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%
116.513993403994213992753992553992543993090.02
216.493987183985113986140.04
单位质量响应值RSD%判断
24185.8924173.070.04数据可信
供试品溶液-1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%
5min1279399-27939969.33181.337.4169.3381.327.41
2337017-33701783.62983.63
3329052-32905281.65281.65
4335458-33545883.24283.24
5340412-34041284.47184.47
6345075-34507585.62885.63
10min1391896-39189697.24797.651.9297.3697.781.92
2393464-39346497.63697.78
3399827-39982799.21599.35
4391732-39173297.20697.34
5402950-40295099.990100.13
6381273-38127394.61194.75
15min1406312-406312100.82499.171.82101.1099.471.81
2398430-39843098.86899.17
3403003-403003100.003100.30
4396240-39624098.32598.63
5406496-406496100.870101.18
6387508-38750896.15896.46
20min1409208-409208101.54399.521.91101.9999.981.90
2398924-39892498.99199.46
3405767-405767100.689101.16
4397271-39727198.58199.05
5406443-406443100.857101.33
6388642-38864296.43996.90
30min1410489-410489101.86199.881.82102.48100.511.82
2401228-40122899.562100.19
3406035-406035100.755101.39
4398560-39856098.90099.53
5408189-408189101.290101.93
6390570-39057096.91897.54
45min1411381-411381102.082100.301.70102.87101.101.69
2404334-404334100.333101.13
3407110-407110101.022101.83
4402709-40270999.930100.72
5408036-408036101.252102.06
6391687-39168797.19597.98
60min1410751-410751101.926100.181.60102.88101.141.60
2404090-404090100.273101.24
3406557-406557100.885101.86
4400100-40010099.283100.24
5407929-407929101.225102.21
6392767-39276797.46398.41
极限1412108-412108102.262100.541.40103.39101.681.39
2405043-405043100.509101.64
3407676-407676101.162102.30
4400297-40029799.331100.46
5408953-408953101.479102.63
6397027-39702798.52099.63
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%
116.513986613984823984613989103993303987690.10
216.494003674004084003880.01
单位质量响应值RSD%判断
24153.1824280.650.38数据可信
供试品溶液-1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%
5min1305278-30527875.63671.025.2675.6471.025.26
2290432-29043271.95871.96
3278348-27834868.96468.96
4265273-26527365.72565.72
5279774-27977469.31769.32
6300805-30080574.52874.53
10min1393050-39305097.38396.401.9597.5196.521.95
2397812-39781298.56398.68
3382993-38299394.89195.01
4386178-38617895.68095.79
5378786-37878693.84993.96
6395602-39560298.01598.14
15min1401212-40121299.405100.931.5199.69101.211.51
2416817-416817103.272103.56
3411129-411129101.862102.14
4409334-409334101.418101.69
5401739-40173999.53699.81
6403963-403963100.087100.37
20min1403473-40347399.965101.611.54100.42102.061.53
2418800-418800103.763104.22
3415498-415498102.945103.39
4412179-412179102.122102.56
5404853-404853100.307100.75
6405945-405945100.578101.03
30min1404873-404873100.312102.001.50100.93102.621.49
2419483-419483103.932104.56
3417986-417986103.561104.18
4413315-413315102.404103.01
5407240-407240100.899101.50
6407234-407234100.897101.52
45min1405314-405314100.422102.201.51101.21102.991.50
2420450-420450104.172104.97
3418783-418783103.759104.55
4413883-413883102.545103.32
5408041-408041101.097101.87
6408527-408527101.218102.01
60min1405626-405626100.499102.351.50101.45103.301.49
2420863-420863104.274105.25
3419568-419568103.953104.91
4414230-414230102.631103.58
5409450-409450101.446102.39
6408827-408827101.292102.25
极限1405265-405265100.409102.311.41101.53103.441.41
2420609-420609104.211105.36
3418157-418157103.604104.74
4414329-414329102.655103.78
5409377-409377101.428102.54
6409802-409802101.534102.66
