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%
119.22204242
204242+0		203895
203895+0		204084
204084+0		203485
203485+0		204107
204107+0		2039630.15
219.03204104
204104+0		203582
203582+0		2038430.19
单位质量响应值RSD%判断
10612.0210711.670.67数据可信
供试品溶液-2023082021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%
5min127506
27506+0		-2750613.51913.547.6613.5213.547.66
225839
25839+0		-2583912.70012.70
325999
25999+0		-2599912.77812.78
429011
29011+0		-2901114.25914.26
531005
31005+0		-3100515.23915.24
625878
25878+0		-2587812.71912.72
10min146422
46422+0		-4642222.81622.552.8422.9722.702.86
243951
43951+0		-4395121.60221.74
346220
46220+0		-4622022.71722.86
447053
47053+0		-4705323.12623.28
547020
47020+0		-4702023.11023.28
644597
44597+0		-4459721.91922.06
15min153261
53261+0		-5326126.17726.521.6926.5826.921.71
254068
54068+0		-5406826.57426.96
353409
53409+0		-5340926.25026.64
455110
55110+0		-5511027.08627.50
554930
54930+0		-5493026.99827.42
652931
52931+0		-5293126.01526.40
20min158508
58508+0		-5850828.75628.812.0229.4529.502.03
259030
59030+0		-5903029.01329.69
357851
57851+0		-5785128.43329.12
459641
59641+0		-5964129.31330.03
559888
59888+0		-5988829.43530.16
656735
56735+0		-5673527.88528.56
30min161377
61377+0		-6137730.16630.600.8731.1831.610.88
262296
62296+0		-6229630.61831.62
362777
62777+0		-6277730.85531.86
462702
62702+0		-6270230.81831.86
562481
62481+0		-6248130.70931.76
661874
61874+0		-6187430.41131.39
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min167720.8
63564+5196*0.8		-67720.833.28433.770.8834.6335.130.87
269175
64963+5265*0.8		-6917533.99935.34
369341.4
65107+5293*0.8		-69341.434.08135.43
468908.2
64641+5334*0.8		-68908.233.86835.25
568826.4
64712+5143*0.8		-68826.433.82835.22
668296
63984+5390*0.8		-6829633.56734.89
60min169406.2
64555+6064*0.8		-69406.234.11334.201.2335.8335.931.20
270808.6
65751+6322*0.8		-70808.634.80236.52
369964.2
65069+6119*0.8		-69964.234.38736.11
469462
64442+6275*0.8		-6946234.14035.90
569649
64757+6115*0.8		-6964934.23236.00
668189.4
63235+6193*0.8		-68189.433.51535.21
极限168810
63594+6520*0.8		-6881033.82034.512.1135.9236.622.01
272134.8
66538+6996*0.8		-72134.835.45437.56
371879
66447+6790*0.8		-7187935.32837.43
469733.6
64280+6817*0.8		-69733.634.27436.41
569960.2
64577+6729*0.8		-69960.234.38536.54
668717.6
63360+6697*0.8		-68717.633.77435.84
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%
119.22203939
203939+0		205112
205112+0		205871
205871+0		205813
205813+0		205555
205555+0		2052580.39
219.03200082
200082+0		201322
201322+0		2007020.44
单位质量响应值RSD%判断
10679.4010546.610.89数据可信
供试品溶液-t2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%
5min126457
26457+0		-2645713.06413.583.7513.0613.583.76
227825
27825+0		-2782513.73913.74
327169
27169+0		-2716913.41513.42
429343
29343+0		-2934314.48914.49
526723
26723+0		-2672313.19513.19
627552
27552+0		-2755213.60413.60
10min144560
44560+0		-4456022.00222.271.7422.1522.421.74
243930
43930+0		-4393021.69121.84
345158
45158+0		-4515822.29722.45
446217
46217+0		-4621722.82022.98
545440
45440+0		-4544022.43722.58
645280
45280+0		-4528022.35822.51
15min151460
51460+0		-5146025.40926.031.6725.8026.421.66
252461
52461+0		-5246125.90326.30
352893
52893+0		-5289326.11726.51
453670
53670+0		-5367026.50026.91
553665
53665+0		-5366526.49826.89
652109
52109+0		-5210925.73026.13
20min157543
57543+0		-5754328.41328.561.1929.0829.241.19
258311
58311+0		-5831128.79229.47
357108
57108+0		-5710828.19828.88
458963
58963+0		-5896329.11429.82
557730
57730+0		-5773028.50529.20
657367
57367+0		-5736728.32629.01
30min160184
60184+0		-6018429.71729.913.1830.7030.913.09
