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)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%
119.49204368
204368+0		205336
205336+0		204082
204082+0		204629
204629+0		204099
204099+0		2045030.26
219.48200625
200625+0		200374
200374+0		2005000.09
单位质量响应值RSD%判断
10492.7110292.611.37数据可信
加速6月-供试品溶液-2023082221批-磷酸盐缓冲液（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%
5min153893.8
47773+7651*0.8		-53893.827.17624.657.5527.1824.657.55
244705.2
39338+6709*0.8		-44705.222.54322.54
346917
41337+6975*0.8		-4691723.65823.66
450422.6
44513+7387*0.8		-50422.625.42625.43
551737.4
45787+7438*0.8		-51737.426.08926.09
645571.4
40225+6683*0.8		-45571.422.98022.98
10min1110833.6
101792+11302*0.8		-110833.655.88956.111.7056.1956.391.70
2110755.2
101480+11594*0.8		-110755.255.84956.10
3113283.2
104064+11524*0.8		-113283.257.12457.39
4113282.4
103996+11608*0.8		-113282.457.12457.41
5111243.8
102083+11451*0.8		-111243.856.09656.39
6108247.2
99264+11229*0.8		-108247.254.58554.84
15min1148716.8
136732+14981*0.8		-148716.874.99274.332.4875.9175.232.45
2150738.6
138385+15442*0.8		-150738.676.01176.88
3151502.2
139391+15139*0.8		-151502.276.39777.29
4147088.2
135225+14829*0.8		-147088.274.17175.09
5144041
132637+14255*0.8		-14404172.63473.55
6142371.2
131024+14184*0.8		-142371.271.79272.65
20min1163308.6
149323+17482*0.8		-163308.682.35083.551.7984.1185.281.76
2170820.4
156106+18393*0.8		-170820.486.13887.85
3167543.6
153242+17877*0.8		-167543.684.48686.23
4165055.8
151019+17546*0.8		-165055.883.23184.97
5164111.4
150345+17208*0.8		-164111.482.75584.48
6163323.4
149317+17508*0.8		-163323.482.35784.02
30min1170735
150435+25375*0.8		-17073586.09588.581.7088.7791.231.65
2179071
157403+27085*0.8		-17907190.29892.97
3177918.6
156641+26597*0.8		-177918.689.71792.40
4175043.4
154209+26043*0.8		-175043.488.26790.93
5174378.8
154134+25306*0.8		-174378.887.93290.57
6176790
156150+25800*0.8		-17679089.14891.72
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1179561.8
151945+34521*0.8		-179561.890.54691.670.7094.1795.300.69
2183418.6
154793+35782*0.8		-183418.692.49196.17
3182107.6
154050+35072*0.8		-182107.691.83095.51
4181655.4
153873+34728*0.8		-181655.491.60295.25
5181721.4
154407+34143*0.8		-181721.491.63595.25
6182280.6
155167+33892*0.8		-182280.691.91795.48
60min1171125.6
134960+45207*0.8		-171125.686.29288.941.7690.9393.601.66
2176866.4
139140+47158*0.8		-176866.489.18793.89
3175001.2
138086+46144*0.8		-175001.288.24692.95
4177073.2
139714+46699*0.8		-177073.289.29193.96
5177978.8
141082+46121*0.8		-177978.889.74894.38
6180276
143176+46375*0.8		-18027690.90695.49
极限1176189.8
134865+51656*0.8		-176189.888.84689.471.0394.4495.111.00
2179935
137807+52660*0.8		-17993590.73496.43
3179092.6
136907+52732*0.8		-179092.690.30995.99
4175257.6
134552+50882*0.8		-175257.688.37594.03
5176340
135900+50550*0.8		-17634088.92194.55
6177729.4
137387+50428*0.8		-177729.489.62295.22
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)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%
119.49206936
206936+0		207254
207254+0		207289
207289+0		207254
207254+0		206712
206712+0		2070890.13
219.48209006
209006+0		205854
205854+0		2074301.08
单位质量响应值RSD%判断
10625.4010648.360.16数据可信
加速6月-供试品溶液-2023082221批-磷酸盐缓冲液（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%
5min148871.2
43796+6344*0.8		-48871.224.07625.476.4524.0825.476.45
251812.4
46342+6838*0.8		-51812.425.52525.52
354509.4
48815+7118*0.8		-54509.426.85326.85
447578.8
42474+6381*0.8		-47578.823.43923.44
550995.8
45751+6556*0.8		-50995.825.12225.12
656411.2
50552+7324*0.8		-56411.227.79027.79
10min1117554
107666+12360*0.8		-11755457.91257.152.1958.1857.432.19
2118110.2
108059+12564*0.8		-118110.258.18658.47
3115430.4
105700+12163*0.8		-115430.456.86557.16
4115976
105940+12545*0.8		-11597657.13457.39
5111286.4
101956+11663*0.8		-111286.454.82455.10
6117663.2
107936+12159*0.8		-117663.257.96558.27
