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%
110.204234320423761642338814236930423988842365270.06
210.244319747432313043214380.06
单位质量响应值RSD%判断
415345.78422015.431.13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%
15min1502059-50205911.99211.443.9011.9911.443.90
2488176-48817611.66111.66
3451719-45171910.79010.79
4461846-46184611.03211.03
5483190-48319011.54211.54
6487312-48731211.64011.64
30min1806845-80684519.27219.322.0119.3319.372.00
2814726-81472619.46119.52
3780134-78013418.63418.69
4805287-80528719.23519.29
5817185-81718519.51919.58
6827954-82795419.77719.83
45min11061362-106136225.35225.132.5925.5125.282.58
21063157-106315725.39525.55
31006012-100601224.03024.18
41034000-103400024.69824.85
51066944-106694425.48525.64
61080577-108057725.81125.97
60min11289794-128979430.80830.102.4131.0930.382.41
21281647-128164730.61430.90
31224195-122419529.24129.51
41222542-122254229.20229.48
51259686-125968630.08930.37
61283585-128358530.66030.95
75min11465248-146524834.99934.831.1735.4435.261.18
21480002-148000235.35135.79
31440693-144069334.41234.83
41435110-143511034.27934.70
51462298-146229834.92935.36
61466594-146659435.03135.47
90min11630229-163022938.94038.541.7739.5539.141.78
21631027-163102738.95939.57
31580805-158080537.75938.34
41573123-157312337.57638.17
51635678-163567839.07039.68
61630306-163030638.94239.56
105min11765681-176568142.17542.441.3342.9843.231.32
21787150-178715042.68843.50
31766768-176676842.20142.98
41740698-174069841.57842.36
51793551-179355142.84143.64
61805808-180580843.13443.94
120min11917779-191777945.80845.001.7446.8346.011.74
21891563-189156345.18246.20
31836297-183629743.86244.85
41850933-185093344.21245.20
51901661-190166145.42346.44
61905636-190563645.51846.54
极限11993611-199361147.62047.200.9548.8748.430.97
21984138-198413847.39348.64
31951875-195187546.62347.83
41953185-195318546.65447.86
51980605-198060547.30948.55
61991745-199174547.57548.83
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%
112.713282733164331563308433269331000.51
212.753330033256332780.10
单位质量响应值RSD%判断
2604.252610.040.16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%
15min136768-3676890.70990.192.2790.7190.192.26
236687-3668790.50990.51
336208-3620889.32889.33
435549-3554987.70287.70
536154-3615489.19489.19
637990-3799093.72493.72
30min136363-3636389.71092.863.5590.1693.323.53
237233-3723391.85692.31
336903-3690391.04291.49
439521-3952197.50197.94
536719-3671990.58891.03
639112-3911296.49296.96
45min136410-3641089.82691.732.4990.7392.642.49
237276-3727691.96392.87
336321-3632189.60690.51
437407-3740792.28693.21
536831-3683190.86591.76
638843-3884395.82896.78
60min137010-3701091.30691.411.9892.6692.781.98
237072-3707291.45992.83
336714-3671490.57691.93
436623-3662390.35291.74
536428-3642889.87091.22
638460-3846094.88496.31
75min136876-3687690.97692.371.3792.7894.201.38
237715-3771593.04694.87
337582-3758292.71794.52
437570-3757092.68894.53
536785-3678590.75192.55
638110-3811094.02095.92
90min136485-3648590.01191.131.4892.2793.421.49
236900-3690091.03593.33
336689-3668990.51492.78
436807-3680790.80593.11
536734-3673490.62592.88
638014-3801493.78396.16
105min140527-4052799.98393.543.76102.7096.293.66
236910-3691091.06093.81
337527-3752792.58295.30
437218-3721891.81994.58
536779-3677990.73693.45
638534-3853495.06697.91
120min136203-3620389.31589.941.5092.5393.161.50
236274-3627489.49192.70
335976-3597688.75591.94
436470-3647089.97493.19
536294-3629489.54092.70
637523-3752392.57295.89
极限135882-3588288.52389.461.5492.1893.121.54
235961-3596188.71892.37
336205-3620589.32092.95
