沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565827885828055826235826865826315827070.02
228.565821235824865823040.05
单位质量响应值RSD%判断
20402.9120388.800.05数据可信
影响因素30天-供试品溶液-2024032421批-缬沙坦钠-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%
5min1190466-19046665.21861.1022.9265.2261.1022.92
2249701-24970185.50185.50
3158139-15813954.14954.15
4142655-14265548.84748.85
5188040-18804064.38764.39
6141632-14163248.49648.50
10min1399158-399158136.676122.039.11136.79122.139.11
2385112-385112131.867132.01
3330788-330788113.266113.36
4325562-325562111.476111.56
5369861-369861126.645126.75
6327785-327785112.237112.32
15min1543163-543163185.985166.916.22186.32167.226.23
2485092-485092166.101166.46
3461496-461496158.022158.30
4466041-466041159.578159.85
5497494-497494170.348170.67
6471503-471503161.448161.72
20min1639072-639072218.826194.016.52219.47194.596.52
2539218-539218184.635185.27
3540440-540440185.053185.60
4560140-560140191.799192.33
5562947-562947192.760193.36
6557691-557691190.960191.50
30min1671419-671419229.902212.014.94230.91212.924.93
2583233-583233199.706200.65
3605826-605826207.442208.29
4633773-633773217.011217.86
5617294-617294211.369212.29
6603493-603493206.643207.50
45min1655585-655585224.480216.532.63225.87217.792.63
2606260-606260207.591208.87
3631609-631609216.270217.47
4640931-640931219.462220.68
5636037-636037217.787219.06
6623790-623790213.593214.79
60min1654120-654120223.978219.681.10225.75221.301.12
2635843-635843217.720219.35
3641067-641067219.509221.07
4643069-643069220.194221.77
5640985-640985219.481221.12
6634355-634355217.211218.77
极限1653464-653464223.754223.200.60225.90225.190.59
2651675-651675223.141225.13
3656125-656125224.665226.59
4645689-645689221.092223.04
5649309-649309222.331224.34
6654807-654807224.214226.13
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.561008348100802010077601007911100781810079710.03
228.561007260100766810074640.03
单位质量响应值RSD%判断
35293.1035275.350.04数据可信
影响因素30天-供试品溶液-2024032421批-沙库巴曲-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%
5min1326099-32609960.98056.8323.4060.9856.8223.40
2427031-42703179.85479.85
3268340-26834050.17950.18
4241070-24107045.07945.08
5321014-32101460.02960.03
6239749-23974944.83244.83
10min1685293-685293128.148114.329.22128.25114.429.23
2661700-661700123.736123.87
3566132-566132105.865105.95
4558037-558037104.351104.43
5634971-634971118.738118.84
6562020-562020105.096105.17
15min1936079-936079175.044156.756.33175.36157.046.33
2834034-834034155.962156.30
3792586-792586148.211148.47
4800822-800822149.752150.00
5854346-854346159.760160.06
6811668-811668151.780152.03
20min11101462-1101462205.970182.346.60206.58182.896.60
2927466-927466173.434174.03
3929752-929752173.861174.37
4964103-964103180.285180.78
5966972-966972180.821181.39
6960861-960861179.678180.18
30min11156068-1156068216.182199.294.97217.13200.144.96
21003634-1003634187.677188.57
31042064-1042064194.863195.66
41091860-1091860204.175204.97
51061930-1061930198.578199.44
61038779-1038779194.249195.05
45min11133248-1133248211.914203.662.81213.22204.842.81
21042154-1042154194.880196.08
31086211-1086211203.119204.24
41104828-1104828206.600207.74
51094644-1094644204.696205.89
61073540-1073540200.749201.88
60min11130338-1130338211.370206.451.32213.03207.981.34
21090072-1090072203.841205.37
31102865-1102865206.233207.69
41106606-1106606206.932208.42
51102843-1102843206.229207.77
61091498-1091498204.107205.57
极限11129410-1129410211.197210.530.60213.21212.400.59
21124855-1124855210.345212.21
31133303-1133303211.925213.73
41115671-1115671208.628210.46
51120940-1120940209.613211.49
61130844-1130844211.465213.27
