比索洛尔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)0
对照品批号100711-202203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2000
标示量(mg)5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%
110.078397083987839508393783895839480.05
210.068351483447834800.06
单位质量响应值RSD%判断
8336.448298.210.33数据可信
供试品溶液-2024021621批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191087-9108798.36799.091.0798.3799.091.07
292856-92856100.277100.28
392913-92913100.339100.34
490519-9051997.75397.75
591846-9184699.18699.19
691313-9131398.61198.61
10min192085-9208599.44499.891.1099.61100.061.10
293864-93864101.366101.53
393461-93461100.930101.10
491335-9133598.63498.80
592638-92638100.042100.21
691593-9159398.91399.08
15min191893-9189399.23799.861.2199.57100.191.20
293713-93713101.203101.54
393283-93283100.738101.07
490969-9096998.23998.57
593314-93314100.772101.10
691652-9165298.97799.31
20min191691-9169199.01999.691.0699.51100.191.06
293415-93415100.881101.39
393569-93569101.047101.55
491196-9119698.48498.98
592239-9223999.611100.11
691790-9179099.12699.62
30min191383-9138398.68699.411.1399.35100.081.13
293444-93444100.912101.58
393113-93113100.555101.23
490959-9095998.22898.88
592195-9219599.563100.23
691235-9123598.52699.19
45min191087-9108798.36799.231.1299.19100.061.12
293171-93171100.617101.46
392478-9247899.869100.71
490911-9091198.17799.00
592754-92754100.167101.00
690941-9094198.20999.03
极限190978-9097898.24998.891.0199.2499.891.01
292783-92783100.198101.21
392515-9251599.909100.91
490512-9051297.74698.73
591720-9172099.050100.05
690935-9093598.20399.19
比索洛尔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)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
113.851036231039381036471037931037521037510.13
213.971031771029471030620.16
单位质量响应值RSD%判断
7491.057377.381.09数据可信
供试品溶液-2024021621批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1110575-11057596.42597.451.7796.4397.451.77
2111322-11132297.07797.08
3112834-11283498.39598.40
4111500-11150097.23297.23
5109267-10926795.28595.28
6114999-114999100.283100.28
10min1113714-11371499.16399.301.2199.3299.461.21
2113028-11302898.56498.73
3114232-11423299.61499.78
4114366-11436699.73199.89
5111911-11191197.59097.75
6115994-115994101.151101.32
15min1113003-11300398.54399.331.6198.8799.661.61
2114209-11420999.59499.92
3115000-115000100.284100.61
4113873-11387399.30199.63
5110984-11098496.78297.10
6116355-116355101.466101.80
20min1111929-11192997.60698.921.3198.1099.411.31
2113772-11377299.21399.71
3114226-11422699.609100.11
4114583-11458399.920100.41
5111264-11126497.02697.51
6114819-114819100.126100.63
30min1110772-11077296.59798.641.7597.2599.291.75
2113702-11370299.15299.81
3114248-11424899.628100.29
4113481-11348198.95999.62
5110751-11075196.57997.22
6115705-115705100.899101.57
45min1111862-11186297.54898.551.6598.3699.371.65
2113675-11367599.12999.95
3113624-11362499.08499.91
4113649-11364999.10699.93
5109937-10993795.86996.67
6115311-115311100.555101.40
极限1111883-11188397.56697.292.9698.5498.282.93
2112932-11293298.48199.47
3105572-10557292.06293.06
4113579-11357999.045100.04
5110522-11052296.37997.34
6114935-114935100.227101.23
比索洛尔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)0
对照品批号100711-202203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2000
标示量(mg)5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%
110.078384783865837958373683880838250.08
210.068386683878838720.02
单位质量响应值RSD%判断
8324.238337.180.11数据可信
供试品溶液-2024021621批-比索洛尔-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min184916-8491691.55591.951.7291.5591.951.72
285548-8554892.23692.24
386846-8684693.63693.64
485941-8594192.66092.66
585841-8584192.55292.55
682584-8258489.04089.04
10min188880-8888095.82997.171.7395.9897.321.73
290157-9015797.20697.36
392273-9227399.48799.64
491025-9102598.14198.30
590507-9050797.58397.74
687907-8790794.78094.93
15min189165-8916596.13697.631.9196.4597.941.91
290315-9031597.37697.69
393165-93165100.449100.77
491684-9168498.85299.17
590603-9060397.68698.00
688378-8837895.28795.59
20min188806-8880695.74997.671.9896.2298.141.98
290147-9014797.19597.67
393468-93468100.775101.26
491428-9142898.57699.06
590956-9095698.06798.55
