缬沙坦氨氯地平口崩片项目信息
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DZP67822106602对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.062423722422312420292420012418922421050.08
216.142415052412552413800.08
单位质量响应值RSD%判断
15075.0314955.390.57数据可信
供试品溶液-24013101-2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%
5min172684-7268427.12024.739.8527.1224.739.86
259221-5922122.09722.10
374388-7438827.75627.76
460704-6070422.65022.65
568732-6873225.64625.65
661887-6188723.09223.09
10min1154504-15450457.65054.777.0057.6954.817.00
2138864-13886451.81451.85
3161783-16178360.36660.41
4134177-13417750.06550.10
5148729-14872955.49555.54
6142667-14266753.23353.27
15min1196338-19633873.25970.684.5773.4070.814.57
2184030-18403068.66768.79
3200779-20077974.91675.06
4178298-17829866.52866.65
5193118-19311872.05872.19
6183962-18396268.64168.77
20min1218681-21868181.59679.953.8381.8680.213.84
2210166-21016678.41978.66
3226783-22678384.61984.89
4202898-20289875.70775.94
5216173-21617380.66080.92
6210993-21099378.72778.97
30min1241745-24174590.20288.253.1790.6088.643.17
2234420-23442087.46987.84
3249249-24924993.00293.41
4232036-23203686.57986.94
5230205-23020585.89686.29
6231445-23144586.35986.73
45min1251083-25108393.68692.952.8594.2493.482.85
2245854-24585491.73592.25
3262592-26259297.98098.55
4244555-24455591.25091.75
5246736-24673692.06492.60
6243833-24383390.98191.50
60min1256000-25600095.52195.211.8296.2395.901.83
2254815-25481595.07895.75
3263766-26376698.41899.15
4253614-25361494.63095.29
5250494-25049493.46694.15
6252271-25227194.12994.80
90min1253765-25376594.68795.841.9395.5596.691.93
2257658-25765896.13996.96
3266530-26653099.450100.34
4254082-25408294.80595.62
5254157-25415794.83395.68
6255013-25501395.15295.98
120min1258917-25891796.60996.541.3597.6397.541.37
2256761-25676195.80596.79
3264814-26481498.80999.87
4255064-25506495.17196.14
5260066-26006697.03898.04
6256702-25670295.78396.77
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1257311-25731196.01096.261.3497.1997.421.35
2254278-25427894.87896.02
3263419-26341998.28999.51
4259150-25915096.69697.82
5259220-25922096.72297.88
6254445-25444594.94096.08
缬沙坦氨氯地平口崩片项目信息
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22AD221对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.4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%
113.914685557468552446854714685045468393346851060.02
213.894683810468146046826350.04
单位质量响应值RSD%判断
336815.67337122.750.07数据可信
供试品溶液-24013101-2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%
5min12238552-223855243.28041.165.8743.2841.165.87
22021535-202153539.08439.08
32291939-229193944.31244.31
41989938-198993838.47338.47
52178996-217899642.12942.13
62051599-205159939.66639.67
10min13007556-300755658.14856.603.8858.2256.663.89
22844346-284434654.99355.06
33091644-309164459.77459.85
42784765-278476553.84153.90
52960280-296028057.23457.30
62875476-287547655.59455.66
15min13460607-346060766.90765.792.7967.0865.962.80
23349946-334994664.76864.92
33546702-354670268.57268.75
43278981-327898163.39663.55
53425698-342569866.23266.40
63355696-335569664.87965.04
20min13771424-377142472.91772.152.3673.2072.432.37
23683745-368374571.22171.49
33870576-387057674.83475.12
43618216-361821669.95570.21
53759173-375917372.68072.96
63688523-368852371.31471.58
30min14191379-419137981.03680.291.8581.4480.691.86
24113233-411323379.52579.91
34282911-428291182.80683.22
44060495-406049578.50678.88
54148352-414835280.20480.60
64121496-412149679.68580.07
45min14557932-455793288.12387.471.5488.6687.991.55
24491416-449141686.83787.35
34647432-464743289.85390.40
44451823-445182386.07186.58
54504209-450420987.08487.62
64491138-449113886.83287.35
60min14788660-478866092.58491.671.3693.2792.341.37
24716147-471614791.18291.84
34847953-484795393.73094.43
44676469-467646990.41591.07
54718647-471864791.23091.91
64700831-470083190.88691.55
90min14976735-497673596.22095.471.0997.0696.301.10
24930897-493089795.33496.15
35026871-502687197.18998.05
44887357-488735794.49295.29
54903526-490352694.80595.63
64902804-490280494.79195.61
120min15052452-505245297.68497.260.8498.6898.240.85
25026967-502696797.19198.16
35102743-510274398.65699.67
44985976-498597696.39997.36
55008080-500808096.82697.81
65006000-500600096.78697.76
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限15073211-507321198.08597.480.8499.2598.620.85
25041521-504152197.47398.61
35107905-510790598.75699.94
45007001-500700196.80597.92
54998823-499882396.64797.79
65021721-502172197.09098.22
缬沙坦氨氯地平口崩片项目信息
