氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.313280143274103274423276313278443276680.08
214.413290203287043288620.07
单位质量响应值RSD%判断
22897.8322821.790.24数据可信
供试品溶液-24062001-1批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1205625-20562552.19654.753.6152.2054.753.61
2226622-22662257.52657.53
3213055-21305554.08254.08
4222260-22226056.41956.42
5216266-21626654.89754.90
6210179-21017953.35253.35
10min1342330-34233086.89889.312.3986.9889.402.39
2361604-36160491.79091.89
3356377-35637790.46390.55
4359166-35916691.17191.27
5348628-34862888.49688.59
6342797-34279787.01687.11
15min1382576-38257697.11498.261.9097.3598.501.90
2394083-394083100.035100.28
3395356-395356100.358100.60
4391000-39100099.25299.50
5381887-38188796.93997.18
6377666-37766695.86796.10
20min1383013-38301397.22598.201.8197.6298.601.81
2394498-394498100.140100.56
3394110-394110100.042100.45
4390255-39025599.06399.47
5380313-38031396.53996.94
6378841-37884196.16696.56
30min1381087-38108796.73697.921.8797.2998.481.88
2393187-39318799.807100.39
3394290-394290100.087100.66
4387294-38729498.31198.89
5382731-38273197.15397.71
6375815-37581595.39895.95
45min1380829-38082996.67097.911.9897.3998.641.98
2392886-39288699.731100.48
3390618-39061899.15599.90
4393659-39365999.927100.67
5380508-38050896.58997.31
6375687-37568795.36596.08
极限1379716-37971696.38897.271.8097.2798.171.80
2389483-38948398.86799.78
3390742-39074299.187100.09
4387100-38710098.26299.17
5378393-37839396.05296.94
6373771-37377194.87995.75
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.313280463277463276443277023277793277830.05
214.413307923304893306400.07
单位质量响应值RSD%判断
22905.8722945.180.13数据可信
供试品溶液-24062001-1批-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%
5min1202527-20252751.26248.2517.1951.2648.2517.19
2197811-19781150.06950.07
3207130-20713052.42752.43
4213014-21301453.91753.92
5124757-12475731.57831.58
6198579-19857950.26350.26
10min1335163-33516384.83482.139.1084.9282.219.11
2333829-33382984.49784.58
3329397-32939783.37583.46
4346875-34687587.79987.89
5265385-26538567.17367.23
6336214-33621485.10085.18
15min1377661-37766195.59195.313.9995.8295.534.01
2383989-38398997.19397.42
3379149-37914995.96896.19
4385745-38574597.63797.87
5346733-34673387.76387.93
6386134-38613497.73697.96
20min1378813-37881395.88397.020.9896.2797.400.99
2385773-38577397.64498.03
3379240-37924095.99196.38
4386650-38665097.86698.27
5382211-38221196.74397.05
6387189-38718998.00398.39
30min1380608-38060896.33796.970.8296.8897.510.82
2384978-38497897.44397.99
3377988-37798895.67496.22
4385617-38561797.60598.17
5383936-38393697.18097.65
6385545-38554597.58798.14
45min1376848-37684895.38596.691.0196.0997.391.01
2383952-38395297.18497.89
3377416-37741695.52996.23
4384802-38480297.39998.12
5383389-38338997.04197.68
6385622-38562297.60698.32
极限1374338-37433894.75096.641.3995.6297.501.38
2383679-38367997.11497.99
3376985-37698595.42096.29
4383888-38388897.16798.05
5382834-38283496.90197.70
6389065-38906598.47899.35
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.313298583293703292123291543291163293420.10
214.413288413285443286920.07
单位质量响应值RSD%判断
23014.8122809.990.64数据可信
供试品溶液-24062001-1批-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%
5min1202108-20210851.18748.9914.0551.1948.9914.06
2209429-20942953.04153.04
3200088-20008850.67550.68
4203580-20358051.55951.56
5138401-13840135.05235.05
6207061-20706152.44152.44
10min1338131-33813185.63682.639.8985.7282.719.89
2342970-34297086.86286.95
3334087-33408784.61284.70
4340114-34011486.13886.22
5260745-26074566.03766.10
6341465-34146586.48186.57
15min1374962-37496294.96494.734.7295.1994.954.74
2381603-38160396.64696.88
3381344-38134496.58196.81
4380308-38030896.31896.55
5338903-33890385.83286.00
6387115-38711598.04298.27
20min1373369-37336994.56195.921.4094.9596.301.41
2376972-37697295.47395.87
3381976-38197696.74197.13
4377561-37756195.62296.01
5374871-37487194.94195.25
6387744-38774498.20198.60
30min1373149-37314994.50596.491.1895.0597.031.18
2380448-38044896.35496.91
3381607-38160796.64797.19
4383795-38379597.20197.75
5380395-38039596.34096.81
6386528-38652897.89398.45
45min1371198-37119894.01195.951.0894.7196.651.07
2378877-37887795.95696.67
3380139-38013996.27596.98
4378645-37864595.89796.61
5381364-38136496.58697.22
6382887-38288796.97197.69
极限1371539-37153994.09796.151.2594.9697.011.24
2380039-38003996.25097.12
3378953-37895395.97596.84
4379473-37947396.10796.98
5382054-38205496.76097.55
6385892-38589297.73298.62
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.313282613281303281443279303280083280950.04
214.413281773279623280700.05
单位质量响应值RSD%判断
22927.6722766.830.50数据可信
供试品溶液-24062001-1批-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%
5min1199956-19995650.78643.7423.9950.7943.7423.99
2117799-11779929.91929.92
3194040-19404049.28349.28
4206016-20601652.32552.32
5120599-12059930.63030.63
6194928-19492849.50949.51
10min1330247-33024783.87777.2216.0983.9677.2916.10
2244373-24437362.06762.12
3331637-33163784.23084.31
4345614-34561487.78087.87
5238293-23829360.52360.57
6334048-33404884.84384.93
15min1383591-38359197.42692.489.3397.6592.689.35
2322430-32243081.89282.05
3385039-38503997.79498.02
4392779-39277999.76099.99
5318706-31870680.94681.10
6382212-38221297.07697.30
20min1384937-38493797.76896.702.9998.1597.053.03
2367150-36715093.25093.54
3387932-38793298.52898.91
4393796-393796100.018100.42
5366238-36623893.01993.31
6384255-38425597.59597.98
30min1385632-38563297.94498.051.1698.4998.561.19
2382430-38243097.13197.58
3388190-38819098.59499.14
4393934-393934100.053100.62
5383964-38396497.52197.96
6382072-38207297.04097.59
45min1383903-38390397.50597.991.2698.2298.671.26
2381990-38199097.01997.63
3387289-38728998.36599.08
4392798-39279899.764100.50
5389088-38908898.82299.43
6379779-37977996.45897.17
极限1384060-38406097.54597.481.1298.4298.331.16
2379948-37994896.50197.27
3385597-38559797.93598.81
4391394-39139499.408100.31
5381391-38139196.86797.64
6380552-38055296.65497.52
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