used for system suitability? 1. A guide to guidelines. Signal-to-Noise definition based on USP <621> Chromatography Chapter (reference USP 38 NF 33, effective 5/1/2015 to 4/30/2016) S/N is calculated as follows: h 2H S/N = where: H = Height of the peak (Figure 2) measured from the peak apex to a baseline extrapolated over a distance ≥ 5 times the peak width at its half-height. Its chapter on Chromatography is <621>, found here, and “defines the terms and procedures used in chromatography and provides general information.” Specifically, it explains the allowable adjustments to chromatography systems in order to meet system suitability requirements. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA and EMA. 31(3) Page 825 Pharmacopeial Forum: Volume No. USP General Chapter <621> Chromatography, section on System Suitability; Date: 8/12/2019 Back to Top 16. USP <621>[2] and European Pharmacopoeia (EP) chapter 2.2.41[3] have both specified requirements for SST for chromatographic analysis to demonstrate that a chromatograph is fit for the analysis it will undertake on the day of analysis. Injection Volume (GC, HPLC): May be reduced as far as is consistent with accepted precision, linearity, and detection limits. System Suitability Formulae and Calculations System Suitability Formulae and Calculations The HP ChemStation uses the following formulae to obtain the results for the various System Suitability tests. They are especially important in the case of chromatographic methods, and submissions to the USP should make note of the requirements under the System Suitability section in the general test chapter Chromatography 621. Calculation of the Height Equivalent to the Theoretical Plate (HETP) 6. h area/wt) and then calc the overall RSD for the 6 std injections, doesn't this satify the USP system suitability criterion? Calculation of Peak Asymmetry 5. System suitability tests are run each time an analysis is undertaken The results are reported using the Performance, Performance + Noise and Performance + Extended report styles. Calculation of Peak Tailing (USP method) 4. Expert Committee: (GC05) General Chapters 05. See USP <621> when the particle size is changed. System Suitability Calculations . Calculation of the number of Theoretical Plates per meter (half-height method) 3. Calculation of the number of Theoretical Plates per meter (USP method) 2. 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