磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.683402493403283405323408393403213404540.08
2 12.723397853392233395040.12
单位质量响应值RSD%判断
26849.6826690.570.43数据可信
供试品溶液-2025060411批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1347503-34750390.88190.173.8590.8890.173.85
2360481-36048194.27594.27
3347323-34732390.83390.83
4320823-32082383.90383.90
5350723-35072391.72391.72
6341941-34194189.42689.43
10min1364732-36473295.38694.951.5595.5495.101.56
2372743-37274397.48197.64
3359819-35981994.10194.25
4359961-35996194.13994.28
5364324-36432495.28095.43
6356746-35674693.29893.45
15min1367697-36769796.16296.341.5196.4796.641.52
2378196-37819698.90799.23
3365473-36547395.58095.89
4368810-36881096.45396.75
5368613-36861396.40196.71
6361374-36137494.50894.81
20min1373731-37373197.74097.281.4398.2197.751.43
2380606-38060699.538100.02
3368711-36871196.42796.89
4372704-37270497.47197.93
5371187-37118797.07497.55
6364879-36487995.42595.89
30min1377287-37728798.67098.251.2499.3098.881.24
2382944-382944100.149100.80
3371845-37184597.24797.87
4377260-37726098.66399.28
5374846-37484698.03198.67
6369822-36982296.71797.34
45min1380366-38036699.47599.331.45100.27100.131.45
2389572-389572101.883102.70
3376539-37653998.47499.26
4381246-38124699.705100.49
5377462-37746298.71699.51
6373792-37379297.75698.54
极限1383113-383113100.193100.311.14101.16101.271.15
2391458-391458102.376103.36
3382288-38228899.978100.93
4384809-384809100.637101.59
5380884-38088499.610100.57
6378809-37880999.068100.01
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.683397403393433391973392103392743393530.07
2 12.723391243388433389840.06
单位质量响应值RSD%判断
26762.8526649.690.30数据可信
供试品溶液-2025060411批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1341919-34191989.63488.244.3489.6388.244.34
2330205-33020586.56386.56
3310179-31017981.31381.31
4340402-34040289.23689.24
5348269-34826991.29891.30
6348720-34872091.41691.42
10min1360575-36057594.52494.340.8594.6794.490.86
2362017-36201794.90295.05
3353869-35386992.76692.90
4361886-36188694.86895.02
5359947-35994794.36094.51
6360998-36099894.63594.79
15min1365654-36565495.85696.670.9496.1696.970.94
2370398-37039897.09997.40
3366230-36623096.00796.30
4369041-36904196.74497.05
5374750-37475098.24098.55
6366454-36645496.06596.38
20min1369553-36955396.87897.350.5597.3497.810.54
2373943-37394398.02998.49
3372487-37248797.64798.10
4372979-37297997.77698.24
5369567-36956796.88197.35
6369513-36951396.86797.34
30min1375114-37511498.33698.630.5498.9699.260.53
2378718-37871899.28099.91
3377134-37713498.86599.48
4377923-37792399.07299.70
5373483-37348397.90898.54
6375112-37511298.33598.97
45min1379365-37936599.45099.670.40100.24100.460.40
2382447-382447100.258101.05
3379626-37962699.518100.30
4381509-381509100.012100.81
5378368-37836899.18999.99
6379808-37980899.566100.36
极限1382657-382657100.313100.380.30101.27101.340.30
2384921-384921100.906101.87
3383164-383164100.446101.39
4382093-382093100.165101.13
5381635-381635100.045101.01
6382917-382917100.381101.34
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.683392303385793391623386263385873388370.10
2 12.723392643391043391840.04
单位质量响应值RSD%判断
26722.1626665.410.16数据可信
供试品溶液-2025060412批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1340171-34017189.21788.700.4789.2288.700.47
2336221-33622188.18188.18
3339250-33925088.97588.98
4339169-33916988.95488.95
5337511-33751188.51988.52
6336804-33680488.33488.33
10min1354802-35480293.05492.781.2493.2092.921.24
2350058-35005891.81091.96
3351918-35191892.29892.45
4361912-36191294.91995.07
5353321-35332192.66692.81
6350447-35044791.91292.06
15min1359509-35950994.28993.990.9494.5994.290.93
2355912-35591293.34593.65
3357204-35720493.68493.99
4364296-36429695.54495.85
5358327-35832793.97994.28
6354932-35493293.08893.39
20min1362426-36242695.05494.850.8495.5195.300.84
2359736-35973694.34894.80
3360436-36043694.53294.99
4367000-36700096.25396.72
5361893-36189394.91495.37
6358327-35832793.97994.43
30min1368420-36842096.62696.210.7897.2496.830.78
2364800-36480095.67696.29
3365017-36501795.73396.35
4371484-37148497.42998.06
5367446-36744696.37096.99
6363909-36390995.44396.05
45min1371934-37193497.54797.520.6798.3398.290.67
2369701-36970196.96297.73
3369754-36975496.97597.75
4376062-37606298.63099.42
5373016-37301697.83198.61
6370419-37041997.15097.92
极限1377009-37700998.87898.670.7499.8299.610.74
2373812-37381298.04098.97
3374081-37408198.11099.05
4381076-38107699.945100.90
5376971-37697198.86899.81
6374357-37435798.18399.12
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.683390603392013392173394413390003391840.06
2 12.723399413395483397440.09
单位质量响应值RSD%判断
26749.5326709.430.11数据可信
供试品溶液-2025060412批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1337862-33786288.49388.632.3288.4988.642.32
2340206-34020689.10789.11
3343735-34373590.03190.03
4336729-33672988.19688.20
5347329-34732990.97290.97
6324549-32454985.00685.01
10min1351387-35138792.03592.901.5592.1893.051.56
2354837-35483792.93993.09
3361638-36163894.72094.87
4350515-35051591.80791.95
5360964-36096494.54494.70
6348812-34881291.36191.50
15min1357178-35717893.55294.571.4493.8594.881.44
2359128-35912894.06394.37
3368590-36859096.54196.85
4358264-35826493.83694.14
5366619-36661996.02596.33
6356659-35665993.41693.71
20min1361833-36183394.77195.481.4195.2395.941.41
2362919-36291995.05695.52
3371093-37109397.19797.67
4362703-36270394.99995.46
5370438-37043897.02597.49
6358158-35815893.80994.26
30min1365540-36554095.74296.921.5296.3697.541.52
2367697-36769796.30796.93
3376213-37621398.53899.17
4365993-36599395.86196.48
5378149-37814999.04599.68
6366648-36664896.03296.64
45min1369964-36996496.90198.051.4397.6898.831.43
2371313-37131397.25498.03
3380325-38032599.615100.41
4371779-37177997.37698.15
5381990-381990100.051100.85
6370636-37063697.07797.84
极限1377741-37774198.93899.521.1999.87100.461.19
2376902-37690298.71899.66
3385627-385627101.003101.96
4377494-37749498.87399.81
5385788-385788101.046102.01
6376131-37613198.51699.44
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