苯磺酸美洛加巴林片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.562051512057492057602053142042982052540.30
219.492054212051792053000.09
单位质量响应值RSD%判断
10493.5610533.610.27数据可信
供试品溶液-2025042021批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1195269-19526994.87392.182.5494.8792.182.54
2191622-19162293.10193.10
3194019-19401994.26594.27
4182765-18276588.79888.80
5188571-18857191.61891.62
6186071-18607190.40490.40
10min1203772-20377299.00498.290.7699.1698.450.76
2200952-20095297.63497.79
3204324-20432499.27299.43
4202467-20246798.37098.52
5201923-20192398.10698.26
6200424-20042497.37797.53
15min1205395-20539599.79299.280.67100.1299.600.67
2202211-20221198.24698.56
3205791-20579199.985100.31
4204736-20473699.47299.78
5203273-20327398.76199.08
6204610-20461099.41199.72
20min1207486-207486100.80899.780.71101.30100.260.71
2203437-20343798.84199.32
3205735-20573599.958100.45
4206155-206155100.162100.64
5204209-20420999.21699.70
6205182-20518299.689100.17
30min1207474-207474100.803100.550.59101.46101.200.58
2206171-206171100.170100.82
3207527-207527100.828101.48
4207846-207846100.983101.63
5204841-20484199.523100.17
6207859-207859100.990101.63
45min1208845-208845101.469100.690.90102.29101.500.89
2206141-206141100.155100.97
3208013-208013101.064101.89
4209354-209354101.716102.53
5204412-20441299.315100.13
6206644-206644100.399101.21
极限1208920-208920101.505100.890.67102.50101.870.66
2206616-206616100.386101.37
3207898-207898101.009102.00
4209178-209178101.630102.61
5205551-20555199.868100.85
6207742-207742100.933101.91
苯磺酸美洛加巴林片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.562051422053462053962042692053122050930.23
219.492048622047022047820.06
单位质量响应值RSD%判断
10485.3310507.030.15数据可信
供试品溶液-2025042021批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1191607-19160793.24892.743.2393.2592.743.23
2199422-19942297.05197.05
3193447-19344794.14394.14
4191830-19183093.35693.36
5183885-18388589.49089.49
6183187-18318789.15089.15
10min1205637-205637100.07598.541.84100.2398.691.85
2206218-206218100.358100.52
3205513-205513100.015100.17
4199990-19999097.32797.48
5199818-19981897.24497.39
6197707-19770796.21696.36
15min1207514-207514100.98999.601.52101.3199.921.53
2207576-207576101.019101.35
3206797-206797100.640100.96
4202310-20231098.45698.77
5203603-20360399.08699.40
6200151-20015197.40697.71
20min1207992-207992101.222100.071.41101.71100.551.42
2208470-208470101.454101.95
3207393-207393100.930101.42
4203699-20369999.13299.61
5205184-20518499.855100.33
6201025-20102597.83198.30
30min1209819-209819102.111100.641.35102.77101.291.35
2208883-208883101.655102.32
3207780-207780101.118101.78
4205111-20511199.819100.47
5206969-206969100.724101.37
6202199-20219998.40299.04
45min1209780-209780102.092100.761.32102.92101.581.32
2209765-209765102.084102.92
3207328-207328100.898101.73
4205551-205551100.034100.85
5207301-207301100.885101.70
6202596-20259698.59699.39
极限1209844-209844102.123100.711.25103.12101.701.26
2208848-208848101.638102.64
3207015-207015100.746101.74
4205624-205624100.069101.05
5207748-207748101.103102.08
6202588-20258898.59299.55
苯磺酸美洛加巴林片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.562053662057112057472053892055142055450.09
219.492051112048262049680.10
单位质量响应值RSD%判断
10508.4410516.570.06数据可信
供试品溶液-2025042121批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186352-18635290.54992.823.2590.5592.823.26
2183747-18374789.28489.28
3194542-19454294.52994.53
4187619-18761991.16591.16
5200368-20036897.36097.36
6193584-19358494.06394.06
10min1197651-19765196.04098.002.0296.1998.162.03
2199366-19936696.87397.02
3202952-20295298.61598.77
4197829-19782996.12696.28
5207664-207664100.905101.07
6204681-20468199.45599.61
15min1200681-20068197.51299.151.8197.8299.471.82
2201632-20163297.97498.28
3205159-20515999.688100.01
4200579-20057997.46297.77
5209547-209547101.820102.15
6206775-206775100.473100.80
20min1202169-20216998.23599.831.5898.71100.321.58
2203162-20316298.71799.19
3206478-206478100.329100.82
4202818-20281898.55099.02
5210068-210068102.073102.57
6208071-208071101.103101.59
30min1202034-20203498.169100.151.7198.81100.801.71
2204411-20441199.32499.96
3207461-207461100.806101.46
4202923-20292398.60199.24
5210602-210602102.332103.00
6209269-209269101.685102.34
45min1203728-20372898.992100.421.4599.79101.231.45
2205103-20510399.660100.46
3207792-207792100.967101.79
4203419-20341998.84299.65
5210176-210176102.125102.97
6209721-209721101.904102.73
极限1203872-20387299.062100.541.33100.03101.521.34
2204778-20477899.503100.47
3207512-207512100.831101.82
4205125-20512599.671100.64
5210337-210337102.204103.21
6209834-209834101.959102.96
苯磺酸美洛加巴林片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.562048322050902052272052962053952051680.11
219.492044072046252045160.08
单位质量响应值RSD%判断
10489.1610493.380.03数据可信
供试品溶液-2025042121批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1189662-18966292.34491.983.3092.3491.983.30
2196497-19649795.67295.67
3192029-19202993.49793.50
4179271-17927187.28587.28
5184082-18408289.62789.63
6192002-19200293.48393.48
10min1205314-20531499.96598.701.97100.1298.851.97
2207773-207773101.162101.32
3203825-20382599.24099.40
4196132-19613295.49495.64
5201445-20144598.08198.23
6201751-20175198.23098.39
15min1206855-206855100.71599.681.50101.04100.001.51
2209043-209043101.781102.11
3204958-20495899.792100.11
4200328-20032897.53797.84
5204553-20455399.59499.91
6202626-20262698.65698.98
20min1207219-207219100.892100.231.25101.38100.721.25
2209608-209608102.056102.55
3206221-206221100.407100.89
4202381-20238198.53799.00
5206061-206061100.329100.81
6203704-20370499.18199.66
30min1207189-207189100.878100.621.10101.53101.271.11
2210208-210208102.348103.02
3206659-206659100.620101.27
4204350-20435099.496100.13
5207477-207477101.018101.66
6204027-20402799.33899.99
45min1206823-206823100.700100.791.17101.52101.601.17
2210584-210584102.531103.37
3207218-207218100.892101.71
4205314-20531499.965100.76
5208415-208415101.475102.29
6203672-20367299.16599.98
极限1207188-207188100.877100.701.09101.87101.681.09
2210181-210181102.335103.34
3205956-205956100.277101.27
4205504-205504100.057101.02
5208273-208273101.406102.39
6203812-20381299.234100.21
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