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D69223050102 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)40 供试品稀释倍数2.5 系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.26202574
202574+0
202650
202650+0
202470
202470+0
202534
202534+0
201473
201473+0
2023400.25
219.29202706
202706+0
201976
201976+0
2023410.26
单位质量响应值RSD%判断
10505.7110489.420.11数据可信
供试品溶液-12087013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%
5min128899.4
27849+1313*0.8
-28899.414.42614.211.8514.4314.211.86
228677.4
27751+1158*0.8
-28677.414.31514.32
329029.2
28102+1159*0.8
-29029.214.49114.49
428314.8
27414+1126*0.8
-28314.814.13414.13
527583.2
26636+1184*0.8
-27583.213.76913.77
628284.8
27284+1251*0.8
-28284.814.11914.12
10min147911.2
46596+1644*0.8
-47911.223.91623.531.0024.0823.681.01
247205.2
46022+1479*0.8
-47205.223.56423.72
347265.4
46099+1458*0.8
-47265.423.59423.75
446973.4
45827+1433*0.8
-46973.423.44823.60
546934.6
45701+1542*0.8
-46934.623.42923.58
646490
45206+1605*0.8
-4649023.20723.36
15min155061.2
53590+1839*0.8
-55061.227.48527.701.0527.9128.111.02
255431.6
54150+1602*0.8
-55431.627.67028.09
354793.2
53510+1604*0.8
-54793.227.35127.77
455549.6
54292+1572*0.8
-55549.627.72928.15
556489.2
55118+1714*0.8
-56489.228.19828.61
655567.6
54126+1802*0.8
-55567.627.73828.15
20min161315.4
59765+1938*0.8
-61315.430.60730.830.9031.3431.560.87
261592
60188+1755*0.8
-6159230.74531.47
361013
59625+1735*0.8
-6101330.45631.18
462394.4
61032+1703*0.8
-62394.431.14631.87
562302.6
60837+1832*0.8
-62302.631.10031.83
661936.2
60377+1949*0.8
-61936.230.91731.64
30min167251.4
65473+2223*0.8
-67251.433.57034.061.1634.6435.131.12
267470.4
65856+2018*0.8
-67470.433.68034.75
367957.2
66326+2039*0.8
-67957.233.92334.99
468829.2
67246+1979*0.8
-68829.234.35835.43
569165.8
67453+2141*0.8
-69165.834.52635.60
668728.8
66952+2221*0.8
-68728.834.30835.37
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min175795
73839+2445*0.8
-7579537.83538.160.9739.2839.610.93
276510
74714+2245*0.8
-7651038.19239.64
375912
74104+2260*0.8
-7591237.89339.34
477252.6
75495+2197*0.8
-77252.638.56340.02
575799.6
73954+2307*0.8
-75799.637.83739.29
677400.4
75398+2503*0.8
-77400.438.63640.08
60min180137.6
78068+2587*0.8
-80137.640.00340.481.0541.8742.351.02
280678.8
78770+2386*0.8
-80678.840.27342.14
380383.6
78454+2412*0.8
-80383.640.12541.99
481950.2
80051+2374*0.8
-81950.240.90742.79
582227
80203+2530*0.8
-8222741.04642.92
681137.8
79065+2591*0.8
-81137.840.50242.38
极限184104.2
81881+2779*0.8
-84104.241.98342.511.1044.2944.841.06
284576.6
82563+2517*0.8
-84576.642.21944.53
384833.2
82810+2529*0.8
-84833.242.34744.66
485242.8
83294+2436*0.8
-85242.842.55144.89
585450.6
83353+2622*0.8
-85450.642.65544.99
686791.8
84563+2786*0.8
-86791.843.32445.65
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D69223050102 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)40 供试品稀释倍数2.5 系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.26201649
201649+0
201008
201008+0
201409
201409+0
201967
201967+0
201250
201250+0
2014570.19
219.29200209
200209+0
199542
199542+0
1998760.24
单位质量响应值RSD%判断
10459.8710361.640.67数据可信
供试品溶液-12087013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%
5min122693
22693+0
-2269311.42213.8910.3911.4213.8910.40
226187.8
25375+1016*0.8
-26187.813.18213.18
327906.8
27030+1096*0.8
-27906.814.04714.05
428701
27737+1205*0.8
-2870114.44714.45
529130.2
28199+1164*0.8
-29130.214.66314.66
630967
29999+1210*0.8
-3096715.58715.59
10min143609
42521+1360*0.8
-4360921.95123.093.3822.0823.253.42
244278
43222+1320*0.8
-4427822.28722.43
346587.6
45498+1362*0.8
-46587.623.45023.61
446437
45261+1470*0.8
-4643723.37423.53
547366.8
46186+1476*0.8
-47366.823.84224.00
646990
