培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.524380474383114382044380974383914382100.04
210.384387324388584387950.03
单位质量响应值RSD%判断
41654.9442273.121.05数据可信
供试品溶液-2025072412批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1255386-25538668.33254.9155.0968.3354.9155.08
296349-9634925.78025.78
3334921-33492189.61389.61
4128632-12863234.41734.42
5323845-32384586.65086.65
692248-9224824.68224.68
10min1364616-36461697.55997.861.4497.6797.951.40
2368718-36871898.65698.70
3358325-35832595.87596.02
4373804-373804100.017100.07
5362987-36298797.12397.27
6366003-36600397.93097.97
15min1367627-36762798.36498.421.0598.6498.681.03
2369714-36971498.92399.13
3362400-36240096.96697.27
4373969-373969100.061100.29
5367500-36750098.33098.64
6365905-36590597.90398.11
20min1365355-36535597.75698.101.2298.2098.511.19
2368806-36880698.68099.05
3362871-36287197.09297.56
4374503-374503100.204100.59
5365470-36547097.78798.26
6362731-36273197.05497.42
30min1365006-36500697.66398.151.3398.2798.741.30
2368515-36851598.60299.14
3364532-36453297.53698.17
4375904-375904100.579101.14
5364529-36452997.53598.17
6362556-36255697.00797.54
极限1367282-36728298.27298.050.9199.0498.800.89
2368385-36838598.56799.27
3362425-36242596.97297.77
4371474-37147499.393100.12
5365561-36556197.81198.61
6363524-36352497.26697.96
培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.524378334380204383984378344383704380910.07
210.384393954393524393740.01
单位质量响应值RSD%判断
41643.6342328.901.16数据可信
供试品溶液-2025072412批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1355904-35590495.17862.6343.3395.1862.6343.34
296680-9668025.85525.85
3222186-22218659.41859.42
4136858-13685836.59936.60
5284471-28447176.07576.08
6309143-30914382.67382.67
10min1365314-36531497.69595.296.0197.8595.396.03
2312804-31280483.65283.70
3367098-36709898.17298.27
4362042-36204296.82096.88
5364164-36416497.38797.51
6366398-36639897.98598.12
15min1367139-36713998.18397.830.6598.5098.090.67
2364640-36464097.51497.70
3369679-36967998.86299.12
4362796-36279697.02197.24
5365169-36516997.65697.95
6365508-36550897.74798.05
20min1365582-36558297.76697.650.6898.2598.080.70
2364176-36417697.39097.74
3369402-36940298.78899.22
4361966-36196696.79997.18
5364300-36430097.42497.88
6365513-36551397.74898.21
30min1366232-36623297.94097.660.8198.5998.250.83
2364184-36418497.39397.90
3369771-36977198.88799.48
4361318-36131896.62697.17
5363266-36326697.14797.76
6366290-36629097.95698.58
极限1366703-36670398.06697.490.8298.8898.240.85
2362799-36279997.02297.69
3369079-36907998.70299.46
4360724-36072496.46797.17
5363410-36341097.18697.96
6364604-36460497.50598.30
培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.524408294413144404474413254412304410290.09
210.384395924399604397760.06
单位质量响应值RSD%判断
41922.9142367.630.75数据可信
供试品溶液-2025072512批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1190286-19028650.69446.5930.5650.6946.5930.55
295255-9525525.37725.38
3164362-16436243.78743.79
4225113-22511359.97259.97
5235921-23592162.85162.85
6138330-13833036.85236.85
10min1366277-36627797.57993.975.9497.6694.055.95
2312618-31261883.28483.33
3366733-36673397.70097.77
4364836-36483697.19597.29
5358319-35831995.45995.56
6347699-34769992.63092.69
15min1371456-37145698.95997.571.5599.2197.801.57
2357287-35728795.18495.37
3370643-37064398.74298.98
4370060-37006098.58798.85
5366041-36604197.51697.78
6361894-36189496.41196.63
20min1370534-37053498.71397.621.1399.1398.021.16
2360872-36087296.13996.48
3370025-37002598.57798.98
4369341-36934198.39598.82
5365158-36515897.28197.71
6362572-36257296.59296.97
30min1370629-37062998.73897.830.9399.3198.380.94
2364087-36408796.99597.50
3370208-37020898.62699.19
4369711-36971198.49499.08
5365658-36565897.41498.00
6362958-36295896.69597.23
极限1369967-36996798.56298.090.5299.3098.810.52
2369008-36900898.30698.97
3368644-36864498.20998.94
4369887-36988798.54199.30
5365616-36561697.40398.15
6366075-36607597.52598.22