258568
58568+0		-5856828.91929.92
359391
59391+0		-5939129.32530.33
460238
60238+0		-6023829.74330.78
564139
60127+5015*0.8		-6413931.67032.68
660897
60897+0		-6089730.06931.07
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min163746.4
59312+5543*0.8		-63746.431.47632.652.1932.7933.982.11
267991.2
63480+5639*0.8		-67991.233.57234.89
365747.6
61242+5632*0.8		-65747.632.46433.79
466781.4
62267+5643*0.8		-66781.432.97434.34
565632.2
61113+5649*0.8		-65632.232.40733.77
666808
62248+5700*0.8		-6680832.98734.32
60min167223.6
61890+6667*0.8		-67223.633.19333.430.6934.8635.120.66
267539.6
62446+6367*0.8		-67539.633.34935.04
368524.4
63258+6583*0.8		-68524.433.83535.52
467422.6
62301+6402*0.8		-67422.633.29135.02
567908.2
62625+6604*0.8		-67908.233.53135.25
667565.8
62361+6506*0.8		-67565.833.36235.06
极限170091
64115+7470*0.8		-7009134.60834.321.1436.6436.391.09
268549.6
62860+7112*0.8		-68549.633.84735.91
368498.2
62695+7254*0.8		-68498.233.82235.88
469670.2
63803+7334*0.8		-69670.234.40136.50
570215.2
64272+7429*0.8		-70215.234.67036.76
670063.6
64170+7367*0.8		-70063.634.59536.67
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%
119.22197394
197394+0		197497
197497+0		198404
198404+0		198353
198353+0		198010
198010+0		1979320.24
219.03190365
190365+0		189885
189885+0		1901250.18
单位质量响应值RSD%判断
10298.239990.802.15数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2023082121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%
5min129006
29006+0		-2900614.98615.624.3514.9915.624.35
232324
32324+0		-3232416.70116.70
329155
29155+0		-2915515.06315.06
429342
29342+0		-2934215.16015.16
530434
30434+0		-3043415.72415.72
631094
31094+0		-3109416.06516.07
10min145822
45822+0		-4582223.67524.121.8123.8424.301.82
247570
47570+0		-4757024.57824.76
347181
47181+0		-4718124.37724.54
445763
45763+0		-4576323.64423.81
546260
46260+0		-4626023.90124.08
647559
47559+0		-4755924.57224.75
15min153130
53130+0		-5313027.45027.891.0627.8828.331.07
254722
54722+0		-5472228.27328.73
353570
53570+0		-5357027.67828.12
454160
54160+0		-5416027.98328.41
554358
54358+0		-5435828.08528.53
653963
53963+0		-5396327.88128.33
20min155791
55791+0		-5579128.82530.535.6429.5631.285.50
257307
57307+0		-5730729.60930.38
364937.2
60398+5674*0.8		-64937.233.55134.30
460872
56788+5105*0.8		-6087231.45032.19
557198
57198+0		-5719829.55230.30
658443
58443+0		-5844330.19530.96
30min164548.8
60300+5311*0.8		-64548.833.35033.124.4234.4034.224.29
264382.6
60153+5287*0.8		-64382.633.26434.37
366560.6
61791+5962*0.8		-66560.634.39035.51
467559.8
62951+5761*0.8		-67559.834.90636.00
560882
60882+0		-6088231.45632.54
660713
60713+0		-6071331.36832.47
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min167873.4
62923+6188*0.8		-67873.435.06835.350.6836.4936.810.71
268262.8
63282+6226*0.8		-68262.835.26936.74
368987.6
63506+6852*0.8		-68987.635.64437.14
468547.4
63325+6528*0.8		-68547.435.41636.90
567998.8
63618+5476*0.8		-67998.835.13336.56
668889.6
64092+5997*0.8		-68889.635.59337.04
60min168072.8
62448+7031*0.8		-68072.835.17136.091.9336.9937.941.88
268747.6
62942+7257*0.8		-68747.635.52037.38
371888.4
65526+7953*0.8		-71888.437.14239.04
469780.6
63807+7467*0.8		-69780.636.05337.93
570141
64913+6535*0.8		-7014136.23938.06
670478
64930+6935*0.8		-7047836.41438.25
极限169999.8
63847+7691*0.8		-69999.836.16635.840.9038.3738.090.85
268488.8
62348+7676*0.8		-68488.835.38637.64
369889.8
63393+8121*0.8		-69889.836.11038.42
469375
63039+7920*0.8		-6937535.84438.12
569689.6
64080+7012*0.8		-69689.636.00638.23
668760.2
62941+7274*0.8		-68760.235.52637.77
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