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%
110.474220011421091442073774205045419948242085660.19
210.354280624429370242871630.22
单位质量响应值RSD%判断
401964.28414218.652.13数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2025081521批-二甲双胍-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
6324299-3242997.9497.97
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
30min1782486-78248619.17919.621.5719.3719.821.58
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
31040792-104079225.51025.80
41045860-104586025.63425.93
51070559-107055926.23926.54
61028423-102842325.20625.49
60min11226924-122692430.07230.682.0930.4831.102.09
21269678-126967831.12031.55
31265607-126560731.02031.44
41278268-127826831.33031.75
51256908-125690830.80731.24
61212229-121222929.71230.12
120min11870221-187022145.83946.721.3646.4047.291.36
21938847-193884747.52148.11
31899524-189952446.55747.13
41919317-191931747.04247.62
51923319-192331947.14047.72
61885038-188503846.20246.76
180min12372430-237243058.14859.131.5058.9459.941.51
22461125-246112560.32261.15
32385075-238507558.45859.27
42430152-243015259.56360.38
52440957-244095759.82760.65
62386143-238614358.48459.27
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12782356-278235668.19568.880.9569.2769.980.95
22814213-281421368.97670.10
32835791-283579169.50570.61
42839226-283922669.58970.70
52814182-281418268.97570.09
62775604-277560468.03069.11
360min13257202-325720279.83381.371.3081.2582.821.30
23341718-334171881.90583.38
33321176-332117681.40182.85
43326815-332681581.54083.00
53381900-338190082.89084.35
63290032-329003280.63882.06
480min13611749-361174988.52390.401.6790.3492.261.66
23706998-370699890.85892.74
33655540-365554089.59791.45
43704305-370430590.79292.66
53790683-379068392.90994.79
63660971-366097189.73091.55
600min13806720-380672093.30295.491.4195.5697.801.40
23894848-389484895.46297.80
33873113-387311394.92997.23
43906100-390610095.73898.06
53970851-397085197.32599.67
63924003-392400396.17798.45
720min14009882-400988298.28299.101.09101.01101.891.08
24076368-407636899.911102.72
33979000-397900097.525100.30
44068530-406853099.719102.52
54093176-4093176100.323103.15
64033536-403353698.861101.62
极限13997294-399729497.97398.230.88101.19101.510.88
24003938-400393898.136101.45
34019422-401942298.515101.78
44000923-400092398.062101.36
54066864-406686499.678103.01
63959245-395924597.040100.29
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%
112.002899729830290612887129135291791.30
212.022986530085299750.52
单位质量响应值RSD%判断
2431.582493.761.79数据可信
供试品溶液-2025081521批-达格列净-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%
5min136770-3677096.05197.082.3096.0597.082.30
238050-3805099.39599.39
337118-3711896.96096.96
437353-3735397.57497.57
537952-3795299.13999.14
635738-3573893.35593.36
10min136870-3687096.31298.201.2996.7998.691.29
237937-3793799.10099.60
337731-3773198.56199.05
437611-3761198.24898.74
538196-3819699.776100.27
637220-3722097.22797.69
15min137108-3710896.93498.991.4097.9099.971.40
238516-38516100.612101.60
338043-3804399.376100.35
438229-3822999.862100.84
538074-3807499.457100.45
637411-3741197.72698.68
20min137530-3753098.03698.350.9899.4899.820.98
237784-3778498.700100.20
337328-3732897.50998.98
437959-3795999.157100.64
538117-3811799.570101.06
637178-3717897.11798.56
30min136952-3695296.52798.811.2398.46100.781.23
238253-3825399.925101.91
337928-3792899.076101.04
438089-3808999.497101.47
538033-3803399.350101.34
637709-3770998.504100.43
45min137037-3703796.74997.961.0699.17100.421.07
238040-3804099.369101.86
337486-3748697.921100.38
437521-3752198.013100.48
537833-3783398.828101.31
637087-3708796.87999.30
60min136932-3693296.47497.721.6499.38100.671.61
237809-3780998.765101.75
337679-3767998.426101.37
438307-38307100.066103.03