15min1151379.8
138911+15586*0.8		-151379.874.57572.971.9975.4973.891.97
2151430
138678+15940*0.8		-15143074.60075.53
3147000.6
134623+15472*0.8		-147000.672.41873.35
4148055.8
135135+16151*0.8		-148055.872.93873.83
5143734.4
131584+15188*0.8		-143734.470.80971.70
6147147.2
134716+15539*0.8		-147147.272.49073.44
20min1166678.8
152098+18226*0.8		-166678.882.11281.141.6483.8582.861.64
2168949
153913+18795*0.8		-16894983.23184.99
3164885.4
150147+18423*0.8		-164885.481.22982.96
4162822.8
148002+18526*0.8		-162822.880.21381.92
5161888.2
147429+18074*0.8		-161888.279.75281.43
6162967.2
148420+18184*0.8		-162967.280.28482.04
30min1175935.8
153971+27456*0.8		-175935.886.67386.891.2989.3289.521.29
2180011.2
157308+28379*0.8		-180011.288.68091.36
3176070.8
153822+27811*0.8		-176070.886.73989.38
4177023.6
154570+28067*0.8		-177023.687.20889.81
5172971.6
151210+27202*0.8		-172971.685.21287.77
6176245.4
154167+27598*0.8		-176245.486.82589.48
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1185244.2
156021+36529*0.8		-185244.291.25890.471.2394.8794.061.22
2185070.2
155547+36904*0.8		-185070.291.17394.84
3186176.2
157001+36469*0.8		-186176.291.71795.32
4183276.8
154196+36351*0.8		-183276.890.28993.85
5180555.6
152218+35422*0.8		-180555.688.94892.46
6181489.6
152972+35647*0.8		-181489.689.40993.02
60min1173430.2
135619+47264*0.8		-173430.285.43887.821.4590.0792.421.38
2181043
141139+49880*0.8		-18104389.18993.87
3178783.8
140259+48156*0.8		-178783.888.07692.70
4177911
139203+48385*0.8		-17791187.64692.21
5179048.4
140630+48023*0.8		-179048.488.20692.70
6179365.8
140457+48636*0.8		-179365.888.36292.97
极限1180523.8
136911+54516*0.8		-180523.888.93387.420.9394.5193.000.86
2176986.2
134059+53659*0.8		-176986.287.19092.86
3176451.8
134239+52766*0.8		-176451.886.92792.53
4176003.6
133646+52947*0.8		-176003.686.70692.25
5177940.6
135559+52977*0.8		-177940.687.66093.14
6176814.8
134298+53146*0.8		-176814.887.10692.70
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)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%
119.49205701
205701+0		206635
206635+0		206693
206693+0		205678
205678+0		205797
205797+0		2061010.26
219.48208671
208671+0		207832
207832+0		2082520.29
单位质量响应值RSD%判断
10574.7010690.550.78数据可信
加速6月-供试品溶液-12355772批-磷酸盐缓冲液（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%
5min152610.6
47401+6512*0.8		-52610.625.92926.516.9725.9326.516.97
251227.6
46414+6017*0.8		-51227.625.24725.25
353827
49147+5850*0.8		-5382726.52926.53
451081.6
46732+5437*0.8		-51081.625.17525.18
561137
55729+6760*0.8		-6113730.13130.13
652818.6
48005+6017*0.8		-52818.626.03226.03
10min1116011.6
107918+10117*0.8		-116011.657.17656.472.5857.4656.772.59
2112182.8
104574+9511*0.8		-112182.855.28955.57
3115247.2
107680+9459*0.8		-115247.256.79957.09
4116987.4
109313+9593*0.8		-116987.457.65757.94
5117240.6
109427+9767*0.8		-117240.657.78258.12
6109835.6
102470+9207*0.8		-109835.654.13254.42
15min1149045.8
138633+13016*0.8		-149045.873.45773.511.8674.3874.441.87
2144762
134898+12330*0.8		-14476271.34672.24
3147685.8
137885+12251*0.8		-147685.872.78773.71
4150650.2
140835+12269*0.8		-150650.274.24875.17
5152925.6
141956+13712*0.8		-152925.675.36976.35
6149880.6
139819+12577*0.8		-149880.673.86874.76
20min1163612.8
151316+15371*0.8		-163612.880.63681.341.6582.3883.081.63
2161610
149726+14855*0.8		-16161079.64981.34
3166137
154341+14745*0.8		-16613781.88083.61
4169653.2
157886+14709*0.8		-169653.283.61385.36
5164592.8
153096+14371*0.8		-164592.881.11982.93
6164598.8
153130+14336*0.8		-164598.881.12282.83
30min1171260
149376+27355*0.8		-17126084.40586.501.6187.0489.141.59
2172722.2
150895+27284*0.8		-172722.285.12687.70
3176921.4
155151+27213*0.8		-176921.487.19589.84
4176918.2
155191+27159*0.8		-176918.287.19489.87
5176869.4
154875+27493*0.8		-176869.487.17089.89
6178361.4
156395+27458*0.8		-178361.487.90590.52
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1183347.6
