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%
116.451999431994892015022005601993542001700.45
216.522002022023162012590.75
单位质量响应值RSD%判断
12168.3912182.750.09数据可信
供试品溶液-3B85SDC1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%
5min17701-77013.7953.754.383.793.754.33
28044-80443.9643.96
37689-76893.7893.79
47624-76243.7573.76
57017-70173.4583.46
67617-76173.7543.75
10min133898-3389816.70516.663.0416.7116.663.03
235710-3571017.59817.60
333471-3347116.49416.50
433815-3381516.66416.67
532741-3274116.13416.14
633183-3318316.35216.36
15min153197-5319726.21525.862.0626.2525.902.06
253912-5391226.56726.60
352197-5219725.72225.76
452838-5283826.03826.07
550822-5082225.04525.08
651919-5191925.58525.62
20min173392-7339236.16733.194.5336.2433.274.51
267029-6702933.03133.11
365948-6594832.49932.58
466851-6685132.94433.02
564979-6497932.02132.10
665945-6594532.49732.57
30min188170-8817043.44943.422.1843.5943.552.18
291640-9164045.15945.29
387079-8707942.91243.04
488557-8855743.64043.77
586399-8639942.57742.70
686811-8681142.78042.91
45min1113694-11369456.02755.340.7456.2455.550.75
2112452-11245255.41555.63
3111877-11187755.13255.33
4112655-11265555.51555.72
5111867-11186755.12755.33
6111307-11130754.85155.05
60min1131124-13112464.61764.200.6264.9264.500.62
2130462-13046264.29064.59
3130430-13043064.27564.57
4130850-13085064.48264.78
5128853-12885363.49863.79
6129974-12997464.05064.34
90min1154295-15429576.03576.611.4276.4577.021.42
2159202-15920278.45378.86
3154118-15411875.94876.35
4157153-15715377.44377.85
5153950-15395075.86576.26
6154085-15408575.93276.33
120min1169224-16922483.39283.981.5283.9384.511.52
2175026-17502686.25186.79
3169553-16955383.55484.08
4171822-17182284.67285.21
5168245-16824582.91083.43
6168579-16857983.07483.60
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1175149-17514986.31287.161.8586.9987.831.84
2181881-18188189.62990.31
3175095-17509586.28586.95
4180110-18011088.75689.43
5174876-17487686.17786.84
6174111-17411185.80086.47
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%
116.452000342011722006691994672005522003790.33
216.522019482009002014240.37
单位质量响应值RSD%判断
12181.0912192.740.07数据可信
供试品溶液-3B85SDC1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%
5min18564-85644.2164.274.174.224.274.19
29306-93064.5824.58
38815-88154.3404.34
48256-82564.0654.06
58687-86874.2774.28
68457-84574.1644.16
10min134117-3411716.79717.777.1616.8017.787.17
238548-3854818.97818.99
335461-3546117.45917.47
433405-3340516.44616.45
539949-3994919.66819.68
635138-3513817.30017.31
15min152458-5245825.82726.472.8025.8626.502.81
255741-5574127.44327.48
353897-5389726.53526.57
451888-5188825.54625.58
555177-5517727.16527.21
653373-5337326.27726.31
20min166888-6688832.93134.827.1033.0134.907.09
275159-7515937.00337.09
368695-6869533.82133.90
466148-6614832.56732.64
568803-6880333.87433.96
678651-7865138.72238.80
30min188464-8846443.55443.801.5043.6943.941.51
290771-9077144.68944.84
388153-8815343.40043.54
487692-8769243.17443.30
590540-9054044.57644.72
688222-8822243.43443.58
45min1113704-11370455.98056.331.3356.1956.541.34
2115510-11551056.86957.09
3113117-11311755.69155.90
4112493-11249355.38455.59
5116314-11631457.26557.48
6115352-11535256.79157.01
60min1132964-13296465.46265.291.5465.7665.601.55
2134728-13472866.33166.65
3130003-13000364.00564.31
4130298-13029864.15064.45
5134552-13455266.24466.56
6133193-13319365.57565.89
90min1156315-15631576.95978.192.7677.3778.602.76
2163268-16326880.38280.81
3155215-15521576.41776.83
4153823-15382375.73276.13
5159879-15987978.71379.14
6164365-16436580.92281.34
120min1172085-17208584.72386.204.3385.2686.754.30
2174157-17415785.74386.30
3168054-16805482.73883.27
4189806-18980693.44793.98
5174718-17471886.01986.57
6171747-17174784.55685.11
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1178221-17822187.74487.431.7488.4288.121.74
2179740-17974088.49289.20
3172791-17279185.07085.74
4175424-17542486.36787.05
5181425-18142589.32190.02
6177889-17788987.58088.28
