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%
110.354220011421087442073774205045419948242085580.19
210.474280461429221842863400.20
单位质量响应值RSD%判断
406623.96409392.550.48数据可信
供试品溶液-2025081521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%
5min1154924-1549243.7974.076.123.804.076.04
2171671-1716714.2084.21
3170631-1706314.1824.18
4157332-1573323.8563.86
5180931-1809314.4354.43
6159738-1597383.9153.92
10min1321539-3215397.8818.243.917.908.263.90
2357828-3578288.7708.79
3339373-3393738.3188.34
4333285-3332858.1698.19
5340566-3405668.3478.37
6324299-3242997.9487.97
15min1475540-47554011.65511.792.2911.7111.852.30
2493137-49313712.08712.15
3482777-48277711.83311.90
4480012-48001211.76511.83
5491028-49102812.03512.10
6463096-46309611.35011.41
20min1578021-57802114.16714.693.3214.2814.813.32
2606051-60605114.85414.98
3604049-60404914.80514.93
4630210-63021015.44615.57
5600754-60075414.72414.85
6577172-57717214.14614.26
30min1782486-78248619.17819.621.5719.3719.821.58
2812755-81275519.92020.12
3803881-80388119.70319.90
4804137-80413719.70919.91
5812302-81230219.90920.11
6788346-78834619.32219.51
45min11020738-102073825.01825.682.2425.3025.972.24
21080561-108056126.48426.78
31040792-104079225.50925.80
41045860-104586025.63425.93
51070559-107055926.23926.54
61028423-102842325.20625.49
60min11226924-122692430.07130.682.1030.4831.102.09
21269678-126967831.11931.55
31265607-126560731.02031.44
41278268-127826831.33031.75
51256908-125690830.80631.23
61212229-121222929.71130.12
120min11870221-187022145.83846.721.3646.4047.291.36
21938847-193884747.52048.11
31899524-189952446.55747.13
41919317-191931747.04247.62
51923319-192331947.14047.72
61885038-188503846.20246.76
180min12372430-237243058.14759.131.5058.9459.941.51
22461125-246112560.32161.15
32385075-238507558.45759.27
42430152-243015259.56260.38
52440957-244095759.82760.65
62386143-238614358.48359.27
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12782356-278235668.19468.880.9569.2769.980.95
22814213-281421368.97570.10
32835791-283579169.50470.61
42839226-283922669.58870.70
52814182-281418268.97470.09
62775604-277560468.02969.11
360min13257202-325720279.83381.371.3081.2582.821.30
23341718-334171881.90483.38
33321176-332117681.40182.85
43326815-332681581.53983.00
53381900-338190082.88984.35
63290032-329003280.63782.06
480min13611749-361174988.52290.401.6790.3492.251.66
23706998-370699890.85792.74
33655540-365554089.59691.45
43704305-370430590.79192.66
53790683-379068392.90894.78
63660971-366097189.72991.55
600min13806720-380672093.30195.491.4195.5697.801.40
23894848-389484895.46197.80
33873113-387311394.92897.23
43906100-390610095.73798.06
53970851-397085197.32499.67
63924003-392400396.17698.45
720min14009882-400988298.28199.101.09101.01101.881.09
24076368-407636899.910102.72
33979000-397900097.524100.30
44068530-406853099.718102.52
54093176-4093176100.322103.15
64033536-403353698.860101.61
极限13997294-399729497.97298.230.88101.19101.510.88
24003938-400393898.135101.45
34019422-401942298.514101.78
44000923-400092398.061101.36
54066864-406686499.677103.01
63959245-395924597.039100.29
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%
110.354305190430505042983584299996429756243012310.09
210.474265598426593842657680.01
单位质量响应值RSD%判断
415577.87407427.701.41数据可信
供试品溶液-2025081521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%
5min1155272-1552723.7744.026.213.774.026.24
2170034-1700344.1324.13
3170182-1701824.1364.14
4156855-1568553.8123.81
5181438-1814384.4104.41
6158396-1583963.8503.85
10min1321908-3219087.8248.183.907.848.203.91
2357378-3573788.6868.71
3339570-3395708.2538.27
4333453-3334538.1048.12
5342812-3428128.3328.35
6324243-3242437.8807.90
15min1474854-47485411.54111.712.1411.6011.782.14
2492287-49228711.96412.03
3486200-48620011.81611.88
4479665-47966511.65811.72
5492436-49243611.96812.03
6466460-46646011.33711.40
20min1578467-57846714.05914.583.1714.1714.703.15
2608553-60855314.79014.91
3602186-60218614.63514.76
4629683-62968315.30415.42
5600100-60010014.58514.71
6580585-58058514.11014.23
30min1781419-78141918.99119.491.7919.1819.681.79
2814148-81414819.78719.98
3812994-81299419.75919.95
4813126-81312619.76219.96
5802667-80266719.50819.70
6787571-78757119.14119.33
45min11015115-101511524.67125.482.5224.9525.772.52
21071442-107144226.04026.34
31035886-103588625.17625.47
41059082-105908225.73926.03
51081367-108136726.28126.58
61026521-102652124.94825.23
60min11232763-123276329.96130.372.1330.3630.782.13
21278913-127891331.08231.51
31262682-126268230.68831.11
41263074-126307430.69731.12
51254799-125479930.49630.92
61204919-120491929.28429.69
120min11882407-188240745.74946.260.8746.3046.830.88
21922987-192298746.73547.32
31899783-189978346.17146.74
41906675-190667546.33946.91
51920503-192050346.67547.25
61889143-188914345.91346.47
180min12364914-236491457.47658.582.1258.2659.382.11
22419601-241960158.80559.62
32398959-239895958.30359.11
42417460-241746058.75359.56
52500928-250092860.78161.59
62361074-236107457.38258.16
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12755683-275568366.97367.891.0368.0468.981.03
22789140-278914067.78668.90
32793591-279359167.89468.99
42837783-283778368.96870.07
52810311-281031168.30169.42
62773798-277379867.41368.48
360min13284940-328494079.83681.111.7581.2482.541.75
23398643-339864382.59984.05
33324446-332444680.79682.23
43357548-335754881.60083.05
53399212-339921282.61384.07
63259544-325954479.21980.62
480min13613389-361338987.81889.621.5689.6291.461.56
23708694-370869490.13492.00
33650445-365044588.71990.56
43705364-370536490.05491.91
53779699-377969991.86093.73
63668463-366846389.15790.96
600min13800748-380074892.37294.741.6094.6297.031.59
23888318-388831894.50096.81
33876347-387634794.20996.49
43939322-393932295.74098.04
53985400-398540096.85999.19
63899653-389965394.77597.02
720min14053529-405352998.51598.051.03101.22100.811.01
24022665-402266597.765100.55
33970245-397024596.49199.24
44018051-401805197.653100.44
54092565-409256599.464102.28
64049721-404972198.423101.14
极限13993426-399342697.05497.890.59100.25101.140.59
24033347-403334798.025101.30
34019491-401949197.688100.92
44013528-401352897.543100.81
54053308-405330898.510101.82
64053300-405330098.510101.72
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