45834+1445*0.8
-4699023.65223.83
15min152412
51176+1545*0.8
-5241226.38227.452.7126.7527.862.76
252954.4
51800+1443*0.8
-52954.426.65527.05
355462.4
54228+1543*0.8
-55462.427.91728.33
455329.8
53993+1671*0.8
-55329.827.85028.27
555108.2
53785+1654*0.8
-55108.227.73928.17
655983.8
54675+1636*0.8
-55983.828.17928.62
20min158911.4
57597+1643*0.8
-58911.429.65330.071.9630.3230.781.99
258480.2
57233+1559*0.8
-58480.229.43630.13
358673.4
57403+1588*0.8
-58673.429.53330.26
460510.2
59091+1774*0.8
-60510.230.45831.19
560734.8
59334+1751*0.8
-60734.830.57131.31
661093.4
59719+1718*0.8
-61093.430.75131.50
30min166186.2
64655+1914*0.8
-66186.233.31533.821.2934.3134.871.32
266274.6
64821+1817*0.8
-66274.633.35934.38
368199.2
66652+1934*0.8
-68199.234.32835.38
467949.2
66310+2049*0.8
-67949.234.20235.27
567638.6
66013+2032*0.8
-67638.634.04635.12
666875.8
65255+2026*0.8
-66875.833.66234.75
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min174643.8
72927+2146*0.8
-74643.837.57237.541.4838.9438.961.48
272649.2
71018+2039*0.8
-72649.236.56837.96
374501.2
72818+2104*0.8
-74501.237.50038.94
475954.2
74135+2274*0.8
-75954.238.23139.68
574479.4
72701+2223*0.8
-74479.437.48938.94
675223.2
73452+2214*0.8
-75223.237.86339.33
60min180313.2
78458+2319*0.8
-80313.240.42640.201.2542.2142.041.24
278442.6
76697+2182*0.8
-78442.639.48441.28
379876.4
78054+2278*0.8
-79876.440.20642.06
481325.2
79362+2454*0.8
-81325.240.93542.81
579130.2
77239+2364*0.8
-79130.239.83041.70
680094.8
78190+2381*0.8
-80094.840.31642.20
极限183250.2
81299+2439*0.8
-83250.241.90441.731.1944.1344.021.17
281530.8
79694+2296*0.8
-81530.841.03843.27
383712.4
81778+2418*0.8
-83712.442.13744.44
484184
82124+2575*0.8
-8418442.37444.70
582527.4
80517+2513*0.8
-82527.441.54043.85
682281.6
80284+2497*0.8
-82281.641.41643.75
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D69223050102 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)40 供试品稀释倍数2.5 系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.26202631
202631+0
202488
202488+0
202463
202463+0
202387
202387+0
201720
201720+0
2023380.18
219.29200864
200864+0
201162
201162+0
2010130.11
单位质量响应值RSD%判断
10505.6110420.580.58数据可信
供试品溶液-12087013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%
5min120352.4
18918+1793*0.8
-20352.410.19314.5420.3210.1914.5420.33
233209.4
31311+2373*0.8
-33209.416.63216.63
326352.8
24920+1791*0.8
-26352.813.19813.20
428014.2
26295+2149*0.8
-28014.214.03014.03
537572
35548+2530*0.8
-3757218.81718.82
628740.8
27012+2161*0.8
-28740.814.39414.39
10min154537.6
51776+3452*0.8
-54537.627.31429.565.5827.4329.725.65
261331
58783+3185*0.8
-6133130.71630.90
356418.8
54110+2886*0.8
-56418.828.25628.40
458556.8
55960+3246*0.8
-58556.829.32729.48
563645.2
61018+3284*0.8
-63645.231.87532.08
659600.6
56879+3402*0.8
-59600.629.85030.01
15min166998.4
63980+3773*0.8
-66998.433.55535.504.2933.9735.994.36
271701.4
68911+3488*0.8
-71701.435.91036.44
367702
65162+3175*0.8
-6770233.90734.37
471423.6
68586+3547*0.8
-71423.635.77136.25
575100.4
72202+3623*0.8
-75100.437.61238.18
672343.6
69358+3732*0.8
-72343.636.23236.72
20min175610.8
72346+4081*0.8
-75610.837.86839.663.4038.6640.553.48
279463.4
76473+3738*0.8
-79463.439.79740.72
376811.2
74004+3509*0.8
-76811.238.46939.31
479643.4
76545+3873*0.8
-79643.439.88840.77
583150.2
80047+3879*0.8
-83150.241.64442.63
680460
77240+4025*0.8
-8046040.29741.19
30min184259.8
80099+5201*0.8
-84259.842.20044.464.2143.4145.784.24
286604.6
82647+4947*0.8
-86604.643.37444.74
386775.2
82984+4739*0.8
-86775.243.45944.72
488927.8
84903+5031*0.8
-88927.844.53745.86
594513.8
90261+5316*0.8
-94513.847.33548.78
691546.6
87297+5312*0.8
-91546.645.84947.19
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1100697.2
