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%
19.998244682470824098241182441824350.04
29.958235182298823240.05
单位质量响应值RSD%判断
8251.758273.770.19数据可信
长期6月-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%
5min190939-9093998.85598.651.2898.8698.651.28
290932-9093298.84798.85
388772-8877296.49996.50
492121-92121100.140100.14
590220-9022098.07398.07
691498-9149899.46399.46
10min191725-9172599.70999.691.3699.8799.851.36
292148-92148100.169100.33
389741-8974197.55397.71
493555-93555101.699101.87
591206-9120699.14599.31
691868-9186899.865100.03
15min191597-9159799.57099.621.4799.9099.951.47
291858-9185899.854100.19
389508-8950897.29997.62
493302-93302101.424101.76
590909-9090998.82299.15
692694-92694100.763101.10
20min191337-9133799.28899.551.3999.78100.041.39
291832-9183299.826100.32
389563-8956397.35997.84
493160-93160101.269101.77
590991-9099198.91299.40
692602-92602100.663101.16
30min191128-9112899.06099.351.4199.72100.011.41
291603-9160399.577100.24
389362-8936297.14197.79
492979-92979101.073101.75
590804-9080498.70899.37
692483-92483100.533101.20
45min190988-9098898.90899.151.3899.7499.981.38
291317-9131799.266100.10
389275-8927597.04697.86
492731-92731100.803101.65
590549-9054998.43199.25
692378-92378100.419101.25
极限190913-9091398.82799.001.4699.82100.001.46
291255-9125599.199100.19
388973-8897396.71897.69
492689-92689100.757101.77
590418-9041898.28999.28
692202-92202100.228101.23
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%
113.54100038996879976899839100052998770.17
213.519976699684997250.06
单位质量响应值RSD%判断
7376.447381.570.05数据可信
长期6月-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%
5min1108416-10841695.24496.181.7695.2496.181.76
2111223-11122397.71097.71
3109737-10973796.40596.40
4106687-10668793.72593.73
5111944-11194498.34498.34
6108856-10885695.63195.63
10min1110220-11022096.82997.971.7596.9998.131.75
2113195-11319599.44399.61
3111995-11199598.38898.55
4108846-10884695.62295.78
5114065-114065100.207100.37
6110763-11076397.30697.47
15min1110162-11016296.77897.931.8997.1098.261.89
2113149-11314999.40299.73
3111169-11116997.66397.99
4108479-10847995.30095.62
5114394-114394100.496100.83
6111492-11149297.94798.27
20min1109598-10959896.28397.851.8196.7698.341.81
2113213-11321399.45899.95
3111591-11159198.03498.52
4108814-10881495.59496.07
5114020-114020100.167100.67
6111053-11105397.56198.05
30min1109813-10981396.47297.721.8797.1198.371.87
2113202-11320299.449100.11
3111168-11116897.66298.31
4108235-10823595.08595.72
5113816-11381699.988100.65
6111199-11119997.68998.34
45min1109164-10916495.90197.341.6796.7098.151.67
2112404-11240498.74899.57
3111106-11110697.60798.42
4108150-10815095.01195.80
5112950-11295099.227100.06
6111053-11105397.56198.37
极限1108058-10805894.93096.951.8995.8997.921.89
2112295-11229598.65299.64
3110357-11035796.94997.93
4107885-10788594.77895.73
5112882-11288299.168100.17
6110648-11064897.20598.18
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%
19.998230682370822378221782157822570.11
29.958205382030820420.02
单位质量响应值RSD%判断
8233.938245.430.10数据可信
长期6月-供试品溶液-2024021821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%
5min189433-8943397.49098.532.2797.4998.532.27
293957-93957102.422102.42
389734-8973497.81897.82
487968-8796895.89395.89
589908-8990898.00898.01
691318-9131899.54599.54
10min190348-9034898.48899.722.3798.6599.882.36
295150-95150103.722103.89
390704-9070498.87699.04
489082-8908297.10897.27
590776-9077698.95499.12
692797-92797101.157101.32
15min190045-9004598.15799.542.3698.4899.872.36
294865-94865103.412103.76
390653-9065398.82099.15
488912-8891296.92297.24
590626-9062698.79199.12
692770-92770101.128101.46
20min189911-8991198.01199.372.3798.5099.872.36
294651-94651103.178103.69
390529-9052998.68599.18
488695-8869596.68697.17
590447-9044798.59599.09
692718-92718101.071101.57
30min190169-9016998.29299.442.3398.95100.102.33
294732-94732103.267103.95
390906-9090699.09699.75
488623-8862396.60797.25
590423-9042398.56999.23
692500-92500100.833101.50
45min189826-8982697.91999.032.3698.7499.852.36
294269-94269102.762103.62
390111-9011198.22999.05
488368-8836896.32997.13
589979-8997998.08598.91
692498-92498100.831101.67
极限189603-8960397.67598.842.3798.6699.832.37
294264-94264102.756103.79
389877-8987797.97498.96
488298-8829896.25397.22
589851-8985197.94698.93
692115-92115100.414101.42
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%
113.549955799592993819944599226994400.15
