托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
1 16.581988851987781992541992561992341990810.12
2 16.531987991983321985660.17
单位质量响应值RSD%判断
12007.3012012.460.04数据可信
加速6月-供试品溶液-2025050921批-SHUI(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1202947-202947101.28998.541.94101.2998.541.94
2192875-19287596.26296.26
3193305-19330596.47696.48
4197709-19770998.67498.67
5199407-19940799.52299.52
6198381-19838199.01099.01
10min1206859-206859103.241101.341.42103.41101.501.42
2198270-19827098.95499.11
3201731-201731100.682100.84
4203630-203630101.630101.79
5204307-204307101.967102.13
6203510-203510101.570101.73
15min1206271-206271102.948101.201.44103.29101.531.44
2197775-19777598.70799.03
3201900-201900100.766101.09
4204749-204749102.188102.52
5203311-203311101.470101.81
6202601-202601101.116101.45
20min1207565-207565103.593101.171.57104.11101.671.57
2197685-19768598.66299.15
3202023-202023100.827101.32
4203395-203395101.512102.02
5203229-203229101.429101.93
6202350-202350100.991101.49
30min1205608-205608102.617100.791.38103.30101.461.38
2197533-19753398.58799.24
3200593-200593100.114100.78
4203617-203617101.623102.30
5202809-202809101.220101.89
6201485-201485100.559101.23
45min1205637-205637102.631100.571.38103.49101.411.38
2197526-19752698.58399.40
3199721-19972199.679100.51
4202876-202876101.253102.10
5201987-201987100.810101.65
6201296-201296100.465101.30
60min1205355-205355102.490100.341.46103.52101.341.46
2196551-19655198.09699.08
3199650-19965099.643100.64
4202394-202394101.013102.02
5201453-201453100.543101.55
6200846-200846100.240101.25
极限1204887-204887102.257100.171.42103.45101.341.42
2196385-19638598.01499.16
3199665-19966599.651100.81
4202163-202163100.897102.08
5201187-201187100.410101.59
6199937-19993799.786100.96
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
1 16.581996621992221988751994231985201991400.23
2 16.531994791974841984820.72
单位质量响应值RSD%判断
12010.8612007.380.03数据可信
中间条件6月-供试品溶液-2025050921批-SHUI(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1200248-20024899.94895.843.5599.9595.843.55
2194979-19497997.31897.32
3186276-18627692.97492.97
4181851-18185190.76690.77
5192454-19245496.05896.06
6196312-19631297.98397.98
10min1205644-205644102.641101.621.14102.81101.781.14
2202833-202833101.238101.40
3199823-19982399.73699.89
4205036-205036102.338102.49
5202590-202590101.117101.28
6205722-205722102.680102.84
15min1205864-205864102.751101.651.02103.09101.981.02
2201844-201844100.745101.08
3201319-201319100.482100.80
4205231-205231102.435102.76
5202260-202260100.952101.28
6205433-205433102.536102.87
20min1205328-205328102.483101.570.97102.99102.070.98
2202110-202110100.877101.38
3200485-200485100.066100.55
4204572-204572102.106102.60
5203077-203077101.360101.86
6205442-205442102.540103.05
30min1204104-204104101.873101.210.79102.55101.880.79
2201471-201471100.558101.23
3200179-20017999.913100.57
4204140-204140101.891102.55
5203385-203385101.514102.18
6203370-203370101.506102.18
45min1203518-203518101.580100.920.87102.43101.760.88
2201301-201301100.474101.31
3199074-19907499.362100.18
4203076-203076101.359102.19
5202525-202525101.084101.92
6203683-203683101.662102.51
60min1203829-203829101.735100.271.25102.75101.271.24
2200319-20031999.983100.99
3198346-19834698.99999.99
4202935-202935101.289102.29
5202131-202131100.888101.89
6197743-19774398.69899.71
极限1202750-202750101.197100.161.11102.39101.341.10
2199504-19950499.577100.75
3196985-19698598.31999.47
4202892-202892101.268102.44
5201062-201062100.354101.53
6200878-200878100.262101.44
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