95530+6459*0.8
-100697.250.43250.972.7252.1152.782.72
2101878
96990+6110*0.8
-10187851.02352.87
396917.2
92398+5649*0.8
-96917.248.53950.29
4104700.8
99652+6311*0.8
-104700.852.43754.25
5102565
97677+6110*0.8
-10256551.36753.34
6103829
98753+6345*0.8
-10382952.00053.85
60min1107431.4
101565+7333*0.8
-107431.453.80554.562.1956.0456.952.25
2107240.4
101746+6868*0.8
-107240.453.70956.13
3105926.6
100641+6607*0.8
-105926.653.05155.34
4111076.2
105345+7164*0.8
-111076.255.63058.03
5111752.8
106012+7176*0.8
-111752.855.96958.51
6110231.8
104411+7276*0.8
-110231.855.20757.64
极限1113688.2
107193+8119*0.8
-113688.256.93856.722.2459.7859.712.19
2114990.6
108741+7812*0.8
-114990.657.59060.60
3111281.4
105403+7348*0.8
-111281.455.73358.61
4114888
108576+7890*0.8
-11488857.53960.56
5115553.8
109197+7946*0.8
-115553.857.87361.03
6109134
103002+7665*0.8
-10913454.65757.70
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D69223050102 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)40 供试品稀释倍数2.5 系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.26199350
199350+0
198907
198907+0
199331
199331+0
199137
199137+0
198525
198525+0
1990500.18
219.29199690
199690+0
199048
199048+0
1993690.23
单位质量响应值RSD%判断
10334.8910335.360.01数据可信
供试品溶液-12087013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%
5min126251
24547+2130*0.8
-2625113.31016.0014.0913.3116.0014.10
232003.2
30048+2444*0.8
-32003.216.22616.23
330081
28285+2245*0.8
-3008115.25215.25
429529.6
27840+2112*0.8
-29529.614.97214.97
531894.2
30019+2344*0.8
-31894.216.17116.17
639555.6
37442+2642*0.8
-39555.620.05620.06
10min157989.2
55290+3374*0.8
-57989.229.40231.075.0629.5531.255.11
260762.8
58110+3316*0.8
-60762.830.80830.99
359732.6
57231+3127*0.8
-59732.630.28630.46
460802
58314+3110*0.8
-6080230.82830.99
561306.4
58776+3163*0.8
-61306.431.08431.26
667132.6
64455+3347*0.8
-67132.634.03834.26
15min168278.4
65376+3628*0.8
-68278.434.61936.664.3135.0937.184.36
270345.4
67459+3608*0.8
-70345.435.66736.19
371977
69213+3455*0.8
-7197736.49437.00
472233.2
69534+3374*0.8
-72233.236.62437.13
573490.2
70707+3479*0.8
-73490.237.26137.79
677497.4
74591+3633*0.8
-77497.439.29339.89
20min179889.6
76688+4002*0.8
-79889.640.50640.822.8141.3641.752.85
277546
74550+3745*0.8
-7754639.31740.24
380022.8
77014+3761*0.8
-80022.840.57341.48
479862.4
76952+3638*0.8
-79862.440.49241.41
581387
78359+3785*0.8
-8138741.26542.20
684359.2
81220+3924*0.8
-84359.242.77243.81
30min188239.2
84024+5269*0.8
-88239.244.73945.180.7946.0546.560.79
290169.6
85984+5232*0.8
-90169.645.71847.07
388563.6
84562+5002*0.8
-88563.644.90446.27
489586.6
85577+5012*0.8
-89586.645.42246.79
589179.8
85159+5026*0.8
-89179.845.21646.61
688896.6
84859+5047*0.8
-88896.645.07246.59
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1102144
97028+6395*0.8
-10214451.78951.690.9253.6053.580.95
2101074
96114+6200*0.8
-10107451.24753.11
3102776.4
97834+6178*0.8
-102776.452.11053.97
4101292
96500+5990*0.8
-10129251.35753.23
5101121.2
96282+6049*0.8
-101121.251.27153.17
6103258.6
98225+6292*0.8
-103258.652.35454.37
60min1109700
103812+7360*0.8
-10970055.62055.350.5858.0057.810.57
2108423.4
102745+7098*0.8
-108423.454.97357.41
3109758.8
103798+7451*0.8
-109758.855.65058.09
4108335.6
101858+8097*0.8
-108335.654.92857.37
5109455.8
103895+6951*0.8
-109455.855.49657.97
6109281.8
103717+6956*0.8
-109281.855.40858.00
极限1114341.8
107821+8151*0.8
-114341.857.97457.871.4660.9760.941.29
2115729
109289+8050*0.8
-11572958.67761.72
3114730.2
108443+7859*0.8
-114730.258.17161.23
4114551.4
108253+7873*0.8
-114551.458.08061.13
5114542.4
108184+7948*0.8
-114542.458.07561.16
6110884
104796+7610*0.8
-11088456.22059.43
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