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 18.12207896
207896+0
208248
208248+0
207576
207576+0
209173
209173+0
206926
206926+0
2079640.41
2 18.18209307
209307+0
207807
207807+0
2085570.51
单位质量响应值RSD%判断
11477.0411471.780.04数据可信
供试品溶液-2024122421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%
5min1156598
153733+2865*1
-15659876.38470.885.1376.3870.885.12
2141176
138666+2510*1
-14117668.86168.86
3146747
144091+2656*1
-14674771.57971.58
4143630
140945+2685*1
-14363070.05870.06
5134665
132337+2328*1
-13466565.68665.69
6149081
146367+2714*1
-14908172.71772.72
10min1193222
190076+3146*1
-19322294.24894.701.1095.1095.491.10
2192642
189405+3237*1
-19264293.96594.73
3192775
189610+3165*1
-19277594.03094.83
4196086
192780+3306*1
-19608695.64596.42
5192622
189441+3181*1
-19262293.95594.69
6197531
194244+3287*1
-19753196.35097.16
15min1200970
197684+3286*1
-20097098.02797.660.7299.9299.500.70
2199214
195906+3308*1
-19921497.17198.98
3202062
198717+3345*1
-20206298.560100.40
4199407
195951+3456*1
-19940797.26599.11
5201264
197824+3440*1
-20126498.17199.94
6198346
195066+3280*1
-19834696.74798.63
20min1195281
191934+3347*1
-19528195.25295.810.8998.2498.740.86
2195981
192716+3265*1
-19598195.59498.48
3194354
191032+3322*1
-19435494.80097.74
4199356
195871+3485*1
-19935697.240100.16
5196294
192917+3377*1
-19629495.74698.61
6197292
193928+3364*1
-19729296.23399.19
30min1194024
190684+3340*1
-19402494.63994.880.6998.6898.870.64
2196940
193439+3501*1
-19694096.061100.01
3193327
189944+3383*1
-19332794.29998.29
4194804
191309+3495*1
-19480495.02099.02
5194689
191269+3420*1
-19468994.96398.89
6193350
189902+3448*1
-19335094.31098.33
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1190787
187306+3481*1
-19078793.06095.191.3398.16100.241.23
2195885
192333+3552*1
-19588595.547100.57
3195648
192021+3627*1
-19564895.431100.47
4193624
190072+3552*1
-19362494.44499.50
5197879
194303+3576*1
-19787996.519101.50
6197106
193450+3656*1
-19710696.142101.21
60min1191049
187431+3618*1
-19104993.18892.920.8899.3299.020.83
2192298
188631+3667*1
-19229893.79799.88
3187336
183750+3586*1
-18733691.37797.47
4190939
187303+3636*1
-19093993.13499.24
5190858
187217+3641*1
-19085893.09599.15
6190480
186728+3752*1
-19048092.91099.05
极限1184941
181365+3576*1
-18494190.20991.741.5397.3798.881.42
2188116
184518+3598*1
-18811691.75798.88
3186918
183227+3691*1
-18691891.17398.28
4193480
189580+3900*1
-19348094.374101.52
5187874
184214+3660*1
-18787491.63998.73
6187216
183587+3629*1
-18721691.31898.49
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 18.12207215
207215+0
207215
207215+0
208122
208122+0
207608
207608+0
207539
207539+0
2075400.18
2 18.18207148
207148+0
208360
208360+0
2077540.42
单位质量响应值RSD%判断
11453.6411427.610.17数据可信
供试品溶液-2025010421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%
5min1120577
119157+1420*1
-12057758.98857.0512.4658.9957.0512.46
2127580
126142+1438*1
-12758062.41462.41
3129049
127539+1510*1
-12904963.13263.13
4118426
116996+1430*1
-11842657.93557.94
5115019
113725+1294*1
-11501956.26956.27
689062
88012+1050*1
-8906243.57043.57
10min1174559
172790+1769*1
-17455985.39688.836.7786.0589.466.74
2164399
162559+1840*1
-16439980.42681.12
3196599
194497+2102*1
-19659996.17896.88
4188684
186707+1977*1
-18868492.30692.95
5190773
188795+1978*1
-19077393.32893.95
6174469
172628+1841*1
-17446985.35285.84
