缬沙坦氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 13.772276932275592269762269192269542272200.17
2 13.792284452288092286270.12
单位质量响应值RSD%判断
16501.0916579.190.34数据可信
供试品溶液-25040101批-氨氯地平-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
15min123013-230138.7858.832.948.788.832.95
223223-232238.8658.86
324411-244119.3189.32
422506-225068.5918.59
523037-230378.7948.79
622630-226308.6398.64
5min150050-5005019.10520.403.5319.1220.423.53
253567-5356720.44820.46
354755-5475520.90220.92
452804-5280420.15720.17
555327-5532721.12021.13
654186-5418620.68420.70
10min173012-7301227.87129.823.7027.9229.873.70
278757-7875730.06430.11
379710-7971030.42830.48
476517-7651729.20929.26
580177-8017730.60630.66
680527-8052730.73930.79
20min194571-9457136.10037.733.3636.1937.833.36
2100472-10047238.35338.45
397054-9705437.04837.15
496376-9637636.78936.89
5103004-10300439.31939.42
6101601-10160138.78438.88
30min1129223-12922349.32850.111.8949.4850.271.89
2129145-12914549.29849.46
3132271-13227150.49250.65
4129000-12900049.24349.40
5134698-13469851.41851.58
6133288-13328850.88051.04
45min1171214-17121465.35764.861.9365.5965.101.93
2168719-16871964.40564.65
3167446-16744663.91964.17
4165373-16537363.12763.37
5173788-17378866.34066.59
6172874-17287465.99166.24
60min1201275-20127576.83275.851.4677.1876.211.46
2197062-19706275.22475.58
3196209-19620974.89875.25
4195193-19519374.51174.86
5201889-20188977.06777.43
6200654-20065476.59576.95
极限1239802-23980291.53989.582.0492.0190.062.03
2231463-23146388.35688.83
3230367-23036787.93888.42
4230095-23009587.83488.30
5240755-24075591.90392.39
6235537-23553789.91190.40
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
1 15.739165104916713491428579133786914616191510080.16
2 15.709224692923261892286550.07
单位质量响应值RSD%判断
581755.12587812.420.74数据可信
供试品溶液-25040101批-缬沙坦-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
15min11266065-126606512.06912.151.7712.0712.151.75
21277904-127790412.18212.18
31310759-131075912.49512.49
41241782-124178211.83711.84
51271077-127107712.11712.12
61282131-128213112.22212.22
5min11996463-199646319.03219.702.1019.0519.712.10
22072222-207222219.75419.77
32109386-210938620.10820.13
42035322-203532219.40219.42
52104845-210484520.06520.08
62078106-207810619.81019.83
10min12476450-247645023.60724.482.1323.6624.542.13
22571508-257150824.51324.57
32593834-259383424.72624.78
42534531-253453124.16124.21
52620419-262041924.97925.03
62612674-261267424.90624.96
20min12866935-286693527.32928.464.3827.4228.554.37
22981218-298121828.41928.51
32945179-294517928.07528.17
42899125-289912527.63627.73
53235139-323513930.83930.93
62986193-298619328.46628.56
30min13440037-344003732.79333.061.2132.9333.201.21
23451292-345129232.90033.04
33456894-345689432.95333.10
43420937-342093732.61132.75
53527001-352700133.62233.77
63511188-351118833.47133.61
45min14017192-401719238.29438.271.2738.4938.471.27
23986455-398645538.00138.20
33975408-397540837.89638.09
43959873-395987337.74837.94
54087602-408760238.96639.17
64060957-406095738.71238.91
60min14398138-439813841.92641.591.3142.1841.851.31
24310793-431079341.09341.35
34314563-431456341.12941.39
44311388-431138841.09941.35
54432819-443281942.25642.52
64412488-441248842.06342.33
极限14827034-482703446.01445.461.2546.3445.791.25
24742855-474285545.21245.54
34704703-470470344.84845.18
44706924-470692444.86945.19
54840244-484024446.14046.48
64793651-479365145.69646.03
缬沙坦氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 13.772277392277112277012278942273162276720.10