154194+36442*0.8		-183347.690.36390.310.7293.9493.910.70
2182229.4
153483+35933*0.8		-182229.489.81193.33
3182694
154038+35820*0.8		-18269490.04093.65
4185526
156698+36035*0.8		-18552691.43695.08
5181898.8
153270+35786*0.8		-181898.889.64993.33
6183707.6
155454+35317*0.8		-183707.690.54094.13
60min1176113.2
139382+45914*0.8		-176113.286.79788.932.3691.3793.532.27
2176943.4
140169+45968*0.8		-176943.487.20691.72
3178230.6
141665+45707*0.8		-178230.687.84192.45
4184652.2
147245+46759*0.8		-184652.291.00695.66
5180198
143378+46025*0.8		-18019888.81093.49
6186503.4
149097+46758*0.8		-186503.491.91896.51
极限1179958
138434+51905*0.8		-17995888.69288.661.2594.2394.261.23
2177327.4
136709+50773*0.8		-177327.487.39692.88
3177820.6
137611+50262*0.8		-177820.687.63993.23
4183259.4
142053+51508*0.8		-183259.490.31995.99
5179456.8
139220+50296*0.8		-179456.888.44594.11
6181537.8
141373+50206*0.8		-181537.889.47195.09
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)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%
119.49202160
202160+0		202640
202640+0		202435
202435+0		202222
202222+0		202444
202444+0		2023800.10
219.48206133
206133+0		206605
206605+0		2063690.17
单位质量响应值RSD%判断
10383.7910593.891.42数据可信
加速6月-供试品溶液-12355772批-磷酸盐缓冲液（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%
5min155314.8
50330+6231*0.8		-55314.827.63727.253.7227.6427.253.71
252090.2
47111+6224*0.8		-52090.226.02626.03
353013.6
48212+6002*0.8		-53013.626.48826.49
453521.2
48346+6469*0.8		-53521.226.74126.74
557567.2
53056+5639*0.8		-57567.228.76328.76
655694.2
50743+6189*0.8		-55694.227.82727.83
10min1108851.2
101152+9624*0.8		-108851.254.38656.852.9054.6957.152.89
2110743.6
102930+9767*0.8		-110743.655.33255.62
3114119.2
106100+10024*0.8		-114119.257.01957.31
4116566.2
108295+10339*0.8		-116566.258.24158.54
5115518
108266+9065*0.8		-11551857.71758.04
6116915.4
109029+9858*0.8		-116915.458.41658.72
15min1139205
129381+12280*0.8		-13920569.55273.132.6770.4674.062.64
2149713.8
139177+13171*0.8		-149713.874.80375.71
3147105.4
136851+12818*0.8		-147105.473.50074.43
4149888
139272+13270*0.8		-14988874.89075.83
5146538.4
136964+11968*0.8		-146538.473.21674.18
6145717.4
135639+12598*0.8		-145717.472.80673.76
20min1161503.6
149262+15302*0.8		-161503.680.69483.032.2782.3884.772.26
2166579.2
154032+15684*0.8		-166579.283.23084.96
3163527.4
151137+15488*0.8		-163527.481.70583.45
4168654.2
155799+16069*0.8		-168654.284.26686.04
5164756.6
153127+14537*0.8		-164756.682.31984.09
6172001.8
159381+15776*0.8		-172001.885.93987.71
30min1169325.8
148009+26646*0.8		-169325.884.60287.702.8187.1890.362.78
2174437.2
152474+27454*0.8		-174437.287.15689.82
3171698
150066+27040*0.8		-17169885.78788.44
4178415.6
155926+28112*0.8		-178415.689.14491.86
5176048.6
154663+26732*0.8		-176048.687.96190.65
6183171.2
160876+27869*0.8		-183171.291.52094.24
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1178631.8
150311+35401*0.8		-178631.889.25291.501.5992.7795.141.58
2185880.8
156340+36926*0.8		-185880.892.87496.50
3183573
154377+36495*0.8		-18357391.72095.33
4185437.8
155945+36866*0.8		-185437.892.65296.36
5180603
152759+34805*0.8		-18060390.23793.90
6184646.6
155797+36062*0.8		-184646.692.25796.00
60min1182977.4
145251+47158*0.8		-182977.491.42391.011.0095.9495.670.97
2180384.6
143175+46512*0.8		-180384.690.12794.79
3182034.6
144745+46612*0.8		-182034.690.95295.58
4182184.2
144673+46889*0.8		-182184.291.02795.76
5180225.6
144008+45272*0.8		-180225.690.04894.72
6185110.2
147643+46834*0.8		-185110.292.48897.25
极限1172041.2
133154+48609*0.8		-172041.285.95989.472.1091.4995.142.06
2178423.6
137794+50787*0.8		-178423.689.14894.81
3179522.2
138787+50919*0.8		-179522.289.69795.33
4182823.2
141324+51874*0.8		-182823.291.34697.09
5181275.8
140947+50411*0.8		-181275.890.57396.24
6180356.2
139729+50784*0.8		-180356.290.11395.90
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