培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.524398014397034392844391604397964395490.07
210.384388264377554382900.18
单位质量响应值RSD%判断
41782.2242224.470.75数据可信
供试品溶液-2025072512批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1270401-27040172.28060.3829.1472.2860.3829.14
2282716-28271675.57275.57
3102008-10200827.26827.27
4246630-24663065.92665.93
5208529-20852955.74155.74
6245121-24512165.52365.52
10min1370187-37018798.95495.412.5299.0795.512.54
2362770-36277096.97197.10
3352910-35291094.33694.38
4354437-35443794.74494.85
5343841-34384191.91192.00
6357453-35745395.55095.66
15min1371370-37137099.27097.391.3199.5697.651.32
2365907-36590797.81098.10
3365368-36536897.66697.87
4363224-36322497.09397.36
5356664-35666495.33995.59
6363514-36351497.17097.44
20min1369094-36909498.66297.501.0099.1197.931.01
2365738-36573897.76598.22
3366480-36648097.96398.33
4364222-36422297.35997.79
5358193-35819395.74896.15
6364869-36486997.53297.96
30min1369484-36948498.76697.810.8099.3898.400.81
2366298-36629897.91498.53
3366794-36679498.04798.58
4367148-36714898.14198.73
5360755-36075596.43397.00
6365079-36507997.58898.18
极限1368945-36894598.62298.400.9199.4099.140.90
2364944-36494497.55298.33
3368297-36829798.44999.14
4373924-37392499.953100.71
5364910-36491097.54398.27
6367614-36761498.26699.02
培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.524388284386254389764391394396174390370.09
210.384371114366644368880.08
单位质量响应值RSD%判断
41733.5642089.400.61数据可信
供试品溶液-2025072612批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1222420-22242059.58445.4946.6359.5845.4846.63
299382-9938226.62426.62
3274755-27475573.60473.60
4104654-10465428.03628.04
5222450-22245059.59259.59
695106-9510625.47825.48
10min1340901-34090191.32490.878.5691.4290.958.55
2369714-36971499.04399.09
3351795-35179594.24394.37
4364387-36438797.61697.66
5308623-30862382.67782.78
6299899-29989980.34080.38
15min1372828-37282899.87799.601.40100.1399.821.40
2379925-379925101.778101.99
3366991-36699198.31498.59
4372554-37255499.804100.01
5373162-37316299.967100.20
6365287-36528797.85798.03
20min1374494-374494100.32499.561.36100.7499.951.36
2377906-377906101.238101.62
3366587-36658798.20598.65
4371063-37106399.40499.78
5374710-374710100.381100.79
6365020-36502097.78698.12
30min1373351-373351100.01799.641.30100.60100.201.30
2379330-379330101.619102.17
3368175-36817598.63199.24
4371421-37142199.500100.04
5373910-373910100.167100.74
6365551-36555197.92898.43
极限1373693-373693100.10999.411.14100.86100.141.14
2377368-377368101.093101.81
3366532-36653298.19198.96
4370261-37026199.19099.90
5372030-37203099.663100.40
6366613-36661398.21298.88
培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.524374974372104377494372114374154374160.06
210.384373854376584375220.05
单位质量响应值RSD%判断
41579.4742150.480.97数据可信
供试品溶液-2025072612批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1334193-33419389.62957.6749.2989.6357.6749.29
292167-9216724.71924.72
3222047-22204759.55259.55
493025-9302524.94924.95
5224997-22499760.34360.34
6323790-32379086.83986.84
10min1342965-34296591.98294.407.8792.1394.507.85
2365899-36589998.13398.17
3299443-29944380.30980.41
4366803-36680398.37598.42
5364098-36409897.65097.75
6372743-37274399.968100.11
15min1369334-36933499.05499.550.8299.3699.800.78
2375266-375266100.645100.85
3374357-374357100.401100.63
4371210-37121099.55799.76
5369196-36919699.01799.28
6367781-36778198.63798.95
20min1369939-36993999.21699.840.9199.68100.260.89
2375301-375301100.654101.03
3374997-374997100.573100.97
4372262-37226299.839100.21
5366743-36674398.35998.79
6374248-374248100.372100.85
30min1368650-36865098.87099.450.8299.50100.040.81
2373566-373566100.189100.73
3373673-373673100.218100.79
4369094-36909498.99099.53
5366711-36671198.35098.94
6373177-373177100.085100.73
极限1368183-36818398.74599.150.7699.5499.900.75
2372727-37272799.964100.67
3372676-37267699.950100.69
4367580-36758098.58499.29
5366090-36609098.18498.94
6370931-37093199.482100.29
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