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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.15204298
204298+0
203878
203878+0
206713
206713+0
205609
205609+0
202448
202448+0
2045890.81
218.07202870
202870+0
205216
205216+0
2040430.82
单位质量响应值RSD%判断
11272.1211291.810.13数据可信
供试品溶液-12654484批-磷酸盐溶液(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%
5min169173
65839+3334*1
-6917334.31635.572.4434.3235.582.44
272107
68637+3470*1
-7210735.77235.77
371138
67796+3342*1
-7113835.29135.29
473329
69923+3406*1
-7332936.37836.38
573850
70521+3329*1
-7385036.63636.64
670652
67095+3557*1
-7065235.05035.05
10min1139064
132490+6574*1
-13906468.98868.411.0769.3768.801.07
2137295
130507+6788*1
-13729568.11168.51
3135299
128249+7050*1
-13529967.12167.51
4138929
132542+6387*1
-13892968.92169.33
5138983
132467+6516*1
-13898368.94869.36
6137801
131361+6440*1
-13780168.36268.75
15min1169294
158388+10906*1
-16929483.98583.401.4385.1384.551.41
2171518
160502+11016*1
-17151885.08986.24
3167149
156389+10760*1
-16714982.92184.06
4169340
158604+10736*1
-16934084.00885.18
5164799
154425+10374*1
-16479981.75582.93
6166564
156273+10291*1
-16656482.63183.78
20min1186586
172416+14170*1
-18658692.56491.381.4094.6493.461.36
2183329
169285+14044*1
-18332990.94893.05
3183116
169135+13981*1
-18311690.84292.90
4184052
170061+13991*1
-18405291.30793.41
5180483
166904+13579*1
-18048389.53691.62
6187588
173585+14003*1
-18758893.06195.13
30min1192402
169263+23139*1
-19240295.44996.851.5198.5699.941.47
2192576
169346+23230*1
-19257695.53598.65
3194971
171481+23490*1
-19497196.72399.79
4200538
176654+23884*1
-20053899.485102.60
5195279
172265+23014*1
-19527996.87699.95
6195551
172822+22729*1
-19555197.011100.11
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1200125
166850+33275*1
-20012599.28097.831.52103.45102.011.48
2195786
163216+32570*1
-19578697.128101.30
3195100
162656+32444*1
-19510096.787100.93
4201058
168081+32977*1
-20105899.743103.97
5193430
162011+31419*1
-19343095.959100.11
6197766
165916+31850*1
-19776698.110102.29
60min1200382
155950+44432*1
-20038299.40898.772.55104.68104.042.45
2193646
150584+43062*1
-19364696.066101.32
3196210
152675+43535*1
-19621097.338102.56
4207620
161973+45647*1
-207620102.998108.33
5195673
153107+42566*1
-19567397.072102.29
6201093
157545+43548*1
-20109399.760105.03
极限1191481
142346+49135*1
-19148194.99295.951.39101.37102.311.35
2191715
142379+49336*1
-19171595.108101.43
3190031
141204+48827*1
-19003194.273100.57
4196275
146595+49680*1
-19627597.370103.85
5194681
145490+49191*1
-19468196.579102.88
6196281
146834+49447*1
-19628197.373103.75
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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.15201297
201297+0
204240
204240+0
203866
203866+0
202920
202920+0
204513
204513+0
2033670.65
218.07204301
204301+0
204934
204934+0
2046180.22
单位质量响应值RSD%判断
11204.7911323.630.75数据可信
供试品溶液-12654484批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127967
25972+1995*1
-2796713.89614.6517.6313.9014.6517.64
233630
31551+2079*1
-3363016.71016.71
321120
18687+2433*1
-2112010.49410.49
435963
33918+2045*1
-3596317.87017.87
527831
25496+2335*1
-2783113.82913.83
630397
28329+2068*1
-3039715.10415.10
10min162912