2 13.792247622247192247400.02
单位质量响应值RSD%判断
16533.9116297.321.02数据可信
供试品溶液-25040101批-氨氯地平-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%
15min1985578-985578379.094381.671.46379.09381.671.46
2978946-978946376.543376.54
31008056-1008056387.740387.74
41005867-1005867386.898386.90
51000775-1000775384.939384.94
6974418-974418374.801374.80
5min1212731-21273181.82584.892.5482.4685.532.53
2219249-21924984.33284.96
3225661-22566186.79987.44
4226654-22665487.18187.83
5223863-22386386.10786.75
6216083-21608383.11483.74
10min1240310-24031092.43395.8910.5093.2096.6710.42
2234094-23409490.04290.81
3242576-24257693.30594.10
4302317-302317116.284117.07
5240570-24057092.53393.32
6235962-23596290.76191.52
20min1241784-24178493.00093.821.5593.9294.761.56
2238272-23827291.64992.57
3245477-24547794.42195.37
4247157-24715795.06796.05
5248381-24838195.53896.48
6242446-24244693.25594.17
30min1244858-24485894.18394.411.3895.2695.511.39
2239234-23923492.01993.09
3246617-24661794.85995.96
4249337-24933795.90597.05
5246542-24654294.83095.93
6246147-24614794.67895.75
45min1243157-24315793.52894.601.4094.7695.851.41
2240741-24074192.59993.82
3247123-24712395.05496.32
4250201-25020196.23897.54
5247966-24796695.37896.63
6246418-24641894.78396.01
60min1245699-24569994.50694.451.1395.9095.861.13
2241072-24107292.72694.10
3248771-24877195.68897.11
4246172-24617294.68896.15
5247643-24764395.25496.67
6243914-24391493.81995.21
极限1243380-24338093.61494.621.6795.1696.181.67
2239384-23938492.07793.61
3247687-24768795.27196.85
4249640-24964096.02297.64
5250173-25017396.22797.80
6245653-24565394.48896.03
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160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%
1 15.739218669922305892289779236107921350292240630.10
2 15.709122462910400391132320.15
单位质量响应值RSD%判断
586399.43580460.640.72数据可信
供试品溶液-25040101批-缬沙坦-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%
15min11985925-198592518.97518.654.6418.9718.654.63
21857455-185745517.74717.75
32109277-210927720.15420.15
41912858-191285818.27718.28
51960597-196059718.73318.73
61884812-188481218.00918.01
5min13840502-384050236.69536.951.8036.7336.981.80
23855098-385509836.83436.86
33957484-395748437.81337.85
43921985-392198537.47437.50
53870140-387014036.97837.01
63757368-375736835.90135.93
10min14685176-468517644.76646.013.3544.8646.103.34
24706779-470677944.97245.06
34847446-484744646.31646.41
45114830-511483048.87148.96
54826440-482644046.11546.21
64713662-471366245.03845.13
20min14892394-489239446.74647.621.3446.9147.781.35
24918648-491864846.99647.16
35026338-502633848.02548.20
45052286-505228648.27348.45
55037916-503791648.13648.31
64972995-497299547.51647.68
30min14948352-494835247.28048.061.3247.5348.311.32
24958741-495874147.37947.62
35061409-506140948.36048.61
45103917-510391748.76749.02
55089181-508918148.62648.88
65021244-502124447.97748.22
45min14965498-496549847.44448.161.2247.7748.491.23
24969326-496932647.48147.80
35065748-506574848.40248.74
45112741-511274148.85149.19
55088907-508890748.62348.95
65039407-503940748.15048.47
60min14960764-496076447.39948.081.2247.8048.491.22
24959636-495963647.38847.79
35057834-505783448.32648.74
45101225-510122548.74149.16
55085364-508536448.58949.00
65026866-502686648.03048.43
极限14955844-495584447.35248.081.2447.8348.571.24
24959456-495945647.38647.87
35057931-505793148.32748.82
45097419-509741948.70449.20
55090228-509022848.63649.13
65030436-503043648.06448.55
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