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%
116.063867073863223866093861813868123865260.07
216.073883303878283880790.10
单位质量响应值RSD%判断
24067.6224149.280.24数据可信
供试品溶液-24122001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%
5min156378-5637813.12810.3426.1113.1310.3426.11
252969-5296912.33412.33
331054-310547.2317.23
451922-5192212.09012.09
529551-295516.8816.88
644600-4460010.38510.39
10min1164657-16465738.34131.1222.1038.3631.1422.10
2160870-16087037.45937.48
399587-9958723.18923.20
4149660-14966034.84934.87
598885-9888523.02623.04
6128149-12814929.84029.86
15min1256901-25690159.82151.3317.4359.9151.4017.44
2250398-25039858.30658.39
3176102-17610241.00641.06
4249149-24914958.01658.09
5171865-17186540.02040.07
6218244-21824450.81950.89
20min1313407-31340772.97866.4512.1773.1666.6012.19
2309813-30981372.14172.32
3242361-24236156.43556.55
4313280-31328072.94973.12
5240981-24098156.11456.23
6292261-29226168.05468.21
30min1372117-37211786.64982.786.1486.9683.046.17
2367493-36749385.57285.87
3326113-32611375.93776.15
4375351-37535187.40287.70
5329851-32985176.80777.02
6362049-36204984.30584.57
45min1399332-39933292.98691.122.4893.4491.522.53
2394173-39417391.78592.23
3374365-37436587.17387.51
4399850-39985093.10793.55
5385896-38589689.85890.20
6394290-39429091.81292.22
60min1405901-40590194.51693.281.3895.1293.831.41
2399948-39994893.13093.73
3390897-39089791.02291.51
4405899-40589994.51595.11
5400307-40030793.21393.70
6400545-40054593.26993.83
极限1405930-40593094.52394.190.8795.2994.900.84
2399772-39977293.08993.84
3405499-40549994.42295.06
4405137-40513794.33895.09
5409512-40951295.35796.00
6401280-40128093.44094.15
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%
116.063869323866723864213869413864093866750.07
216.073881793885543883660.07
单位质量响应值RSD%判断
24076.9024167.140.27数据可信
供试品溶液-24122401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%
5min160835-6083514.15813.1825.0514.1613.1825.04
272100-7210016.77916.78
363645-6364514.81214.81
439650-396509.2289.23
538271-382718.9078.91
665246-6524615.18415.18
10min1181558-18155842.25337.3621.3042.2837.3821.30
2192437-19243744.78544.81
3174880-17488040.69940.72
4118140-11814027.49427.51
5115901-11590126.97326.99
6180204-18020441.93841.96
15min1280462-28046265.27058.5514.8365.3658.6314.83
2278710-27871064.86264.97
3270156-27015662.87262.96
4204594-20459447.61447.68
5202785-20278547.19347.25
6272710-27271063.46663.56
20min1344589-34458980.19473.609.2680.4073.789.29
2335062-33506277.97778.19
3327817-32781776.29176.49
4280822-28082265.35465.49
5277504-27750464.58264.72
6331650-33165077.18377.38
30min1397961-39796192.61587.934.6692.9588.244.69
2388913-38891390.50990.85
3382388-38238888.99189.32
4357155-35715583.11883.37
5355199-35519982.66382.91
6385428-38542889.69890.03
45min1422467-42246798.31894.492.8898.8194.942.91
2411556-41155695.77996.27
3404442-40444294.12394.60
4389362-38936290.61491.00
5397339-39733992.47092.85
6410862-41086295.61796.10
60min1425531-42553199.03195.872.0799.6996.482.11
2412176-41217695.92396.57
3410509-41050995.53596.16
4401063-40106393.33793.88
5405842-40584294.44994.99
6416486-41648696.92697.56
极限1425890-42589099.11596.731.6299.9397.491.64
2412467-41246795.99196.80
3412487-41248795.99696.78
4406474-40647494.59695.29
5417097-41709797.06897.76
6419385-41938597.60198.40