536894-3689496.37599.36
636829-3682996.20599.11
120min136877-3687796.33197.911.2199.72101.351.20
238247-3824799.909103.39
337327-3732797.506100.95
437627-3762798.290101.75
537317-3731797.480100.94
637504-3750497.968101.35
180min136982-3698296.60598.521.42100.47102.441.40
238517-38517100.615104.59
337327-3732797.506101.43
437643-3764398.332102.29
538009-3800999.288103.24
637807-3780798.760102.63
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137703-3770398.48898.810.59102.84103.230.58
237957-3795799.152103.63
338200-3820099.787104.20
437804-3780498.752103.20
537716-3771698.522102.97
637588-3758898.188102.56
360min136635-3663595.69897.391.06100.54102.301.05
237793-3779398.723103.70
337393-3739397.679102.59
437297-3729797.428102.37
537480-3748097.906102.84
637094-3709496.897101.76
480min136694-3669495.85397.241.04101.17102.641.03
237835-3783598.833104.30
337141-3714197.020102.42
437086-3708696.877102.30
537459-3745997.851103.28
637135-3713597.005102.35
600min136248-3624894.68896.811.25100.49102.691.21
237255-3725597.318103.28
336871-3687196.315102.20
437057-3705796.801102.71
537522-3752298.015103.93
637403-3740397.705103.53
720min136845-3684596.24796.910.86102.52103.280.85
237656-3765698.366104.82
336795-3679596.116102.48
437202-3720297.180103.57
536940-3694096.495102.90
637159-3715997.067103.38
极限136489-3648995.31795.941.01102.07102.790.99
237079-3707996.858103.80
337230-3723097.253104.10
436520-3652095.398102.28
536770-3677096.051102.94
636271-3627194.748101.55
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%
110.474305190430505042983584299996429756243012310.09
210.354265598426593842657680.01
单位质量响应值RSD%判断
410814.80412151.500.23数据可信
供试品溶液-2025081521批-二甲双胍-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%
5min1155272-1552723.7734.026.213.774.026.24
2170034-1700344.1324.13
3170182-1701824.1364.14
4156855-1568553.8123.81
5181438-1814384.4094.41
6158396-1583963.8493.85
10min1321908-3219087.8238.183.907.848.203.91
2357378-3573788.6858.71
3339570-3395708.2528.27
4333453-3334538.1048.12
5342812-3428128.3318.35
6324243-3242437.8807.90
15min1474854-47485411.54011.712.1411.6011.782.16
2492287-49228711.96412.03
3486200-48620011.81611.88
4479665-47966511.65711.72
5492436-49243611.96712.03
6466460-46646011.33611.39
20min1578467-57846714.05814.583.1714.1714.703.16
2608553-60855314.78914.91
3602186-60218614.63514.76
4629683-62968315.30315.42
5600100-60010014.58414.71
6580585-58058514.11014.22
30min1781419-78141918.99019.491.7919.1819.681.79
2814148-81414819.78619.98
3812994-81299419.75819.95
4813126-81312619.76119.96
5802667-80266719.50719.70
6787571-78757119.14019.33
45min11015115-101511524.67025.472.5224.9525.762.51
21071442-107144226.03926.34
31035886-103588625.17525.47
41059082-105908225.73826.03
51081367-108136726.28026.57
61026521-102652124.94725.23
60min11232763-123276329.95930.372.1330.3630.782.13
21278913-127891331.08131.51
31262682-126268230.68631.11
41263074-126307430.69631.12
51254799-125479930.49530.92
61204919-120491929.28229.69
120min11882407-188240745.74746.260.8746.3046.830.88
21922987-192298746.73347.32
31899783-189978346.16946.74
41906675-190667546.33746.91
51920503-192050346.67347.25
61889143-188914345.91146.46
180min12364914-236491457.47358.582.1258.2659.382.11
22419601-241960158.80259.62
32398959-239895958.30059.10
42417460-241746058.75059.56
52500928-250092860.77961.59
62361074-236107457.38058.16
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12755683-275568366.97067.891.0368.0468.981.03
22789140-278914067.78368.89
32793591-279359167.89168.99
42837783-283778368.96570.07
52810311-281031168.29769.41
62773798-277379867.41068.48
360min13284940-328494079.83281.111.7581.2482.541.75
23398643-339864382.59584.04
33324446-332444680.79282.23
43357548-335754881.59683.04
