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%
118.931989641988271989881990111988091989200.05
219.021986391985571985980.03
单位质量响应值RSD%判断
10508.1910441.540.45数据可信
供试品溶液-YBA2319批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1202635-20263598.81698.081.3698.8298.081.36
2199614-19961497.34397.34
3203424-20342499.20199.20
4197457-19745796.29196.29
5199235-19923597.15897.16
6204337-20433799.64699.65
10min1208336-208336101.596101.110.64101.76101.280.64
2208564-208564101.707101.87
3207499-207499101.188101.35
4206253-206253100.580100.74
5205281-205281100.106100.27
6208135-208135101.498101.66
15min1208116-208116101.489101.040.67101.82101.370.67
2208344-208344101.600101.93
3207603-207603101.239101.57
4205940-205940100.428100.76
5204996-20499699.967100.30
6208119-208119101.490101.83
20min1207993-207993101.429100.800.64101.93101.300.64
2207705-207705101.289101.79
3206601-206601100.750101.25
4205582-205582100.253100.75
5204757-20475799.851100.35
6207621-207621101.248101.75
30min1208898-208898101.870100.750.81102.54101.420.81
2207510-207510101.193101.86
3206151-206151100.531101.20
4205262-205262100.097100.76
5204345-20434599.650100.31
6207471-207471101.174101.85
45min1207852-207852101.360100.480.76102.20101.320.76
2207057-207057100.973101.81
3205971-205971100.443101.28
4204681-20468199.814100.64
5203773-20377399.371100.20
6206966-206966100.928101.77
极限1207884-207884101.376100.350.80102.39101.350.81
2206734-206734100.815101.82
3205535-205535100.230101.24
4204770-20477099.857100.85
5203220-20322099.101100.09
6206533-206533100.717101.73
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%
118.931985851987211985331985841982921985430.08
219.021978361980421979390.08
单位质量响应值RSD%判断
10488.2710406.890.56数据可信
供试品溶液-YBA2319批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1132488-13248864.77883.4712.0864.7883.4812.08
2181680-18168088.82988.83
3184133-18413390.02890.03
4188662-18866292.24392.24
5172750-17275084.46384.46
6164662-16466280.50880.51
10min1206088-206088100.763101.600.69100.87101.740.70
2209292-209292102.329102.48
3209133-209133102.252102.40
4207358-207358101.384101.54
5208639-208639102.010102.15
6206267-206267100.850100.98
15min1206297-206297100.865101.490.56101.14101.790.57
2208766-208766102.072102.39
3208908-208908102.142102.46
4206921-206921101.170101.49
5208054-208054101.724102.03
6206461-206461100.945101.25
20min1205881-205881100.662101.270.65101.11101.750.66
2208600-208600101.991102.48
3208393-208393101.890102.38
4206280-206280100.857101.35
5207957-207957101.677102.16
6205604-205604100.526101.00
30min1205855-205855100.649101.110.51101.26101.760.52
2207646-207646101.525102.18
3208080-208080101.737102.40
4206135-206135100.786101.45
5207460-207460101.434102.08
6205652-205652100.550101.19
45min1204717-204717100.093100.810.63100.87101.620.64
2207394-207394101.401102.23
3207387-207387101.398102.23
4205516-205516100.483101.31
5207184-207184101.299102.12
6204866-204866100.165100.97
极限1204563-204563100.017100.620.67100.96101.610.68
2207778-207778101.589102.59
3206749-206749101.086102.09
4204955-204955100.209101.20
5206370-206370100.901101.89
6204420-20442099.947100.92
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%
118.931984561988001984561983641983601984870.10
219.021984351979251981800.19
单位质量响应值RSD%判断
10485.3110419.560.45数据可信
供试品溶液-YBA2319批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1200441-20044197.95696.681.7797.9696.681.77
2200857-20085798.15998.16
3191409-19140993.54293.54
4197535-19753596.53696.54
5199546-19954697.51897.52
6197144-19714496.34596.34
10min1207094-207094101.207100.650.65101.37100.810.65
2205683-205683100.518100.68
3205852-205852100.600100.76
4205799-205799100.574100.74
5207515-207515101.413101.58
6203749-20374999.57299.73
15min1206943-206943101.133100.670.70101.47101.000.70
2206405-206405100.870101.20
3205266-205266100.314100.64
4206474-206474100.904101.23
5207440-207440101.376101.71
6203484-20348499.44399.77
20min1206373-206373100.855100.380.66101.36100.880.67
2204997-204997100.182100.68
3205278-205278100.320100.81
4205592-205592100.473100.97
5207095-207095101.208101.71
6203133-20313399.27199.76
30min1206117-206117100.730100.160.67101.40100.820.67
2204803-204803100.088100.75
3204652-204652100.014100.67
4205058-205058100.212100.88
5206477-206477100.906101.57
6202582-20258299.00299.66
45min1205263-205263100.31299.880.66101.15100.720.66
2204017-20401799.703100.54
3204153-20415399.770100.59
4204864-204864100.117100.95
5205929-205929100.638101.48
6202090-20209098.76299.58
极限1205090-205090100.22899.710.66101.23100.700.66
2204119-20411999.753100.75
3203402-20340299.403100.39
4204215-20421599.800100.80
5205548-205548100.452101.46
6201759-20175998.60099.59
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