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%
116.512001322002742002082003262003922002660.06
216.492018862024152021500.19
单位质量响应值RSD%判断
12129.9812258.940.75数据可信
供试品溶液-2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%
5min1181494-18149489.30285.528.2089.3085.528.20
2179579-17957988.36088.36
3189681-18968193.33193.33
4148533-14853373.08473.08
5175193-17519386.20286.20
6168382-16838282.85182.85
10min1199311-19931198.06996.472.7698.2296.612.77
2197245-19724597.05297.20
3198894-19889497.86498.02
4185559-18555991.30391.42
5195406-19540696.14896.29
6199959-19995998.38898.53
15min1200605-20060598.70698.021.1999.0298.321.20
2198609-19860997.72498.03
3200414-20041498.61298.93
4195407-19540796.14896.42
5198070-19807097.45897.76
6202126-20212699.45499.76
20min1201840-20184099.31398.531.0699.7999.001.06
2198797-19879797.81698.29
3201438-20143899.11699.60
4197588-19758897.22197.66
5198845-19884597.84098.31
6202925-20292599.847100.32
30min1202145-20214599.46399.010.95100.1199.640.96
2199591-19959198.20798.84
3202354-20235499.566100.21
4199629-19962998.22698.82
5199565-19956598.19498.82
6204056-204056100.404101.04
45min1203114-20311499.94099.480.98100.75100.280.98
2200467-20046798.63899.44
3203720-203720100.238101.05
4200673-20067398.73999.50
5200212-20021298.51299.31
6204858-204858100.798101.60
60min1203558-203558100.15999.490.82101.13100.440.82
2200529-20052998.66899.63
3202999-20299999.884100.86
4201694-20169499.242100.17
5200158-20015898.48699.44
6204198-204198100.474101.44
极限1203921-203921100.33799.830.89101.48100.960.89
2200823-20082398.81399.94
3204201-204201100.475101.62
4202694-20269499.734100.82
5200739-20073998.77299.89
6204986-204986100.861102.00
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%
116.512011802013792009402008522012982011300.12
216.492027672029972028820.09
单位质量响应值RSD%判断
12182.3112303.340.70数据可信
供试品溶液-2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%
5min1172898-17289884.73685.812.3384.7485.812.33
2179208-17920887.82987.83
3176595-17659586.54886.55
4167904-16790482.28982.29
5177164-17716486.82786.83
6176777-17677786.63886.64
10min1201301-20130198.65798.030.6698.8098.180.66
2199125-19912597.59097.74
3200640-20064098.33398.48
4197847-19784796.96497.10
5200301-20030198.16798.31
6200955-20095598.48798.63
15min1203556-20355699.76299.300.63100.0799.600.63
2202068-20206899.03399.34
3204061-204061100.009100.32
4200461-20046198.24598.54
5202857-20285799.41999.73
6202638-20263899.31299.62
20min1204121-204121100.03999.650.64100.51100.130.64
2203345-20334599.658100.13
3205209-205209100.572101.05
4201341-20134198.67699.14
5203219-20321999.597100.07
6202788-20278899.38599.86
30min1205081-205081100.50999.930.82101.15100.570.82
2204160-204160100.058100.70
3205947-205947100.934101.58
4201077-20107798.54799.17
5203426-20342699.698100.34
6203761-20376199.862100.50
45min1205488-205488100.709100.160.82101.51100.960.82
2204094-204094100.025100.83
3206452-206452101.181101.99
4201554-20155498.78199.57
5204714-204714100.329101.14
6203928-20392899.944100.75
60min1205680-205680100.803100.260.78101.78101.240.78
2204954-204954100.447101.42
3206137-206137101.027102.01
4201647-20164798.82699.78
5204191-204191100.073101.05
6204877-204877100.409101.38
极限1206184-206184101.050100.120.88102.19101.260.88
2205362-205362100.647101.79
3205472-205472100.701101.85
4201228-20122898.62199.74
5203747-20374799.855101.00
6203769-20376999.866101.01
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