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(%)0.03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%
119.582045442044882045302046132041102044570.10
219.632042142043912043020.07
单位质量响应值RSD%判断
10442.1310407.640.24数据可信
供试品溶液-YBA2319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%
5min1162452-16245279.57660.8222.9879.5860.8222.98
2131472-13147264.40164.40
397998-9799848.00448.00
4131291-13129164.31264.31
583843-8384341.07041.07
6137876-13787667.53867.54
10min1209777-209777102.758102.491.42102.89102.591.43
2211713-211713103.706103.81
3209175-209175102.463102.54
4212373-212373104.029104.14
5204100-20410099.977100.05
6208255-208255102.012102.12
15min1210605-210605103.163103.850.67103.47104.120.67
2213167-213167104.418104.70
3212977-212977104.325104.58
4213657-213657104.658104.94
5211038-211038103.375103.61
6210589-210589103.155103.44
20min1210306-210306103.017103.900.69103.49104.340.68
2212678-212678104.179104.63
3213794-213794104.725105.15
4213521-213521104.592105.05
5211587-211587103.644104.05
6210769-210769103.244103.70
30min1209412-209412102.579103.740.76103.23104.360.75
2212440-212440104.062104.69
3213248-213248104.458105.06
4213479-213479104.571105.20
5211594-211594103.648104.23
6210475-210475103.100103.73
45min1208969-208969102.362103.540.88103.18104.330.87
2211830-211830103.763104.56
3213093-213093104.382105.16
4213535-213535104.599105.40
5211297-211297103.502104.26
6209481-209481102.613103.41
60min1208618-208618102.190103.410.92103.18104.380.90
2211203-211203103.456104.43
3212963-212963104.318105.27
4213451-213451104.557105.54
5211164-211164103.437104.36
6209253-209253102.501103.47
极限1208169-208169101.970103.301.04103.13104.431.03
2211374-211374103.540104.69
3212577-212577104.129105.25
4213814-213814104.735105.89
5210610-210610103.166104.26
6208701-208701102.231103.37
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(%)0.03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%
119.582033732038272038302035602038572036890.11
219.632046562044612045580.07
单位质量响应值RSD%判断
10402.9110420.680.13数据可信
供试品溶液-YBA2319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%
5min1111351-11135154.61362.6522.5554.6162.6522.55
2130473-13047363.99163.99
3167193-16719382.00182.00
481870-8187040.15440.15
5139850-13985068.59068.59
6135661-13566166.53666.54
10min1211372-211372103.669103.780.63103.76103.890.63
2210644-210644103.312103.42
3210156-210156103.073103.21
4211427-211427103.696103.76
5213921-213921104.919105.03
6212130-212130104.041104.15
15min1214397-214397105.153104.620.77105.42104.900.75
2213429-213429104.678104.96
3210278-210278103.132103.44
4214006-214006104.961105.20
5214830-214830105.365105.65
6212905-212905104.421104.71
20min1214568-214568105.236104.490.88105.68104.950.86
2213449-213449104.688105.14
3209707-209707102.852103.33
4213765-213765104.843105.26
5214598-214598105.251105.72
6212249-212249104.099104.56
30min1213981-213981104.949104.240.88105.56104.860.86
2212865-212865104.401105.03
3209013-209013102.512103.16
4213590-213590104.757105.35
5213673-213673104.798105.44
6212076-212076104.014104.65
45min1213605-213605104.764104.070.85105.55104.870.83
2212535-212535104.239105.04
3208874-208874102.444103.27
4213551-213551104.738105.50
5213011-213011104.473105.29
6211541-211541103.752104.56
60min1213023-213023104.479103.910.86105.44104.880.84
2212079-212079104.016104.99
3208724-208724102.370103.36
4213173-213173104.552105.49
5213401-213401104.664105.65
6210800-210800103.388104.37
极限1213200-213200104.566103.900.84105.70105.050.83
2212136-212136104.044105.19
3208560-208560102.290103.45
4212725-212725104.333105.45
5213230-213230104.580105.74
6211255-211255103.612104.76
