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MAD-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(%)94.94对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
114.754537004544904536534537054535034538100.09
214.694550494559354554920.14
单位质量响应值RSD%判断
30766.7831006.940.55数据可信
制剂处方摸索--供试品溶液-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%
5min1233461-23346143.81542.627.0843.8242.627.08
2230099-23009943.18443.18
3243739-24373945.74445.74
4222433-22243341.74541.75
5197508-19750837.06837.07
6235377-23537744.17544.17
10min1440310-44031082.63679.834.8982.7179.904.89
2422619-42261979.31679.39
3443023-44302383.14583.22
4416013-41601378.07678.15
5389407-38940773.08373.14
6440635-44063582.69782.77
15min1544628-544628102.21499.252.72102.4299.462.73
2525406-52540698.60698.81
3531759-53175999.799100.01
4522329-52232998.02998.23
5505999-50599994.96495.15
6542944-542944101.898102.11
20min1552959-552959103.778101.731.53104.16102.101.52
2535531-535531100.507100.88
3536854-536854100.755101.14
4532348-53234899.909100.27
5546404-546404102.547102.89
6548344-548344102.911103.29
30min1552602-552602103.711101.531.55104.26102.071.55
2533071-533071100.045100.58
3535664-535664100.532101.08
4532450-53245099.928100.46
5546190-546190102.507103.02
6545994-545994102.470103.02
45min1551110-551110103.431101.361.51104.16102.071.50
2533918-533918100.204100.91
3533789-533789100.180100.90
4531306-53130699.714100.41
5544841-544841102.254102.94
6545549-545549102.387103.11
60min1550335-550335103.285101.251.50104.18102.121.49
2533080-533080100.047100.92
3534623-534623100.336101.22
4529958-52995899.461100.32
5543153-543153101.937102.79
6545663-545663102.408103.30
极限1547521-547521102.757101.021.42103.83102.061.42
2531788-53178899.804100.84
3532452-53245299.929100.98
4530110-53011099.489100.52
5543904-543904102.078103.10
6543784-543784102.056103.12
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MAD-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(%)94.94对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
114.754553544545954553404545694556414551000.11
214.694568494568424568460.01
单位质量响应值RSD%判断
30854.2431099.120.56数据可信
制剂处方摸索--供试品溶液-24030401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%
5min1251902-25190247.13945.637.9647.1445.647.96
2251439-25143947.05247.05
3256399-25639947.98147.98
4263586-26358649.32649.33
5214074-21407440.06040.06
6225750-22575042.24542.25
10min1454999-45499985.14583.944.0385.2284.014.03
2457129-45712985.54485.62
3455650-45565085.26785.35
4470427-47042788.03288.11
5423807-42380779.30879.37
6429210-42921080.31980.39
15min1554281-554281103.724102.571.19103.94102.791.20
2551880-551880103.275103.50
3548364-548364102.617102.84
4553795-553795103.633103.86
5539523-539523100.962101.16
6540869-540869101.214101.42
20min1561220-561220105.023103.960.58105.42104.350.58
2554770-554770103.816104.21
3552645-552645103.418103.81
4556387-556387104.118104.52
5552653-552653103.419103.79
6555706-555706103.991104.36
30min1562582-562582105.277104.230.68105.85104.790.68
2557326-557326104.294104.86
3551797-551797103.259103.82
4556987-556987104.230104.81
5554098-554098103.690104.23
6559047-559047104.616105.16
45min1560865-560865104.956103.910.65105.70104.640.65
2553899-553899103.653104.39
3550739-550739103.061103.80
4555595-555595103.970104.72
5552859-552859103.458104.17
6557586-557586104.343105.06
60min1558552-558552104.523103.710.45105.44104.620.46
2553169-553169103.516104.43
3555247-555247103.905104.81
4553666-553666103.609104.53
5551290-551290103.164104.05
6553341-553341103.548104.44
极限1559427-559427104.687103.360.68105.78104.440.68
2550851-550851103.082104.17
3548607-548607102.662103.74
4551398-551398103.185104.28
5550839-550839103.080104.14
6552911-552911103.468104.53
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MAD-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(%)94.94对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
114.752259802261732259532261932262572261110.07
214.692246522246222246370.01
单位质量响应值RSD%判断
15329.5615291.830.18数据可信
制剂处方摸索--供试品溶液-2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%
5min1140105-14010553.04450.9513.4453.0450.9513.44
2139528-13952852.82652.83
397990-9799037.09937.10
4146353-14635355.41055.41
5141408-14140853.53753.54
6141999-14199953.76153.76
10min1248803-24880394.19789.789.8694.2989.869.87
2241251-24125191.33891.43
3190497-19049772.12372.18
4254799-25479996.46896.56
5245352-24535292.89192.98
6242072-24207291.64991.74
15min1270746-270746102.505100.943.32102.75101.183.34
2266214-266214100.789101.03
3249372-24937294.41394.59
4274084-274084103.769104.02
5270640-270640102.465102.71
6268653-268653101.713101.96
20min1270459-270459102.396102.301.01102.81102.711.01
2266585-266585100.930101.34
3269499-269499102.033102.37
4274848-274848104.058104.48
5270834-270834102.538102.95
6269079-269079101.874102.29
30min1270102-270102102.261102.211.06102.85102.781.05
2265424-265424100.490101.07
3271799-271799102.904103.41
4273875-273875103.690104.29
5269832-269832102.159102.74
6268749-268749101.749102.33
45min1268471-268471101.644101.830.69102.40102.580.68
2267515-267515101.282102.03
3270355-270355102.357103.04
4272002-272002102.981103.75
5268014-268014101.471102.23
6267416-267416101.244102.00
60min1267894-267894101.425101.730.98102.35102.640.97
2264843-264843100.270101.18
3270810-270810102.529103.38
4272335-272335103.107104.05
5268522-268522101.663102.59
6267754-267754101.372102.29
极限1268192-268192101.538101.461.09102.63102.541.08
2263087-26308799.605100.69
3269682-269682102.102103.12
4271887-271887102.937104.05
5267766-267766101.377102.47
6267311-267311101.205102.29
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