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%
110.354248773425043742518704251672425290642511320.04
210.374267048426644842667480.01
单位质量响应值RSD%判断
410737.39411451.110.13数据可信
供试品溶液-2025081721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%
5min1142711-1427113.4714.1320.103.474.1320.14
2171794-1717944.1794.18
3233722-2337225.6855.69
4143080-1430803.4803.48
5172692-1726924.2014.20
6153682-1536823.7383.74
10min1332656-3326568.0928.446.838.118.466.86
2361673-3616738.7988.82
3381564-3815649.2829.31
4323509-3235097.8697.89
5357592-3575928.6998.72
6324190-3241907.8867.90
15min1470715-47071511.45011.898.0811.5111.958.09
2480427-48042711.68711.75
3567897-56789713.81413.89
4469921-46992111.43111.49
5480892-48089211.69811.76
6462215-46221511.24411.30
20min1588341-58834114.31214.853.4414.4314.983.47
2634069-63406915.42415.55
3634351-63435115.43115.57
4588082-58808214.30514.42
5615743-61574314.97815.10
6602870-60287014.66514.78
30min1801975-80197519.50819.793.3419.6919.993.38
2812228-81222819.75819.96
3865136-86513621.04521.27
4799128-79912819.43919.62
5816004-81600419.85020.05
6787565-78756519.15819.35
45min11057949-105794925.73526.222.6426.0226.522.66
21077329-107732926.20626.51
31132482-113248227.54827.87
41053837-105383725.63525.92
51074929-107492926.14826.45
61070327-107032726.03626.32
60min11278232-127823231.09331.492.8231.5131.922.84
21283907-128390731.23131.66
31368779-136877933.29633.76
41277027-127702731.06431.47
51281820-128182031.18131.61
61278009-127800931.08831.50
120min11926933-192693346.87347.842.8647.4448.422.87
21958665-195866547.64548.23
32076548-207654850.51351.14
41927345-192734546.88347.45
51964350-196435047.78348.37
61945190-194519047.31747.89
180min12409417-240941758.61059.511.9759.4160.341.99
22449866-244986659.59460.42
32537198-253719861.71862.60
42407689-240768958.56859.37
52448595-244859559.56360.39
62426761-242676159.03259.84
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12790521-279052167.88069.422.6668.9870.542.67
22864719-286471969.68570.81
32995927-299592772.87774.07
42794125-279412567.96869.06
52853476-285347669.41270.53
62824860-282486068.71669.82
360min13370874-337087481.99882.742.3683.4384.212.36
23360856-336085681.75483.23
33562788-356278886.66688.22
43367193-336719381.90883.34
53355940-335594081.63483.10
63390728-339072882.48183.93
480min13729952-372995290.73291.452.7792.5893.332.77
23718243-371824390.44892.33
33970036-397003696.57298.56
43729254-372925490.71592.56
53710063-371006390.24992.12
63698408-369840889.96591.82
600min13887855-388785594.57395.882.3696.8798.222.38
23933703-393370395.68998.02
34127617-4127617100.406102.88
43882917-388291794.45396.75
53902654-390265494.93397.26
63915330-391533095.24297.55
720min14018537-401853797.75298.732.53100.52101.552.52
24178381-4178381101.641104.45
34198621-4198621102.133105.11
43961514-396151496.36599.13
53984531-398453196.92599.73
64011706-401170697.586100.37
极限13958549-395854996.29398.043.6199.55101.353.58
24017039-401703997.716101.03
34318902-4318902105.059108.54
43927615-392761595.54198.79
54005766-400576697.442100.73
63953489-395348996.17099.44
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6250
标示量(mg)10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%
112.002950629573296322954729555295630.16
212.022944329488294660.11
单位质量响应值RSD%判断
2463.582451.410.36数据可信
供试品溶液-2025081721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%
5min135276-3527692.32894.932.5792.3394.942.57
236652-3665295.93095.93
337743-3774398.78598.79
435337-3533792.48892.49
536569-3656995.71295.71
636052-3605294.35994.36
10min137371-3737197.81299.161.1998.2799.631.19
238206-3820699.997100.48
337732-3773298.75699.25
437388-3738897.85698.32
538250-38250100.112100.59
638366-38366100.416100.89
15min137350-3735097.75799.832.1598.71100.802.14
238320-38320100.295101.28
339529-39529103.460104.45
437373-3737397.81798.77
538430-38430100.583101.56
637849-3784999.063100.04
20min137223-3722397.42499.792.0198.86101.262.00
238559-38559100.921102.40
338528-38528100.840102.34
437226-3722697.43298.87
539096-39096102.326103.81