60153+2759*1
-6291231.26031.353.8231.4131.513.89
264428
61870+2558*1
-6442832.01332.20
359192
56350+2842*1
-5919229.41229.53
466245
63568+2677*1
-6624532.91633.11
561897
59002+2895*1
-6189730.75630.91
663868
61298+2570*1
-6386831.73531.90
15min177129
73894+3235*1
-7712938.32437.383.1938.8337.893.24
275832
72822+3010*1
-7583237.68038.22
370538
67264+3274*1
-7053835.04935.49
476802
73761+3041*1
-7680238.16238.73
575642
72402+3240*1
-7564237.58538.08
675426
72157+3269*1
-7542637.47838.00
20min186190
82484+3706*1
-8619042.82741.053.4643.7541.973.47
281414
78048+3366*1
-8141440.45341.41
377842
74336+3506*1
-7784238.67939.51
484453
81080+3373*1
-8445341.96442.95
583130
79632+3498*1
-8313041.30642.22
682615
79255+3360*1
-8261541.05041.99
30min189095
84860+4235*1
-8909544.27044.983.5245.6746.363.54
291581
87487+4094*1
-9158145.50546.91
384684
80544+4140*1
-8468442.07843.34
493023
88697+4326*1
-9302346.22247.68
592704
88391+4313*1
-9270446.06347.44
692051
87848+4203*1
-9205145.73947.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1103722
98067+5655*1
-10372251.53850.672.4553.4352.552.49
2100530
95250+5280*1
-10053049.95251.87
398015
92451+5564*1
-9801548.70250.43
4103994
98670+5324*1
-10399451.67353.64
5101224
95851+5373*1
-10122450.29752.18
6104370
98935+5435*1
-10437051.86053.76
60min1106951
100089+6862*1
-10695153.14253.233.5155.6155.683.51
2109282
102279+7003*1
-10928254.30156.77
399682
92489+7193*1
-9968249.53151.80
4109378
102355+7023*1
-10937854.34856.89
5108955
101718+7237*1
-10895554.13856.58
6108552
101613+6939*1
-10855253.93856.42
极限1115883
107926+7957*1
-11588357.58157.031.9660.6460.072.01
2115139
107371+7768*1
-11513957.21160.28
3111363
103418+7945*1
-11136355.33558.16
4117430
109363+8067*1
-11743058.34961.50
5115979
107940+8039*1
-11597957.62860.67
6112845
105108+7737*1
-11284556.07159.15
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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.15205061
205061+0
205703
205703+0
202268
202268+0
205229
205229+0
205895
205895+0
2048310.72
218.07204242
204242+0
205323
205323+0
2047820.38
单位质量响应值RSD%判断
11285.4511332.710.30数据可信
供试品溶液-12654484批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12192
1395+797*1
-21921.0851.3120.491.081.3020.69
22515
1695+820*1
-25151.2451.24
32256
1344+912*1
-22561.1171.12
43151
2165+986*1
-31511.5591.56
52245
1333+912*1
-22451.1111.11
63466
2376+1090*1
-34661.7151.72
10min15694
4653+1041*1
-56942.8182.8612.482.832.8812.43
26053
4923+1130*1
-60532.9963.01
34433
3226+1207*1
-44332.1942.21
46417
5212+1205*1
-64173.1763.19
55746
4500+1246*1
-57462.8442.86
66321
5234+1087*1
-63213.1283.15
15min16625
5387+1238*1
-66253.2793.168.213.323.208.19
26864
5769+1095*1
-68643.3973.44
35384
4104+1280*1
-53842.6652.70
46589
5400+1189*1
-65893.2613.31
56559
5319+1240*1
-65593.2463.29
66281
5140+1141*1
-62813.1083.16
20min16754
5503+1251*1
-67543.3433.196.343.423.286.34
26673
5525+1148*1
-66733.3023.39
35637
4368+1269*1
-56372.7902.86
46522
5095+1427*1
-65223.2283.32
56566
5199+1367*1
-65663.2503.33
66573
5404+1169*1
-65733.2533.34
30min16622
5318+1304*1
-66223.2773.315.583.393.425.57
26843
5556+1287*1
-68433.3873.51
36282
4956+1326*1
-62823.1093.21
47307
5620+1687*1
-73073.6163.74
56717