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%
116.452008031990212015552002581995922002460.50
216.522008511997452002980.40
单位质量响应值RSD%判断
12173.0112124.580.29数据可信
供试品溶液-2J95SDC1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%
5min16939-69393.4273.617.103.433.617.15
28233-82334.0664.07
36832-68323.3743.37
47552-75523.7303.73
57294-72943.6023.60
67047-70473.4803.48
10min131702-3170215.65716.073.0215.6616.083.02
233870-3387016.72816.73
331492-3149215.55315.56
433556-3355616.57316.58
532071-3207115.83915.85
632545-3254516.07316.08
15min149441-4944124.41824.952.3424.4524.982.35
251498-5149825.43425.47
349996-4999624.69224.72
451886-5188625.62525.66
549037-4903724.21824.25
651235-5123525.30425.34
20min163692-6369231.45631.582.9131.5331.662.90
264072-6407231.64431.72
361983-6198330.61230.68
465128-6512832.16532.24
562025-6202530.63330.71
666813-6681332.99733.07
30min183086-8308641.03442.627.0541.1642.757.03
284525-8452541.74541.87
398430-9843048.61248.74
485566-8556642.25942.39
581913-8191340.45540.58
684247-8424741.60841.74
45min1108305-10830553.48953.061.5953.6853.261.59
2108625-10862553.64853.85
3106218-10621852.45952.66
4109445-10944554.05254.25
5104849-10484951.78351.97
6107219-10721952.95353.15
60min1125013-12501361.74161.701.5062.0261.991.49
2125689-12568962.07562.36
3123063-12306360.77861.07
4127082-12708262.76363.05
5122359-12235960.43060.71
6126389-12638962.42162.71
90min1148699-14869973.43972.911.4973.8273.301.48
2147591-14759172.89273.28
3146095-14609572.15372.55
4150229-15022974.19574.59
5144190-14419071.21271.59
6148967-14896773.57273.96
120min1174155-17415586.01180.713.4786.5281.223.45
2161146-16114679.58680.10
3160388-16038879.21279.73
4164107-16410781.04981.57
5158002-15800278.03478.53
6162694-16269480.35180.87
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1170330-17033084.12285.414.9584.7786.054.90
2168333-16833383.13683.78
3167264-16726482.60883.25
4171353-17135384.62885.28
5190107-19010793.89094.52
6170211-17021184.06484.71
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%
116.452000152017172010021996882007932006430.41
216.522014162009842012000.16
单位质量响应值RSD%判断
12197.1412179.180.11数据可信
供试品溶液-2J95SDC1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%
5min15274-52742.5962.797.012.602.806.99
26353-63533.1273.13
35913-59132.9112.91
45639-56392.7762.78
55475-54752.6952.70
65406-54062.6612.66
10min130106-3010614.82114.572.5614.8214.582.56
230540-3054015.03415.04
330170-3017014.85214.86
428864-2886414.20914.21
528795-2879514.17514.18
629159-2915914.35414.36
15min149677-4967724.45524.112.6724.4824.132.67
250305-5030524.76424.79
349631-4963124.43224.46
449557-4955724.39624.42
547525-4752523.39623.42
647128-4712823.20023.23
20min163915-6391531.46431.871.6331.5331.941.63
266189-6618932.58432.66
363876-6387631.44531.52
465184-6518432.08932.16
563670-6367031.34431.41
665551-6555132.27032.34
30min186599-8659942.63142.631.6942.7542.751.69
287789-8778943.21743.34
386321-8632142.49442.62
488595-8859543.61443.74
585703-8570342.19042.31
684520-8452041.60841.73
45min1110568-11056854.43155.102.6454.6255.302.64
2112979-11297955.61755.82
3109815-10981554.06054.25
4117480-11748057.83358.03
5110953-11095354.62054.81
6109831-10983154.06854.26
60min1128533-12853363.27464.221.5463.5664.511.54
2131375-13137564.67364.96
3129838-12983863.91764.20
4134076-13407666.00366.29
5129207-12920763.60663.89
6129751-12975163.87464.15
90min1151454-15145474.55875.551.1974.9575.951.19
2154867-15486776.23876.64
3152903-15290375.27175.66
4156430-15643077.00877.41
5152525-15252575.08575.47
6152684-15268475.16375.55
120min1166005-16600581.72183.612.0582.2384.132.04
2170484-17048483.92684.45
3167323-16732382.37082.89
4173953-17395385.63486.16
5173854-17385485.58586.10
6167430-16743082.42382.93
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1172542-17254284.93985.901.3485.5986.561.34
2176549-17654986.91287.58
3172933-17293385.13285.78
4178098-17809887.67488.35
5172546-17254684.94185.60
6174341-17434185.82586.47
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