坎地沙坦酯片项目信息
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100685-201903对照品来源中检所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)8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%
115.987767677592776357759177824776640.13
216.077809978173781360.07
单位质量响应值RSD%判断
4860.084862.230.04数据可信
供试品溶液-24122002批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18153-81539.41510.338.799.4210.348.77
210222-1022211.80511.80
38333-83339.6239.62
48555-85559.8799.88
58938-893810.32210.32
69495-949510.96510.97
10min125901-2590129.91130.464.3129.9330.474.31
227818-2781832.12532.14
325110-2511028.99829.01
425194-2519429.09529.11
527301-2730131.52831.54
626907-2690731.07331.09
15min143514-4351450.25150.962.5750.3251.032.57
246239-4623953.39853.47
343594-4359450.34350.41
443011-4301149.67049.73
544270-4427051.12451.19
644154-4415450.99051.06
20min156389-5638965.11966.231.9465.2766.391.94
259194-5919468.35868.52
356829-5682965.62765.78
456232-5623264.93865.09
557750-5775066.69166.85
657716-5771666.65266.81
30min171661-7166182.75583.051.5983.0183.311.59
273606-7360685.00285.28
371515-7151582.58782.84
470275-7027581.15581.41
571693-7169382.79283.06
672735-7273583.99684.26
45min180011-8001192.39892.851.6692.7993.251.66
282348-8234895.09795.51
380603-8060393.08293.48
478560-7856090.72391.11
579607-7960791.93292.34
681296-8129693.88294.29
60min182826-8282695.64995.821.9096.2096.381.91
285493-8549398.72999.31
383301-8330196.19896.75
480973-8097393.50994.05
581704-8170494.35394.91
683539-8353996.47297.04
极限184219-8421997.25896.351.8297.9797.071.82
285459-8545998.69099.43
384107-8410797.12897.84
481550-8155094.17594.87
581773-8177394.43395.15
683497-8349796.42497.15
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所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)8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%
115.987835378191781547823578380782630.13
216.077882379190790060.33
单位质量响应值RSD%判断
4897.564916.370.28数据可信
供试品溶液-24122402批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18853-885310.1289.847.7510.139.847.77
28419-84199.6329.63
39485-948510.85110.85
48848-884810.12210.12
58559-85599.7929.79
67468-74688.5448.54
10min126854-2685430.72230.364.2230.7430.384.22
226037-2603729.78729.80
327803-2780331.80831.83
427150-2715031.06131.08
526807-2680730.66830.68
624577-2457728.11728.13
15min145854-4585452.45951.192.5352.5351.262.53
243183-4318349.40349.47
345475-4547552.02552.10
444650-4465051.08151.15
545686-4568652.26752.33
643607-4360749.88849.95
20min160426-6042669.13067.022.6569.2967.182.66
255982-5598264.04664.19
359411-5941167.96968.13
458041-5804166.40166.56
559448-5944868.01168.17
658207-5820766.59166.74
30min174626-7462685.37584.041.7385.6584.301.74
271734-7173482.06782.32
373968-7396884.62284.89
472987-7298783.50083.76
574966-7496685.76486.03
672478-7247882.91883.17
45min183032-8303294.99293.421.4995.4193.821.50
279954-7995491.47191.86
381719-8171993.49093.90
481991-8199193.80194.20
582734-8273494.65195.06
680513-8051392.11092.50
60min185943-8594398.32296.261.4998.8996.821.49
282824-8282494.75495.30
383847-8384795.92496.49
484154-8415496.27696.84
585200-8520097.47298.04
682861-8286194.79695.34
极限186143-8614398.55196.861.2299.2997.581.22
284190-8419096.31797.02
384018-8401896.12096.85
484946-8494697.18297.90
585389-8538997.68998.42
683297-8329795.29596.00
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所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)8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%
115.987818478466783887832378189783100.16
216.077886378976789200.11
单位质量响应值RSD%判断
4900.504911.010.16数据可信
供试品溶液-YD1批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17825-78258.9548.875.178.958.875.17
28178-81789.3589.36
38221-82219.4079.41
47456-74568.5328.53
57224-72248.2678.27
67581-75818.6758.68
10min124852-2485228.43928.223.5928.4528.243.60
225438-2543829.10929.12
325841-2584129.57029.59
424047-2404727.51727.53
524331-2433127.84227.86
623478-2347826.86626.88
15min143698-4369850.00449.061.4850.0749.131.49
243391-4339149.65349.72
343081-4308149.29849.36
442736-4273648.90448.96
542045-4204548.11348.17
642310-4231048.41648.48
20min156997-5699765.22364.680.8365.3764.820.83
257010-5701065.23865.38
355779-5577963.82963.98
456369-5636964.50464.65
556313-5631364.44064.58
656651-5665164.82764.97
30min172551-7255183.02282.491.0983.2882.741.09
272587-7258783.06383.32
370646-7064680.84281.10
471741-7174182.09582.34
572300-7230082.73482.98
672689-7268983.17983.43
45min181490-8149093.25192.540.4993.6492.930.49
281150-8115092.86293.26
380375-8037591.97592.36
480792-8079292.45292.84
580677-8067792.32092.71
680731-8073192.38292.77
60min183581-8358195.64395.430.2996.1995.970.29
283468-8346895.51496.06
383211-8321195.22095.76
483676-8367695.75296.29
583378-8337895.41195.95
683032-8303295.01595.56
极限184098-8409896.23595.730.3796.9496.430.37
283523-8352395.57796.29
383274-8327495.29295.99
483860-8386095.96396.66
583420-8342095.45996.16
683751-8375195.83896.54
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所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)8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%
115.987902778586789227912179124789560.29
216.077952779566795460.04
单位质量响应值RSD%判断
4940.934949.970.13数据可信
供试品溶液-YD2批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119402-1940222.02415.0639.7122.0215.0639.69
28068-80689.1589.16
39184-918410.42510.43
48307-83079.4309.43
517217-1721719.54419.54
617408-1740819.76019.76
10min136423-3642341.34534.7916.0841.3834.8216.09
225477-2547728.92028.94
326609-2660930.20530.22
426587-2658730.18030.20
534745-3474539.44039.47
634064-3406438.66738.70
15min153817-5381761.09054.099.8561.2054.179.88
243105-4310548.93048.99
344269-4426950.25150.32
443167-4316749.00049.07
551276-5127658.20558.30
650249-5024957.03957.14
20min165336-6533674.16567.886.3874.3768.066.40
256489-5648964.12364.27
357867-5786765.68765.84
455474-5547462.97163.12
562285-6228570.70270.90
661350-6135069.64169.83
30min177108-7710887.52883.293.6187.8683.583.64
271201-7120180.82381.07
372486-7248682.28182.54
469949-6994979.40279.65
574871-7487184.98985.30
674636-7463684.72285.03
45min185624-8562497.19593.062.5597.6793.482.57
281072-8107292.02892.41
381165-8116592.13392.53
479397-7939790.12690.51
582176-8217693.28193.74
682432-8243293.57294.02
60min187392-8739299.20295.591.9399.8496.171.95
283744-8374495.06195.60
383609-8360994.90895.46
482836-8283694.03094.57
583435-8343594.71095.32
684238-8423895.62296.23
极限187249-8724999.03996.091.6799.8496.831.69
284386-8438695.79096.49
384215-8421595.59596.31
482981-8298194.19594.89
584292-8429295.68396.45
684782-8478296.23997.00
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