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%
110.174259241425940542572704260654425554542584230.05
210.224270409427772942740690.13
单位质量响应值RSD%判断
418723.99418206.360.09数据可信
供试品溶液-2025081521批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1517271-51727112.36112.531.9312.3612.531.95
2522449-52244912.48512.48
3527616-52761612.60812.61
4536274-53627412.81512.82
5509366-50936612.17212.17
6533327-53332712.74512.74
30min1876155-87615520.93721.121.8521.0021.191.85
2871101-87110120.81720.88
3882004-88200421.07721.14
4894241-89424121.37021.43
5868797-86879720.76220.82
6911568-91156821.78421.85
45min11140455-114045527.25327.561.1227.4227.731.12
21139685-113968527.23527.40
31154299-115429927.58427.75
41162594-116259427.78227.95
51150077-115007727.48327.65
61172778-117277828.02628.20
60min11369002-136900232.71533.001.1633.0233.311.17
21368057-136805732.69232.99
31392765-139276533.28333.59
41398030-139803033.40933.72
51363018-136301832.57232.87
61395612-139561233.35133.66
75min11565168-156516837.40337.321.5737.8737.801.56
21546149-154614936.94837.41
31551332-155133237.07237.54
41549531-154953137.02937.51
51549430-154943037.02737.49
61609827-160982738.47038.95
90min11734325-173432541.44542.031.3742.1042.691.36
21735553-173555341.47442.13
31769107-176910742.27642.93
41765263-176526342.18442.85
51751739-175173941.86142.51
61798046-179804642.96843.64
105min11867695-186769544.63245.131.1945.4946.001.19
21860727-186072744.46645.32
31879476-187947644.91445.78
41901766-190176645.44646.32
51905152-190515245.52746.39
61915901-191590145.78446.67
120min12020797-202079748.29149.001.1049.3750.101.10
22031046-203104648.53649.62
32063023-206302349.30050.39
42065443-206544349.35850.46
52044054-204405448.84649.93
62079146-207914649.68550.80
极限12137646-213764651.08351.380.7652.4152.720.76
22128825-212882550.87252.20
32168059-216805951.81053.15
42146005-214600551.28352.63
52152098-215209851.42852.76
62168869-216886951.82953.19
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%
112.803226932671324583229632247323880.56
212.893260133049328250.97
单位质量响应值RSD%判断
2530.312546.550.46数据可信
供试品溶液-2025081521批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min138265-3826596.95995.391.7796.9695.381.77
238539-3853997.65397.65
337761-3776195.68295.68
436974-3697493.68893.69
537387-3738794.73494.73
636938-3693893.59693.60
30min138707-3870798.07997.331.1398.5697.811.14
238919-3891998.61699.10
338612-3861297.83898.32
437893-3789396.01696.48
538460-3846097.45397.93
637881-3788195.98696.45
45min139115-3911599.11397.171.67100.0998.141.67
238855-3885598.45499.44
338660-3866097.96098.93
437508-3750895.04195.99
538214-3821496.83097.79
637740-3774095.62896.58
60min138511-3851197.58296.961.9899.0598.411.97
238724-3872498.12299.60
339197-3919799.320100.78
437800-3780095.78097.20
538327-3832797.11698.56
637042-3704293.86095.29
75min138274-3827496.98295.851.3398.9497.781.33
238164-3816496.70398.67
337822-3782295.83697.79
436898-3689893.49595.40
538094-3809496.52598.46
637706-3770695.54297.44
90min138231-3823196.87396.851.2499.3299.271.24
238486-3848697.51999.97
338911-3891198.596101.03
437485-3748594.98297.35
538093-3809396.52398.94
638136-3813696.63299.00
105min137307-3730794.53194.821.4997.4697.711.46
237404-3740494.77797.71
337496-3749695.01097.94
437223-3722394.31897.16
538397-3839797.293100.19
636689-3668992.96595.82
120min138125-3812596.60495.471.13100.0098.841.13
237833-3783395.86499.27
337958-3795896.18199.58
437491-3749194.99898.31
537739-3773995.62699.01
636929-3692993.57396.89
极限138182-3818296.74895.341.78100.6399.181.75
237841-3784195.88499.77
337865-3786595.94599.83
436694-3669492.97896.77
538266-3826696.961100.82
636899-3689993.49797.29
