托伐普坦口崩片项目信息
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101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.371959141970871966271961461964801964510.24
216.341977821976761977290.04
单位质量响应值RSD%判断
12000.6712100.920.59数据可信
供试品溶液-3B85SDC1批-SHUI(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1156691-15669178.01777.471.1878.0277.471.18
2156733-15673378.03878.04
3154603-15460376.97776.98
4157056-15705678.19878.20
5152324-15232475.84275.84
6156152-15615277.74877.75
10min1194687-19468796.93596.921.0397.0697.051.03
2194857-19485797.02097.15
3193698-19369896.44296.57
4196757-19675797.96698.10
5191343-19134395.27095.40
6196591-19659197.88398.01
15min1203366-203366101.256101.501.07101.55101.791.07
2203185-203185101.166101.46
3203926-203926101.535101.82
4206417-206417102.775103.07
5200347-20034799.753100.04
6205891-205891102.513102.81
20min1206253-206253102.694102.671.06103.15103.131.06
2204994-204994102.067102.53
3205321-205321102.230102.69
4209784-209784104.452104.92
5203535-203535101.340101.79
6207360-207360103.245103.71
30min1207871-207871103.499103.431.09104.13104.061.09
2206949-206949103.040103.67
3207112-207112103.121103.75
4210744-210744104.930105.57
5204258-204258101.700102.32
6209504-209504104.312104.95
45min1207713-207713103.421102.970.86104.22103.780.86
2206598-206598102.865103.67
3206684-206684102.908103.71
4207977-207977103.552104.37
5203514-203514101.330102.12
6208379-208379103.752104.56
60min1207053-207053103.092103.040.87104.07104.020.88
2206078-206078102.606103.58
3206075-206075102.605103.58
4209586-209586104.353105.34
5204548-204548101.845102.80
6208345-208345103.735104.72
极限1206469-206469102.801102.970.94103.95104.120.94
2205581-205581102.359103.50
3208148-208148103.637104.78
4209027-209027104.075105.24
5203761-203761101.453102.58
6207853-207853103.490104.65
托伐普坦口崩片项目信息
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101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.371992921992231988171988811994201991270.14
216.341998522003142000830.17
单位质量响应值RSD%判断
12164.1412244.980.47数据可信
供试品溶液-3B85SDC1批-SHUI(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1155554-15555476.47476.971.4376.4776.971.44
2159404-15940478.36778.37
3155959-15595976.67376.67
4156986-15698677.17877.18
5158365-15836577.85677.86
6153074-15307475.25575.25
10min1202535-20253599.57196.751.6199.7096.881.61
2196920-19692096.81196.94
3195749-19574996.23596.36
4195691-19569196.20796.34
5196929-19692996.81596.94
6192985-19298594.87695.00
15min1211916-211916104.183100.941.65104.48101.231.65
2202547-20254799.57799.87
3203784-203784100.185100.47
4204439-204439100.507100.80
5205501-205501101.029101.32
6203696-203696100.142100.43
20min1212841-212841104.638102.051.34105.10102.501.34
2204899-204899100.733101.19
3206331-206331101.437101.89
4206790-206790101.663102.12
5208108-208108102.311102.77
6206456-206456101.499101.95
30min1213457-213457104.941102.571.29105.58103.201.29
2206576-206576101.558102.18
3208292-208292102.402103.03
4208091-208091102.303102.93
5209516-209516103.003103.63
6205922-205922101.236101.86
45min1213604-213604105.013102.641.22105.83103.441.22
2206153-206153101.350102.15
3207880-207880102.199102.99
4208644-208644102.575103.37
5208763-208763102.633103.43
6207600-207600102.061102.85
60min1212665-212665104.551102.151.20105.54103.121.19
2205695-205695101.125102.09
3206569-206569101.554102.52
4207108-207108101.819102.79
5207239-207239101.884102.86
6207385-207385101.956102.91
极限1212439-212439104.440102.051.21105.61103.191.21
2205200-205200100.881102.01
3206468-206468101.505102.64
4206964-206964101.749102.89
5207506-207506102.015103.16
6206876-206876101.705102.83
