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%
118.84200996
200996+0		201431
201431+0		200573
200573+0		200828
200828+0		201081
201081+0		2009820.16
218.83198738
198738+0		197962
197962+0		1983500.28
单位质量响应值RSD%判断
10667.8310533.720.90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%
5min163864
63864+0		-6386431.57036.307.7231.5736.307.72
276103
76103+0		-7610337.62037.62
372568
72568+0		-7256835.87335.87
477906
77906+0		-7790638.51238.51
579291
79291+0		-7929139.19639.20
670814
70814+0		-7081435.00635.01
10min1138644.8
133760+6106*0.8		-138644.868.53769.630.8968.8970.040.92
2140360.4
135062+6623*0.8		-140360.469.38569.80
3141356.2
136085+6589*0.8		-141356.269.87770.28
4141083.4
135785+6623*0.8		-141083.469.74270.17
5142287.8
136963+6656*0.8		-142287.870.33870.77
6141460
136456+6255*0.8		-14146069.92970.32
15min1168619
160467+10190*0.8		-16861983.35483.910.7784.4785.090.79
2169203.8
160635+10711*0.8		-169203.883.64384.83
3168527
160003+10655*0.8		-16852783.30984.48
4171875.6
163194+10852*0.8		-171875.684.96486.17
5170687.6
162154+10667*0.8		-170687.684.37785.59
6169573.8
161393+10226*0.8		-169573.883.82684.99
20min1179721
166621+16375*0.8		-17972188.84290.681.4490.8892.791.45
2182865.8
168965+17376*0.8		-182865.890.39792.52
3181620.4
167966+17068*0.8		-181620.489.78191.88
4185566.6
171689+17347*0.8		-185566.691.73293.88
5186969.6
172980+17487*0.8		-186969.692.42594.58
6183898.4
170528+16713*0.8		-183898.490.90793.00
30min1183098
169694+16755*0.8		-18309890.51289.711.6193.5492.821.55
2185800.6
172119+17102*0.8		-185800.691.84894.97
3180853
167645+16510*0.8		-18085389.40292.50
4181930.8
168930+16251*0.8		-181930.889.93593.10
5179918.6
167037+16102*0.8		-179918.688.94092.12
6177242.4
164596+15808*0.8		-177242.487.61790.72
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1194656.2
165137+36899*0.8		-194656.296.22593.781.62100.2697.891.53
2186386.4
157768+35773*0.8		-186386.492.13796.28
3187778.4
159144+35793*0.8		-187778.492.82596.92
4189947.8
161059+36111*0.8		-189947.893.89898.06
5191672.2
162885+35984*0.8		-191672.294.75098.92
6187794
159834+34950*0.8		-18779492.83396.91
60min1186907
147103+49755*0.8		-18690792.39591.521.1897.4996.681.10
2181758.8
142606+48941*0.8		-181758.889.85095.02
3183428.6
144159+49087*0.8		-183428.690.67595.80
4186259.6
146426+49792*0.8		-186259.692.07597.28
5185156.8
145936+49026*0.8		-185156.891.52996.75
6187356.4
148070+49108*0.8		-187356.492.61797.73
极限1182855.2
138884+54964*0.8		-182855.290.39290.180.9596.5296.350.89
2180339.4
136257+55103*0.8		-180339.489.14895.31
3181550
137474+55095*0.8		-18155089.74695.88
4184386
139450+56170*0.8		-18438691.14897.38
5181013.6
137524+54362*0.8		-181013.689.48195.72
6184393.6
140544+54812*0.8		-184393.691.15297.29
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%
118.84200043
200043+0		201214
201214+0		199742
199742+0		200264
200264+0		201914
201914+0		2006350.45
218.83199888
199888+0		199156
199156+0		1995220.26
单位质量响应值RSD%判断
10649.4210595.960.36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%
5min126941
26941+0		-2694113.29014.193.9913.2914.194.00
228662
28662+0		-2866214.13914.14
328430
28430+0		-2843014.02414.02
428654
28654+0		-2865414.13514.13
530320
30320+0		-3032014.95714.96
629599
29599+0		-2959914.60114.60
10min144492
44492+0		-4449221.94822.071.0322.1022.231.04
244076
44076+0		-4407621.74321.90
344543
44543+0		-4454321.97322.13
445272
45272+0		-4527222.33322.49
545188
45188+0		-4518822.29122.46
644889
44889+0		-4488922.14422.31
15min153278
53278+0		-5327826.28226.161.3626.6726.561.32
252658
52658+0		-5265825.97626.37
