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%
1 19.291964811961651969771973491970281968000.24
2 19.311963711967121965420.13
单位质量响应值RSD%判断
10202.1810178.250.17数据可信
长期6月-供试品溶液-2025042021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%
5min1199832-199832100.17098.371.32100.1798.381.32
2196221-19622198.36098.36
3196385-19638598.44398.44
4197757-19775799.13099.13
5192086-19208696.28896.29
6195213-19521397.85597.86
10min1203279-203279101.898100.620.74102.07100.780.74
2199694-199694100.101100.27
3198921-19892199.71499.88
4200747-200747100.629100.79
5200792-200792100.652100.81
6200948-200948100.730100.89
15min1203093-203093101.805100.720.81102.14101.050.81
2199341-19934199.924100.26
3198804-19880499.65599.99
4200799-200799100.655100.99
5201818-201818101.166101.49
6201732-201732101.123101.45
20min1204570-204570102.545101.410.87103.05101.900.87
2200699-200699100.605101.10
3199941-199941100.225100.72
4202179-202179101.347101.85
5202729-202729101.623102.12
6203671-203671102.095102.59
30min1203620-203620102.069101.150.75102.75101.820.75
2200112-200112100.311100.98
3199787-199787100.148100.81
4202305-202305101.410102.08
5202559-202559101.537102.20
6202318-202318101.417102.09
45min1203438-203438101.978100.870.77102.83101.710.77
2199643-199643100.076100.91
3199385-19938599.946100.78
4201104-201104100.808101.65
5202148-202148101.331102.17
6201603-201603101.058101.90
极限1203123-203123101.820100.620.94102.84101.620.93
2198850-19885099.678100.68
3198320-19832099.412100.41
4200440-200440100.475101.48
5201891-201891101.203102.21
6201699-201699101.106102.11
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%
1 19.291969501969111967151968691967291968350.06
2 19.311967021960431963720.24
单位质量响应值RSD%判断
10203.9910169.450.24数据可信
长期6月-供试品溶液-2025042121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%
5min1193552-19355297.05694.163.3397.0694.163.33
2187967-18796794.25594.26
3177493-17749389.00389.00
4183451-18345191.99191.99
5192184-19218496.37096.37
6192005-19200596.28096.28
10min1198560-19856099.56799.450.5299.7399.600.53
2198666-19866699.62099.78
3196954-19695498.76298.91
4199668-199668100.123100.28
5198830-19883099.70299.86
6197225-19722598.89899.06
15min1198814-19881499.69499.790.56100.02100.120.56
2198666-19866699.62099.94
3198286-19828699.43099.74
4200851-200851100.716101.04
5199711-199711100.144100.47
6197729-19772999.15099.48
20min1198331-19833199.45299.650.6299.95100.140.61
2198027-19802799.30099.79
3198159-19815999.36699.84
4200948-200948100.765101.25
5199257-19925799.917100.41
6197641-19764199.10699.60
30min1198416-19841699.495100.120.74100.15100.770.73
2199308-19930899.942100.60
3199015-19901599.795100.44
4202306-202306101.446102.10
5200311-200311100.445101.11
6198575-19857599.575100.23
45min1198741-19874199.658100.000.58100.48100.820.58
2198553-19855399.564100.38
3199685-199685100.131100.94
4201558-201558101.070101.90
5199465-199465100.021100.85
6198567-19856799.571100.39
极限1198174-19817499.37499.570.59100.37100.560.58
2198176-19817699.375100.36
3198083-19808399.328100.31
4200608-200608100.594101.59
5199102-19910299.839100.83
6197276-19727698.92399.91
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%
1 19.291967751966781969641966161967191967500.07
2 19.311962661960211961440.09
单位质量响应值RSD%判断
10199.5910157.640.30数据可信
长期6月-供试品溶液-2025042221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%
5min1186446-18644693.56795.771.9193.5795.771.91
2193208-19320896.96196.96
3193724-19372497.22097.22
4192647-19264796.67996.68
5193115-19311596.91496.91
6185906-18590693.29693.30
10min1194388-19438897.55399.381.6097.7199.541.60
2203492-203492102.122102.28
3198002-19800299.36699.53
4197589-19758999.15999.32
5199038-19903899.886100.05
6195691-19569198.20798.36
15min1194986-19498697.85399.611.7398.1799.931.73
2204437-204437102.596102.93
3198053-19805399.39299.72
4198169-19816999.45099.78
5199737-199737100.237100.57
6195500-19550098.11198.43
20min1194566-19456697.64299.341.8598.1299.831.85
2204588-204588102.672103.17
3197814-19781499.27299.77
4196935-19693598.83199.32
5198852-19885299.793100.29
6194905-19490597.81298.29
30min1195414-19541498.068100.051.7798.71100.701.77
2205637-205637103.198103.87
3198781-19878199.757100.42
4198864-19886499.799100.46
5200409-200409100.574101.24
6197040-19704098.88499.53
45min1194862-19486297.79199.711.8298.60100.541.82
2205084-205084102.921103.77
3198549-19854999.641100.47
4198065-19806599.398100.22
5199712-199712100.225101.05
6195894-19589498.30999.12
极限1194694-19469497.70699.461.9098.68100.451.89
2205042-205042102.899103.92
3198214-19821499.473100.46
4197307-19730799.018100.01
5198840-19884099.787100.78
6195057-19505797.88998.86
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%
1 19.291965191962761968391963331965261964990.12
2 19.311961751959181960460.10
单位质量响应值RSD%判断
10186.5710152.560.24数据可信
长期6月-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%
5min1131187-13118765.89471.505.9865.8971.505.98
2146950-14695073.81273.81
3136879-13687968.75368.75
4136863-13686368.74568.75
5150147-15014775.41875.42
6152114-15211476.40676.41
10min1200819-200819100.870101.110.40100.98101.240.40
2202441-202441101.684101.81
3200865-200865100.893101.01
4201896-201896101.411101.53
5201507-201507101.215101.34
6200298-200298100.608100.74
15min1201962-201962101.444101.680.43101.72101.970.43
2203478-203478102.205102.50
3201838-201838101.382101.66
4203598-203598102.266102.55
5201693-201693101.309101.60
6202030-202030101.478101.77
20min1203639-203639102.286102.300.37102.73102.760.37
2204341-204341102.639103.10
3202830-202830101.880102.33
4204258-204258102.597103.05
5204240-204240102.588103.05
6202715-202715101.822102.29
30min1203086-203086102.008101.980.39102.63102.610.39
2203719-203719102.326102.96
3202442-202442101.685102.31
4204025-204025102.480103.11
5202966-202966101.948102.58
6201908-201908101.417102.05
45min1202470-202470101.699101.690.29102.49102.480.29
2202963-202963101.947102.75
3201798-201798101.361102.15
4203000-203000101.965102.76
5202783-202783101.856102.66
6201665-201665101.295102.10
极限1202424-202424101.676101.500.40102.63102.470.40
2203156-203156102.044103.02
3201219-201219101.071102.03
4202425-202425101.676102.64
5202200-202200101.563102.54
6201025-201025100.973101.94
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