美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.07201403
201403+0		201345
201345+0		201624
201624+0		201331
201331+0		201122
201122+0		2013650.09
219.07200949
200949+0		201013
201013+0		2009810.03
单位质量响应值RSD%判断
10559.2610539.120.14数据可信
供试品溶液-12460835批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12263.6
1646+772*0.8		-2263.61.1241.066.291.121.066.24
22147.4
1497+813*0.8		-2147.41.0671.07
32253.6
1692+702*0.8		-2253.61.1191.12
41990.8
1334+821*0.8		-1990.80.9890.99
51952.6
1459+617*0.8		-1952.60.9700.97
62213.2
1698+644*0.8		-2213.21.0991.10
10min13210.2
2447+954*0.8		-3210.21.5951.644.391.611.664.20
23488.2
2749+924*0.8		-3488.21.7331.74
33406.4
2680+908*0.8		-3406.41.6921.70
43416.6
2595+1027*0.8		-3416.61.6971.71
53155.8
2427+911*0.8		-3155.81.5681.58
63171.2
2424+934*0.8		-3171.21.5751.59
15min13693
2921+965*0.8		-36931.8341.773.171.861.803.15
23717.6
2884+1042*0.8		-3717.61.8471.88
33461.8
2713+936*0.8		-3461.81.7201.75
43500.8
2664+1046*0.8		-3500.81.7391.77
53547.4
2817+913*0.8		-3547.41.7621.79
63469.6
2712+947*0.8		-3469.61.7231.75
20min13849.4
3127+903*0.8		-3849.41.9121.822.981.961.872.92
23733.4
2971+953*0.8		-3733.41.8551.91
33550
2782+960*0.8		-35501.7631.81
43579.4
2729+1063*0.8		-3579.41.7781.83
53661.2
2802+1074*0.8		-3661.21.8191.87
63651
2775+1095*0.8		-36511.8141.86
30min13765.2
2926+1049*0.8		-3765.21.8701.746.211.941.806.04
23597.8
2825+966*0.8		-3597.81.7871.86
33420.6
2663+947*0.8		-3420.61.6991.77
43403.6
2534+1087*0.8		-3403.61.6911.76
53630.6
2797+1042*0.8		-3630.61.8031.87
63149.2
2298+1064*0.8		-3149.21.5641.63
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min14051.6
3194+1072*0.8		-4051.62.0131.856.692.111.946.56
23999
3127+1090*0.8		-39991.9862.08
33698
2846+1065*0.8		-36981.8371.93
43433.2
2554+1099*0.8		-3433.21.7051.79
53557.8
2745+1016*0.8		-3557.81.7671.86
63606.8
2778+1036*0.8		-3606.81.7921.88
60min13806.2
2911+1119*0.8		-3806.21.8911.833.982.011.943.82
23886.2
2971+1144*0.8		-3886.21.9302.04
33583
2723+1075*0.8		-35831.7801.89
43673.4
2735+1173*0.8		-3673.41.8251.93
53678.8
2774+1131*0.8		-3678.81.8271.94
63480.6
2519+1202*0.8		-3480.61.7291.84
极限13887
2971+1145*0.8		-38871.9311.916.742.072.046.56
24211
3279+1165*0.8		-42112.0922.23
33969.2
3058+1139*0.8		-3969.21.9722.10
43576.4
2558+1273*0.8		-3576.41.7771.90
53879.4
2917+1203*0.8		-3879.41.9272.05
63513
2569+1180*0.8		-35131.7451.87
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.07201335
201335+0		201368
201368+0		201270
201270+0		201383
201383+0		201457
201457+0		2013630.04
219.07201332
201332+0		201595
201595+0		2014640.10
单位质量响应值RSD%判断
10559.1510564.450.04数据可信
供试品溶液-12460835批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11883.6
1342+677*0.8		-1883.60.9351.0112.880.931.0112.94
22126.8
1590+671*0.8		-2126.81.0551.06
32163.6
1522+802*0.8		-2163.61.0731.07
42290.6
1669+777*0.8		-2290.61.1361.14
51565.4
995+713*0.8		-1565.40.7770.78
62127.6
1586+677*0.8		-2127.61.0561.06
10min12969.4
2299+838*0.8		-2969.41.4731.524.551.481.544.68
23253.6
2600+817*0.8		-3253.61.6141.63
32985.6
2164+1027*0.8		-2985.61.4811.49
42943.8
2239+881*0.8		-2943.81.4611.47
53038.6
2269+962*0.8		-3038.61.5081.52
63242.4
2540+878*0.8		-3242.41.6091.62
15min13475
2743+915*0.8		-34751.7241.703.721.751.733.52
23429
2669+950*0.8		-34291.7011.73
33638.2
2739+1124*0.8		-3638.21.8051.83
43340.8
2628+891*0.8		-3340.81.6581.69
53452.6
2699+942*0.8		-3452.61.7131.74
63263.2
2440+1029*0.8		-3263.21.6191.65
20min13297.4
2555+928*0.8		-3297.41.6361.685.591.681.735.45
23082.2
2371+889*0.8		-3082.21.5291.58
33464.4
2602+1078*0.8		-3464.41.7191.77
43451.6
2762+862*0.8		-3451.61.7121.76
53424.6
2583+1052*0.8		-3424.61.6991.74
63645.4
2563+1353*0.8		-3645.41.8091.86
30min13532.2
2729+1004*0.8		-3532.21.7521.754.851.821.824.79
23473.2
2646+1034*0.8		-3473.21.7231.79
33788.8
2884+1131*0.8		-3788.81.8801.95
43609
2737+1090*0.8		-36091.7911.86
53465.6
2616+1062*0.8		-3465.61.7191.78
63275.8
2399+1096*0.8		-3275.81.6251.69
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min13480.8
2616+1081*0.8		-3480.81.7271.855.591.811.935.50
23886.2
2991+1119*0.8		-3886.21.9282.01
33986.2
2963+1279*0.8		-3986.21.9782.07
43788
2900+1110*0.8		-37881.8791.97
53723.4
2857+1083*0.8		-3723.41.8471.93
63483
2635+1060*0.8		-34831.7281.81
60min13657.4
2843+1018*0.8		-3657.41.8151.762.601.921.862.56
23473.4
2683+988*0.8		-3473.41.7231.83
33658
2734+1155*0.8		-36581.8151.93
43459
2631+1035*0.8		-34591.7161.82
53491.6
2482+1262*0.8		-3491.61.7321.84
63512.8
2560+1191*0.8		-3512.81.7431.85
极限13667.4
2653+1268*0.8		-3667.41.8201.815.141.941.944.80
23541.6
2636+1132*0.8		-3541.61.7571.88
33873.8
2933+1176*0.8		-3873.81.9222.05
43795.4
2873+1153*0.8		-3795.41.8832.01
53688
2736+1190*0.8		-36881.8301.95
63347.6
2398+1187*0.8		-3347.61.6611.79
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