利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.174936104944054942654941374937184940270.08
215.124925854917474921660.13
单位质量响应值RSD%判断
32566.0532550.660.04数据可信
供试品溶液-2024123021批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108211-10821119.86221.596.5019.8621.596.50
2122635-12263522.50922.51
3108990-10899020.00520.00
4117064-11706421.48721.49
5126631-12663123.24323.24
6122294-12229422.44722.45
10min1173132-17313231.77832.451.8831.8132.481.89
2178674-17867432.79532.83
3173060-17306031.76531.80
4175908-17590832.28732.32
5181333-18133333.28333.32
6178498-17849832.76332.80
15min1207957-20795738.17038.450.8338.2638.540.83
2210663-21066338.66738.76
3207842-20784238.14938.24
4208040-20804038.18538.27
5211789-21178938.87338.97
6210534-21053438.64338.73
20min1233184-23318442.80042.590.4942.9542.750.49
2232918-23291842.75142.91
3230339-23033942.27842.43
4231096-23109642.41742.57
5232745-23274542.72042.88
6232068-23206842.59542.75
30min1259123-25912347.56147.480.4647.7847.710.46
2260699-26069947.85148.08
3258404-25840447.42947.65
4258831-25883147.50847.73
5257740-25774047.30747.54
6257355-25735547.23747.46
45min1283677-28367752.06852.000.5852.3752.300.57
2285205-28520552.34952.66
3284459-28445952.21252.51
4283395-28339552.01652.32
5280586-28058651.50151.81
6282453-28245351.84452.15
60min1296039-29603954.33754.410.6154.7254.800.60
2298048-29804854.70655.10
3297879-29787954.67555.06
4297270-29727054.56354.95
5293226-29322653.82154.22
6296105-29610554.34954.74
极限1306302-30630256.22156.360.4356.7056.840.43
2308753-30875356.67157.16
3308010-30801056.53457.01
4306984-30698456.34656.83
5305011-30501155.98456.47
6307196-30719656.38556.87
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.174926994931474936794929384927184930360.09
215.124926494914614920550.18
单位质量响应值RSD%判断
32500.7332543.320.10数据可信
供试品溶液-2024123021批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1117936-11793621.67121.263.6521.6721.263.66
2111657-11165720.51720.52
3116939-11693921.48821.49
4115043-11504321.13921.14
5122000-12200022.41822.42
6110597-11059720.32220.32
10min1177881-17788132.68632.131.4432.7232.171.44
2171995-17199531.60531.64
3174720-17472032.10532.14
4173955-17395531.96532.00
5177869-17786932.68432.72
6172802-17280231.75331.79
15min1210317-21031738.64638.110.7838.7438.200.78
2206040-20604037.86037.95
3206816-20681638.00338.09
4206432-20643237.93238.02
5208130-20813038.24438.34
6206554-20655437.95538.04
20min1231951-23195142.62242.120.7042.7842.270.70
2228345-22834541.95942.11
3228143-22814341.92242.07
4227563-22756341.81541.97
5229787-22978742.22442.38
6229554-22955442.18142.33
30min1259112-25911247.61247.090.6847.8447.320.67
2256193-25619347.07647.30
3254606-25460646.78447.01
4254609-25460946.78547.01
5255941-25594147.03047.26
6257305-25730547.28047.50
45min1282334-28233451.88051.550.6252.1851.850.62
2280957-28095751.62751.92
3278767-27876751.22451.52
4278445-27844551.16551.46
5280274-28027451.50151.81
6282520-28252051.91452.21
60min1294299-29429954.07854.010.5754.4754.400.57
2294790-29479054.16854.55
3292679-29267953.78054.17
4291228-29122853.51453.90
5294994-29499454.20654.60
6295663-29566354.32954.71
极限1305382-30538256.11556.090.2356.6056.570.23
2305690-30569056.17156.65
3304770-30477056.00256.48
4304223-30422355.90256.38
5305319-30531956.10356.58
6306185-30618556.26256.74
