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%
116.484026024024264027344030604027294027100.06
216.554099084105354102220.11
单位质量响应值RSD%判断
24436.2924786.831.01数据可信
供试品溶液-1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141275-4127510.06310.437.5210.0610.437.51
239247-392479.5689.57
341416-4141610.09710.10
444597-4459710.87310.87
541748-4174810.17810.18
648314-4831411.77911.78
10min190699-9069922.11222.415.0622.1322.425.06
287464-8746421.32421.34
390104-9010421.96721.98
490123-9012321.97221.99
592207-9220722.48022.50
6100862-10086224.59024.61
15min1125964-12596430.71030.963.2330.7631.023.23
2124547-12454730.36530.42
3125171-12517130.51730.57
4123240-12324030.04630.10
5128526-12852631.33531.39
6134533-13453332.79932.86
20min1153412-15341237.40237.652.4237.5137.762.42
2151435-15143536.92037.02
3155484-15548437.90738.01
4149948-14994836.55736.66
5155884-15588438.00538.11
6160457-16045739.11939.23
30min1188768-18876846.02246.342.1946.1946.512.19
2188903-18890346.05546.22
3185713-18571345.27745.44
4187252-18725245.65245.82
5192651-19265146.96847.14
6197091-19709148.05148.23
45min1227032-22703255.35055.351.6755.5955.601.67
2225748-22574855.03755.28
3222669-22266954.28754.53
4224247-22424754.67154.91
5229289-22928955.90156.15
6233180-23318056.84957.11
60min1254053-25405361.93861.681.2962.2762.021.30
2255288-25528862.23962.57
3248836-24883660.66661.00
4249429-24942960.81161.14
5253396-25339661.77862.12
6257068-25706862.67363.03
90min1285817-28581769.68269.811.0970.1270.251.09
2286505-28650569.85070.29
3281169-28116968.54968.98
4285453-28545369.59470.03
5289328-28932870.53870.98
6289704-28970470.63071.09
120min1307017-30701774.85174.930.8975.4175.490.89
2308604-30860475.23875.79
3304037-30403774.12474.67
4304301-30430174.18974.74
5310550-31055075.71276.27
6309555-30955575.47076.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1317596-31759677.43077.360.9878.1178.050.98
2319588-31958877.91678.59
3312280-31228076.13476.81
4315109-31510976.82477.50
5320375-32037578.10878.80
6318961-31896177.76378.47
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%
116.484047824055474050904051414052664051650.07
216.554060254063274061760.06
单位质量响应值RSD%判断
24585.2524542.360.13数据可信
供试品溶液-1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137495-374959.15910.039.839.1610.039.83
241310-4131010.09010.09
348723-4872311.90111.90
440165-401659.8119.81
540588-405889.9149.91
638084-380849.3029.30
10min183680-8368020.44020.551.6620.4620.561.66
284976-8497620.75620.77
384948-8494820.75020.77
481578-8157819.92619.94
584197-8419720.56620.58
685393-8539320.85820.87
15min1121445-12144529.66429.521.3029.7129.571.30
2120612-12061229.46129.51
3120298-12029829.38429.44
4118647-11864728.98129.03
5120763-12076329.49829.55
6123429-12342930.14930.20
20min1149784-14978436.58736.501.2236.6936.601.22
2149291-14929136.46636.57
3148288-14828836.22136.32
4146833-14683335.86635.96
5150322-15032236.71836.82
6152159-15215937.16737.27
30min1186732-18673245.61245.891.2845.7746.051.28
2187322-18732245.75645.92
3187045-18704545.68845.85
4185557-18555745.32545.48
5188124-18812445.95246.11
6192438-19243847.00547.17
45min1223093-22309354.49354.940.9254.7355.180.91
2224948-22494854.94655.18
3225304-22530455.03355.27
4222884-22288454.44254.68
5224839-22483954.92055.16
6228582-22858255.83456.07
60min1249754-24975461.00561.370.5961.3361.700.60
2252276-25227661.62161.95
3250468-25046861.18061.51
4249936-24993661.05061.37
5251567-25156761.44861.78
6253531-25353161.92862.26
90min1283418-28341869.22869.550.5969.6669.980.59
2286237-28623769.91770.35
3283954-28395469.35969.79
4282893-28289369.10069.53
5284808-28480869.56870.00
6287167-28716770.14470.58
120min1305062-30506274.51574.740.3975.0675.280.39
2306206-30620674.79475.34
3305373-30537374.59175.14
4305250-30525074.56175.10
5305676-30567674.66575.21
6308237-30823775.29175.84
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1315919-31591977.16777.690.6177.8378.360.61
2318936-31893677.90478.58
3317243-31724377.49078.16
4316023-31602377.19277.86
5320313-32031378.24078.91
6319897-31989778.13978.82
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%
116.484011744009324002384002454003634005900.11
216.554096244095974096100.01
单位质量响应值RSD%判断
24307.6524749.851.28数据可信
供试品溶液-2批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142121-4212110.30410.362.4410.3010.362.45
241473-4147310.14610.15
340962-4096210.02110.02
442721-4272110.45110.45
543802-4380210.71510.72
642916-4291610.49910.50
10min184369-8436920.63920.441.2520.6620.461.25
281719-8171919.99120.01
383429-8342920.40920.43
483386-8338620.39920.42
583640-8364020.46120.48
684692-8469220.71820.74
15min1118058-11805828.88128.441.7328.9328.491.72
2113423-11342327.74727.80
3117005-11700528.62328.67
4114333-11433327.96928.02
5116379-11637928.47028.52
6118384-11838428.96029.01
20min1145409-14540935.57235.211.4735.6735.301.47
2140367-14036734.33834.43
3143341-14334135.06635.16
4145897-14589735.69135.79
5143021-14302134.98735.09
6145441-14544135.57935.68
30min1183848-18384844.97544.241.5645.1344.391.55
2177064-17706443.31543.47
3181833-18183344.48244.64
4178472-17847243.66043.82
5179963-17996344.02444.18
6183804-18380444.96445.12
45min1222674-22267454.47353.801.3754.7154.031.37
2216635-21663552.99653.22
3221516-22151654.19054.42
4216452-21645252.95153.18
5219043-21904353.58553.82
6223267-22326754.61854.85
60min1251743-25174361.58460.401.5561.9160.721.54
2242626-24262659.35459.67
3249174-24917460.95661.28
4244066-24406659.70660.02
5243948-24394859.67760.00
6249841-24984161.11961.44
90min1299102-29910273.17069.552.7573.6069.972.74
2278327-27832768.08768.50
3284377-28437769.56769.99
4279306-27930668.32768.74
5279455-27945568.36368.78
6285274-28527469.78770.21
120min1305904-30590474.83474.521.3775.3875.061.37
2300516-30051673.51574.04
3307481-30748175.21975.76
4301949-30194973.86674.40
5300971-30097173.62774.16
6310845-31084576.04276.59
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1320075-32007578.30077.351.3578.9778.011.35
2311320-31132076.15876.81
3317169-31716977.58978.25
4313707-31370776.74277.40
5312841-31284176.53177.19
6321958-32195878.76179.43
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