厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.058799548783878775588783748768268782200.14
215.088767078759348763200.07
单位质量响应值RSD%判断
58353.4958111.410.30数据可信
供试品溶液-1批-厄贝沙坦-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%
5min1178905-17890518.43423.8337.8318.4323.8337.83
2169724-16972417.48817.49
3182756-18275618.83018.83
4393751-39375140.57040.57
5192672-19267219.85219.85
6269695-26969527.78827.79
10min1708999-70899973.05272.886.2473.2673.146.32
2690846-69084671.18271.38
3720768-72076874.26574.47
4778476-77847680.21180.66
5642672-64267266.21866.44
6702063-70206372.33872.65
15min1873997-87399790.05389.123.5091.0790.193.48
2824547-82454784.95885.94
3915692-91569294.34995.38
4864935-86493589.11990.46
5848757-84875787.45288.41
6861538-86153888.76989.88
20min1916330-91633094.41593.162.4296.4395.232.39
2882367-88236790.91592.84
3932160-93216096.04698.13
4887254-88725491.41993.75
5884828-88482891.16993.10
6922117-92211795.01197.11
30min1929173-92917395.73894.732.5398.8097.832.50
2901581-90158192.89595.83
3945829-94582997.454100.60
4902411-90241192.98196.33
5893418-89341892.05495.00
6944160-94416097.282100.44
45min1931830-93183096.01293.864.52100.1498.024.38
2875992-87599290.25994.23
3981849-981849101.166105.40
4877599-87759990.42494.81
5885270-88527091.21495.18
6913408-91340894.11498.35
60min1899967-89996792.72994.764.2097.9399.963.92
2887391-88739191.43396.41
3916050-91605094.38699.74
4885587-88558791.24796.63
5984672-984672101.456106.43
6944496-94449697.317102.60
90min1883247-88324791.00691.351.9297.2397.601.95
2867945-86794589.42995.42
3884508-88450891.13697.54
4910999-91099993.865100.27
5870862-87086289.73095.83
6902134-90213492.95299.31
120min1881336-88133690.80992.636.3698.0599.895.92
2838655-83865586.41193.40
3892264-89226491.93599.35
4845909-84590987.15994.60
5968825-96882599.824106.93
6967021-96702199.638107.03
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1910651-91065193.83091.743.76102.08100.043.44
2917294-91729494.514102.46
3893897-89389792.103100.54
4860253-86025388.63797.05
5839424-83942486.49194.70
6920863-92086394.882103.38
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.161314791311921309341312361310481311780.16
210.111306991306031306510.06
单位质量响应值RSD%判断
12911.2212922.950.07数据可信
供试品溶液-1批-非奈利酮-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%
5min110864-108647.5637.9712.727.567.9612.70
212469-124698.6818.68
39588-95886.6756.68
411722-117228.1618.16
510417-104177.2527.25
613593-135939.4639.46
10min131070-3107021.63121.825.2721.7121.915.29
233465-3346523.29823.39
329129-2912920.27920.35
432791-3279122.82922.92
529954-2995420.85420.93
631669-3166922.04822.15
15min145929-4592931.97632.051.0632.3032.391.09
245808-4580831.89132.25
345732-4573231.83832.14
446849-4684932.61632.96
545544-4554431.70732.02
646395-4639532.30032.65
20min155843-5584338.87839.132.0839.5639.822.11
256634-5663439.42840.14
354756-5475638.12138.77
457215-5721539.83340.54
555091-5509138.35439.02
657665-5766540.14640.86
30min171579-7157949.83350.162.2350.9451.282.25
272455-7245550.44351.59
370445-7044549.04350.12
473775-7377551.36252.51
570169-7016948.85149.94
673898-7389851.44752.60
45min189253-8925362.13761.522.3163.8063.202.22
286067-8606759.91961.63
391499-9149963.70165.32
489161-8916162.07363.79
586393-8639360.14661.78
687863-8786361.17062.90
60min199569-9956969.31971.403.9571.6873.763.81
299698-9969869.40971.78
399469-9946969.25071.58
4102665-10266571.47573.88
5109840-10984076.47078.77
6104082-10408272.46174.87
90min1115199-11519980.20180.873.1483.3384.033.06
2114622-11462279.79982.94
3113840-11384079.25582.35
4123459-12345985.95189.16
5114058-11405879.40782.56
6115798-11579880.61883.83
120min1124339-12433986.56488.304.6990.5892.354.49
2119520-11952083.20987.24
3125282-12528287.22191.20
4123702-12370286.12190.28
5134187-13418793.42097.45
6133943-13394393.25097.36
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1129048-12904889.84288.932.9494.8293.972.78
2130371-13037190.76495.72
3127222-12722288.57193.52
4128137-12813789.20894.32
5120647-12064783.99489.07
6131041-13104191.23096.37
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