非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院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)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%
110.031498773149490614962581494584149400914957060.13
210.201510663151076315107130.01
单位质量响应值RSD%判断
149123.23148109.120.49数据可信
供试品溶液-3786A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%
5min1148700-1487009.0058.2121.669.018.2221.64
2110744-1107446.7076.71
387505-875055.2995.30
4157442-1574429.5359.53
5155353-1553539.4089.41
6154107-1541079.3339.33
10min1308553-30855318.68617.627.9418.7117.647.95
2257955-25795515.62215.64
3265343-26534316.06916.08
4309587-30958718.74818.77
5304234-30423418.42418.45
6300299-30029918.18618.21
15min1382139-38213923.14222.882.7523.2022.942.77
2366289-36628922.18222.23
3364842-36484222.09522.14
4391539-39153923.71123.77
5383133-38313323.20223.26
6379303-37930322.97023.03
20min1428995-42899525.98025.781.1526.0925.881.17
2426448-42644825.82525.92
3420690-42069025.47725.57
4433205-43320526.23526.35
5420907-42090725.49025.60
6423759-42375925.66325.77
30min1479841-47984129.05928.751.2829.2328.921.27
2480056-48005629.07229.23
3472190-47219028.59628.75
4466862-46686228.27328.45
5480192-48019229.08029.25
6469129-46912928.41028.58
45min1521967-52196731.61031.481.1431.8531.711.14
2523118-52311831.68031.90
3512062-51206231.01031.23
4523165-52316531.68331.92
5525884-52588431.84732.08
6512802-51280231.05531.29
60min1526459-52645931.88232.321.4532.1932.621.43
2535793-53579332.44732.74
3543605-54360532.92033.21
4541482-54148232.79233.10
5527116-52711631.92232.23
6527348-52734831.93632.24
极限1556296-55629633.68933.320.8634.0733.690.87
2547020-54702033.12733.49
3545584-54558433.04033.40
4551638-55163833.40733.79
5554798-55479833.59833.97
6545832-54583233.05533.43
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院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)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%
110.031516263151566615159491515745151569015158630.02
210.201537368153760815374880.02
单位质量响应值RSD%判断
151132.90150734.120.19数据可信
供试品溶液-3786A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%
5min1162331-1623319.6809.6226.859.689.6226.85
293739-937395.5905.59
3196534-19653411.71911.72
4184225-18422510.98510.99
5204118-20411812.17112.17
6126563-1265637.5477.55
10min1304834-30483418.17717.9212.7018.2017.9412.71
2250983-25098314.96614.98
3332198-33219819.80919.83
4322822-32282219.25019.27
5336436-33643620.06120.09
6255607-25560715.24215.26
15min1380539-38053922.69122.745.5822.7522.805.60
2350903-35090320.92420.97
3401646-40164623.95024.02
4395533-39553323.58523.65
5398784-39878423.77923.85
6361025-36102521.52821.58
20min1425216-42521625.35525.483.5925.4725.593.63
2406882-40688224.26224.35
3441554-44155426.32926.45
4436551-43655126.03126.15
5441807-44180726.34526.47
6411447-41144724.53424.63
30min1477423-47742328.46828.772.9328.6428.942.95
2472558-47255828.17828.32
3487871-48787129.09129.27
4485817-48581728.96929.15
5505599-50559930.14830.33
6465303-46530327.74627.90
45min1513757-51375730.63531.012.9530.8731.242.95
2511445-51144530.49730.71
3548975-54897532.73532.98
4509041-50904130.35430.60
5525306-52530631.32331.57
6511334-51133430.49030.71
60min1531498-53149831.69331.980.7431.9932.280.78
2536048-53604831.96432.24
3539879-53987932.19232.51
4538207-53820732.09332.40
5540544-54054432.23232.55
6531699-53169931.70531.99
极限1555071-55507133.09832.771.9933.4733.142.03
2539760-53976032.18532.53
3557470-55747033.24133.63
4554164-55416433.04433.42
5559070-55907033.33733.73
6532323-53232331.74232.09
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