53399212-339921282.60984.07
63259544-325954479.21580.62
480min13613389-361338987.81489.621.5689.6291.461.56
23708694-370869490.13091.99
33650445-365044588.71590.55
43705364-370536490.04991.90
53779699-377969991.85693.73
63668463-366846389.15290.95
600min13800748-380074892.36794.741.6094.6197.021.59
23888318-388831894.49596.81
33876347-387634794.20596.49
43939322-393932295.73598.04
53985400-398540096.85599.18
63899653-389965394.77197.02
720min13970245-397024596.48698.051.0399.19100.811.03
24053529-405352998.510101.30
34022665-402266597.760100.51
44018051-401805197.648100.43
54092565-409256599.459102.27
64049721-404972198.418101.14
极限13993426-399342697.05097.880.59100.24101.140.60
24033347-403334798.020101.30
34019491-401949197.683100.92
44013528-401352897.538100.81
54053308-405330898.505101.82
64053300-405330098.505101.72
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%
112.002950729281299572950229543295580.84
212.022954529553295490.02
单位质量响应值RSD%判断
2463.172458.320.14数据可信
供试品溶液-2025081521批-达格列净-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%
5min136699-3669995.92696.882.2795.9396.882.27
238069-3806999.50799.51
337322-3732297.55497.55
437052-3705296.84896.85
537598-3759898.27598.28
635636-3563693.14793.15
10min136776-3677696.12798.711.8096.6199.201.80
237589-3758998.25298.75
337885-3788599.02699.51
438091-3809199.564100.05
538803-38803101.425101.92
637452-3745297.89498.36
15min137253-3725397.37499.001.0298.3399.971.02
238212-3821299.880100.87
337798-3779898.79899.78
438262-38262100.011100.99
538058-3805899.478100.48
637660-3766098.43799.39
20min137314-3731497.53398.321.5398.9899.791.51
238137-3813799.684101.17
336694-3669495.91397.39
438205-3820599.862101.34
537858-3785898.955100.45
637477-3747797.95999.41
30min136831-3683196.27199.241.5898.21101.211.56
238236-3823699.943101.93
338241-3824199.956101.91
438554-38554100.774102.76
537980-3798099.274101.26
637963-3796399.229101.17
45min136901-3690196.45497.741.1498.87100.201.13
237513-3751398.053100.54
337228-3722897.30899.76
437588-3758898.249100.73
538073-3807399.517102.00
637062-3706296.87499.31
60min136878-3687896.39397.501.5799.29100.451.56
237914-3791499.101102.08
337632-3763298.364101.31
437803-3780398.811101.79
537160-3716097.131100.12
636420-3642095.19698.11
120min137509-3750998.04397.960.64101.42101.400.61
237688-3768898.511101.98
337224-3722497.298100.73
437176-3717697.172100.64
537505-3750598.032101.50
637768-3776898.720102.11
180min137058-3705896.86498.371.98100.73102.301.94
237776-3777698.741102.71
337209-3720997.259101.18
437548-3754898.145102.10
539054-39054102.081106.04
637170-3717097.157101.04
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137138-3713897.07398.360.97101.43102.770.95
237922-3792299.122103.58
337740-3774098.647103.05
438110-3811099.614104.06
537362-3736297.659102.13
637499-3749998.017102.39
360min136639-3663995.76997.651.62100.61102.561.58
238341-38341100.218105.17
337203-3720397.243102.14
437302-3730297.502102.45
537727-3772798.613103.57
636951-3695196.584101.45
480min136403-3640395.15297.191.38100.47102.591.36
237816-3781698.845104.30
336809-3680996.213101.60
437370-3737097.679103.11
537533-3753398.106103.56
637176-3717697.172102.52
600min136189-3618994.59396.791.32100.39102.681.30
237327-3732797.567103.52
336963-3696396.616102.48
437422-3742297.815103.74
537459-3745997.912103.85
636817-3681796.234102.07
720min136484-3648495.36496.811.01101.63103.180.99
237499-3749998.017104.45
337397-3739797.750104.10
436897-3689796.443102.85
537046-3704696.833103.26
636903-3690396.459102.77
极限136391-3639195.12196.430.88101.87103.280.85
237175-3717597.170104.10
337241-3724197.342104.18
436723-3672395.988102.88
536776-3677696.127103.04
637040-3704096.817103.61
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