他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
标示量(mg)20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%
112.585135575139805142585141015139245139640.06
212.585149035148045148540.02
单位质量响应值RSD%判断
40855.6440926.390.13数据可信
长期24月-供试品溶液-2022032001批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1232562-23256245.46750.4114.3245.4750.4114.31
2265687-26568751.94351.94
3281645-28164555.06355.06
4314635-31463561.51361.51
5239028-23902846.73146.73
6213535-21353541.74741.75
10min1380865-38086574.46175.116.1774.5575.216.18
2387734-38773475.80475.91
3396396-39639677.49777.61
4420395-42039582.18982.31
5351572-35157268.73468.83
6368084-36808471.96272.05
15min1445429-44542987.08485.373.9387.3285.623.94
2431419-43141984.34584.60
3443038-44303886.61686.88
4462306-46230690.38390.67
5414475-41447581.03281.26
6423439-42343982.78583.01
20min1474887-47488792.84390.723.1093.2691.143.11
2457833-45783389.50989.93
3468103-46810391.51791.95
4484407-48440794.70495.17
5446122-44612287.21987.61
6452945-45294588.55388.95
30min1496418-49641897.05295.912.0197.6596.512.03
2482640-48264094.35994.96
3494245-49424596.62797.25
4505041-50504198.73899.40
5478368-47836893.52394.09
6486604-48660495.13495.70
45min1508625-50862599.43998.341.32100.2399.141.33
2494870-49487096.75097.54
3502536-50253698.24899.06
4508483-50848399.411100.27
5508448-50844899.404100.16
6495080-49508096.79197.55
极限1508313-50831399.37899.630.81100.37100.620.80
2511513-511513100.003100.99
3512789-512789100.253101.26
4507839-50783999.285100.34
5514231-514231100.535101.49
6502938-50293898.32799.28
他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
标示量(mg)20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%
112.585158355153895143805149725153855151920.11
212.585208205212305210250.06
单位质量响应值RSD%判断
40953.2641416.930.80数据可信
长期24月-供试品溶液-2022032001批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1178113-17811334.57450.3720.3834.5750.3820.39
2224488-22448843.57743.58
3244660-24466047.49247.49
4302805-30280558.77958.78
5312589-31258960.67860.68
6294405-29440557.14857.15
10min1318419-31841961.81075.4612.4161.8875.5612.42
2358301-35830169.55269.64
3368171-36817171.46871.56
4419356-41935681.40381.52
5422139-42213981.94482.06
6446093-44609386.59386.71
15min1377543-37754373.28786.309.2473.4886.559.25
2428563-42856383.19183.42
3432861-43286184.02584.26
4470093-47009391.25291.53
5463504-46350489.97390.26
6494802-49480296.04996.34
20min1420453-42045381.61691.756.7481.9692.176.77
2460948-46094889.47789.87
3464092-46409290.08790.49
4495133-49513396.11396.58
5483701-48370193.89494.36
6511493-51149399.28999.77
30min1464259-46425990.12096.944.1990.6297.544.23
2485969-48596994.33494.91
3503750-50375097.78698.37
4507377-50737798.49099.14
5513556-51355699.689100.34
6521378-521378101.207101.89
45min1486115-48611594.36298.482.8295.0599.282.86
2492625-49262595.62696.39
3513596-51359699.697100.48
4514031-51403199.781100.63
5516596-516596100.279101.13
6520848-520848101.105101.99
极限1515492-515492100.06599.282.02100.94100.282.04
2491340-49134095.37796.33
3512137-51213799.414100.39
4513961-51396199.768100.82
5514504-51450499.873100.93
6521289-521289101.190102.27
他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
标示量(mg)20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%
112.585132975139375136225132975132605134830.06
212.585209905218695214300.12
单位质量响应值RSD%判断
40817.4141449.131.09数据可信
长期24月-供试品溶液-2022032001批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1269380-26938052.35847.2114.8552.3647.2214.85
2235254-23525445.72545.73
3224476-22447643.63043.63
4202380-20238039.33639.34
5301430-30143058.58758.59
6224546-22454643.64443.64
10min1386884-38688475.19771.476.9875.3071.566.99
2347376-34737667.51867.61
3370332-37033271.98072.07
4337395-33739565.57865.66
5406325-40632578.97579.09
6357963-35796369.57669.66
15min1444365-44436586.36984.314.1186.6284.554.12
2421575-42157581.93982.17
3448134-44813487.10287.33
4410731-41073179.83280.04
5455296-45529688.49488.77
6422605-42260582.14082.37
20min1479141-47914193.12892.033.5693.5692.443.58
2467969-46796990.95791.35
3482201-48220193.72394.13
4449716-44971687.40987.78
5498365-49836596.86597.32
6463601-46360190.10890.50
30min1500028-50002897.18897.922.0397.8098.512.06
2500940-50094097.36597.94
3509889-50988999.10599.70
4491838-49183895.59696.14
5521035-521035101.271101.92
6498994-49899496.98797.56
45min1513909-51390999.886100.371.25100.69101.161.28
2513743-51374399.854100.62
3520525-520525101.172101.96
4507108-50710898.56499.30
5525924-525924102.221103.07
6517201-517201100.526101.29
极限1519421-519421100.957101.450.67101.97102.440.69
2523446-523446101.740102.71
3525211-525211102.083103.08
4516350-516350100.360101.29
5525074-525074102.056103.11
6522135-522135101.485102.45
他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
标示量(mg)20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%
112.585156035157055158215159565157905157750.03
212.585158025158275158140.01
单位质量响应值RSD%判断
40999.6041002.700.01数据可信
长期24月-供试品溶液-2022032001批-pH6.8(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1224433-22443343.76048.1621.0743.7648.1621.07
2315028-31502861.42461.42
3197904-19790438.58738.59
4199105-19910538.82138.82
5307222-30722259.90259.90
6238435-23843546.49046.49
10min1366571-36657171.47476.7510.2171.5676.8510.22
2463619-46361990.39690.52
3366823-36682371.52371.60
4363028-36302870.78370.86
5419283-41928381.75281.87
6382530-38253074.58674.68
15min1442201-44220186.22089.486.7686.4589.736.78
2509887-50988799.41899.72
3428865-42886583.62083.84
4440991-44099185.98486.20
5483277-48327794.22994.51
6448239-44823987.39887.64
20min1474266-47426692.47294.784.8992.8895.214.92
2524346-524346102.237102.74
3459286-45928689.55289.94
4475021-47502192.62093.01
5504255-50425598.32098.79
6479379-47937993.46993.89
30min1497242-49724296.95298.663.0497.5499.283.07
2531311-531311103.595104.30
3487916-48791695.13495.70
4502987-50298798.07298.65
5515772-515772100.565101.23
6500729-50072997.63298.24
45min1508941-50894199.233100.451.91100.02101.271.95
2532019-532019103.733104.65
3503115-50311598.09798.85
4513270-513270100.077100.85
5517883-517883100.977101.85
6515866-515866100.583101.38
极限1521580-521580101.698102.310.95102.68103.320.98
2532170-532170103.762104.88
3519156-519156101.225102.18
4525984-525984102.556103.53
5521097-521097101.603102.67
6528298-528298103.007104.01
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