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%
1 18.12208542
208542+0		208902
208902+0		208871
208871+0		209241
209241+0		208681
208681+0		2088470.13
2 18.18208574
208574+0		208841
208841+0		2087080.10
单位质量响应值RSD%判断
11525.7711480.090.29数据可信
供试品溶液-12461045批-pH6.8(内含1%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
15min1113905
112268+1637*1		-11390555.42263.269.3255.4263.269.31
2145581
143533+2048*1		-14558170.83470.83
3119465
117809+1656*1		-11946558.12758.13
4138526
136742+1784*1		-13852667.40267.40
5126615
125039+1576*1		-12661561.60661.61
6135978
133951+2027*1		-13597866.16266.16
5min1176691
174201+2490*1		-17669185.97193.444.5686.5994.154.59
2198738
196017+2721*1		-19873896.69997.49
3186339
183859+2480*1		-18633990.66691.31
4196128
193902+2226*1		-19612895.42996.18
5197228
194833+2395*1		-19722895.96496.65
6197144
194383+2761*1		-19714495.92396.66
10min1192525
189874+2651*1		-19252593.67598.583.0795.25100.323.12
2207191
204308+2883*1		-207191100.811102.67
3197394
194706+2688*1		-19739496.04597.70
4204750
202327+2423*1		-20475099.624101.43
5206066
203699+2367*1		-206066100.264102.01
6207718
204805+2913*1		-207718101.068102.87
20min1196930
194143+2787*1		-19693095.819100.272.5298.43103.112.57
2207054
204302+2752*1		-207054100.745103.73
3203761
200954+2807*1		-20376199.143101.86
4208031
205509+2522*1		-208031101.220104.14
5211817
209147+2670*1		-211817103.062105.93
6208901
206013+2888*1		-208901101.643104.57
30min1200357
197488+2869*1		-20035797.48699.001.79101.16102.951.82
2205471
202593+2878*1		-20547199.975104.08
3201850
199142+2708*1		-20185098.213102.03
4198969
196506+2463*1		-19896996.811100.85
5205732
203172+2560*1		-205732100.102104.11
6208408
205401+3007*1		-208408101.404105.46
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1194568
191585+2983*1		-19456894.67097.361.7099.43102.411.74
2199227
196250+2977*1		-19922796.936102.15
3199813
196921+2892*1		-19981397.222102.13
4199598
196983+2615*1		-19959897.117102.23
5203889
201273+2616*1		-20388999.205104.33
6203444
200385+3059*1		-20344498.988104.17
60min1196754
193607+3147*1		-19675495.73396.901.51101.54103.031.56
2199321
196308+3013*1		-19932196.982103.27
3195263
192325+2938*1		-19526395.008101.00
4198946
196205+2741*1		-19894696.800103.00
5200934
198152+2782*1		-20093497.767103.99
6203703
200514+3189*1		-20370399.114105.39
极限1189630
186599+3031*1		-18963092.26795.742.6799.14102.952.65
2198447
195287+3160*1		-19844796.557103.92
3193670
190646+3024*1		-19367094.233101.28
4194102
191312+2790*1		-19410294.443101.71
5203836
201044+2792*1		-20383699.179106.49
6200946
197651+3295*1		-20094697.773105.15
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%
1 18.12209072
209072+0		208621
208621+0		208581
208581+0		208701
208701+0		208705
208705+0		2087360.10
2 18.18209641
209641+0		210017
210017+0		2098290.13
单位质量响应值RSD%判断
11519.6511541.750.14数据可信
供试品溶液-2025010621批-pH7.4
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
15min147567
44613+2954*1		-4756723.08923.701.4823.0923.701.48
248853
45934+2919*1		-4885323.71323.71
349056
46280+2776*1		-4905623.81123.81
449802
46995+2807*1		-4980224.17324.17
548752
46105+2647*1		-4875223.66423.66
648933
45305+3628*1		-4893323.75223.75
5min161361
58906+2455*1		-6136129.78431.847.7630.0432.117.69
272247
69340+2907*1		-7224735.06835.33
370326
67436+2890*1		-7032634.13634.40
465852
63170+2682*1		-6585231.96432.23
564893
62212+2681*1		-6489331.49831.76
658947
56617+2330*1		-5894728.61228.88
10min191667
88013+3654*1		-9166744.49445.855.1445.0846.475.13
2102379
98074+4305*1		-10237949.69450.35
396889
92897+3992*1		-9688947.02947.67
495348
91589+3759*1		-9534846.28146.90
591866
88207+3659*1		-9186644.59145.20
688671
85223+3448*1		-8867143.04043.62
20min1115040
109236+5804*1		-11504055.83956.555.3556.9257.685.30
2125366
118761+6605*1		-12536660.85162.06
3119966
113973+5993*1		-11996658.23059.40
4107594