托伐普坦口崩片项目信息
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101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.371962091967211975061966941966051967470.24
216.341966291963241964760.11
单位质量响应值RSD%判断
12018.7512024.240.04数据可信
供试品溶液-2J95SDC1批-SHUI(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1146531-14653173.13572.641.4873.1372.641.48
2144781-14478172.26172.26
3149084-14908474.40974.41
4144387-14438772.06472.06
5145708-14570872.72472.72
6142793-14279371.26971.27
10min1182369-18236991.02190.760.6291.1490.880.62
2180778-18077890.22790.35
3183511-18351191.59191.72
4181135-18113590.40690.53
5182459-18245991.06691.19
6180787-18078790.23290.35
15min1195926-19592697.78897.910.8098.0698.180.80
2193632-19363296.64396.91
3196259-19625997.95498.23
4195703-19570397.67797.95
5197225-19722598.43698.71
6198233-19823398.93999.21
20min1199857-19985799.75099.800.96100.19100.240.96
2197571-19757198.60999.04
3201114-201114100.377100.82
4201188-201188100.414100.85
5202212-202212100.925101.36
6197785-19778598.71699.15
30min1202136-202136100.887101.020.75101.49101.620.74
2200382-200382100.012100.61
3202791-202791101.214101.82
4203625-203625101.630102.23
5204354-204354101.994102.60
6201121-201121100.381100.98
45min1202870-202870101.254101.050.94102.02101.820.93
2200820-200820100.230100.99
3202795-202795101.216101.99
4204239-204239101.937102.71
5204372-204372102.003102.78
6199640-19964099.642100.41
60min1203384-203384101.510101.041.08102.45101.981.07
2200196-20019699.919100.85
3202341-202341100.990101.93
4204190-204190101.912102.85
5204960-204960102.297103.24
6199548-19954899.596100.53
极限1201846-201846100.743100.650.94101.85101.760.93
2199615-19961599.629100.73
3202036-202036100.837101.95
4203322-203322101.479102.59
5203849-203849101.742102.86
6199266-19926699.455100.55
托伐普坦口崩片项目信息
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101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.371996242001332000961997351995381998250.14
216.342000712004922002820.15
单位质量响应值RSD%判断
12206.7812257.160.30数据可信
供试品溶液-2J95SDC1批-SHUI(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1155888-15588876.46675.221.4676.4775.221.46
2152281-15228174.69774.70
3150978-15097874.05874.06
4151001-15100174.06974.07
5154281-15428175.67875.68
6155638-15563876.34476.34
10min1191849-19184994.10692.820.9594.2392.950.95
2188637-18863792.53092.65
3186840-18684091.64991.77
4188240-18824092.33592.46
5189173-18917392.79392.92
6190675-19067593.53093.66
15min1203176-20317699.66298.711.3199.9598.991.31
2199775-19977597.99498.27
3197400-19740096.82997.10
4204766-204766100.442100.72
5200322-20032298.26298.54
6202018-20201899.09499.38
20min1207160-207160101.61699.771.27102.07100.221.27
2203152-20315299.650100.09
3199925-19992598.06798.50
4201353-20135398.76899.21
5203932-203932100.033100.48
6204892-204892100.504100.95
30min1207646-207646101.855100.271.16102.47100.881.16
2204535-204535100.328100.94
3201140-20114098.66399.26
4202364-20236499.26499.87
5204932-204932100.523101.13
6205892-205892100.994101.61
45min1208949-208949102.494100.381.39103.28101.161.39
2204365-204365100.245101.02
3200883-20088398.53799.30
4202599-20259999.379100.15
5204610-204610100.365101.14
6206444-206444101.265102.05
60min1206951-206951101.51499.931.23102.47100.881.22
2204286-204286100.206101.15
3200132-20013298.16999.10
4201452-20145298.81699.76
5204488-204488100.305101.25
6205031-205031100.572101.52
极限1213599-213599104.775100.332.37105.90101.442.35
2204028-204028100.080101.19
3199789-19978998.00099.09
4201149-20114998.66899.77
5203865-203865100.000101.11
6204775-204775100.446101.57
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