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565825815829025828345826615827765827510.03
228.565824195827145825660.04
单位质量响应值RSD%判断
20404.4520397.970.03数据可信
影响因素30天-供试品溶液-2024032421批-缬沙坦钠-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%
5min1130017-13001744.50868.5918.6844.5168.5818.68
2194329-19432966.52366.52
3234273-23427380.19780.20
4223994-22399476.67876.68
5217868-21786874.58174.58
6201635-20163569.02469.02
10min1301087-301087103.069127.1610.35103.14127.2710.36
2377777-377777129.321129.43
3408717-408717139.913140.05
4378248-378248129.483129.61
5400905-400905137.239137.36
6362045-362045123.936124.05
15min1413499-413499141.550166.649.39141.80166.979.40
2467053-467053159.882160.21
3497399-497399170.271170.64
4515135-515135176.342176.69
5547799-547799187.524187.88
6479890-479890164.277164.60
20min1487001-487001166.711186.387.38167.19186.997.39
2524508-524508179.551180.14
3545948-545948186.890187.54
4561796-561796192.315192.95
5608025-608025208.140208.81
6539550-539550184.700185.30
30min1549650-549650188.157201.916.17188.92202.836.18
2571475-571475195.628196.52
3583397-583397199.710200.67
4592570-592570202.850203.81
5657502-657502225.077226.09
6584417-584417200.059200.96
45min1582924-582924199.548209.884.19200.62211.134.21
2599029-599029205.061206.28
3611808-611808209.435210.73
4613656-613656210.068211.36
5659722-659722225.837227.22
6611521-611521209.337210.57
60min1602959-602959206.406214.793.04207.81216.393.07
2615498-615498210.698212.26
3627127-627127214.679216.32
4627496-627496214.806216.45
5659975-659975225.924227.69
6631654-631654216.229217.81
极限1649828-649828222.450224.550.74224.20226.510.78
2651515-651515223.028224.94
3662371-662371226.744228.75
4654921-654921224.194226.20
5659988-659988225.928228.07
6657119-657119224.946226.89
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.561007167100838710079391007843100849210079660.06
228.561007109100794310075260.06
单位质量响应值RSD%判断
35292.9335277.520.04数据可信
影响因素30天-供试品溶液-2024032421批-沙库巴曲-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%
5min1219305-21930541.00864.2019.2341.0164.2019.23
2332931-33293162.25562.26
3403224-40322475.40075.40
4385118-38511872.01472.01
5374298-37429869.99169.99
6345141-34514164.53964.54
10min1514670-51467096.239119.2310.5696.31119.3410.56
2649185-649185121.392121.50
3702903-702903131.437131.56
4648945-648945121.348121.47
5689485-689485128.928129.04
6620442-620442116.018116.13
15min1709705-709705132.709155.949.01132.94156.249.02
2802308-802308150.025150.33
3855328-855328159.940160.28
4887128-887128165.886166.21
5925455-925455173.053173.38
6823577-823577154.002154.30
20min1836015-836015156.328175.007.51156.78175.577.51
2901287-901287168.534169.09
3938649-938649175.520176.13
4965906-965906180.617181.22
51047517-1047517195.877196.50
6925824-925824173.122173.68
30min1943518-943518176.430189.516.33177.14190.366.34
2980484-980484183.343184.18
31002821-1002821187.520188.42
41017581-1017581190.280191.18
51133176-1133176211.895212.84
61003061-1003061187.564188.41
45min11001456-1001456187.264197.234.30188.27198.404.32
21029410-1029410192.491193.63
31052918-1052918196.887198.10
41055037-1055037197.284198.50
51137153-1137153212.639213.94
61052490-1052490196.807197.97
60min11036097-1036097193.742201.823.19195.06203.323.22
21058586-1058586197.947199.41
31078426-1078426201.657203.20
41078054-1078054201.588203.13
51139151-1139151213.012214.67
61085458-1085458202.972204.46
极限11121977-1121977209.801211.800.72211.44213.640.76
21125389-1125389210.439212.23
31142526-1142526213.643215.52
41131160-1131160211.518213.40
51139915-1139915213.155215.16
61134981-1134981212.232214.06