102114+5480*1		-10759452.22553.36
5118649
112766+5883*1		-11864957.59158.70
6112379
106664+5715*1		-11237954.54855.61
30min1125579
116418+9161*1		-12557960.95564.995.1362.6666.745.09
2142267
130971+11296*1		-14226769.05570.94
3137920
127914+10006*1		-13792066.94568.76
4138875
128584+10291*1		-13887567.40869.13
5131943
122468+9475*1		-13194364.04465.79
6126732
118287+8445*1		-12673261.51463.18
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1148557
134981+13576*1		-14855772.10876.274.0974.4978.744.09
2163936
147970+15966*1		-16393679.57382.22
3162137
147414+14723*1		-16213778.70081.26
4159686
144806+14880*1		-15968677.51079.98
5158524
144207+14317*1		-15852476.94679.41
6149895
137233+12662*1		-14989572.75775.11
60min1166257
142620+23637*1		-16625780.69984.122.7883.8887.442.81
2180477
152649+27828*1		-18047787.60291.13
3173433
148604+24829*1		-17343384.18387.61
4173916
148589+25327*1		-17391684.41787.75
5175417
150006+25411*1		-17541785.14688.46
6170268
147611+22657*1		-17026882.64685.80
极限1167533
134199+33334*1		-16753381.31988.644.3385.4092.904.19
2184534
144737+39797*1		-18453489.57194.08
3181214
144014+37200*1		-18121487.95992.33
4185362
146860+38502*1		-18536289.97394.24
5187421
149279+38142*1		-18742190.97295.23
6189605
150727+38878*1		-18960592.03296.11
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%
1 18.12208671
208671+0		209053
209053+0		208907
208907+0		209015
209015+0		208320
208320+0		2087930.15
2 18.18209032
209032+0		208552
208552+0		2087920.17
单位质量响应值RSD%判断
11522.7911484.710.24数据可信
供试品溶液-12461045批-pH7.4
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
15min147960
43520+4440*1		-4796023.33425.134.3823.3325.134.38
250415
45008+5407*1		-5041524.52824.53
351487
45598+5889*1		-5148725.05025.05
454351
49166+5185*1		-5435126.44326.44
553202
46954+6248*1		-5320225.88425.88
652500
46976+5524*1		-5250025.54325.54
5min170164
67349+2815*1		-7016434.13735.193.1634.4035.473.15
270501
67428+3073*1		-7050134.30134.57
372042
68857+3185*1		-7204235.05035.33
473190
70119+3071*1		-7319035.60935.90
571679
68533+3146*1		-7167934.87435.16
676419
73024+3395*1		-7641937.18037.46
10min196996
92836+4160*1		-9699647.19147.182.8147.8347.852.78
297954
93366+4588*1		-9795447.65748.31
397743
92930+4813*1		-9774347.55548.22
499849
95346+4503*1		-9984948.57949.27
591779
87558+4221*1		-9177944.65345.33
697541
93134+4407*1		-9754147.45648.15
20min1111640
105768+5872*1		-11164054.31655.475.3855.4856.665.30
2116458
109919+6539*1		-11645856.66057.84
3118089
111236+6853*1		-11808957.45458.65
4117832
111472+6360*1		-11783257.32958.56
5102495
96744+5751*1		-10249549.86751.04
6117544
110928+6616*1		-11754457.18858.41
30min1128387
118821+9566*1		-12838762.46463.083.5664.2364.893.52
2132857
122374+10483*1		-13285764.63966.45
3125433
114874+10559*1		-12543361.02762.86
4131580
121498+10082*1		-13158064.01765.88
5123782
114081+9701*1		-12378260.22361.95
6135855
124782+11073*1		-13585566.09767.96
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1139568
126884+12684*1		-13956867.90472.054.8670.3674.564.77
2157962
142744+15218*1		-15796276.85379.38
3146528
131374+15154*1		-14652871.29073.80
4152988
138621+14367*1		-15298874.43377.01
5140696
127444+13252*1		-14069668.45270.85
6150789
135729+15060*1		-15078973.36375.96
60min1152777
131090+21687*1		-15277774.33078.055.1777.5581.365.09
2162990
138676+24314*1		-16299079.29982.68
3157783
131903+25880*1		-15778376.76680.07
4171216
145944+25272*1		-17121683.30186.71
5150207
127969+22238*1		-15020773.08076.23
6167509
141324+26185*1		-16750981.49884.91
极限1170953
137106+33847*1		-17095383.17381.005.6887.2185.185.51
2169322
134846+34476*1		-16932282.38086.65
3153711
118944+34767*1		-15371174.78578.94
4172031
137212+34819*1		-17203183.69888.03
5155888
124012+31876*1		-15588875.84479.81
6177052
139038+38014*1		-17705286.14190.46
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