213.519910099063990820.03
单位质量响应值RSD%判断
7344.177333.970.10数据可信
长期6月-供试品溶液-2024021821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%
5min1112109-11210999.02598.132.2999.0298.132.29
2107908-10790895.31495.31
3108678-10867895.99495.99
4114630-114630101.251101.25
5112669-11266999.51999.52
6110581-11058197.67597.67
10min1115140-115140101.702100.672.39101.87100.842.39
2110132-11013297.27897.44
3111208-11120898.22998.39
4117196-117196103.518103.69
5115452-115452101.977102.14
6114735-114735101.344101.51
15min1115089-115089101.657100.642.40101.99100.982.40
2109948-10994897.11697.44
3111178-11117898.20298.53
4116949-116949103.300103.64
5115411-115411101.941102.28
6115065-115065101.636101.97
20min1114654-114654101.273100.312.59101.78100.822.59
2109019-10901996.29596.78
3111008-11100898.05298.54
4116886-116886103.244103.76
5115093-115093101.660102.17
6114752-114752101.359101.86
30min1114442-114442101.08599.742.52101.76100.412.52
2108750-10875096.05896.70
3110063-11006397.21797.87
4115911-115911102.383103.07
5113764-113764100.486101.16
6114596-114596101.221101.89
45min1114066-114066100.75399.572.58101.59100.402.58
2108454-10845495.79696.60
3109867-10986797.04497.86
4115878-115878102.354103.21
5113547-113547100.295101.14
6114561-114561101.190102.03
极限1113805-113805100.52399.432.12101.53100.422.12
2109249-10924996.49897.46
3109786-10978696.97397.95
4114444-114444101.087102.11
5113905-113905100.611101.62
6114203-114203100.874101.88
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%
19.998211382135821028206782085821000.04
29.958224682226822360.02
单位质量响应值RSD%判断
8218.228264.920.41数据可信
长期6月-供试品溶液-2024022021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%
5min191604-9160499.83598.291.9499.8398.301.94
289673-8967397.73097.73
391322-9132299.52799.53
491919-91919100.178100.18
589239-8923997.25797.26
687389-8738995.24195.24
10min192314-92314100.60899.712.10100.7799.882.10
290640-9064098.78498.95
392768-92768101.103101.27
493681-93681102.098102.27
591293-9129399.49699.66
688262-8826296.19296.35
15min192564-92564100.88199.762.15101.21100.092.15
290810-9081098.96999.30
392760-92760101.094101.43
493761-93761102.185102.52
591109-9110999.29599.62
688201-8820196.12696.44
20min192325-92325100.62099.542.08101.12100.042.08
290594-9059498.73499.23
392492-92492100.802101.31
493501-93501101.902102.41
590961-9096199.13499.63
688123-8812396.04196.52
30min191922-91922100.18199.392.23100.85100.062.23
290356-9035698.47499.13
392623-92623100.945101.62
493647-93647102.061102.74
590787-9078798.94499.60
687866-8786695.76196.40
45min192042-92042100.31299.292.23101.15100.122.23
290165-9016598.26699.09
392408-92408100.711101.55
493583-93583101.991102.84
590573-9057398.71199.53
687847-8784795.74096.54
极限191810-91810100.05999.311.91101.06100.301.91
291565-9156599.792100.78
391900-91900100.157101.16
493062-93062101.424102.44
590365-9036598.48499.47
688041-8804195.95196.91
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%
113.549911699127992589920699191991800.06
213.519944499268993560.13
单位质量响应值RSD%判断
7324.967354.260.29数据可信
长期6月-供试品溶液-2024022021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%
5min1105381-10538193.07593.921.9293.0893.921.92
2108350-10835095.69895.70
3107589-10758995.02595.03
4103792-10379291.67291.67
5104481-10448192.28092.28
6108400-10840095.74295.74
10min1107152-10715294.63996.351.4494.7996.511.44
2110290-11029097.41197.57
3111402-11140298.39398.55
4107962-10796295.35595.51
5108427-10842795.76695.92
6109302-10930296.53896.70
15min1107219-10721994.69996.491.6395.0196.811.63
2111058-11105898.08998.41
3111316-11131698.31798.64
4107563-10756395.00295.31
5108399-10839995.74196.05
6109942-10994297.10497.42
20min1106585-10658594.13996.331.7194.6196.801.71
2110771-11077197.83698.32
3111347-11134798.34598.83
4107917-10791795.31595.79
5107987-10798795.37795.85
6109763-10976396.94697.43
30min1105663-10566393.32495.862.0393.9596.502.03
2110151-11015197.28897.94
3111730-11173098.68399.33
4107097-10709794.59195.22
5107578-10757895.01695.65
6109001-10900196.27396.92
45min1105925-10592593.55695.711.6294.3496.501.62
2109377-10937796.60597.42
3110932-11093297.97898.79
4107343-10734394.80895.59
5107721-10772195.14295.93
6108864-10886496.15296.96
极限1105504-10550493.18495.441.6994.1296.401.69
2109371-10937196.59997.57
3110630-11063097.71198.69
4107315-10731594.78395.73
5107032-10703294.53395.48
6108489-10848995.82096.78
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