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%
110.354246633426005642654884253654426760442586870.21
210.474267387425490142611440.21
单位质量响应值RSD%判断
411467.34406986.060.78数据可信
供试品溶液-2025081721批-二甲双胍-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1156743-1567433.8304.059.313.834.059.33
2151497-1514973.7023.70
3181294-1812944.4304.43
4186125-1861254.5484.55
5150153-1501533.6693.67
6167756-1677564.0994.10
10min1345841-3458418.4518.806.838.478.826.83
2354179-3541798.6558.67
3403562-4035629.8629.88
4351442-3514428.5888.61
5333775-3337758.1568.17
6371027-3710279.0679.09
15min1504731-50473112.33412.543.1112.4012.603.09
2512067-51206712.51312.58
3515518-51551812.59812.67
4513172-51317212.54012.61
5492120-49212012.02612.09
6540456-54045613.20713.27
20min1642283-64228315.69615.741.6715.8215.871.70
2644747-64474715.75615.88
3642520-64252015.70115.84
4653022-65302215.95816.09
5625468-62546815.28515.40
6656150-65615016.03416.17
30min1867982-86798221.21121.192.5621.4121.402.54
2886824-88682421.67121.87
3880265-88026521.51121.72
4878740-87874021.47421.68
5825369-82536920.17020.37
6864262-86426221.12021.33
45min11157608-115760828.28928.222.7828.6028.532.77
21189476-118947629.06729.38
31189312-118931229.06329.38
41143926-114392627.95428.27
51104764-110476426.99727.29
61144016-114401627.95628.27
60min11379037-137903733.70033.782.2834.1534.232.29
21387561-138756133.90834.36
31437571-143757135.13035.60
41370875-137087533.50033.96
51340977-134097732.77033.20
61376689-137668933.64234.10
120min12053160-205316050.17350.762.5350.7951.382.52
22101245-210124551.34851.97
32167441-216744152.96653.61
42024822-202482249.48150.10
52035967-203596749.75350.35
62080565-208056550.84351.47
180min12592879-259287963.36262.681.5264.2363.561.53
22593440-259344063.37664.26
32603446-260344663.62164.53
42514007-251400761.43562.31
52521197-252119761.61162.45
62565388-256538862.69163.57
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12951283-295128372.12171.611.6973.3172.801.69
22972657-297265772.64373.84
32996193-299619373.21874.44
42892613-289261370.68771.86
52889798-288979870.61871.77
62879087-287908770.35671.55
360min13472310-347231084.85383.761.5086.4085.301.49
23451919-345191984.35585.92
33482253-348225385.09686.69
43361214-336121482.13883.67
53424777-342477783.69285.20
63371920-337192082.40083.94
480min13688066-368806690.12690.420.9092.1092.390.90
23756264-375626491.79293.78
33697255-369725590.35092.37
43658706-365870689.40891.35
53684521-368452190.03991.96
63715809-371580990.80392.76
600min13865114-386511494.45293.481.9196.8795.901.89
23834169-383416993.69696.14
33868763-386876394.54197.01
43695952-369595290.31892.71
53790800-379080092.63695.01
63897516-389751695.24497.65
720min13772561-377256192.19093.092.3195.0895.972.27
23855025-385502594.20597.12
33846762-384676294.00496.94
43739389-373938991.38094.22
53701263-370126390.44893.29
63940238-394023896.28899.18
极限13839019-383901993.81495.632.5697.1798.982.50
23874654-387465494.68598.07
33963375-396337596.853100.26
43834195-383419593.69696.99
53874888-387488894.69197.98
64094437-4094437100.056103.42
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%
112.002971429646297372963329734296930.17
212.022986129743298020.28
单位质量响应值RSD%判断
2474.422479.370.15数据可信
供试品溶液-2025081721批-达格列净-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min137211-3721196.63097.872.0196.6397.872.01
237414-3741497.15797.16
338263-3826399.36299.36
437673-3767397.82997.83
536741-3674195.40995.41
638837-38837100.852100.85
10min138248-3824899.32399.911.1899.81100.401.18
238935-38935101.107101.59
338774-38774100.689101.19
437966-3796698.59099.08
538006-3800698.69499.17
638917-38917101.060101.56
15min138347-3834799.580100.651.36100.56101.641.35
239804-39804103.363104.35
338683-38683100.452101.45
438553-38553100.115101.10
538652-38652100.372101.34
638510-38510100.003101.01
20min138415-3841599.756100.231.39101.23101.721.38
238714-38714100.533102.04
337825-3782598.22499.73
438407-3840799.735101.22
538770-38770100.678102.15
639451-39451102.447103.96
30min138321-3832199.51299.380.89101.49101.370.89
238408-3840899.738101.75
338281-3828199.408101.40
438366-3836699.629101.61
537620-3762097.69299.67
638622-38622100.294102.32
45min138537-38537100.07399.571.27102.55102.061.25
238327-3832799.528102.04
339044-39044101.390103.88
437728-3772897.972100.45
537867-3786798.333100.80
638563-38563100.141102.66
60min137744-3774498.01499.251.41100.99102.241.39
238074-3807498.871101.88
339145-39145101.652104.65
437811-3781198.188101.16
537982-3798298.632101.59
638571-38571100.161103.19
120min138281-3828199.40899.401.58102.87102.881.55
238042-3804298.788102.29
339129-39129101.610105.12
437430-3743097.198100.66
538004-3800498.689102.14
638778-38778100.699104.22
180min138103-3810398.94697.971.33102.91101.961.30
237759-3775998.053102.05
337787-3778798.125102.14
436834-3683495.65199.60
537620-3762097.692101.63
638267-3826799.372103.40
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min137709-3770997.92397.411.68102.38101.881.63
237621-3762197.694102.18
338434-3843499.806104.31
436495-3649594.77099.19
537506-3750697.396101.83
637296-3729696.850101.38
360min137537-3753797.47696.581.46102.42101.541.41
237111-3711196.370101.34
337535-3753597.471102.47
436214-3621494.04198.94
537694-3769497.884102.80
637057-3705796.230101.24
480min137025-3702596.14795.551.27101.58100.991.23
236965-3696595.991101.45
336550-3655094.913100.40
435984-3598493.44398.81
536942-3694295.931101.34
637300-3730096.861102.35
600min137023-3702396.14294.742.49102.06100.662.39
237038-3703896.180102.12
336660-3666095.199101.16
434736-3473690.20396.04
536316-3631694.306100.19
637116-3711696.383102.36
720min135345-3534591.78492.022.5398.1898.422.43
235675-3567592.64199.06
335811-3581192.99499.44
434191-3419188.78795.07
534805-3480590.38296.74
636791-3679195.539102.00
极限137126-3712696.40998.632.88103.26105.482.74
238515-38515100.016106.90
337635-3763597.731104.64
437434-3743497.209103.94
537213-3721396.635103.45
639961-39961103.771110.71
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