达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.494222363423226241764314215079421171442115700.51
29.594254412424867042515410.10
单位质量响应值RSD%判断
443790.31443330.660.08数据可信
供试品溶液-2025081521批-二甲双胍-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%
5min1173251-1732513.9064.4614.183.914.4614.14
2248877-2488775.6115.61
3194432-1944324.3834.38
4208387-2083874.6984.70
5185212-1852124.1764.18
6176810-1768103.9863.99
10min1369545-3695458.3318.552.788.358.572.84
2397747-3977478.9679.00
3378823-3788238.5418.56
4384311-3843118.6648.69
5372594-3725948.4008.42
6372292-3722928.3938.41
15min1533964-53396412.03812.211.2212.1012.271.25
2549380-54938012.38612.46
3536681-53668112.09912.16
4540102-54010212.17712.24
5539346-53934612.15912.22
6549724-54972412.39312.46
20min1659893-65989314.87715.582.9815.0015.712.97
2706721-70672115.93316.07
3684475-68447515.43115.56
4679465-67946515.31815.45
5699509-69950915.77015.89
6716581-71658116.15516.28
30min1908585-90858520.48420.571.1220.6820.771.12
2912074-91207420.56320.78
3901299-90129920.32020.52
4907148-90714820.45220.66
5913086-91308620.58520.79
6931059-93105920.99121.20
45min11153992-115399226.01727.062.1426.3127.362.14
21221499-122149927.53927.86
31214223-121422327.37427.68
41186531-118653126.75027.06
51215308-121530827.39927.70
61209392-120939227.26627.58
60min11474946-147494633.25232.990.7133.6833.430.69
21457648-145764832.86233.32
31446069-144606932.60133.04
41466468-146646833.06133.50
51462688-146268832.97633.42
61471114-147111433.16633.61
120min12232488-223248850.33150.140.2550.9350.750.25
22226402-222640250.19450.81
32216481-221648149.97050.57
42220171-222017150.05350.66
52225779-222577950.18050.79
62222980-222298050.11750.73
180min12875666-287566664.83162.901.5665.6863.761.53
22763544-276354462.30463.17
32766941-276694162.38063.23
42792801-279280162.96363.82
52767304-276730462.38863.25
62773435-277343562.52763.39
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min13117535-311753570.28470.710.9771.4571.880.96
23134749-313474970.67271.85
33153527-315352771.09672.26
43094946-309494669.77570.95
53135036-313503670.67971.85
63183683-318368371.77672.95
360min13801227-380122785.69884.950.5187.2286.480.50
23746159-374615984.45785.99
33773592-377359285.07586.60
43764965-376496584.88186.40
53768964-376896484.97186.49
63754392-375439284.64286.18
480min14143447-414344793.41392.740.4995.3694.700.48
24088696-408869692.17994.14
34093322-409332292.28394.23
44120997-412099792.90794.85
54119495-411949592.87394.82
64116836-411683692.81394.77
600min14309796-430979697.16498.260.8099.58100.670.78
24341315-434131597.874100.29
34366218-436621898.436100.84
44414521-441452199.525101.93
54367875-436787598.473100.89
64350982-435098298.092100.51
720min14410572-441057299.436100.071.46102.34102.981.41
24380997-438099798.769101.68
34498439-4498439101.417104.32
44355780-435578098.200101.11
54480803-4480803101.019103.92
64505292-4505292101.571104.48
极限14422763-442276399.711100.670.98103.11104.080.95
24478694-4478694100.971104.37
34418435-441843599.613103.02
44463492-4463492100.629104.03
54470881-4470881100.795104.21
64537860-4537860102.305105.72
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数12500
标示量(mg)5供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.943229532259318363215331852320790.69
2 11.913246832166323170.67
单位质量响应值RSD%判断
2686.682713.430.71数据可信
供试品溶液-2025081521批-达格列净-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%
5min134639-3463982.51894.117.4482.5294.117.44
240048-4004895.40495.40
340906-4090697.44797.45
437410-3741089.11989.12
541669-4166999.26599.27
642357-42357100.904100.90
10min140633-4063396.79797.971.6897.2198.441.69
240298-4029895.99996.48
342113-42113100.323100.81
440707-4070796.97397.42
541493-4149398.84699.34
641517-4151798.90399.41
15min140894-4089497.419100.432.2598.32101.392.26
241867-4186799.737100.69
342314-42314100.802101.79
441513-4151398.89399.82
542826-42826102.021103.01
643538-43538103.717104.72
20min140639-4063996.811100.172.3398.20101.642.35
241666-4166699.258100.71
342680-42680101.674103.17
441363-4136398.53699.96
542804-42804101.969103.47
643144-43144102.779104.30
30min141119-4111997.95599.831.8299.82101.791.84
241665-4166599.256101.21
342017-42017100.094102.10
441125-4112597.96999.89
542461-42461101.152103.16
643045-43045102.543104.57
45min139520-3952094.14699.873.5096.50102.333.48
242151-42151100.413102.86
342330-42330100.840103.34
441012-4101297.700100.11
542886-42886102.164104.68
643643-43643103.968106.51
60min141649-4164999.217100.591.61102.05103.561.64
241973-4197399.989102.94
342073-42073100.228103.23
441608-4160899.120102.02
542694-42694101.707104.73
643360-43360103.293106.36
120min141993-41993100.037101.421.17103.36104.891.22
242775-42775101.900105.35
342369-42369100.933104.44
442136-42136100.378103.77
542876-42876102.140105.68
643302-43302103.155106.74
180min142699-42699101.719101.260.83105.54105.230.84
242408-42408101.026104.99
342171-42171100.461104.47
442119-42119100.337104.23
542579-42579101.433105.48
643060-43060102.579106.68
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min140332-4033296.08099.202.22100.41103.682.22
241903-4190399.823104.29
342007-42007100.070104.58
440736-4073697.042101.44
542078-42078100.239104.79
642792-42792101.940106.55
360min141198-4119898.14399.551.49102.96104.521.52
241507-4150798.879103.84
342010-42010100.077105.09
441130-4113097.981102.86
542161-42161100.437105.49
642722-42722101.774106.89
480min140239-4023995.85998.411.70101.16103.881.72
241086-4108697.876103.33
341585-4158599.065104.58
440920-4092097.481102.85
541901-4190199.818105.37
642129-42129100.361105.99
600min139677-3967794.52098.572.26100.30104.532.25
241148-4114898.024103.97
341731-4173199.413105.42
441340-4134098.481104.34
542183-42183100.490106.55
642179-42179100.480106.61
720min139435-3943593.94397.172.84100.20103.632.79
240228-4022895.832102.27
341659-4165999.241105.75
439682-3968294.532100.88
541550-4155098.982105.54
642195-42195100.518107.15
极限139361-3936193.76797.792.83100.49104.732.78
241056-4105697.805104.72
340830-4083097.266104.27
440473-4047396.416103.24
541843-4184399.680106.73
642738-42738101.812108.95
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