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DZP67822106602对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.062437592439112440532438722436282438450.07
216.142425042422662423850.07
单位质量响应值RSD%判断
15183.3715017.660.78数据可信
供试品溶液-P0133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%
5min173204-7320427.16130.137.8827.1630.137.88
283502-8350230.98130.98
373553-7355327.29027.29
484347-8434731.29531.29
583733-8373331.06731.07
688975-8897533.01233.01
10min1159288-15928859.10061.243.8359.1561.293.83
2165431-16543161.37961.43
3155872-15587257.83257.88
4167963-16796362.31862.37
5169178-16917862.76962.82
6172529-17252964.01364.07
15min1204659-20465975.93477.332.1676.0877.482.16
2206693-20669376.68876.84
3203072-20307275.34575.49
4209622-20962277.77577.93
5211311-21131178.40278.56
6215132-21513279.81979.98
20min1230667-23066785.58385.971.6385.8586.251.64
2230259-23025985.43285.71
3227616-22761684.45184.72
4230688-23068885.59185.88
5232280-23228086.18286.47
6238759-23875988.58688.88
30min1252161-25216193.55893.211.2593.9793.631.25
2248843-24884392.32792.75
3250005-25000592.75893.17
4248511-24851192.20492.63
5250785-25078593.04793.48
6256992-25699295.35095.79
45min1259952-25995296.44995.361.2897.0295.941.28
2254803-25480394.53895.12
3255235-25523594.69995.26
4254406-25440694.39194.97
5255489-25548994.79395.38
6262278-26227897.31297.91
60min1259723-25972396.36495.201.8097.0995.941.80
2254935-25493594.58795.32
3256020-25602094.99095.71
4253146-25314693.92394.66
5251584-25158493.34494.09
6264111-26411197.99298.76
90min1259247-25924796.18795.261.7397.0896.161.73
2251176-25117693.19394.09
3256235-25623595.07095.95
4254181-25418194.30795.20
5255597-25559794.83395.73
6264037-26403797.96498.89
120min1259560-25956096.30395.241.4097.3596.301.40
2254640-25464094.47895.53
3253574-25357494.08295.12
4253907-25390794.20695.26
5256005-25600594.98496.04
6262534-26253497.40798.50
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1258382-25838295.86694.881.3697.0896.101.36
2253355-25335594.00195.21
3255679-25567994.86396.06
4252337-25233793.62394.83
5253387-25338794.01395.23
6261273-26127396.93998.19
缬沙坦氨氯地平口崩片项目信息
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22AD221对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.4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%
113.914730313473451147390754737361473438847351300.08
213.894712573471001347112930.04
单位质量响应值RSD%判断
340411.93339185.960.26数据可信
供试品溶液-P0133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%
5min12463569-246356947.23449.514.5747.2349.514.57
22609768-260976850.03750.04
32411056-241105646.22746.23
42675528-267552851.29851.30
52630203-263020350.42950.43
62702480-270248051.81551.81
10min13718485-371848571.29572.592.4271.3772.672.42
23762959-376295972.14772.23
33662131-366213170.21470.29
43819163-381916373.22573.31
53833980-383398073.50973.59
63919800-391980075.15475.24
15min14379153-437915383.96284.601.7584.1684.801.75
24367277-436727783.73483.94
34333722-433372283.09183.28
44401868-440186884.39784.60
54439542-443954285.11985.33
64551627-455162787.26987.48
20min14748454-474845491.04291.061.4991.3891.401.49
24699317-469931790.10090.44
34698019-469801990.07590.41
44712853-471285390.36090.71
54751853-475185391.10791.46
64884466-488446693.65094.01
30min15051395-505139596.85196.281.3697.3496.781.36
24974367-497436795.37495.87
34987453-498745395.62596.11
44962634-496263495.14995.65
55008208-500820896.02396.52
65144909-514490998.64499.16
45min15160059-516005998.93497.941.4499.5898.601.44
25060796-506079697.03197.68
35079693-507969397.39398.04
45040788-504078896.64797.30
55075218-507521897.30797.97
65233272-5233272100.338101.02
60min15154970-515497098.83697.911.4999.6598.731.49
25053474-505347496.89097.70
35089793-508979397.58798.39
45031217-503121796.46497.28
55074608-507460897.29698.12
65235990-5235990100.390101.23
90min15140728-514072898.56397.711.4599.5498.701.45
25046228-504622896.75297.73
35066602-506660297.14298.11
45031856-503185696.47697.46
55066080-506608097.13298.12
65225957-5225957100.197101.21
120min15165041-516504199.03098.021.41100.1799.161.40
25057010-505701096.95898.10
35083230-508323097.46198.59
45048627-504862796.79897.94
55087810-508781097.54998.70
65232120-5232120100.316101.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限15157034-515703498.87697.761.44100.1999.081.43
25050801-505080196.83998.14
35069825-506982597.20498.50
45023456-502345696.31597.62
55075821-507582197.31998.63
65216902-5216902100.024101.37
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