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%
110.174286871429568742955354294052429830342940900.11
210.224293414428882942911220.08
单位质量响应值RSD%判断
422231.07419874.950.40数据可信
供试品溶液-2025081521批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1533219-53321912.66412.084.6012.6612.084.58
2504685-50468511.98611.99
3494955-49495511.75511.76
4493851-49385111.72911.73
5541790-54179012.86812.87
6484035-48403511.49611.50
30min1854984-85498420.30620.232.0720.3720.292.08
2836404-83640419.86519.92
3845184-84518420.07320.13
4850546-85054620.20120.26
5884772-88477221.01321.08
6838790-83879019.92119.98
45min11114817-111481726.47726.862.2826.6427.022.28
21109769-110976926.35726.52
31148273-114827327.27227.43
41139345-113934527.06027.22
51169543-116954327.77727.95
61103658-110365826.21226.37
60min11365038-136503832.42032.132.0732.7232.432.07
21322288-132228831.40531.70
31341278-134127831.85632.15
41361365-136136532.33332.63
51398462-139846233.21433.52
61329710-132971031.58131.87
75min11578755-157875537.49636.612.2137.9637.072.22
21536814-153681436.50036.95
31498931-149893135.60036.05
41533440-153344036.41936.88
51584862-158486237.64138.12
61516559-151655936.01936.46
90min11707750-170775040.55941.101.7441.2141.741.73
21716154-171615440.75941.39
31725681-172568140.98541.62
41742080-174208041.37542.01
51785749-178574942.41243.07
61706802-170680240.53741.16
105min11871258-187125844.44343.702.5145.2944.552.49
21824596-182459643.33444.17
31784751-178475142.38843.23
41838388-183838843.66244.51
51913047-191304745.43546.31
61807893-180789342.93843.77
120min12008589-200858947.70447.861.6648.7848.921.66
21996276-199627647.41248.46
32005161-200516147.62348.67
42010963-201096347.76148.82
52080840-208084049.42050.52
61988631-198863147.23048.27
极限12102013-210201349.92350.791.9151.2352.091.88
22115916-211591650.25351.54
32120766-212076650.36951.66
42213970-221397052.58253.88
52154903-215490351.17952.53
62123884-212388450.44351.72
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%
112.803235032543325103255232633325180.32
212.893305632628328420.93
单位质量响应值RSD%判断
2540.472547.870.21数据可信
供试品溶液-2025081521批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min137786-3778695.52895.322.6395.5395.322.63
237779-3777995.51195.51
338678-3867897.78397.78
437017-3701793.58493.58
538774-3877498.02698.03
636178-3617891.46391.46
30min137939-3793995.91596.531.2796.3997.011.28
237820-3782095.61496.09
338989-3898998.57099.06
438182-3818296.52997.00
538474-3847497.26897.76
637690-3769095.28695.74
45min138594-3859497.57197.391.6398.5398.351.63
238325-3832596.89197.85
339538-3953899.958100.94
438275-3827596.76597.72
538760-3876097.99198.97
637643-3764395.16796.10
60min138749-3874997.96396.751.2499.4198.201.24
237908-3790895.83797.28
338716-3871697.87999.36
438094-3809496.30797.74
538540-3854097.43598.90
637603-3760395.06696.48
75min138775-3877598.02995.761.4999.9697.691.48
237971-3797195.99697.92
337772-3777295.49397.46
437685-3768595.27397.19
538023-3802396.12798.08
637043-3704393.65095.53
90min137395-3739594.54096.321.3996.9698.731.38
238220-3822096.62699.02
338760-3876097.991100.44
437912-3791295.84798.24
538602-3860297.591100.03
637708-3770895.33197.68
105min137588-3758895.02893.571.5497.9396.461.51
237096-3709693.78496.67
336439-3643992.12395.06
436859-3685993.18596.06
537726-3772695.37798.30
636367-3636791.94194.77
120min137730-3773095.38794.351.1798.7697.721.17
236978-3697893.48696.84
337727-3772795.37998.78
436892-3689293.26896.61
537700-3770095.31198.71
636903-3690393.29696.59
极限137365-3736594.46495.541.6398.3199.371.55
237654-3765495.19599.01
337889-3788995.78999.66
438896-3889698.335102.14
537118-3711893.84097.72
637825-3782595.62799.38
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%
