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%
110.031964863196417019666621966696196736419659510.07
210.202003706200455120041280.03
单位质量响应值RSD%判断
196007.08196483.140.18数据可信
供试品溶液-3780C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%
5min1227120-22712010.4168.3636.3310.428.3636.35
2189094-1890948.6728.67
3226939-22693910.40810.41
4169953-1699537.7947.79
5224682-22468210.30410.30
656064-560642.5712.57
10min1424706-42470619.47718.0212.7519.5018.0412.78
2395276-39527618.12818.15
3431579-43157919.79319.82
4386305-38630517.71617.73
5422813-42281319.39119.41
6297519-29751913.64513.65
15min1518784-51878423.79223.035.3623.8623.095.40
2506223-50622323.21623.28
3520434-52043423.86823.93
4496756-49675622.78222.84
5520033-52003323.84923.92
6450800-45080020.67420.71
20min1566155-56615525.96426.123.1926.0826.233.22
2569549-56954926.12026.23
3599784-59978427.50727.63
4562257-56225725.78625.89
5575290-57529026.38326.50
6544436-54443624.96825.05
30min1636194-63619429.17729.090.8729.3529.260.90
2639822-63982229.34329.51
3633944-63394429.07329.25
4635701-63570129.15429.32
5636078-63607829.17129.35
6623808-62380828.60928.75
45min1684067-68406731.37231.620.6531.6131.860.68
2689067-68906731.60131.84
3691225-69122531.70031.95
4691895-69189531.73131.96
5695854-69585431.91332.16
6684959-68495931.41331.61
60min1715071-71507132.79432.810.3233.1133.110.32
2714642-71464232.77433.08
3712940-71294032.69633.01
4715159-71515932.79833.10
5719599-71959933.00233.31
6715056-71505632.79333.06
极限1733347-73334733.63233.550.9034.0233.920.88
2729964-72996433.47733.85
3719356-71935632.99033.38
4733204-73320433.62634.00
5738424-73842433.86534.25
6734938-73493833.70534.05
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%
110.032011727201035120031322002635199666220049010.31
210.202019802202102520204140.05
单位质量响应值RSD%判断
199890.43198079.800.65数据可信
供试品溶液-3780C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%
5min1265515-26551512.00910.6417.9012.0110.6417.90
2164096-1640967.4227.42
3271981-27198112.30212.30
4261753-26175311.83911.84
5207076-2070769.3669.37
6240430-24043010.87510.87
10min1444383-44438320.10019.218.4920.1319.248.50
2359919-35991916.27916.30
3452834-45283420.48220.51
4450026-45002620.35520.38
5405748-40574818.35218.37
6435502-43550219.69819.72
15min1557375-55737525.21024.227.4125.2824.287.42
2481473-48147321.77721.83
3597568-59756827.02827.10
4538635-53863524.36324.43
5513472-51347223.22523.29
6524330-52433023.71623.78
20min1628506-62850628.42826.614.0928.5526.734.09
2555271-55527125.11525.22
3591815-59181526.76826.90
4593012-59301226.82226.95
5577149-57714926.10526.22
6583626-58362626.39826.52
30min1647973-64797329.30829.341.0229.5029.521.04
2636493-63649328.78928.95
3650394-65039429.41829.61
4656162-65616229.67929.86
5650029-65002929.40129.57
6651550-65155029.47029.65
45min1692496-69249631.32231.622.2931.5831.862.28
2694034-69403431.39131.61
3730400-73040033.03633.29
4697577-69757731.55231.80
5695320-69532031.45031.69
6684750-68475030.97231.22
60min1720741-72074132.59932.570.6532.9232.890.61
2720718-72071832.59832.89
3711118-71111832.16432.50
4721318-72131832.62632.95
5723644-72364432.73133.04
6723418-72341832.72133.03
极限1734878-73487833.23933.320.7733.6433.710.73
2738843-73884333.41833.78
3726141-72614132.84433.25
4740052-74005233.47333.87
5738460-73846033.40133.78
6741715-74171533.54833.93
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%
