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101242-201201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(%)100.0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 16.452001702002131994112004472001072000700.20
2 16.521997631992291994960.19
单位质量响应值RSD%判断
12162.3112076.030.51数据可信
供试品溶液-3E99SDC1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%
5min1142027-14202770.31674.222.8770.3274.222.87
2149158-14915873.84773.85
3151870-15187075.18975.19
4150921-15092174.71974.72
5154836-15483676.65876.66
6150638-15063874.57974.58
10min1180437-18043789.33392.772.4989.4592.892.49
2183461-18346190.83090.95
3189107-18910793.62593.75
4187651-18765192.90493.03
5192958-19295895.53295.66
6190668-19066894.39894.52
15min1194316-19431696.20498.651.6696.4798.921.66
2196469-19646997.27097.54
3199563-19956398.80299.08
4200370-20037099.20199.48
5203195-203195100.600100.89
6201580-20158099.800100.08
20min1199660-19966098.850100.331.0899.28100.771.08
2201160-20116099.592100.03
3202839-202839100.423100.87
4202172-202172100.093100.54
5205759-205759101.869102.32
6204264-204264101.129101.58
30min1203093-203093100.549101.300.85101.14101.910.86
2204720-204720101.355101.96
3204343-204343101.168101.78
4202381-202381100.197100.81
5206941-206941102.454103.08
6206137-206137102.056102.67
45min1205012-205012101.499101.560.70102.26102.340.70
2205180-205180101.583102.35
3204681-204681101.335102.12
4202777-202777100.393101.17
5206508-206508102.240103.04
6206669-206669102.320103.11
60min1204557-204557101.274101.540.87102.20102.480.87
2204367-204367101.180102.12
3207436-207436102.699103.65
4202279-202279100.146101.09
5206177-206177102.076103.04
6205715-205715101.847102.80
极限1204503-204503101.247101.250.83102.34102.360.83
2204496-204496101.244102.35
3203694-203694100.847101.97
4201810-20181099.914101.03
5206001-206001101.989103.12
6206535-206535102.253103.38
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101242-201201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(%)100.0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 16.451998541996782011592004981996372001650.33
2 16.522003212010842007020.27
单位质量响应值RSD%判断
12168.0912149.030.12数据可信
供试品溶液-3E99SDC1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%
5min1155381-15538176.67776.622.0876.6876.622.08
2151627-15162774.82574.82
3155521-15552176.74676.75
4161020-16102079.46079.46
5152910-15291075.45875.46
6155093-15509376.53576.54
10min1193789-19378995.63195.190.6695.7695.320.66
2193024-19302495.25395.38
3194253-19425395.86095.99
4193625-19362595.55095.68
5191363-19136394.43494.56
6191343-19134394.42494.55
15min1204253-204253100.795100.190.60101.08100.480.60
2202894-202894100.124100.41
3203963-203963100.652100.94
4203903-203903100.622100.91
5201662-20166299.51699.80
6201528-20152899.45099.73
20min1207147-207147102.223101.300.68102.68101.750.68
2204563-204563100.948101.40
3206004-206004101.659102.11
4206225-206225101.768102.23
5203889-203889100.615101.06
6203784-203784100.563101.01
30min1207807-207807102.549101.720.80103.17102.340.80
2205508-205508101.414102.03
3207234-207234102.266102.89
4207554-207554102.424103.05
5204665-204665100.998101.61
6203960-203960100.650101.27
45min1208096-208096102.691101.700.87103.49102.490.87
2204885-204885101.107101.89
3206461-206461101.884102.68
4208070-208070102.678103.48
5205291-205291101.307102.09
6203705-203705100.524101.31
60min1208069-208069102.678101.490.82103.65102.460.82
2205266-205266101.295102.25
3205745-205745101.531102.50
4206935-206935102.118103.09
5204619-204619100.975101.93
6203357-203357100.353101.31
极限1206757-206757102.030101.190.63103.17102.320.63
2205076-205076101.201102.33
3204614-204614100.973102.11
4204996-204996101.161102.30
5205945-205945101.630102.75
6202949-202949100.151101.27