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565824505825225816655824155823505822800.07
228.565832725831515832120.02
单位质量响应值RSD%判断
20387.9620420.590.12数据可信
影响因素30天-供试品溶液-2024032421批-缬沙坦钠-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%
5min1171453-17145358.68362.9820.4458.6862.9820.44
2195328-19532866.85566.86
3156152-15615253.44653.45
4152585-15258552.22552.23
5254193-25419387.00387.00
6174269-17426959.64759.65
10min1360514-360514123.393125.919.51123.49126.029.52
2363379-363379124.374124.49
3345905-345905118.393118.48
4328994-328994112.605112.69
5430667-430667147.405147.55
6377826-377826129.319129.42
15min1464496-464496158.983167.954.48159.29168.264.49
2489505-489505167.543167.86
3496634-496634169.983170.27
4466557-466557159.689159.96
5519161-519161177.694178.08
6507837-507837173.818174.13
20min1516035-516035176.624191.145.16177.19191.735.15
2550995-550995188.589189.19
3602848-602848206.337206.91
4549159-549159187.961188.50
5558002-558002190.988191.67
6573622-573622196.334196.94
30min1575263-575263196.896208.564.39197.76209.484.37
2612320-612320209.579210.49
3649791-649791222.404223.32
4595915-595915203.964204.82
5594582-594582203.508204.51
6628270-628270215.038215.97
45min1603052-603052206.407215.282.99207.60216.542.99
2632584-632584216.515217.78
3651981-651981223.154224.44
4616760-616760211.099212.29
5621772-621772212.814214.16
6647714-647714221.694222.98
60min1618525-618525211.703218.362.15213.24219.982.16
2643221-643221220.156221.78
3651691-651691223.055224.71
4628563-628563215.139216.68
5632710-632710216.558218.26
6653082-653082223.531225.19
极限1645652-645652220.988223.340.92222.88225.320.93
2659333-659333225.670227.66
3650901-650901222.784224.81
4649705-649705222.375224.28
5649111-649111222.172224.23
6660451-660451226.053228.09
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.561007240100731610064851007022100677410069670.04
228.561008702100873010087160.01
单位质量响应值RSD%判断
35257.9535319.190.13数据可信
影响因素30天-供试品溶液-2024032421批-沙库巴曲-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%
5min1293438-29343854.86558.7820.9954.8758.7820.99
2334131-33413162.47462.47
3265598-26559849.66049.66
4258219-25821948.28048.28
5437307-43730781.76581.77
6297409-29740955.60855.61
10min1618815-618815115.703117.949.61115.79118.049.62
2622868-622868116.460116.56
3592582-592582110.798110.88
4563260-563260105.315105.40
5739594-739594138.285138.42
6647720-647720121.107121.20
15min1798365-798365149.274157.654.50149.56157.944.51
2841514-841514157.342157.64
3853856-853856159.649159.92
4800621-800621149.696149.95
5892371-892371166.851167.22
6872115-872115163.063163.36
20min1886320-886320165.719179.605.24166.25180.165.23
2947428-947428177.145177.71
31038738-1038738194.217194.75
4945468-945468176.778177.28
5959581-959581179.417180.06
6985868-985868184.332184.90
30min1988060-988060184.742196.004.49185.55196.864.48
21053381-1053381196.955197.81
31120369-1120369209.480210.34
41025405-1025405191.725192.52
51022468-1022468191.175192.12
61080038-1080038201.940202.81
45min11036206-1036206193.744202.323.06194.86203.503.05
21088400-1088400203.503204.69
31123499-1123499210.066211.27
41060572-1060572198.300199.42
51070328-1070328200.124201.39
61113480-1113480208.192209.40
60min11063297-1063297198.809205.332.20200.25206.842.21
21106927-1106927206.967208.49
31122991-1122991209.971211.53
41081831-1081831202.275203.72
51089812-1089812203.767205.36
61124027-1124027210.164211.72
极限11115002-1115002208.477210.670.92210.25212.540.93
21138327-1138327212.838214.71
31123845-1123845210.130212.04
41121979-1121979209.781211.57
51120745-1120745209.551211.49
61140587-1140587213.261215.17