638130-3813099.798101.27
30min137611-3761198.44099.561.44100.37101.531.44
238212-38212100.013102.00
338891-38891101.790103.80
437549-3754998.277100.21
538371-38371100.429102.42
637591-3759198.387100.36
45min137377-3737797.82799.881.67100.25102.351.67
238297-38297100.235102.72
339025-39025102.141104.66
437462-3746298.050100.47
538261-38261100.141102.64
638545-38545100.884103.34
60min137172-3717297.29199.201.78100.20102.171.76
237828-3782899.008101.99
339000-39000102.075105.10
437444-3744498.003100.91
537604-3760498.421101.42
638364-38364100.411103.38
120min137066-3706697.01399.392.18100.41102.852.16
237954-3795499.337102.82
339397-39397103.114106.65
437246-3724697.484100.88
538114-3811499.756103.24
638068-3806899.636103.10
180min136967-3696796.75499.311.98100.63103.271.97
238001-3800199.460103.44
339155-39155102.481106.54
437360-3736097.783101.67
538077-3807799.659103.65
638102-3810299.725103.69
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137074-3707497.03499.672.56101.40104.132.52
238298-38298100.238104.71
339713-39713103.941108.51
437080-3708097.050101.43
538127-3812799.790104.28
638198-3819899.976104.44
360min137115-3711597.14299.282.42101.99104.242.38
237683-3768398.628103.61
339667-39667103.821108.91
437358-3735897.778102.64
537636-3763698.505103.49
638139-3813999.822104.78
480min137470-3747098.07199.542.63103.40104.982.58
237723-3772398.733104.20
340061-40061104.852110.46
437546-3754698.270103.62
537716-3771698.715104.19
637661-3766198.571104.03
600min136852-3685296.45398.752.53102.28104.702.49
237758-3775898.824104.79
339459-39459103.276109.41
436931-3693196.660102.50
537416-3741697.929103.90
637964-3796499.364105.32
720min137099-3709997.10099.023.00103.41105.462.92
239006-39006102.091108.55
339416-39416103.164109.81
436572-3657295.720102.05
537197-3719797.356103.82
637695-3769598.660105.11
极限136866-3686696.49098.303.87103.28105.243.73
237440-3744097.992104.96
340404-40404105.750112.91
436287-3628794.974101.78
537340-3734097.730104.68
637018-3701896.888103.83
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%
110.354224487422505042283494231212422895742276110.07
210.374257893426706942624810.16
单位质量响应值RSD%判断
408464.83411039.630.45数据可信
供试品溶液-2025081721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%
5min1172524-1725244.2104.376.604.214.376.59
2201513-2015134.9184.92
3168340-1683404.1084.11
4181658-1816584.4334.43
5176510-1765104.3084.31
6174399-1743994.2564.26
10min1353020-3530208.6168.882.438.648.902.41
2374295-3742959.1359.16
3355217-3552178.6698.69
4371306-3713069.0629.08
5367997-3679978.9819.00
6360068-3600688.7888.81
15min1505306-50530612.33212.462.3812.4012.532.38
2524566-52456612.80212.87
3492411-49241112.01712.08
4508365-50836512.40712.47
5523921-52392112.78612.85
6509819-50981912.44212.51
20min1640892-64089215.64115.581.9415.7715.721.93
2639427-63942715.60515.74
3629546-62954615.36415.49
4658495-65849516.07116.20
5641148-64114815.64715.78
6622075-62207515.18215.31
30min1836430-83643020.41320.602.3620.6220.812.34
2832513-83251320.31820.53
3819354-81935419.99720.20
4876052-87605221.38021.59
5856237-85623720.89721.11
6844182-84418220.60220.81
45min11101278-110127826.87726.911.4227.1827.221.42
21096229-109622926.75427.07
31079024-107902426.33426.63
41108464-110846427.05227.37
51126818-112681827.50027.81
61103552-110355226.93227.24
60min11300560-130056031.74032.301.8732.1832.741.85
21309336-130933631.95532.40
31306678-130667831.89032.32
41329790-132979032.45432.91
51326184-132618432.36632.82
61368054-136805433.38833.83
120min11980464-198046448.33448.490.5648.9349.100.56
22008639-200863949.02149.63
31985977-198597748.46849.06
41984792-198479248.43949.05
51977956-197795648.27248.88
61983755-198375548.41449.02
180min12491261-249126160.80060.200.8061.6461.060.79
22480379-248037960.53461.39
32454236-245423659.89660.73
42460497-246049760.04960.91
52437727-243772759.49360.35
62477158-247715860.45661.31
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12782243-278224367.90169.501.7269.0570.641.69
22902478-290247870.83671.99
32842942-284294269.38370.52
