氢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%
114.746777956793456765986800896783856784420.20
214.836777466775626776540.02
单位质量响应值RSD%判断
46027.2745694.810.52数据可信
供试品溶液-第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%
5min1195538-19553824.74226.798.7824.7426.808.77
2230344-23034429.14629.15
3201215-20121525.46025.46
4229937-22993729.09429.09
5224458-22445828.40128.40
6189088-18908823.92523.93
10min1415246-41524652.54155.667.0652.5855.707.06
2468214-46821459.24459.29
3426802-42680254.00454.05
4472006-47200659.72359.77
5459739-45973958.17158.22
6397305-39730550.27150.31
15min1580146-58014673.40676.225.7973.5476.365.79
2630952-63095279.83579.98
3586971-58697174.27074.40
4637312-63731280.64080.79
5627971-62797179.45879.60
6550969-55096969.71569.84
20min1688797-68879787.15490.274.9187.4190.534.91
2740329-74032993.67493.95
3695608-69560888.01688.27
4750311-75031194.93895.22
5740593-74059393.70893.98
6664782-66478284.11584.36
30min1788637-78863799.787100.841.24100.18101.261.25
2792429-792429100.267100.70
3797473-797473100.905101.31
4808807-808807102.339102.78
5808545-808545102.306102.74
6786068-78606899.46299.84
45min1790518-790518100.025101.520.87100.59102.110.88
2800403-800403101.276101.88
3801969-801969101.474102.04
4811459-811459102.675103.29
5804340-804340101.774102.38
6805534-805534101.925102.47
极限1792705-792705100.302101.420.71101.03102.170.72
2798829-798829101.077101.85
3799340-799340101.141101.88
4808699-808699102.325103.11
5804782-804782101.830102.60
6804678-804678101.817102.53
氢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%
114.746761036782096779266750196774436769400.20
214.836758326751396754860.08
单位质量响应值RSD%判断
45925.3745548.620.59数据可信
供试品溶液-第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%
5min1274169-27416934.78530.3619.0334.7930.3619.04
2231868-23186829.41829.42
3268235-26823534.03234.03
4281838-28183835.75835.76
5162053-16205320.56020.56
6217405-21740527.58327.58
10min1521717-52171766.19360.3011.6466.2560.3511.65
2450505-45050557.15857.21
3499618-49961863.38963.45
4538375-53837568.30668.37
5389240-38924049.38549.42
6451958-45195857.34257.39
15min1684784-68478486.88281.268.5587.0581.418.56
2611673-61167377.60677.75
3657283-65728383.39283.55
4708256-70825689.86090.03
5556610-55661070.62070.74
6624181-62418179.19379.33
20min1781124-78112499.10594.205.8699.4294.495.87
2715107-71510790.72991.00
3754717-75471795.75496.06
4791601-791601100.434100.76
5674587-67458785.58885.82
6737810-73781093.60993.88
30min1806953-806953102.382100.931.70102.86101.371.72
2787814-78781499.954100.38
3788238-788238100.007100.47
4804987-804987102.132102.62
5775748-77574898.42398.80
6809164-809164102.662103.09
45min1806941-806941102.380100.991.65103.03101.601.67
2789168-789168100.125100.72
3792517-792517100.550101.18
4804376-804376102.055102.72
5774623-77462398.28098.82
6808145-808145102.533103.13
极限1808735-808735102.608101.241.99103.43102.022.01
2788514-788514100.042100.80
3795366-795366100.912101.71
4814899-814899103.390104.22
5772341-77234197.99098.70
6807973-807973102.511103.28
氢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%
114.746781316749916761606745686783606764420.26
214.836748776753256751010.05
单位质量响应值RSD%判断
45891.5945522.660.58数据可信
供试品溶液-第3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%
5min172917-729179.25725.2242.439.2625.2242.42
2255536-25553632.44232.44
3271233-27123334.43534.44
4111906-11190614.20714.21
5229397-22939729.12429.12
6250758-25075831.83631.84
10min1292412-29241237.12455.2326.5637.1455.2726.56
2514098-51409865.26965.32
3534287-53428767.83267.89
4282632-28263235.88235.91
5482502-48250261.25761.31
6504197-50419764.01264.06
15min1464338-46433858.95176.1020.3959.0376.2420.41
2679662-67966286.28886.45
3700343-70034388.91489.08
4422710-42271053.66653.75
5659899-65989983.77983.93
6669630-66963085.01485.17
20min1590583-59058374.97989.5215.8775.1589.7815.90
2772337-77233798.05498.36
3792621-792621100.629100.95
4535265-53526567.95668.13
5765635-76563597.20397.49
6774252-77425298.29798.60
30min1755229-75522995.88297.665.9196.1898.075.97
2793083-793083100.688101.16
3804513-804513102.139102.63
4683101-68310186.72587.01
5793758-793758100.773101.23
6785711-78571199.752100.22
45min1802098-802098101.832100.301.55102.29100.881.58
2787761-787761100.012100.65
3803869-803869102.057102.71
4771358-77135897.93098.36
5792407-792407100.602101.22
6782820-78282099.385100.02
极限1806791-806791102.428100.341.48103.06101.081.47
2786468-78646899.848100.65
3801261-801261101.726102.55
4779088-77908898.91199.50
5790355-790355100.341101.13
6778335-77833598.81599.61
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