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565831535836315836415834515832785834310.04
228.565859665859435859540.01
单位质量响应值RSD%判断
20428.2620516.600.31数据可信
影响因素30天-供试品溶液-2024032421批-缬沙坦钠-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%
5min1184112-18411262.80759.0012.3362.8159.0012.33
2210932-21093271.95671.96
3154037-15403752.54752.55
4165797-16579756.55956.56
5157709-15770953.80053.80
6165095-16509556.31956.32
10min1370469-370469126.379122.926.63126.48123.026.63
2394624-394624134.619134.74
3340828-340828116.268116.36
4346684-346684118.265118.36
5332973-332973113.588113.68
6376368-376368128.391128.49
15min1474546-474546161.883167.056.23162.20167.356.23
2537287-537287183.286183.63
3482277-482277164.520164.80
4474541-474541161.881162.17
5454535-454535155.057155.34
6514901-514901175.650175.96
20min1538750-538750183.785186.905.64184.37187.485.64
2604152-604152206.096206.75
3540599-540599184.416184.97
4533018-533018181.830182.39
5513918-513918175.314175.85
6556836-556836189.955190.56
30min1614487-614487209.622204.684.65210.51205.574.65
2644648-644648219.910220.90
3598724-598724204.244205.11
4589891-589891201.231202.10
5561440-561440191.526192.36
6590756-590756201.526202.44
45min1632767-632767215.857212.743.00217.10213.983.01
2651417-651417222.220223.58
3626314-626314213.656214.86
4612536-612536208.956210.16
5596085-596085203.344204.49
6622730-622730212.434213.69
60min1640485-640485218.490216.631.92220.09218.221.94
2652948-652948222.742224.47
3632846-632846215.884217.44
4626702-626702213.789215.34
5617850-617850210.769212.26
6639393-639393218.118219.72
极限1646920-646920220.686222.220.83222.65224.170.83
2654948-654948223.424225.53
3642855-642855219.299221.22
4655923-655923223.757225.66
5652343-652343222.535224.37
6655454-655454223.597225.57
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.561009110100945310090821009028100927510091900.02
228.561013049101316610131080.01
单位质量响应值RSD%判断
35335.7835472.970.28数据可信
影响因素30天-供试品溶液-2024032421批-沙库巴曲-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%
5min1313215-31321558.37254.8912.6058.3754.8912.60
2360902-36090267.25967.26
3261762-26176248.78348.78
4281885-28188552.53352.53
5267324-26732449.81949.82
6282119-28211952.57752.58
10min1632110-632110117.802115.076.66117.90115.166.66
2676327-676327126.043126.15
3584437-584437108.918109.00
4594702-594702110.831110.92
5569787-569787106.187106.27
6647253-647253120.624120.71
15min1813580-813580151.622156.886.37151.92157.176.37
2924933-924933172.374172.70
3829748-829748154.635154.90
4816310-816310152.130152.40
5779732-779732145.314145.57
6886546-886546165.220165.51
20min1924992-924992172.385175.585.76172.93176.125.77
21041379-1041379194.075194.68
3929809-929809173.282173.80
4917283-917283170.948171.47
5882262-882262164.421164.92
6957173-957173178.382178.95
30min11056343-1056343196.864192.284.75197.70193.114.75
21110114-1110114206.885207.82
31030390-1030390192.027192.84
41015655-1015655189.281190.09
5963347-963347179.533180.31
61014471-1014471189.060189.92
45min11089496-1089496203.042199.963.05204.20201.123.06
21120885-1120885208.892210.17
31077335-1077335200.776201.91
41054855-1054855196.586197.71
51023865-1023865190.811191.89
61071439-1071439199.677200.85
60min11103295-1103295205.614203.661.93207.11205.151.96
21124100-1124100209.491211.12
31088706-1088706202.895204.36
41078524-1078524200.997202.45
51063302-1063302198.161199.55
61098991-1098991204.812206.32
极限11117225-1117225208.210209.660.83210.05211.490.83
21131038-1131038210.784212.76
31110123-1110123206.886208.69
41132552-1132552211.066212.86
51126933-1126933210.019211.74
61132080-1132080210.978212.83