15min1179094
177199+1895*1
-17909487.61593.523.6989.2295.143.64
2188059
186004+2055*1
-18805992.00193.59
3197509
195342+2167*1
-19750996.62498.39
4196470
194350+2120*1
-19647096.11597.78
5189973
187995+1978*1
-18997392.93794.60
6195913
193875+2038*1
-19591395.84397.28
20min1180193
178141+2052*1
-18019388.15293.173.8990.7395.833.79
2191925
189850+2075*1
-19192593.89296.50
3193406
191289+2117*1
-19340694.61697.46
4196685
194562+2123*1
-19668596.22098.96
5182559
180556+2003*1
-18255989.31092.00
6197939
195698+2241*1
-19793996.83499.33
30min1193061
190774+2287*1
-19306194.44894.381.6798.0098.081.65
2192812
190478+2334*1
-19281294.32697.98
3196138
193871+2267*1
-19613895.95399.85
4194143
191969+2174*1
-19414394.97798.78
5186828
184703+2125*1
-18682891.39895.09
6194598
192287+2311*1
-19459895.20098.77
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1188092
185797+2295*1
-18809292.01792.971.7496.6297.711.62
2193815
191468+2347*1
-19381594.81699.52
3187270
184928+2342*1
-18727091.61596.58
4190776
188523+2253*1
-19077693.33098.19
5186361
184071+2290*1
-18636191.17095.87
6193869
191516+2353*1
-19386994.84399.47
60min1188365
185876+2489*1
-18836592.15091.622.1797.7897.402.04
2183518
181105+2413*1
-18351889.77995.53
3189573
187025+2548*1
-18957392.74198.72
4185854
183514+2340*1
-18585490.92296.82
5182812
180435+2377*1
-18281289.43495.15
6193574
191039+2535*1
-19357494.699100.38
极限1186410
183812+2598*1
-18641091.19490.351.5197.8597.141.46
2183861
181378+2483*1
-18386189.94796.70
3184616
182133+2483*1
-18461690.31697.33
4188560
186017+2543*1
-18856092.24699.15
5180206
177583+2623*1
-18020688.15994.87
6184427
181993+2434*1
-18442790.22496.96
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 18.12207474
207474+0
207554
207554+0
207009
207009+0
207684
207684+0
207210
207210+0
2073860.14
2 18.18206724
206724+0
206972
206972+0
2068480.09
单位质量响应值RSD%判断
11445.1411377.780.42数据可信
供试品溶液-2025010521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%
5min188071
87056+1015*1
-8807143.19639.8723.7543.2039.8723.75
293970
92896+1074*1
-9397046.08946.09
357064
56285+779*1
-5706427.98827.99
460765
60010+755*1
-6076529.80329.80
5106745
105527+1218*1
-10674552.35552.35
681111
79839+1272*1
-8111139.78239.78
10min1168658
166795+1863*1
-16865882.72180.089.6283.2080.529.69
2172262
170298+1964*1
-17226284.48985.00
3147395
145749+1646*1
-14739572.29272.60
4143925
142213+1712*1
-14392570.59070.92
5185483
183480+2003*1
-18548390.97391.55
6161891
160088+1803*1
-16189179.40279.84
15min1189159
187160+1999*1
-18915992.77689.386.8294.1790.726.88
2186559
184543+2016*1
-18655991.50192.95
3164257
162360+1897*1
-16425780.56281.68
4183942
181760+2182*1
-18394290.21791.33
5198294
196162+2132*1
-19829497.25698.85
6171231
169252+1979*1
-17123183.98385.31
20min1187741
185784+1957*1
-18774192.08090.505.6594.5192.825.67
2192579
190579+2000*1
-19257994.45396.92
3167867
165897+1970*1
-16786782.33384.34
4193669
191386+2283*1
-19366994.98897.11
5189647
187563+2084*1
-18964793.01595.69
6175575
173667+1908*1
-17557586.11388.37
30min1189213
187123+2090*1
-18921392.80292.345.7196.2695.675.77
2196267
194093+2174*1
-19626796.26299.78
3169582
167462+2120*1
-16958283.17486.10
4191590
189322+2268*1
-19159093.96897.14
5199573
197327+2246*1
-19957397.884101.59
6183390
181174+2216*1
-18339089.94693.16
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1185300