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101242-201201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(%)100.0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 16.454014884042574032854017434042084029960.33
2 16.524011124063814037460.93
单位质量响应值RSD%判断
24498.2424439.830.17数据可信
供试品溶液-3F70SDB1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%
5min1290449-29044971.22073.442.0971.2273.442.09
2301842-30184274.01474.01
3304116-30411674.57274.57
4307202-30720275.32875.33
5299152-29915273.35573.35
6294264-29426472.15672.16
10min1358566-35856687.92390.411.9088.0490.531.90
2361553-36155388.65688.78
3372599-37259991.36491.49
4376236-37623692.25692.38
5370666-37066690.89091.01
6372642-37264291.37591.50
15min1380450-38045093.28996.342.1593.5596.612.15
2383924-38392494.14194.41
3397234-39723497.40597.68
4398572-39857297.73398.01
5397422-39742297.45197.72
6399768-39976898.02698.30
20min1391332-39133295.95898.902.0196.3899.332.00
2394750-39475096.79697.22
3407862-407862100.011100.45
4407945-407945100.031100.47
5407947-407947100.032100.47
6410035-410035100.544100.98
30min1404642-40464299.222100.971.3499.80101.571.34
2405533-40553399.440100.03
3411740-411740100.962101.57
4415719-415719101.938102.55
5415856-415856101.971102.57
6417199-417199102.301102.90
45min1410813-410813100.735101.670.74101.48102.440.75
2411958-411958101.015101.77
3413735-413735101.451102.23
4417038-417038102.261103.04
5415365-415365101.851102.62
6418889-418889102.715103.49
60min1410589-410589100.680101.560.71101.59102.500.71
2412639-412639101.182102.11
3413617-413617101.422102.37
4413820-413820101.472102.42
5415233-415233101.819102.76
6419220-419220102.796103.74
极限1407206-40720699.850101.300.97100.93102.400.97
2410452-410452100.646101.74
3412864-412864101.238102.35
4414291-414291101.588102.71
5415125-415125101.792102.90
6418698-418698102.668103.78
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101242-201201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(%)100.0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 16.454030774043394055224028004036714038820.28
2 16.524041534033074037300.15
单位质量响应值RSD%判断
24552.1024438.860.33数据可信
供试品溶液-3F70SDB1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%
5min1299254-29925473.30174.342.2073.3074.332.20
2294265-29426572.07972.08
3308406-30840675.54275.54
4312662-31266276.58576.58
5305517-30551774.83574.83
6300771-30077173.67273.67
10min1371687-37168791.04392.642.1291.1692.772.12
2383657-38365793.97594.09
3385349-38534994.38994.52
4387183-38718394.83894.97
5372145-37214591.15591.28
6369347-36934790.47090.59
15min1395338-39533896.83698.221.8697.1198.501.86
2409696-409696100.353100.63
3405778-40577899.39399.68
4407462-40746299.806100.09
5392561-39256196.15696.43
6395173-39517396.79597.07
20min1404590-40459099.102100.161.3899.54100.601.38
2412604-412604101.065101.51
3413492-413492101.283101.73
4414827-414827101.610102.06
5400686-40068698.14698.58
6407308-40730899.768100.20
30min1417419-417419102.244101.590.94102.84102.190.94
2416072-416072101.915102.53
3415970-415970101.890102.51
4418515-418515102.513103.13
5407973-40797399.931100.53
6412425-412425101.021101.62
45min1419552-419552102.767101.830.89103.54102.610.89
2416755-416755102.082102.86
3411812-411812100.871101.66
4419112-419112102.659103.45
5410721-410721100.604101.37
6416462-416462102.010102.78
60min1416715-416715102.072101.770.65103.01102.720.65
2416757-416757102.082103.03
3412711-412711101.091102.05
4418987-418987102.629103.59
5411942-411942100.903101.84
6415854-415854101.861102.80
极限1416551-416551102.032101.280.80103.14102.400.80
2414568-414568101.546102.67
3411103-411103100.697101.82
4414386-414386101.502102.64
5408060-40806099.952101.05
6416317-416317101.975103.08
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