110.032001958200108219999481998571199752319998160.10
210.202036966203762320372940.03
单位质量响应值RSD%判断
199383.45199734.710.13数据可信
供试品溶液-3785B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%
5min1252036-25203611.36710.6710.8411.3710.6710.82
2185098-1850988.3488.35
3242609-24260910.94210.94
4242015-24201510.91510.91
5251760-25176011.35411.35
6246638-24663811.12311.12
10min1418759-41875918.88618.905.3418.9118.925.35
2376281-37628116.97016.99
3435166-43516619.62619.65
4427432-42743219.27719.30
5437598-43759819.73519.76
6419231-41923118.90718.93
15min1518999-51899923.40723.282.9123.4723.342.92
2487041-48704121.96522.02
3526645-52664523.75123.82
4520545-52054523.47623.54
5527982-52798223.81223.88
6516099-51609923.27623.34
20min1573622-57362225.87025.801.5425.9925.921.55
2554716-55471625.01725.12
3577663-57766326.05226.17
4577937-57793726.06526.18
5575880-57588025.97226.09
6573079-57307925.84625.96
30min1639798-63979828.85528.790.6929.0328.960.71
2629619-62961928.39528.56
3639733-63973328.85229.03
4638951-63895128.81628.99
5642121-64212128.95929.14
6639729-63972928.85129.03
45min1676936-67693630.52930.820.6830.7731.060.67
2684495-68449530.87031.09
3682639-68263930.78731.03
4682380-68238030.77531.02
5682716-68271630.79031.03
6691241-69124131.17531.41
60min1694425-69442531.31831.931.1131.6332.241.10
2703431-70343131.72432.02
3711914-71191432.10732.42
4715586-71558632.27332.58
5710368-71036832.03732.35
6712836-71283632.14932.46
极限1705566-70556631.82132.391.5032.2032.771.50
2703734-70373431.73832.10
3723266-72326632.61933.00
4729094-72909432.88233.26
5723412-72341232.62533.01
6724350-72435032.66833.05
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%
110.032032560203107120303012028516202815420301200.09
210.202026931202769920273150.03
单位质量响应值RSD%判断
202404.79198756.371.29数据可信
供试品溶液-3785B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%
5min1219486-2194869.84910.576.369.8510.576.34
2240140-24014010.77610.78
3247227-24722711.09411.09
4246491-24649111.06111.06
5213835-2138359.5969.60
6246309-24630911.05311.05
10min1398094-39809417.86418.613.2817.8918.633.28
2429545-42954519.27519.30
3424084-42408419.03019.05
4418777-41877718.79218.82
5397633-39763317.84317.86
6420003-42000318.84718.87
15min1538646-53864624.17123.573.9624.2323.633.96
2518468-51846823.26523.33
3522939-52293923.46623.53
4558246-55824625.05025.12
5498200-49820022.35622.42
6514689-51468923.09623.16
20min1559394-55939425.10225.421.1425.2225.541.15
2569731-56973125.56625.68
3573300-57330025.72625.85
4566373-56637325.41525.54
5558285-55828525.05225.16
6572167-57216725.67525.79
30min1617448-61744827.70728.081.6627.8828.251.66
2638589-63858928.65628.83
3633089-63308928.40928.59
4626511-62651128.11428.29
5610236-61023627.38327.55
6628504-62850428.20328.38
45min1678575-67857530.45030.260.8930.6830.500.88
2672192-67219230.16430.40
3675043-67504330.29230.53
4664281-66428129.80930.05
5674823-67482330.28230.51
6681728-68172830.59130.83
60min1661432-66143229.68131.183.6029.9831.493.57
2738803-73880333.15333.46
3689948-68994830.96031.27
4689363-68936330.93431.24
5697459-69745931.29731.59
6692724-69272431.08531.39
极限1718332-71833232.23431.802.2032.6032.172.17
2710721-71072131.89332.27
3728626-72862632.69633.07
4704378-70437831.60831.98
5707729-70772931.75832.12
6682370-68237030.62030.99
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