42805128-280512868.46069.62
52900713-290071370.79371.94
62851734-285173469.59770.75
360min13375911-337591182.39082.600.7183.8784.100.70
23401307-340130783.01084.52
33358966-335896681.97683.46
43390322-339032282.74284.24
53361550-336155082.03983.54
63420132-342013283.46984.97
480min13717714-371771490.73290.851.1392.6392.761.12
23763793-376379391.85693.78
33648594-364859489.04590.94
43719532-371953290.77692.69
53722411-372241190.84692.76
63762689-376268991.82993.75
600min13897632-389763295.12395.311.1497.4797.681.12
23989734-398973497.37099.75
33894466-389446695.04597.38
43906624-390662495.34297.71
53858936-385893694.17896.55
63885599-388559994.82997.21
720min13924523-392452395.77996.410.7498.6099.250.74
23986635-398663597.295100.17
33917772-391777295.61498.43
43951422-395142296.43599.28
53939354-393935496.14198.98
63983222-398322297.211100.06
极限13997039-399703997.54995.641.16100.8598.961.12
23919370-391937095.65399.01
33861070-386107094.23097.52
43894432-389443295.04598.37
53928766-392876695.88299.20
63911086-391108695.45198.79
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6250
标示量(mg)10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%
112.002919429191294612959329382293640.60
212.022955729869297130.75
单位质量响应值RSD%判断
2447.002471.960.72数据可信
供试品溶液-2025081721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%
5min137671-3767198.51999.401.7798.5299.401.77
237839-3783998.95998.96
337133-3713397.11297.11
439075-39075102.191102.19
538440-38440100.530100.53
637897-3789799.11099.11
10min138606-38606100.964101.121.36101.46101.621.36
237901-3790199.12199.62
338319-38319100.214100.70
439387-39387103.007103.52
539032-39032102.079102.58
638745-38745101.328101.82
15min138149-3814999.769100.201.56100.77101.201.56
238265-38265100.073101.06
337250-3725097.41898.40
438570-38570100.870101.90
538678-38678101.153102.17
638965-38965101.903102.91
20min138562-38562100.84999.481.12102.35100.981.11
238326-38326100.232101.72
337357-3735797.69899.17
437983-3798399.335100.87
538189-3818999.874101.39
637808-3780898.877100.39
30min138540-38540100.79299.311.58102.79101.311.56
237437-3743797.90799.90
337074-3707496.95898.92
438005-3800599.393101.42
538456-38456100.572102.59
638330-38330100.243102.25
45min138588-38588100.91799.591.98103.42102.081.96
237504-3750498.082100.56
336983-3698396.72099.17
438508-38508100.708103.23
538988-38988101.963104.48
637901-3790199.121101.63
60min137680-3768098.54398.551.83101.55101.541.81
237037-3703796.86199.83
336803-3680396.24999.18
437838-3783898.956101.98
538051-3805199.513102.54
638692-38692101.189104.19
120min138041-3804199.48798.660.63102.99102.140.65
237470-3747097.994101.45
337439-3743997.912101.32
437904-3790499.129102.65
537731-3773198.676102.20
637758-3775898.747102.26
180min138125-3812599.70798.301.22103.71102.281.20
237643-3764398.446102.39
336882-3688296.456100.36
437649-3764998.462102.48
537255-3725597.431101.45
637965-3796599.288103.29
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137017-3701796.80997.741.18101.31102.221.15
237582-3758298.286102.72
336927-3692796.573100.96
437101-3710197.028101.54
538077-3807799.581104.09
637544-3754498.187102.69
360min137569-3756998.25297.741.35103.23102.701.33
236922-3692296.560101.49
336705-3670595.993100.86
437645-3764598.451103.45
537310-3731097.575102.58
638082-3808299.594104.58
480min137227-3722797.35896.901.87102.83102.351.83
236766-3676696.152101.56
335839-3583993.72899.07
437347-3734797.672103.16
537256-3725697.434102.93
637876-3787699.055104.54
600min136984-3698496.72296.391.05102.68102.321.03
237161-3716197.185103.08
336221-3622194.727100.54
437243-3724397.400103.38
536583-3658395.674101.66
636948-3694896.628102.61
720min136385-3638595.15694.911.73101.60101.321.68
235758-3575893.51699.90
335325-3532592.38498.67
436541-3654195.564102.03
536786-3678696.205102.66
636940-3694096.607103.07
极限136589-3658995.68993.831.93102.61100.721.86
235323-3532392.37999.23
334838-3483891.11097.86
435984-3598494.107101.05
536555-3655595.601102.54
635978-3597894.092101.04
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