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565845075843795842125843315842635843380.02
228.565859725859645859680.01
单位质量响应值RSD%判断
20460.0120517.090.20数据可信
影响因素30天-供试品溶液-2024032421批-缬沙坦钠-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%
5min1242119-24211982.52965.9718.0682.5365.9718.06
2171168-17116858.34558.34
3184599-18459962.92362.92
4168614-16861457.47457.47
5232785-23278579.34879.35
6161900-16190055.18655.19
10min1402876-402876137.326127.689.52137.46127.789.52
2365203-365203124.484124.58
3374891-374891127.787127.89
4347790-347790118.549118.64
5426863-426863145.502145.63
6329771-329771112.407112.50
15min1506939-506939172.797169.715.26173.16170.045.26
2531695-531695181.235181.54
3502228-502228171.191171.51
4462063-462063157.500157.79
5512556-512556174.712175.09
6471854-471854160.838161.12
20min1553138-553138188.544189.383.82189.20189.993.82
2586869-586869200.042200.65
3567575-567575193.465194.07
4523405-523405178.410178.97
5556111-556111189.558190.22
6546442-546442186.262186.81
30min1594188-594188202.537205.962.98203.51206.882.97
2620472-620472211.496212.44
3617709-617709210.554211.48
4578296-578296197.120197.97
5593645-593645202.352203.33
6621035-621035211.688212.55
45min1614131-614131209.335212.302.32210.64213.562.31
2639628-639628218.026219.32
3631241-631241215.167216.44
4602975-602975205.532206.71
5614235-614235209.370210.69
6634695-634695216.344217.55
60min1626444-626444213.532215.461.83215.19217.081.83
2648890-648890221.183222.84
3634777-634777216.372218.01
4615593-615593209.833211.36
5627721-627721213.967215.64
6639245-639245217.895219.47
极限1648496-648496221.048219.971.28223.06221.951.29
2660076-660076224.996227.02
3641196-641196218.560220.56
4636651-636651217.011218.88
5641067-641067218.516220.54
6644525-644525219.695221.63
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.561011112101121710110651011257101099710111300.02
228.561013501101343910134700.01
单位质量响应值RSD%判断
35403.7135485.640.17数据可信
影响因素30天-供试品溶液-2024032421批-沙库巴曲-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%
5min1417709-41770977.75761.7818.5977.7661.7818.59
2292116-29211654.37854.38
3315344-31534458.70258.70
4288198-28819853.64853.65
5401328-40132874.70874.71
6276449-27644951.46151.46
10min1692220-692220128.858119.739.66128.99119.839.66
2627087-627087116.733116.82
3643846-643846119.853119.95
4597215-597215111.172111.26
5734276-734276136.686136.81
6564517-564517105.085105.17
15min1871482-871482162.227159.385.38162.57159.685.39
2916555-916555170.618170.90
3863025-863025160.653160.95
4794873-794873147.966148.24
5882348-882348164.250164.60
6808908-808908150.579150.84
20min1951608-951608177.143177.943.85177.76178.513.85
21010349-1010349188.078188.65
3976251-976251181.730182.30
4900278-900278167.588168.11
5957000-957000178.147178.77
6939757-939757174.937175.45
30min11021930-1021930190.233193.583.01191.14194.452.99
21068433-1068433198.890199.77
31063007-1063007197.880198.75
4995310-995310185.278186.08
51021485-1021485190.151191.07
61069427-1069427199.075199.88
45min11055390-1055390196.462199.552.39197.69200.732.39
21101806-1101806205.102206.32
31086813-1086813202.311203.51
41037194-1037194193.075194.18
51057069-1057069196.775198.01
61093515-1093515203.559204.69
60min11076375-1076375200.368202.491.87201.92204.011.87
21117576-1117576208.038209.59
31091862-1091862203.251204.79
41059228-1059228197.176198.61
51080915-1080915201.213202.78
61100761-1100761204.908206.38
极限11120337-1120337208.552207.461.29210.44209.321.30
21140039-1140039212.219214.12
31107379-1107379206.140208.01
41099024-1099024204.585206.34
51107097-1107097206.087207.99
61113010-1113010207.188209.00