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(%)0.03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%
119.582042362042762047622041162035642041910.21
219.632037112034182035640.11
单位质量响应值RSD%判断
10428.5510370.050.40数据可信
供试品溶液-YBA2320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%
5min1103074-10307450.61554.0118.9450.6154.0018.94
288960-8896043.68443.68
394060-9406046.18846.19
4119874-11987458.86458.86
5146336-14633671.85871.86
6107592-10759252.83352.83
10min1204932-204932100.632101.421.06100.72101.521.07
2203650-203650100.002100.08
3207190-207190101.741101.82
4209845-209845103.045103.14
5207630-207630101.957102.08
6206003-206003101.158101.25
15min1210208-210208103.223103.550.41103.47103.810.41
2210401-210401103.318103.56
3211723-211723103.967104.21
4211756-211756103.983104.25
5209772-209772103.009103.30
6211437-211437103.826104.08
20min1210400-210400103.317103.470.35103.74103.910.35
2210647-210647103.438103.85
3211106-211106103.664104.08
4211982-211982104.094104.54
5210121-210121103.180103.64
6210073-210073103.156103.59
30min1209973-209973103.107103.350.37103.70103.950.36
2210339-210339103.287103.87
3210958-210958103.591104.18
4211519-211519103.867104.48
5209343-209343102.798103.43
6210668-210668103.449104.05
45min1208997-208997102.628103.070.49103.40103.850.49
2209884-209884103.064103.82
3210139-210139103.189103.95
4211685-211685103.948104.74
5208822-208822102.542103.35
6209865-209865103.054103.83
60min1208757-208757102.510102.770.54103.45103.720.54
2208403-208403102.336103.26
3209650-209650102.949103.89
4211345-211345103.781104.74
5208406-208406102.338103.31
6209175-209175102.716103.66
极限1208198-208198102.236102.670.65103.35103.790.64
2208806-208806102.534103.63
3209631-209631102.939104.05
4211459-211459103.837104.97
5207649-207649101.966103.11
6208738-208738102.501103.62
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(%)0.03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%
119.582032712044712034712054542031702039670.48
219.632035422037162036290.07
单位质量响应值RSD%判断
10417.1110373.360.30数据可信
供试品溶液-YBA2320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%
5min175888-7588837.27950.6320.8637.2850.6320.86
295529-9552946.92846.93
3129451-12945163.59263.59
4110275-11027554.17254.17
5123189-12318960.51560.52
684066-8406641.29741.30
10min1202796-20279699.622102.341.6699.68102.431.68
2206084-206084101.237101.32
3209948-209948103.135103.24
4209608-209608102.968103.06
5212747-212747104.510104.61
6208823-208823102.582102.65
15min1210743-210743103.526104.100.78103.75104.350.79
2209131-209131102.734102.98
3212964-212964104.617104.89
4213215-213215104.740105.00
5213056-213056104.662104.94
6212342-212342104.311104.55
20min1210925-210925103.615104.110.77104.02104.540.78
2209344-209344102.838103.26
3213427-213427104.844105.30
4213650-213650104.954105.39
5212326-212326104.303104.75
6211889-211889104.089104.50
30min1210500-210500103.406103.960.83103.98104.560.84
2208627-208627102.486103.08
3213010-213010104.639105.27
4213028-213028104.648105.26
5212532-212532104.404105.03
6212025-212025104.155104.74
45min1210324-210324103.320103.670.75104.07104.440.76
2208212-208212102.282103.04
3212347-212347104.314105.11
4212437-212437104.358105.14
5211363-211363103.830104.63
6211519-211519103.907104.67
60min1209177-209177102.756103.390.88103.67104.340.89
2207433-207433101.900102.83
3212020-212020104.153105.13
4212175-212175104.229105.19
5211193-211193103.747104.72
6210810-210810103.558104.49
极限1208942-208942102.641103.170.85103.73104.290.85
2207045-207045101.709102.81
3211486-211486103.891105.04
4211628-211628103.960105.09
5210117-210117103.218104.36
6210944-210944103.624104.73
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