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 16.451992081979201999211998591979431989700.50
2 16.522003432005732004580.09
单位质量响应值RSD%判断
12095.4412134.260.23数据可信
供试品溶液-2J95SDC1批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119441-194419.6289.4610.619.639.4610.60
219648-196489.7319.73
316509-165098.1768.18
417546-175468.6908.69
519014-190149.4179.42
622406-2240611.09711.10
10min134931-3493117.30017.373.1917.3217.393.18
237199-3719918.42318.44
334787-3478717.22917.24
435014-3501417.34117.36
534645-3464517.15817.17
633877-3387716.77816.80
15min150682-5068225.10125.442.3825.1525.492.38
253221-5322126.35826.41
350830-5083025.17425.22
452041-5204125.77425.82
551738-5173825.62425.67
649733-4973324.63124.68
20min164179-6417931.78532.292.5731.8732.372.57
267623-6762333.49133.58
364847-6484732.11632.20
465909-6590932.64232.73
565831-6583132.60432.69
662748-6274831.07731.16
30min184912-8491242.05443.192.1842.1943.332.18
289673-8967344.41244.56
387150-8715043.16243.30
488746-8874643.95244.09
587617-8761743.39343.53
685167-8516742.18042.32
45min1111250-11125055.09855.911.6155.3156.121.61
2115553-11555357.22957.45
3112828-11282855.87956.09
4113816-11381656.36956.58
5113395-11339556.16056.37
6110527-11052754.74054.95
60min1130418-13041864.59165.271.4364.8965.581.43
2134267-13426766.49766.81
3129645-12964564.20864.51
4132832-13283265.78766.09
5133199-13319965.96866.28
6130379-13037964.57264.87
90min1153372-15337275.95977.491.3176.3777.901.31
2158722-15872278.60979.04
3155447-15544776.98777.40
4156497-15649777.50777.92
5158668-15866878.58279.00
6156054-15605477.28777.70
120min1172038-17203885.20485.680.9585.7486.220.95
2173057-17305785.70886.27
3171445-17144584.91085.45
4173049-17304985.70486.25
5176091-17609187.21187.76
6172305-17230585.33685.87
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1184041-18404191.14893.191.4391.8393.871.43
2190250-19025094.22394.92
3186321-18632192.27892.96
4188130-18813093.17393.86
5191461-19146194.82395.52
6188721-18872193.46694.15
240min1190336-19033694.26695.152.2795.1095.992.25
2195863-19586397.00397.86
3191877-19187795.02995.86
4193376-19337695.77296.62
5184647-18464791.44892.30
6196612-19661297.37498.21
极限1191120-19112094.65496.682.1795.6497.682.16
2200074-20007499.089100.11
3191853-19185395.01796.01
4193298-19329895.73396.74
5200935-20093599.515100.52
6193956-19395696.05997.06
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 16.452009482015041992632009732000182005410.45
2 16.522042442057552050000.53
单位质量响应值RSD%判断
12190.9412409.201.26数据可信
供试品溶液-2J95SDC1批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121115-2111510.3019.109.2710.309.109.26
218399-183998.9768.98
316380-163807.9917.99
417172-171728.3778.38
519147-191479.3419.34
619758-197589.6399.64
10min135004-3500417.07616.502.3917.0916.522.38
233963-3396316.56916.58
333739-3373916.45916.47
432496-3249615.85315.87
533708-3370816.44416.46
634070-3407016.62116.64
15min151355-5135525.05324.431.4225.1024.471.43
249750-4975024.27024.31
349655-4965524.22424.26
449362-4936224.08124.12
550004-5000424.39424.44
650350-5035024.56324.61
20min164902-6490231.66231.261.1631.7531.351.16
263324-6332430.89230.98
364133-6413331.28731.37
463070-6307030.76830.85
564380-6438031.40731.49
664693-6469331.56031.64
30min187168-8716842.52442.150.8242.6642.290.82
286110-8611042.00842.14
385791-8579141.85241.99
485543-8554341.73141.86
587208-8720842.54442.68
686611-8661142.25242.39
45min1111313-11131354.30354.370.9454.5154.580.94
2111843-11184354.56254.77
3109798-10979853.56453.77
4110847-11084754.07654.28
5112661-11266154.96155.17
6112286-11228654.77854.99
60min1130394-13039463.61163.710.9563.9164.010.95
2130466-13046663.64763.94
3128627-12862762.74963.04
4130326-13032663.57863.87
5132254-13225464.51964.82
6131539-13153964.17064.47
90min1156731-15673176.46076.121.5776.8776.521.56
2155769-15576975.99076.39
3151525-15152573.92074.32
4157989-15798977.07377.47
5158256-15825677.20477.61
6155906-15590676.05776.46
120min1172264-17226484.03783.741.0484.5784.261.04
2171318-17131883.57684.10
3168627-16862782.26382.78
4172679-17267984.24084.77
5171136-17113683.48784.02
6173861-17386184.81685.35
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1188636-18863692.02491.851.4392.7092.521.43
2186506-18650690.98591.65
3184192-18419289.85690.51
4191955-19195593.64394.31
5188587-18858792.00092.67
6189834-18983492.60993.28
240min1195262-19526295.25794.731.0396.0995.561.04
2192972-19297294.14094.96
3190911-19091193.13493.94
4194480-19448094.87595.70
5194855-19485595.05895.89
6196657-19665795.93796.77
极限1192810-19281094.06194.951.2895.0595.941.28
2195186-19518695.22096.20
3190709-19070993.03694.00
4195123-19512395.18996.17
5197441-19744196.32097.31
6196581-19658195.90096.89
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 16.452001332022391998222015502016142010720.52