353621
53621+0		-5362126.45126.85
453978
53978+0		-5397826.62727.03
552607
52607+0		-5260725.95126.36
652059
52059+0		-5205925.68126.09
20min158947
58947+0		-5894729.07829.572.7329.7630.262.68
260044
60044+0		-6004429.62030.31
363088
63088+0		-6308831.12131.82
459860
59860+0		-5986029.52930.23
558994
58994+0		-5899429.10229.80
658707
58707+0		-5870728.96029.65
30min165107
65107+0		-6510732.11732.961.6633.1233.981.63
266166
66166+0		-6616632.64033.66
367112
67112+0		-6711233.10634.15
467570
67570+0		-6757033.33234.36
566683
66683+0		-6668332.89533.92
668272
68272+0		-6827233.67834.69
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min174473
74473+0		-7447336.73736.591.1338.1037.981.08
274112
74112+0		-7411236.55937.94
373806
73806+0		-7380636.40837.82
474471
74471+0		-7447136.73638.14
572855
72855+0		-7285535.93937.33
675360
75360+0		-7536037.17538.56
60min176602
76602+0		-7660237.78838.541.8739.5640.341.80
278378
78378+0		-7837838.66440.45
377453
77453+0		-7745338.20740.02
480833
80833+0		-8083339.87541.68
578108
78108+0		-7810838.53140.32
677443
77443+0		-7744338.20240.01
极限182008
82008+0		-8200840.45440.360.9342.6542.590.86
283046
83046+0		-8304640.96643.18
382221
82221+0		-8222140.55942.80
481342
81342+0		-8134240.12642.38
581042
81042+0		-8104239.97842.20
681246
81246+0		-8124640.07842.31
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%
118.84199264
199264+0		200196
200196+0		199508
199508+0		200616
200616+0		199362
199362+0		1997890.30
218.83196206
196206+0		195525
195525+0		1958660.25
单位质量响应值RSD%判断
10604.5110401.811.37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%
5min11795
1795+0		-17950.8960.6852.820.900.6852.88
21142
1142+0		-11420.5700.57
31620
1620+0		-16200.8080.81
41937
1937+0		-19370.9660.97
51661
1661+0		-16610.8290.83
6
+0		-0.0000.00
10min14246
4246+0		-42462.1192.185.442.132.185.40
24109
4109+0		-41092.0502.06
34400
4400+0		-44002.1952.20
44423
4423+0		-44232.2072.22
54781
4781+0		-47812.3862.39
64215
4215+0		-42152.1032.10
15min16076.2
5257+1024*0.8		-6076.23.0322.739.423.072.769.48
24827
4827+0		-48272.4082.44
35982.8
5162+1026*0.8		-5982.82.9853.02
45404
5404+0		-54042.6962.73
55541
5541+0		-55412.7652.80
64952
4952+0		-49522.4712.49
20min16195.2
5352+1054*0.8		-6195.23.0913.006.313.163.066.25
26324.4
5450+1093*0.8		-6324.43.1563.21
36431
5583+1060*0.8		-64313.2093.28
45470
5470+0		-54702.7292.79
55668
5668+0		-56682.8282.89
66008.6
5155+1067*0.8		-6008.62.9983.05
30min16729.4
5795+1168*0.8		-6729.43.3583.176.483.463.266.38
26287.6
5426+1077*0.8		-6287.63.1373.23
36727.4
5777+1188*0.8		-6727.43.3573.46
45632
5632+0		-56322.8102.91
56488.8
5660+1036*0.8		-6488.83.2383.34
66214.4
5336+1098*0.8		-6214.43.1013.18
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min16804.4
5854+1188*0.8		-6804.43.3953.374.063.533.504.07
26562.2
5615+1184*0.8		-6562.23.2743.40
37262.6
6221+1302*0.8		-7262.63.6243.76
46661.8
5813+1061*0.8		-6661.83.3243.45
56704
5808+1120*0.8		-67043.3453.48
66497.2
5562+1169*0.8		-6497.23.2423.36
60min16478.4
5532+1183*0.8		-6478.43.2323.322.823.413.482.76
26686
5658+1285*0.8		-66863.3363.50
36705.2
5650+1319*0.8		-6705.23.3463.53
46773.8
5865+1136*0.8		-6773.83.3803.54
56861
5933+1160*0.8		-68613.4233.59
66364.8
5412+1191*0.8		-6364.83.1763.33
极限16667.6
5598+1337*0.8		-6667.63.3273.391.573.543.601.55
26754.4
5752+1253*0.8		-6754.43.3703.57
36924.4
5894+1288*0.8		-6924.43.4553.67
46709.8
5793+1146*0.8		-6709.83.3483.55
56909.2
5990+1149*0.8		-6909.23.4473.66
66838
5814+1280*0.8		-68383.4123.60
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