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%
118.84204622
204622+0		204416
204416+0		204914
204914+0		204525
204525+0		204355
204355+0		2045660.11
218.83201987
201987+0		202266
202266+0		2021260.10
单位质量响应值RSD%判断
10858.0710734.250.82数据可信
供试品溶液-1251473批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min174553
74553+0		-7455336.18735.525.4036.1935.525.41
277064
77064+0		-7706437.40637.41
373367
73367+0		-7336735.61135.61
466773
66773+0		-6677332.41132.41
576799
76799+0		-7679937.27737.28
670568
70568+0		-7056834.25334.25
10min1141659.6
136618+6302*0.8		-141659.668.75968.362.4569.1668.752.46
2143191.8
137767+6781*0.8		-143191.869.50369.92
3143290.6
138145+6432*0.8		-143290.669.55169.95
4137918.8
132842+6346*0.8		-137918.866.94467.30
5143637.4
138311+6658*0.8		-143637.469.71970.13
6135312.6
130407+6132*0.8		-135312.665.67966.06
15min1168480.4
160202+10348*0.8		-168480.481.77883.201.1282.9484.351.11
2171756.4
163158+10748*0.8		-171756.483.36884.56
3172212.6
163767+10557*0.8		-172212.683.58984.76
4173441.6
165120+10402*0.8		-173441.684.18685.29
5172786.4
164360+10533*0.8		-172786.483.86885.06
6169742.4
161432+10388*0.8		-169742.482.39083.50
20min1194966.2
175663+24129*0.8		-194966.294.63494.890.8096.7196.970.77
2195871.8
175971+24876*0.8		-195871.895.07397.19
3193870
174390+24350*0.8		-19387094.10296.20
4198384.4
178374+25013*0.8		-198384.496.29398.33
5195195.2
175688+24384*0.8		-195195.294.74596.87
6194704.6
175931+23467*0.8		-194704.694.50796.53
30min1191122.8
172442+23351*0.8		-191122.892.76893.761.9295.8996.901.88
2197933.2
178318+24519*0.8		-197933.296.07499.24
3193422.6
174617+23507*0.8		-193422.693.88497.03
4196258.4
177548+23388*0.8		-196258.495.26198.37
5192744.4
174246+23123*0.8		-192744.493.55596.73
6187543.4
169769+22218*0.8		-187543.491.03194.11
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1186792.8
159172+34526*0.8		-186792.890.66692.581.9894.8296.761.94
2193493.8
164277+36521*0.8		-193493.893.91998.16
3191946.4
163580+35458*0.8		-191946.493.16897.35
4194987.2
166724+35329*0.8		-194987.294.64498.81
5191721
163885+34795*0.8		-19172193.05897.27
6185499.4
158381+33898*0.8		-185499.490.03994.13
60min1185377
146721+48320*0.8		-18537789.97990.991.5595.1496.201.53
2191257.6
150924+50417*0.8		-191257.692.83498.12
3186242.6
147285+48697*0.8		-186242.690.39995.62
4188570.8
150042+48161*0.8		-188570.891.52996.75
5189746.6
150509+49047*0.8		-189746.692.10097.35
6183562.6
145925+47047*0.8		-183562.689.09894.19
极限1183467.2
140460+53759*0.8		-183467.289.05290.450.9195.2296.670.89
2187772
143052+55900*0.8		-18777291.14297.45
3186175.6
142078+55122*0.8		-186175.690.36796.59
4188280.6
144387+54867*0.8		-188280.691.38997.62
5186173.6
142800+54217*0.8		-186173.690.36696.64
6186262
142762+54375*0.8		-18626290.40996.49
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%
118.84204512
204512+0		204758
204758+0		204869
204869+0		204864
204864+0		205032
205032+0		2048070.10
218.83203279
203279+0		203318
203318+0		2032980.02
单位质量响应值RSD%判断
10870.8610796.490.49数据可信
供试品溶液-1251473批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min129834
29834+0		-2983414.43114.633.8914.4314.633.89
230241
30241+0		-3024114.62714.63
331220
31220+0		-3122015.10115.10
429512
29512+0		-2951214.27514.27
531959
31959+0		-3195915.45815.46
628729
28729+0		-2872913.89613.90
10min145879
45879+0		-4587922.19122.252.6822.3522.412.68
246393
46393+0		-4639322.44022.60
347170
47170+0		-4717022.81622.98
445970
45970+0		-4597022.23522.39
546894
46894+0		-4689422.68222.85
643709
43709+0		-4370921.14221.30
15min152769
52769+0		-5276925.52426.162.2025.9326.572.20
254660
54660+0		-5466026.43926.85
354669
