hplc法在國內(nèi)外藥典中的應(yīng)用與比較(編輯修改稿)
2025-01-19 00:23 本頁面
【文章內(nèi)容簡介】 EP() JP(XV) 12122RWWtt??? ）（)(W2h /22,h /21,12 ??? ）（ ttR2h112s hRRwwtt??? ）（12s hhRR WW tt ???* 有爭議時，以峰寬（ W）計算結(jié)果為準(zhǔn)； described in individual monograph 3/1/2023 32 山東省藥品檢驗所 USP(32) ? Chromatographic system — The liquid chromatograph is equipped with a 275nm detector and a 15cm column that contains packing L1 …… the resolution, R, between the impurity C and famotidine peaks is not less than 。 the resolution, R, between the famotidine and impurity D peaks is not less than 。 Famotidine Tablets Assary 3/1/2023 33 山東省藥品檢驗所 EP() ?左甲狀腺素鈉含量測定： ?左羥丙哌嗪對映體純度： 3/1/2023 34 山東省藥品檢驗所 重復(fù)性 評價連續(xù)進樣中，色譜系統(tǒng)響應(yīng)值的重復(fù)性能。 CHP(2023): ? 外標(biāo)法：對照品溶液，連續(xù)進樣 5次，峰面積RSD不得過 %。 ? 內(nèi)標(biāo)法：配制相當(dāng)于 80%、 100%、 120%的對照品溶液，加入內(nèi)標(biāo)溶液，分別至少進樣 2次，計算平均校正因子的 RSD不得過 % 。 3/1/2023 35 山東省藥品檢驗所 重復(fù)性 USP(32): ? Unless otherwise specified in the individual monograph , data from five replicate injections of the analyte are used to calculate the relative standard deviation, SR, if the requirment is % or less。 data from six replicate injections are used if the relative standard deviation requirment is more than %. 3/1/2023 36 山東省藥品檢驗所 重復(fù)性 EP(): ? The repeatability of response is expressed as an es timated percentage relative standard deviation(Sr(%)) of a consecutive series of measurements for NOT fewer than 3 injections or applications of a reference solution. 1y100(%)S2r ??? ?nyyi ）（mean of individual values individual values expressed as peak area, peak height, or ratio of areas by the interal standardisation method number of individual values 3/1/2023 37 山東省藥品檢驗所 重復(fù)性 EP(): ? Unless otherwise prescribed, the maximum permitted RSD does not exceed the appropriate value given in table. Number of individual injections 3 4 5 6 B(percent) Maximum permitted relative standard deviation 3/1/2023 38 山東省藥品檢驗所 重復(fù)性 ? NOTE: This requirement does not apply to tests for related substances. 1%,90ma xr (%)S??ntnKBupper limit given in the definition of the individual monograph minus 100% contant() number of replicate injections of the reference solution (3≤n≤6) 90% probability level， n1 degrees of freedom EP(): ? In an assay of an active substance where the value is 100 percent for a pure substance, the maximum permitted (Sr(%)max) for defined limits is calculated using the following equation: 3/1/2023 39 山東省藥品檢驗所 重復(fù)性 JP(XV): 公式與 EP相同。 ? 重復(fù)次數(shù)及限度在各論中要求。 ? 例： Ritodrine Hydrochloride Related subsances System suitability— Test for required detectability: ............ System performance:............ System repeatability: When the test is repeated 6 times with ......，the relative standard deviation of the peak areas of deferoxamine is not more than %. 3/1/2023 40 山東省藥品檢驗所 拖尾因子（對稱因子） ? 用于評價色譜峰的對稱性 3/1/2023 41 山東省藥品檢驗所 拖尾因子 T（ or Symmetry factor） CHP(2023) ? T=? 應(yīng)符合個論項下的規(guī)定 ? 除另有規(guī)定外 ， 峰高法定量時 T應(yīng)在 ~ USP(32) T=EP() ? As=? An As value of signifies symmetry. When As ＞ , the peak is tailing. When As ＜ , the peak is fronting. ? In a related substances test or assay, for a peak in the chromatogram obtained with a reference solution used for quantification, the symmetry factor is to , unless otherwise prescribed. JP(XV) S= 3/1/2023 42 山東省藥品檢驗所 USP ? It is also a mon practice to measure the Asymmetry factor as the ratio of the distance between the vertical line connecting the peak apex with the interpolated baseline and the peak front, and the distance between that line and the peak back measure at 10% of the peak height, it would be ()/ ? However, for the purpose of USP, only the formula presented in the Glossary of Symbols is valid. 3/1/2023 43 山東省藥品檢驗所 EP中系統(tǒng)適用性： p/v and S/N ? The peaktovalley ratio (p/v) may be employed as a system suitability criterion in a test for related substances when baseline separation
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