183061+2239*1
-18530090.88389.435.3695.3793.795.46
2188736
186487+2249*1
-18873692.56897.16
3165270
163035+2235*1
-16527081.05984.91
4183554
181292+2262*1
-18355490.02794.24
5193104
190811+2293*1
-19310494.71199.51
6178070
175763+2307*1
-17807087.33791.55
60min1186317
183979+2338*1
-18631791.38289.584.9496.8894.935.05
2189508
187106+2402*1
-18950892.94798.56
3167175
164665+2510*1
-16717581.99486.74
4184975
182464+2511*1
-18497590.72495.94
5190925
188455+2470*1
-19092593.64299.49
6176972
174445+2527*1
-17697286.79991.98
极限1187224
184769+2455*1
-18722491.82790.365.0698.3496.715.15
2188734
186202+2532*1
-18873492.56799.22
3173163
170467+2696*1
-17316384.93090.59
4182917
180434+2483*1
-18291789.71495.94
5198271
195624+2647*1
-19827197.245104.13
6175151
172617+2534*1
-17515185.90592.05
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 18.12204695
204695+0
204638
204638+0
204859
204859+0
204460
204460+0
203996
203996+0
2045300.17
2 18.18208110
208110+0
208324
208324+0
2082170.08
单位质量响应值RSD%判断
11287.5311453.081.03数据可信
供试品溶液-2025010621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%
5min1142101
139610+2491*1
-14210169.95166.988.8469.9566.998.84
2117192
115354+1838*1
-11719257.68957.69
3139803
137543+2260*1
-13980368.82068.82
4138129
135934+2195*1
-13812967.99668.00
5151578
149183+2395*1
-15157874.61674.62
6127652
125706+1946*1
-12765262.83862.84
10min1174066
171301+2765*1
-17406685.68690.104.2786.4690.844.24
2183910
181161+2749*1
-18391090.53291.17
3180321
177600+2721*1
-18032188.76589.53
4175983
173393+2590*1
-17598386.63087.39
5193799
190876+2923*1
-19379995.40096.23
6190123
187271+2852*1
-19012393.59094.29
15min1192238
189153+3085*1
-19223894.63296.023.3096.3697.773.27
2196481
193442+3039*1
-19648196.72098.37
3193244
190296+2948*1
-19324495.12796.88
4185032
182187+2845*1
-18503291.08492.80
5200134
197114+3020*1
-20013498.518100.41
6203232
200208+3024*1
-203232100.043101.78
20min1194163
191146+3017*1
-19416395.57996.872.8898.3699.682.81
2200827
197761+3066*1
-20082798.860101.58
3188544
185698+2846*1
-18854492.81395.62
4195183
192103+3080*1
-19518396.08198.81
5197028
194027+3001*1
-19702896.98999.97
6204952
201755+3197*1
-204952100.890103.74
30min1189758
186785+2973*1
-18975893.41195.511.7997.2599.401.79
2195788
192656+3132*1
-19578896.379100.20
3195740
192622+3118*1
-19574096.355100.19
4189406
186297+3109*1
-18940693.23797.04
5196370
193289+3081*1
-19637096.666100.73
6197060
193835+3225*1
-19706097.005100.98
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1186335
182878+3457*1
-18633591.72695.322.2196.61100.272.19
2193724
190571+3153*1
-19372495.363100.25
3193532
190325+3207*1
-19353295.269100.18
4192486
189197+3289*1
-19248694.75499.59
5198396
195061+3335*1
-19839697.663102.80
6197317
194073+3244*1
-19731797.132102.18
60min1188923
185486+3437*1
-18892393.00093.300.6498.9099.310.63
2188764
185397+3367*1
-18876492.92198.87
3190780
187406+3374*1
-19078093.91499.88
4189034
185662+3372*1
-18903493.05498.94
5188404
185195+3209*1
-18840492.74498.96
6191295
187910+3385*1
-19129594.167100.30
极限1184924
181616+3308*1
-18492491.03193.062.0797.96100.102.04
2188235
184812+3423*1
-18823592.66199.64
3185674
182421+3253*1
-18567491.40098.41
4187947
184519+3428*1
-18794792.51999.44
5194636
191192+3444*1
-19463695.812103.06
6192844
189434+3410*1
-19284494.930102.10
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