2 16.521989901980891985400.33
单位质量响应值RSD%判断
12223.2212018.161.20数据可信
供试品溶液-2J95SDC1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%
5min123345-2334511.55711.5510.5511.5611.5510.53
225213-2521312.48212.48
321103-2110310.44710.45
427195-2719513.46313.46
521039-2103910.41510.42
622078-2207810.93010.93
10min146969-4696923.25222.642.2823.2722.662.28
245853-4585322.70022.72
344785-4478522.17122.19
446835-4683523.18623.21
545595-4559522.57222.59
644416-4441621.98822.01
15min169070-6907034.19432.702.9634.2532.762.96
266358-6635832.85132.91
363791-6379131.58031.63
466742-6674233.04133.10
566338-6633832.84132.90
664015-6401531.69131.75
20min184797-8479741.97940.832.5542.0940.942.55
281134-8113440.16640.28
380936-8093640.06840.17
485261-8526142.20942.33
582346-8234640.76640.88
680327-8032739.76639.87
30min1108490-10849053.70953.062.1253.8953.242.11
2105461-10546152.20952.39
3105661-10566152.30852.48
4109740-10974054.32854.51
5104447-10444751.70751.88
6109333-10933354.12654.30
45min1133299-13329965.99164.971.4266.2765.241.42
2130028-13002864.37164.64
3129430-12943064.07564.34
4133789-13378966.23366.51
5130900-13090064.80365.07
6129952-12995264.33464.60
60min1151107-15110774.80773.671.1475.1974.041.14
2148615-14861573.57373.95
3147455-14745572.99973.37
4150591-15059174.55174.94
5148095-14809573.31573.69
6146955-14695572.75173.12
90min1171422-17142284.86483.700.9185.3784.200.92
2169650-16965083.98684.48
3168295-16829583.31683.80
4169636-16963683.97984.49
5168509-16850983.42283.92
6166899-16689982.62483.12
120min1182635-18263590.41589.541.2691.0790.181.26
2180092-18009289.15689.79
3178603-17860388.41989.05
4183734-18373490.95991.61
5182020-18202090.11090.74
6178145-17814588.19288.82
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1195002-19500296.53794.831.4597.3495.611.45
2191669-19166994.88795.67
3188709-18870993.42294.20
4194461-19446196.26997.07
5190922-19092294.51795.30
6188504-18850493.32094.10
240min1198381-19838198.21097.051.4299.1797.991.41
2198870-19887098.45299.40
3194598-19459896.33797.27
4198210-19821098.12599.09
5193477-19347795.78296.72
6192656-19265695.37696.31
极限1197944-19794497.99496.721.1099.1297.821.10
2192827-19282795.46096.57
3195105-19510596.58897.68
4198002-19800298.02299.15
5194165-19416596.12397.22
6194137-19413796.10997.20
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 16.451994551985432000841995441990081993270.30
2 16.522006711995452001080.40
单位质量响应值RSD%判断
12117.1412113.080.03数据可信
供试品溶液-2J95SDC1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%
5min125385-2538512.57211.679.3912.5711.679.39
223373-2337311.57511.58
322645-2264511.21511.21
421938-2193810.86510.86
526981-2698113.36213.36
621120-2112010.46010.46
10min146690-4669023.12324.6415.3623.1424.6615.35
265220-6522032.30032.32
348276-4827623.90923.93
446062-4606222.81222.83
547037-4703723.29523.32
645280-4528022.42522.44
15min166999-6699933.18133.631.3333.2433.691.33
267465-6746533.41233.49
369154-6915434.24834.31
467297-6729733.32933.38
568908-6890834.12734.19
667611-6761133.48433.54
20min185215-8521542.20342.101.3642.3242.211.37
285042-8504242.11742.25
385353-8535342.27142.39
483273-8327341.24141.35
586759-8675942.96743.09
684347-8434741.77341.88
30min1107130-10713053.05653.911.3053.2454.101.30
2108595-10859553.78253.98
3109721-10972154.33954.53
4107870-10787053.42353.60
5111132-11113255.03855.23
6108704-10870453.83654.02
45min1133623-13362366.17765.811.3566.4566.091.34
2131727-13172765.23865.53
3134126-13412666.42666.70
4130724-13072464.74165.01
5135433-13543367.07367.35
6131706-13170665.22765.50
60min1148167-14816773.38073.661.4173.7674.041.41
2148388-14838873.48973.89
3149997-14999774.28674.67
4145962-14596272.28872.66
5152063-15206375.30975.70
6147792-14779273.19473.57
90min1167778-16777883.09283.680.9183.6084.190.91
2167338-16733882.87483.39
3169028-16902883.71184.22
4168722-16872283.55984.06
5171701-17170185.03585.55
6169271-16927183.83184.33
120min1179626-17962688.96089.210.8789.6089.860.87
2178987-17898788.64389.30
3180861-18086189.57190.22
4179167-17916788.73289.37
5182971-18297190.61691.28
6179162-17916288.73089.37
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1188257-18825793.23494.070.9194.0394.870.91
2189451-18945193.82594.63
3191977-19197795.07695.88
4189391-18939193.79694.58
5192183-19218395.17995.99
6188432-18843293.32194.11
240min1193407-19340795.78595.970.7396.7396.920.73
2192543-19254395.35796.32
3193305-19330595.73496.69
4193994-19399496.07597.02
5196468-19646897.30198.27
6192973-19297395.57096.51
极限1194529-19452996.34096.580.8697.4597.690.86
2194151-19415196.15397.27
3195696-19569696.91898.04
4194312-19431296.23397.33
5198031-19803198.07599.21
6193318-19331895.74196.84
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