688702-8870295.63796.10
30min188394-8839495.30597.612.2695.9498.262.25
290324-9032497.38698.03
393670-93670100.993101.65
491738-9173898.91099.56
590761-9076197.85798.50
688328-8832895.23495.86
45min187648-8764894.50097.042.4495.2997.842.44
289746-8974696.76297.56
393571-93571100.886101.71
491108-9110898.23199.04
590061-9006197.10297.91
687879-8787994.74995.53
极限187109-8710993.91996.562.5394.8797.522.52
289021-8902195.98196.94
393260-93260100.551101.54
490795-9079597.89398.87
589633-8963396.64197.61
687532-8753294.37595.32
比索洛尔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)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
113.851036321033311034891035311034391034840.11
213.971032051030141031100.14
单位质量响应值RSD%判断
7471.777380.820.87数据可信
供试品溶液-2024021621批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194908-9490882.85081.142.5582.8581.142.55
294580-9458082.56382.56
391009-9100979.44679.45
489184-8918477.85377.85
594791-9479182.74782.75
693226-9322681.38181.38
10min1104438-10443891.16990.043.1191.3190.183.11
2106570-10657093.03093.17
3100438-10043887.67787.81
498459-9845985.94986.08
5106074-10607492.59792.73
6102890-10289089.81789.95
15min1109674-10967495.74092.852.6796.0393.132.67
2108240-10824094.48894.78
3104010-10401090.79591.07
4102318-10231889.31889.59
5108203-10820394.45594.75
6105722-10572292.29092.57
20min1107222-10722293.59992.752.4194.0593.192.42
2109166-10916695.29695.75
3104569-10456991.28391.71
4102602-10260289.56689.99
5108714-10871494.90195.35
6105196-10519691.83092.27
30min1102717-10271789.66692.192.3690.2792.782.36
2108743-10874394.92795.54
3103817-10381790.62791.21
4104119-10411990.89091.46
5108294-10829494.53595.14
6105963-10596392.50093.09
45min199734-9973487.06292.403.3687.8293.153.34
2108906-10890695.06995.84
3106747-10674793.18493.92
4104210-10421090.97091.69
5109406-10940695.50696.27
6106094-10609492.61493.36
极限1101052-10105288.21392.282.9489.1193.182.92
2108456-10845694.67695.60
3106938-10693893.35194.24
4103093-10309389.99590.87
5108943-10894395.10196.03
6105806-10580692.36393.26
比索洛尔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)0
对照品批号100711-202203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2000
标示量(mg)5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%
110.078351483482834578345483439834690.04
210.068374083730837350.01
单位质量响应值RSD%判断
8288.888323.560.30数据可信
供试品溶液-2024021621批-比索洛尔-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%
5min192852-92852100.40797.652.17100.4197.652.17
289821-8982197.12997.13
391931-9193199.41199.41
488135-8813595.30695.31
588159-8815995.33295.33
690896-9089698.29298.29
10min194259-94259101.92898.852.20102.1099.012.20
290360-9036097.71297.87
393362-93362100.958101.12
489469-8946996.74896.91
589608-8960896.89997.06
691400-9140098.83799.00
15min193983-93983101.63098.872.02101.9799.202.02
290594-9059497.96598.29
393384-93384100.982101.32
489695-8969596.99397.31
589729-8972997.03097.35
691193-9119398.61398.94
20min193851-93851101.48798.722.17101.9999.222.17
290646-9064698.02198.51
393505-93505101.113101.62
489438-8943896.71597.20
589257-8925796.51997.00
691067-9106798.47798.97
30min193542-93542101.15398.482.15101.8399.142.15
290059-9005997.38698.04
393400-93400100.999101.67
489226-8922696.48697.13
589318-8931896.58597.23
690886-9088698.28198.94
45min193527-93527101.13798.392.05101.9899.212.05
290172-9017297.50998.32
392991-92991100.557101.40
489499-8949996.78197.58
589012-8901296.25497.06
690705-9070598.08598.91
极限193640-93640101.25997.982.29102.2798.972.29
289412-8941296.68797.66
392692-92692100.234101.24
489051-8905196.29697.26
588603-8860395.81296.78
690272-9027297.61798.60
比索洛尔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)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
113.851030101030201027271027511025791028170.19
213.971031611030881031240.06
单位质量响应值RSD%判断
7423.617381.820.40数据可信
供试品溶液-2024021621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%
5min1104922-10492291.88091.982.2991.8891.982.29
2105364-10536492.26792.27
3105380-10538092.28192.28
4101361-10136188.76288.76
5108855-10885595.32495.32
6104311-10431191.34591.35
10min1113079-11307999.02399.032.5499.1899.182.54