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.174927974927474926494930494920454926570.08
215.124935524937794936660.04
单位质量响应值RSD%判断
32475.7432649.870.38数据可信
供试品溶液-2024123021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%
5min1183557-18355733.68734.044.3833.6934.044.37
2186202-18620234.17234.17
3184725-18472533.90133.90
4194686-19468635.72935.73
5192154-19215435.26535.26
6171531-17153131.48031.48
10min1245985-24598545.14444.771.1945.2044.831.19
2244378-24437844.84944.91
3242442-24244244.49444.55
4247716-24771645.46245.52
5243805-24380544.74444.80
6239388-23938843.93343.99
15min1270964-27096449.72849.210.9849.8649.340.98
2269077-26907749.38249.51
3268178-26817849.21749.35
4270319-27031949.61049.75
5266194-26619448.85348.99
6264014-26401448.45348.58
20min1283382-28338252.00751.670.9352.2251.890.93
2282148-28214851.78151.99
3284010-28401052.12352.34
4283132-28313251.96152.18
5279004-27900451.20451.42
6277690-27769050.96351.17
30min1299041-29904154.88154.400.7255.1854.700.72
2297423-29742354.58454.88
3297107-29710754.52654.83
4297323-29732354.56654.87
5294026-29402653.96154.26
6293623-29362353.88754.18
45min1309694-30969456.83656.370.6757.2356.760.67
2307219-30721956.38256.77
3307550-30755056.44356.83
4308872-30887256.68557.08
5304701-30470155.92056.31
6304886-30488655.95456.33
60min1315773-31577357.95257.500.6558.4457.980.65
2314143-31414357.65358.14
3313733-31373357.57758.06
4314302-31430257.68258.17
5311750-31175057.21357.70
6310181-31018156.92657.40
极限1320575-32057558.83358.470.5059.4259.060.50
2319017-31901758.54759.13
3319900-31990058.70959.29
4318499-31849958.45259.04
5317362-31736258.24358.82
6316342-31634258.05658.63
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.174922714931514926654927364921054925860.09
215.124928744929304929020.01
单位质量响应值RSD%判断
32471.0632599.340.28数据可信
供试品溶液-2024123021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%
5min1183058-18305833.62433.543.2933.6233.543.29
2189768-18976834.85634.86
3183159-18315933.64233.64
4186484-18648434.25334.25
5180864-18086433.22133.22
6172128-17212831.61631.62
10min1242869-24286944.61044.291.2644.6744.341.26
2243764-24376444.77444.83
3242875-24287544.61144.67
4241532-24153244.36444.42
5240048-24004844.09244.15
6235537-23553743.26343.32
15min1266515-26651548.95348.780.4949.0848.900.49
2266669-26666948.98149.11
3266510-26651048.95249.08
4265243-26524348.71948.85
5264998-26499848.67448.80
6263363-26336348.37448.50
20min1279475-27947551.33451.300.2651.5551.510.26
2280191-28019151.46551.68
3280062-28006251.44151.65
4278622-27862251.17751.39
5278771-27877151.20451.41
6278687-27868751.18951.39
30min1295575-29557554.29154.140.2454.5954.440.24
2295015-29501554.18854.49
3295227-29522754.22754.52
4293552-29355253.91954.22
5294578-29457854.10854.40
6294704-29470454.13154.42
45min1305996-30599656.20556.230.2256.5956.620.21
2306890-30689056.36956.76
3306705-30670556.33556.72
4305144-30514456.04856.44
5306405-30640556.28056.67
6305794-30579456.16856.55
60min1311753-31175357.26257.310.3157.7457.790.31
2312139-31213957.33357.82
3312794-31279457.45457.94
4310427-31042757.01957.50
5311833-31183357.27757.76
6313119-31311957.51357.99
极限1316313-31631358.10058.120.1958.6858.700.19
2316614-31661458.15558.74
3316636-31663658.15958.74
4315913-31591358.02658.60
5315780-31578058.00258.58
6317391-31739158.29858.87
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