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%
119.652037002035372035882042742038112037820.15
219.752037212043232040220.21
单位质量响应值RSD%判断
10370.5910330.230.28数据可信
加速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%
5min1202159-20215999.76996.012.7699.7796.012.76
2196869-19686997.15897.16
3193975-19397595.73095.73
4186501-18650192.04192.04
5196550-19655097.00197.00
6191199-19119994.36094.36
10min1203873-203873100.615100.550.81100.78100.710.81
2204616-204616100.981101.14
3203973-203973100.664100.82
4205035-205035101.188101.34
5204447-204447100.898101.06
6200527-20052798.96399.12
15min1203469-203469100.415100.740.69100.75101.070.69
2204768-204768101.056101.39
3204322-204322100.836101.16
4205636-205636101.485101.81
5204901-204901101.122101.45
6201673-20167399.52999.85
20min1203808-203808100.583100.580.88101.08101.080.88
2204920-204920101.131101.63
3203866-203866100.611101.11
4205411-205411101.374101.86
5204470-204470100.909101.41
6200381-20038198.89199.38
30min1202256-20225699.817100.430.76100.49101.090.76
2204217-204217100.784101.45
3203459-203459100.410101.07
4205253-205253101.296101.96
5204610-204610100.978101.64
6201162-20116299.27799.93
45min1202521-20252199.947100.270.93100.78101.100.92
2203971-203971100.663101.50
3203638-203638100.499101.33
4205406-205406101.371102.20
5203666-203666100.512101.35
6199846-19984698.62799.45
极限1202088-20208899.73499.950.82100.74100.950.82
2203447-203447100.404101.41
3202503-20250399.938100.94
4203927-203927100.641101.64
5203679-203679100.519101.52
6199484-19948498.44999.43
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%
119.652034872037222040152042852038632038740.15
219.752046692046992046840.02
单位质量响应值RSD%判断
10375.2710363.750.08数据可信
加速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%
5min1203687-203687100.33797.252.94100.3497.252.94
2196837-19683796.96396.96
3193344-19334495.24295.24
4205297-205297101.130101.13
5191128-19112894.15194.15
6194252-19425295.69095.69
10min1207396-207396102.164100.981.72102.33101.141.72
2200097-20009798.56998.73
3202617-20261799.81099.97
4209974-209974103.434103.60
5203958-203958100.471100.63
6205889-205889101.422101.58
15min1207895-207895102.410100.881.69102.75101.211.69
2199770-19977098.40898.73
3202852-20285299.926100.25
4209205-209205103.056103.40
5203676-203676100.332100.66
6205327-205327101.145101.47
20min1207166-207166102.051100.501.68102.56101.001.68
2198998-19899898.02798.52
3201971-20197199.49299.98
4208288-208288102.604103.12
5203348-203348100.170100.66
6204357-204357100.667101.16
30min1207155-207155102.046100.761.73102.72101.421.73
2199207-19920798.13098.78
3202645-20264599.824100.48
4209377-209377103.140103.82
5204108-204108100.545101.20
6204727-204727100.850101.51
45min1207008-207008101.973100.261.83102.82101.091.83
2198337-19833797.70298.52
3200871-20087198.95099.77
4208215-208215102.568103.42
5202610-20261099.807100.63
6204092-204092100.537101.37
极限1205612-205612101.286100.111.66102.30101.111.66
2198646-19864697.85498.83
3200844-20084498.93799.93
4207929-207929102.427103.45
5202202-20220299.606100.60
6204147-204147100.564101.56
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%
119.652042322039332035162048282037912040600.25
219.752042662041782042220.04
单位质量响应值RSD%判断
10384.7310340.350.31数据可信
加速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%
5min1180950-18095089.19794.563.8389.2094.563.83
2203663-203663100.393100.39
3189526-18952693.42593.42
4192218-19221894.75294.75
5193962-19396295.61195.61
6190662-19066293.98593.98
10min1197593-19759397.40199.451.3697.5599.611.36
2205162-205162101.132101.30
3203947-203947100.533100.69
4202482-20248299.81199.97
5201288-20128899.22399.38
6200068-20006898.62198.78
15min1197720-19772097.46499.441.2097.7799.771.20
2204795-204795100.951101.29
3202766-20276699.951100.27
4202981-202981100.057100.38
5201162-20116299.16099.49
6201008-20100899.08599.41
20min1197814-19781497.51099.551.1697.98100.041.17
2204479-204479100.796101.30
3202800-20280099.968100.46
4203295-203295100.212100.70
5200912-20091299.03799.53
6202392-20239299.767100.25
30min1196932-19693297.07599.101.2297.7199.761.23
2203939-203939100.529101.20
3202039-20203999.593100.25
4202689-20268999.913100.57
5200380-20038098.77599.43
6200304-20030498.73899.39
45min1196402-19640296.81498.811.1597.6199.631.16
2203337-203337100.233101.07
3201344-20134499.250100.07
4201233-20123399.195100.02
5199887-19988798.53299.35
6200485-20048598.82799.64
极限1197168-19716897.19298.891.0898.1599.881.08
2203247-203247100.188101.19
3202018-20201899.582100.57
4201636-20163699.394100.38
5199940-19994098.55899.54
6199697-19969798.43899.42
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%
119.652034562035892047962038262042032039740.27
219.752028472033292030880.17
单位质量响应值RSD%判断
10380.3610282.940.67数据可信
加速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%
5min171877-7187735.53857.0322.0435.5457.0322.04
2136767-13676767.62167.62
3121140-12114059.89459.89
4114000-11400056.36456.36
5105540-10554052.18152.18
6142758-14275870.58370.58
10min1200457-20045799.110101.401.1399.17101.491.14
2205924-205924101.813101.93
3206098-206098101.899102.00
4206472-206472102.084102.18
5206208-206208101.954102.04
6205328-205328101.519101.64
15min1205298-205298101.504102.380.69101.73102.640.69
2206700-206700102.197102.48
3208243-208243102.960103.23
4207237-207237102.462102.73
5209040-209040103.354103.61
6205891-205891101.797102.08
20min1205096-205096101.404102.210.44101.80102.640.45
2206688-206688102.191102.64
3207420-207420102.553102.99
4207079-207079102.384102.82
5207608-207608102.646103.07
6206471-206471102.084102.54
30min1205544-205544101.625102.020.52102.19102.630.52
2206601-206601102.148102.77
3207400-207400102.543103.16
4206759-206759102.226102.83
5207143-207143102.416103.02
6204627-204627101.172101.80
45min1203990-203990100.857101.560.64101.59102.330.64
2205032-205032101.372102.17
3206690-206690102.192102.98
4205847-205847101.775102.55
5206912-206912102.302103.07
6203951-203951100.838101.63
极限1203678-203678100.703101.270.48101.60102.220.48
2204841-204841101.278102.24
3205707-205707101.706102.66
4204945-204945101.329102.27
5206046-206046101.874102.81
6203761-203761100.744101.71
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