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%
116.063867603861823870213863583857273864100.14
216.073901143898463899800.05
单位质量响应值RSD%判断
24060.4024267.580.61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%
5min154315-5431512.61913.425.7312.6213.425.73
259409-5940913.80213.80
363299-6329914.70614.71
456782-5678213.19213.19
558015-5801513.47813.48
654867-5486712.74712.75
10min1164484-16448438.21337.883.6538.2337.903.66
2163305-16330537.94037.96
3172353-17235340.04240.07
4161997-16199737.63637.66
5162357-16235737.71937.74
6153746-15374635.71935.74
15min1267124-26712462.05959.243.5262.1459.333.52
2247580-24758057.51957.60
3263438-26343861.20361.29
4255324-25532459.31859.40
5252703-25270358.70958.79
6243875-24387556.65856.74
20min1331591-33159177.03673.602.7077.2273.792.69
2309764-30976471.96572.15
3320020-32002074.34874.54
4317719-31771973.81374.00
5313579-31357972.85273.03
6308212-30821271.60571.78
30min1380325-38032588.35886.921.6188.6787.231.60
2367799-36779985.44885.75
3371015-37101586.19586.51
4380256-38025688.34288.65
5377676-37767687.74388.05
6367734-36773485.43385.73
45min1396264-39626492.06192.711.6692.5393.171.65
2394049-39404991.54791.99
3393737-39373791.47491.94
4406897-40689794.53294.99
5408087-40808794.80895.26
6395384-39538491.85792.29
60min1399792-39979292.88193.941.3993.5094.541.38
2399991-39999192.92793.52
3400572-40057293.06293.68
4411891-41189195.69296.30
5410949-41094995.47396.08
6402850-40285093.59194.18
极限1400259-40025992.98994.691.2993.7695.461.28
2404809-40480994.04694.80
3407139-40713994.58895.36
4413181-41318195.99196.76
5414030-41403096.18996.96
6406160-40616094.36095.11
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%
116.063867523861453868903862153860993864200.10
216.073904233902863903540.03
单位质量响应值RSD%判断
24061.0224290.850.68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%
5min183318-8331819.34715.6218.2819.3515.6218.28
273918-7391817.16417.16
364121-6412114.88914.89
473953-7395317.17317.17
548921-4892111.36011.36
659352-5935213.78213.78
10min1210236-21023648.81941.3312.7348.8541.3612.73
2185175-18517542.99943.03
3176913-17691341.08141.11
4189252-18925243.94643.97
5145545-14554533.79733.82
6160833-16083337.34737.37
15min1297545-29754569.09362.806.9669.2162.906.97
2274356-27435663.70863.81
3275957-27595764.08064.17
4277148-27714864.35664.46
5246791-24679157.30757.38
6250888-25088858.25958.34
20min1353793-35379382.15476.704.3382.3876.904.35
2331423-33142376.95977.17
3334863-33486377.75877.96
4329844-32984476.59376.80
5320044-32004474.31774.49
6311780-31178072.39872.58
30min1398724-39872492.58789.372.1392.9589.702.14
2384949-38494989.38989.72
3385547-38554789.52889.86
4382259-38225988.76489.10
5384559-38455989.29889.59
6373219-37321986.66586.97
45min1417456-41745696.93794.851.2897.4695.331.30
2407883-40788394.71495.20
3406387-40638794.36794.85
4409466-40946695.08295.57
5408150-40815094.77695.22
6401519-40151993.23693.68
60min1420462-42046297.63595.781.0898.3296.411.10
2412577-41257795.80496.45
3409375-40937595.06195.70
4411756-41175695.61496.26
5412982-41298295.89896.50
6407585-40758594.64595.25
极限1419485-41948597.40895.871.0898.2596.661.09
2416025-41602596.60597.41
3409792-40979295.15895.95
4411382-41138295.52796.33
5413331-41333195.97996.74
6407182-40718294.55195.31
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