2111982-11198298.06398.22
3111863-11186397.95998.11
4109294-10929495.70995.86
5117781-117781103.141103.30
6114510-114510100.276100.43
15min1111868-11186897.96398.662.3398.2898.982.33
2111316-11131697.48097.80
3110818-11081897.04397.36
4110372-11037296.65396.96
5117115-117115102.558102.89
6114510-114510100.276100.60
20min1111016-11101697.21798.782.1497.7099.262.14
2111806-11180697.90998.39
3112012-11201298.08998.57
4110703-11070396.94397.41
5116980-116980102.439102.94
6114297-114297100.090100.58
30min1112381-11238198.41298.672.0999.0699.322.09
2110958-11095897.16697.81
3113104-11310499.04599.69
4109699-10969996.06496.69
5116541-116541102.055102.73
6113388-11338899.29499.95
45min1110331-11033196.61798.922.4297.4299.742.42
2111905-11190597.99598.80
3112464-11246498.48599.29
4111043-11104397.24098.03
5117824-117824103.179104.02
6114225-114225100.027100.85
极限1111859-11185997.95598.782.6798.9299.762.66
2111289-11128997.45698.42
3111894-11189497.98698.96
4109644-10964496.01596.97
5118293-118293103.589104.60
6113835-11383599.685100.67
比索洛尔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)0
对照品批号100711-202203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2000
标示量(mg)5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%
110.078369383611836998363583601836480.06
210.068374683716837310.03
单位质量响应值RSD%判断
8306.658323.160.15数据可信
供试品溶液-2024021621批-比索洛尔-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%
5min186807-8680793.77196.444.3193.7796.444.31
287658-8765894.69194.69
385359-8535992.20792.21
487922-8792294.97694.98
592543-9254399.96899.97
695385-95385103.038103.04
10min188634-8863495.74599.304.0095.9099.464.01
291533-9153398.87799.03
387157-8715794.15094.30
492254-9225499.65699.81
595457-95457103.115103.28
696541-96541104.286104.46
15min189044-8904496.188100.044.0596.50100.374.05
292589-92589100.017100.34
387691-8769194.72695.04
493235-93235100.715101.04
595693-95693103.370103.71
697430-97430105.247105.59
20min188872-8887296.002100.074.1496.48100.564.13
292641-92641100.074100.56
387619-8761994.64995.12
493397-93397100.890101.38
595833-95833103.522104.03
697437-97437105.254105.78
30min188786-8878695.909100.103.9396.55100.763.93
293112-93112100.582101.24
387875-8787594.92595.55
493582-93582101.090101.75
595809-95809103.496104.18
696812-96812104.579105.28
45min188840-8884095.96899.984.0096.76100.814.00
292782-92782100.226101.05
387689-8768994.72495.51
493431-93431100.927101.76
595280-95280102.924103.78
697314-97314105.121105.99
极限188604-8860495.71399.574.1496.67100.574.14
292513-9251399.935100.93
386850-8685093.81894.76
493131-93131100.603101.60
595126-95126102.758103.79
696851-96851104.621105.67
比索洛尔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)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
113.851027791028331030471030161027661028880.13
213.971031211029731030470.11
单位质量响应值RSD%判断
7428.747376.310.51数据可信
供试品溶液-2024021621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%
5min164390-6439056.38852.206.3556.3952.206.35
258379-5837951.12451.12
363427-6342755.54555.54
454340-5434047.58747.59
557423-5742350.28750.29
659660-5966052.24652.25
10min183894-8389473.46868.594.7273.5668.684.72
274469-7446965.21565.30
380811-8081170.76870.86
474351-7435165.11165.19
578654-7865468.87968.96
677785-7778568.11868.21
15min190776-9077679.49575.183.8379.7175.383.84
284549-8454974.04274.24
388055-8805577.11277.32
481258-8125871.16071.35
584402-8440273.91374.11
686050-8605075.35675.56
20min193886-9388682.21977.583.9182.5777.913.92
287704-8770476.80577.12
389266-8926678.17378.51
483070-8307072.74773.05
588994-8899477.93578.26
688619-8861977.60677.93
30min195770-9577083.86879.854.0384.3580.304.03
290204-9020478.99479.44
393968-9396882.29082.76
485097-8509774.52274.95
591439-9143980.07680.53
690596-9059679.33779.79
45min197747-9774785.60082.273.4786.2382.863.47
292412-9241280.92881.50
397401-9740185.29785.90
489075-8907578.00578.56
593433-9343381.82282.41
693587-9358781.95782.54
极限1106061-10606192.88181.6228.3793.6582.3528.13
239288-3928834.40635.12
3104015-10401591.08991.84
4102221-10222189.51890.20
5103888-10388890.97891.70
6103753-10375390.85991.58
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