110.174251364425006342507654250964425109442508500.02
210.224305831430368643047580.04
单位质量响应值RSD%判断
417979.35421209.200.55数据可信
供试品溶液-2025081721批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1476706-47670611.36111.962.9011.3611.962.91
2512247-51224712.20812.21
3515200-51520012.27912.28
4495126-49512611.80011.80
5510963-51096312.17812.18
6499875-49987511.91311.91
30min1790445-79044518.83919.992.9218.9020.052.91
2848503-84850320.22220.28
3856325-85632520.40920.47
4838071-83807119.97420.03
5852417-85241720.31620.38
6847254-84725420.19320.25
45min11068446-106844625.46426.231.7625.6226.401.76
21092697-109269726.04226.20
31114519-111451926.56226.73
41094677-109467726.08926.25
51116966-111696626.62126.78
61117288-111728826.62826.79
60min11282308-128230830.56131.621.6730.8431.921.67
21338218-133821831.89432.19
31335360-133536031.82632.12
41332452-133245231.75632.05
51332310-133231031.75332.05
61340508-134050831.94832.24
75min11458956-145895634.77135.461.3535.2035.911.35
21502138-150213835.80036.25
31475037-147503735.15435.61
41478961-147896135.24835.70
51509873-150987335.98536.44
61503014-150301435.82136.27
90min11591827-159182737.93839.252.0138.5439.882.00
21627477-162747738.78739.42
31651561-165156139.36139.99
41684418-168441840.14540.77
51656113-165611339.47040.10
61670100-167010039.80340.44
105min11807832-180783243.08644.992.1543.8845.812.14
21898870-189887045.25646.08
31921023-192102345.78446.61
41893338-189333845.12445.95
51911144-191114445.54846.38
61893290-189329045.12345.95
120min12002191-200219147.71848.712.0948.7349.762.07
22019586-201958648.13349.18
32040903-204090348.64149.70
42121366-212136650.55851.61
52020006-202000648.14349.20
62058061-205806149.05050.11
极限12125032-212503250.64650.840.8651.8952.130.86
22119176-211917650.50651.80
32131900-213190050.80952.11
42169442-216944251.70453.01
52128441-212844150.72752.03
62125307-212530750.65251.95
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%
112.803255232689326003245432441325470.32
212.893288632819328520.15
单位质量响应值RSD%判断
2542.732548.640.17数据可信
供试品溶液-2025081721批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min135391-3539189.42091.902.4889.4291.902.48
237320-3732094.29494.29
337515-3751594.78694.79
435517-3551789.73889.74
536503-3650392.23092.23
635986-3598690.92390.92
30min136447-3644792.08894.371.8692.5494.831.86
237726-3772695.32095.79
337997-3799796.00496.48
436518-3651892.26792.72
537521-3752194.80295.26
637894-3789495.74496.20
45min137297-3729794.23694.851.0995.1495.781.09
237691-3769195.23196.18
337823-3782395.56596.52
436820-3682093.03093.94
537730-3773095.33096.26
637871-3787195.68696.62
60min137487-3748794.71695.061.0596.0996.461.05
238157-3815796.40997.83
337507-3750794.76696.20
436994-3699493.47094.85
537832-3783295.58797.00
637755-3775595.39396.80
75min136419-3641992.01793.301.3893.8795.181.38
237560-3756094.90096.81
336978-3697893.43095.34
436247-3624791.58393.43
537310-3731094.26996.16
637042-3704293.59195.48
90min136185-3618591.42692.580.9093.7494.920.88
236636-3663692.56694.95
336360-3636091.86894.24
437050-3705093.61295.91
536929-3692993.30695.67
636679-3667992.67495.03
105min137404-3740494.50697.051.9697.2899.861.94
239113-3911398.824101.67
339029-3902998.612101.44
437582-3758294.95697.72
538901-3890198.288101.12
638441-3844197.12699.95
120min138637-3863797.62197.310.77100.86100.610.73
238848-3884898.154101.49
338487-3848797.242100.57
438677-3867797.722100.97
537995-3799595.99999.32
638442-3844297.129100.43
极限138033-3803396.09596.340.7699.83100.120.73
238453-3845397.156100.98
338235-3823596.606100.42
438335-3833596.858100.59
538082-3808296.219100.02
637639-3763995.10098.89
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