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565845525844905845045843465824975840780.16
228.565848925849085849000.01
单位质量响应值RSD%判断
20450.9120479.690.10数据可信
影响因素30天-供试品溶液-2024032421批-缬沙坦钠-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%
5min1196950-19695067.20967.4019.7167.2167.4019.71
2151167-15116751.58651.59
3150725-15072551.43551.43
4232590-23259079.37179.37
5238839-23883981.50481.50
6214857-21485773.32073.32
10min1356390-356390121.618124.218.22121.73124.338.23
2329723-329723112.518112.60
3331926-331926113.270113.36
4401542-401542137.026137.16
5390365-390365133.212133.35
6374021-374021127.635127.76
15min1488561-488561166.721164.653.19167.04164.963.20
2458951-458951156.617156.89
3477263-477263162.866163.14
4505798-505798172.604172.96
5485353-485353165.627165.98
6478946-478946163.440163.78
20min1575843-575843196.506187.304.48197.10187.904.46
2530894-530894181.168181.70
3580478-580478198.088198.63
4551888-551888188.332188.98
5529371-529371180.648181.28
6524765-524765179.076179.68
30min1632681-632681215.902204.875.16216.82205.785.13
2575790-575790196.488197.32
3645344-645344220.224221.10
4593758-593758202.620203.58
5577701-577701197.140198.08
6576853-576853196.851197.76
45min1648144-648144221.179212.513.25222.46213.753.24
2602416-602416205.574206.74
3648056-648056221.149222.39
4614152-614152209.579210.88
5615430-615430210.015211.28
6608166-608166207.537208.77
60min1652939-652939222.815215.772.33224.46217.372.33
2616924-616924210.525212.03
3647581-647581220.987222.60
4629180-629180214.708216.36
5620346-620346211.693213.31
6626818-626818213.902215.48
极限1658165-658165224.599221.760.91226.62223.720.93
2642120-642120219.123220.98
3647471-647471220.949222.93
4652009-652009222.498224.51
5645459-645459220.263222.23
6653866-653866223.132225.07
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.561011492101108210111351010837100775210104600.16
228.561011870101160210117360.02
单位质量响应值RSD%判断
35380.2535424.930.09数据可信
影响因素30天-供试品溶液-2024032421批-沙库巴曲-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%
5min1337398-33739862.88263.2120.2362.8863.2120.23
2257798-25779848.04648.05
3256512-25651247.80747.81
4401093-40109374.75374.75
5411648-41164876.72076.72
6370598-37059869.06969.07
10min1611215-611215113.913116.498.31114.02116.608.32
2565271-565271105.351105.43
3569865-569865106.207106.29
4690073-690073128.610128.74
5671140-671140125.082125.21
6642765-642765119.794119.91
15min1839254-839254156.414154.623.26156.71154.923.27
2787949-787949146.852147.11
3821602-821602153.124153.38
4870641-870641162.263162.60
5834669-834669155.559155.90
6823787-823787153.531153.85
20min1991214-991214184.735176.004.59185.29176.554.57
2912372-912372170.041170.54
31000899-1000899186.540187.05
4949137-949137176.893177.50
5910584-910584169.708170.30
6901760-901760168.063168.63
30min11089571-1089571203.066192.595.25203.93193.445.23
2988580-988580184.244185.03
31112648-1112648207.367208.19
41021605-1021605190.399191.30
5994535-994535185.354186.23
6993195-993195185.104185.95
45min11115270-1115270207.855199.753.29209.06200.933.28
21036880-1036880193.246194.34
31117100-1117100208.196209.36
41057097-1057097197.013198.24
51057625-1057625197.112198.30
61046835-1046835195.101196.26
60min11124897-1124897209.650202.872.44211.20204.372.44
21060484-1060484197.645199.06
31116897-1116897208.159209.67
41082649-1082649201.776203.33
51066659-1066659198.796200.31
61079401-1079401201.170202.65
极限11137130-1137130211.929209.110.93213.83210.960.94
21109139-1109139206.713208.46
31117650-1117650208.299210.16
41124632-1124632209.600211.49
51113870-1113870207.594209.44
61129603-1129603210.527212.35
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