1 16.581995231984722003182000571987651994270.41
2 16.531996271983701989980.45
单位质量响应值RSD%判断
12028.1712038.600.07数据可信
加速6月-供试品溶液-2025051021批-SHUI(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1201250-201250100.24699.351.71100.2599.351.71
2195824-19582497.54397.54
3198592-19859298.92298.92
4203239-203239101.236101.24
5202480-202480100.858100.86
6195299-19529997.28197.28
10min1208667-208667103.940102.841.65104.11103.001.64
2203934-203934101.582101.75
3206979-206979103.099103.26
4209012-209012104.112104.28
5209257-209257104.234104.40
6200847-200847100.045100.21
15min1208235-208235103.725102.711.68104.07103.051.68
2203229-203229101.231101.56
3207159-207159103.189103.53
4208830-208830104.021104.36
5209040-209040104.126104.47
6200679-20067999.961100.29
20min1207726-207726103.471102.871.93103.98103.381.93
2203802-203802101.517102.02
3207071-207071103.145103.65
4208829-208829104.021104.54
5211461-211461105.332105.85
6200184-20018499.715100.21
30min1207774-207774103.495102.531.63104.18103.211.63
2204184-204184101.707102.38
3206144-206144102.683103.36
4208010-208010103.613104.30
5208985-208985104.098104.79
6199927-19992799.587100.25
45min1207262-207262103.240102.181.86104.10103.031.86
2203172-203172101.203102.04
3205098-205098102.162103.01
4207834-207834103.525104.39
5208846-208846104.029104.89
6198597-19859798.92499.75
60min1207912-207912103.564102.152.01104.59103.172.00
2202549-202549100.893101.90
3205589-205589102.407103.43
4207738-207738103.477104.51
5208656-208656103.935104.97
6198036-19803698.64599.64
极限1207269-207269103.244101.961.86104.45103.151.86
2202396-202396100.816101.99
3205111-205111102.169103.36
4207068-207068103.144104.35
5208121-208121103.668104.88
6198173-19817398.71399.87
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
1 16.582002501991231996992005631989451997160.35
2 16.532010902009272010080.06
单位质量响应值RSD%判断
12045.6012160.190.67数据可信
中间条件6月-供试品溶液-2025051021批-SHUI(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1199129-19912998.62296.532.1098.6296.542.10
2187386-18738692.80692.81
3197392-19739297.76197.76
4195328-19532896.73996.74
5194035-19403596.09996.10
6196223-19622397.18297.18
10min1207824-207824102.928101.771.13103.09101.931.12
2204579-204579101.321101.48
3204656-204656101.359101.52
4202102-202102100.094100.26
5205399-205399101.727101.89
6208333-208333103.180103.34
15min1207340-207340102.688101.821.07103.02102.141.06
2205033-205033101.546101.87
3204502-204502101.283101.61
4202341-202341100.212100.54
5205722-205722101.887102.22
6208533-208533103.279103.61
20min1207885-207885102.958101.671.04103.47102.171.04
2204447-204447101.255101.75
3203939-203939101.004101.50
4202218-202218100.151100.65
5206053-206053102.051102.55
6207140-207140102.589103.10
30min1206990-206990102.515101.291.08103.19101.961.08
2203635-203635100.853101.51
3203164-203164100.620101.29
4201404-20140499.748100.41
5205011-205011101.535102.20
6206879-206879102.460103.14
45min1206914-206914102.477100.981.03103.33101.821.03
2203106-203106100.591101.42
3202529-202529100.305101.14
4201171-20117199.633100.46
5204049-204049101.058101.90
6205602-205602101.827102.68
60min1205553-205553101.803100.591.23102.82101.591.23
2202193-202193100.139101.14
3201541-20154199.816100.82
4199579-19957998.84499.84
5203590-203590100.831101.84
6206124-206124102.086103.10
极限1204775-204775101.41899.951.01102.61101.131.01
2201844-20184499.966101.13
3200960-20096099.528100.70
4199767-19976798.938100.10
5203639-203639100.855102.03
6199903-19990399.005100.19
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