5386+1331*1
-67173.3243.44
66344
5241+1103*1
-63443.1403.26
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min17069
5672+1397*1
-70693.4983.525.743.653.675.58
26785
5480+1305*1
-67853.3583.52
36617
4837+1780*1
-66173.2753.41
47078
5601+1477*1
-70783.5033.67
57757
5490+2267*1
-77573.8393.99
67360
5183+2177*1
-73603.6423.80
60min17661
6116+1545*1
-76613.7913.497.063.983.686.88
27216
5856+1360*1
-72163.5713.77
36284
4842+1442*1
-62843.1103.28
47329
5900+1429*1
-73293.6273.83
57155
5690+1465*1
-71553.5413.74
66648
5370+1278*1
-66483.2903.49
极限17057
5602+1455*1
-70573.4933.465.613.733.695.66
27161
5668+1493*1
-71613.5443.78
36226
4791+1435*1
-62263.0813.28
47233
5715+1518*1
-72333.5803.82
57284
5786+1498*1
-72843.6053.84
66934
5571+1363*1
-69343.4323.67
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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.15205877
205877+0
205545
205545+0
204362
204362+0
203082
203082+0
205920
205920+0
2049570.60
218.07205122
205122+0
205408
205408+0
2052650.10
单位质量响应值RSD%判断
11292.4011359.440.42数据可信
供试品溶液-12654484批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133995
32438+1557*1
-3399516.79917.023.5016.8017.023.50
234247
32715+1532*1
-3424716.92416.92
336844
35232+1612*1
-3684418.20718.21
434004
32419+1585*1
-3400416.80416.80
533501
32062+1439*1
-3350116.55516.56
634055
32587+1468*1
-3405516.82916.83
10min149033
47017+2016*1
-4903324.23124.854.1224.4225.034.10
249236
47117+2119*1
-4923624.33124.52
353893
51641+2252*1
-5389326.63226.83
450704
48627+2077*1
-5070425.05625.24
547996
46114+1882*1
-4799623.71823.90
650808
48795+2013*1
-5080825.10825.29
15min157851
55442+2409*1
-5785128.58828.821.3529.0429.281.37
259178
56613+2565*1
-5917829.24429.70
358805
56487+2318*1
-5880529.06029.56
458698
56199+2499*1
-5869829.00729.47
556997
54640+2357*1
-5699728.16628.61
658399
55934+2465*1
-5839928.85929.32
20min162535
59822+2713*1
-6253530.90331.222.6931.6832.012.67
262385
59717+2668*1
-6238530.82931.61
365608
62915+2693*1
-6560832.42133.24
464202
61422+2780*1
-6420231.72732.51
560697
58160+2537*1
-6069729.99530.76
663668
60811+2857*1
-6366831.46332.25
30min170818
67521+3297*1
-7081834.99635.852.3136.1136.982.20
271590
68350+3240*1
-7159035.37836.50
370816
67658+3158*1
-7081634.99536.18
474227
70922+3305*1
-7422736.68137.82
574382
70871+3511*1
-7438236.75737.85
673459
70106+3353*1
-7345936.30137.44
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min179201
75360+3841*1
-7920139.13939.311.6640.6440.841.65
279870
75966+3904*1
-7987039.46940.99
381734
77657+4077*1
-8173440.39041.96
479305
75520+3785*1
-7930539.19040.74
577657
74086+3571*1
-7765738.37639.88
679490
75732+3758*1
-7949039.28240.82
60min178404
74177+4227*1
-7840438.74541.142.9540.6943.112.84
284019
79403+4616*1
-8401941.52043.48
384808
80198+4610*1
-8480841.91043.93
483866
79409+4457*1
-8386641.44443.43
585008
80517+4491*1
-8500842.00843.94
683391
78831+4560*1
-8339141.20943.19
极限188475
83451+5024*1
-8847543.72243.971.7646.0946.391.66
288406
83415+4991*1
-8840643.68846.11
389627
84614+5013*1
-8962744.29146.78
487278
82472+4806*1
-8727843.13045.57
591772
86679+5093*1
-9177245.35147.75
688266
83267+4999*1
-8826643.61846.05
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