54669+0		-5466926.44326.86
454726
54726+0		-5472626.47126.88
555305
55305+0		-5530526.75127.17
652423
52423+0		-5242325.35725.75
20min160070
60070+0		-6007029.05528.982.1229.7529.682.10
259994
59994+0		-5999429.01929.72
361729
61729+0		-6172929.85830.57
460446
60446+0		-6044629.23729.94
559391
59391+0		-5939128.72729.45
657878
57878+0		-5787827.99528.67
30min166435
66435+0		-6643532.13432.851.9433.1533.871.92
267992
67992+0		-6799232.88733.92
368647
68647+0		-6864733.20434.25
469886
69886+0		-6988633.80334.83
568016
68016+0		-6801632.89933.94
666495
66495+0		-6649532.16333.15
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min174735
74735+0		-7473536.14936.421.5837.5237.811.56
277050
77050+0		-7705037.26938.66
374873
74873+0		-7487336.21637.63
475881
75881+0		-7588136.70338.10
575665
75665+0		-7566536.59938.00
673573
73573+0		-7357335.58736.93
60min176779
76779+0		-7677937.13838.141.8838.9139.931.86
279927
79927+0		-7992738.66040.47
380533
80533+0		-8053338.95340.77
478837
78837+0		-7883738.13339.94
579612
79612+0		-7961238.50840.32
677419
77419+0		-7741937.44739.18
极限182437
82437+0		-8243739.87440.311.3842.0642.521.39
283842
83842+0		-8384240.55442.79
385131
85131+0		-8513141.17743.43
483607
83607+0		-8360740.44042.67
583097
83097+0		-8309740.19342.43
681864
81864+0		-8186439.59741.75
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%
118.84201934
201934+0		201637
201637+0		201937
201937+0		201935
201935+0		202220
202220+0		2019330.11
218.83203011
203011+0		203587
203587+0		2032990.21
单位质量响应值RSD%判断
10718.3110796.550.52数据可信
供试品溶液-1251473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%
5min11644
1644+0		-16440.8010.7715.760.800.7715.78
21812
1812+0		-18120.8830.88
31393
1393+0		-13930.6790.68
41543
1543+0		-15430.7520.75
51213
1213+0		-12130.5910.59
61864
1864+0		-18640.9080.91
10min14828
4828+0		-48282.3522.5013.002.362.5112.94
26021
5197+1030*0.8		-60212.9332.94
34715
4715+0		-47152.2972.30
45959.6
5134+1032*0.8		-5959.62.9032.91
54638
4638+0		-46382.2592.27
64642
4642+0		-46422.2612.27
15min15716
5716+0		-57162.7843.037.792.823.077.77
26900.4
5910+1238*0.8		-6900.43.3613.40
35623
5623+0		-56232.7392.77
46514.6
5589+1157*0.8		-6514.63.1733.21
56286.2
5407+1099*0.8		-6286.23.0623.09
66334.4
5332+1253*0.8		-6334.43.0863.12
20min16951.8
6139+1016*0.8		-6951.83.3863.156.823.453.226.76
26954.6
6021+1167*0.8		-6954.63.3883.47
36151
6151+0		-61512.9963.06
46357.6
5416+1177*0.8		-6357.63.0973.17
55852
5852+0		-58522.8512.92
66580.6
5711+1087*0.8		-6580.63.2063.28
30min16785.4
5851+1168*0.8		-6785.43.3053.273.393.413.383.39
26869.6
5788+1352*0.8		-6869.63.3463.46
36263.6
5438+1032*0.8		-6263.63.0513.15
46798
5766+1290*0.8		-67983.3113.42
56852.8
6036+1021*0.8		-6852.83.3383.44
66733.4
5835+1123*0.8		-6733.43.2803.39
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min16519.6
5550+1212*0.8		-6519.63.1763.383.723.323.523.56
27221.6
6076+1432*0.8		-7221.63.5183.67
37206.4
6200+1258*0.8		-7206.43.5103.64
46885.6
5896+1237*0.8		-6885.63.3543.50
56889
5961+1160*0.8		-68893.3563.49
66909
5965+1180*0.8		-69093.3663.51
60min17048.6
6003+1307*0.8		-7048.63.4343.403.953.613.573.91
27439.4
6373+1333*0.8		-7439.43.6243.82
37007.2
6152+1069*0.8		-7007.23.4133.58
46642.2
5735+1134*0.8		-6642.23.2363.42
56774.8
5930+1056*0.8		-6774.83.3003.47
66907.4
5849+1323*0.8		-6907.43.3653.54
极限16916
5928+1235*0.8		-69163.3693.373.113.583.592.84
27002.4
6004+1248*0.8		-7002.43.4113.64
37163.6
6226+1172*0.8		-7163.63.4903.70
46607.6
5578+1287*0.8		-6607.63.2193.44
57103.8
6119+1231*0.8		-7103.83.4603.67
66738.4
5708+1288*0.8		-6738.43.2823.50
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