436492-3649290.02893.69
535756-3575688.21391.82
637265-3726591.93595.72
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%
110.204250310425338342529604248433425177442513720.05
210.244333589433487143342300.03
单位质量响应值RSD%判断
416801.18423264.651.09数据可信
供试品溶液-2025081521批-达格列净
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1449492-44949210.70210.322.5810.7010.322.58
2435532-43553210.37010.37
3442991-44299110.54710.55
4425700-42570010.13610.14
5423616-42361610.08610.09
6422682-42268210.06410.06
30min1737287-73728717.55417.531.3217.6117.591.31
2743107-74310717.69317.74
3745006-74500617.73817.79
4719817-71981717.13817.19
5742967-74296717.68917.74
6730642-73064217.39617.45
45min1978100-97810023.28823.121.9023.4323.261.90
2982271-98227123.38723.53
3997781-99778123.75623.90
4951824-95182422.66222.80
5963911-96391122.95023.09
6951605-95160522.65722.79
60min11188590-118859028.29927.471.8528.5627.721.85
21158255-115825527.57727.83
31160984-116098427.64227.90
41127615-112761526.84727.10
51148750-114875027.35127.60
61137215-113721527.07627.33
75min11351462-135146232.17731.742.0932.5832.132.08
21350766-135076632.16032.56
31364773-136477332.49432.89
41296886-129688630.87831.26
51331025-133102531.69032.08
61303349-130334931.03231.42
90min11633884-163388438.90139.190.8039.4639.740.77
21627159-162715938.74139.30
31645459-164545939.17739.74
41660535-166053539.53640.07
51650332-165033239.29339.84
61657525-165752539.46440.01
105min11513814-151381436.04235.641.5236.8036.391.52
21513470-151347036.03436.78
31525091-152509136.31137.07
41476065-147606535.14435.88
51477841-147784135.18635.93
61476037-147603735.14335.88
120min11784707-178470742.49242.090.5143.4343.020.52
21770252-177025242.14843.08
31762665-176266541.96742.91
41761301-176130141.93542.85
51766429-176642942.05742.98
61761166-176116641.93242.85
极限11882634-188263444.82444.711.0545.9745.851.03
21894251-189425145.10046.24
31883597-188359744.84745.99
41850984-185098444.07045.19
51857057-185705744.21545.35
61899079-189907945.21546.34
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%
112.713333333425333173334833358333560.13
212.753399733573337850.89
单位质量响应值RSD%判断
2624.392649.800.69数据可信
供试品溶液-2025081521批-二甲双胍
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min136543-3654389.13290.101.3589.1390.101.35
237645-3764591.82091.82
337369-3736991.14791.15
437069-3706990.41590.42
536545-3654589.13789.14
636471-3647188.95688.96
30min136348-3634888.65691.752.0089.1092.202.00
238048-3804892.80393.26
337941-3794192.54293.00
437121-3712190.54290.99
538418-3841893.70594.15
637816-3781692.23792.68
45min136852-3685289.88691.511.3890.7792.421.38
238072-3807292.86193.78
338063-3806392.84093.76
437158-3715890.63291.54
537768-3776892.12093.03
637201-3720190.73791.64
60min136915-3691590.03989.930.7191.3891.300.71
237185-3718590.69892.09
336961-3696190.15291.53
436489-3648989.00090.36
537038-3703890.33991.71
636635-3663589.35790.72
75min136627-3662789.33789.991.8091.1391.801.78
237247-3724790.84992.69
337920-3792092.49194.32
436125-3612588.11389.92
537110-3711090.51592.34
636330-3633088.61390.42
90min135593-3559386.81590.122.0689.0592.392.01
236519-3651989.07491.37
337196-3719690.72593.02
437488-3748891.43793.68
537399-3739991.22093.50
637493-3749391.44993.70
105min136410-3641088.80890.031.5091.4892.751.48
237328-3732891.04793.79
337823-3782392.25495.00
436633-3663389.35292.05
536778-3677889.70592.44
636501-3650189.03091.74
120min136112-3611288.08189.130.7191.1992.300.71
236389-3638988.75691.95
336709-3670989.53792.75
436558-3655889.16992.32
536817-3681789.80092.98
636674-3667489.45292.60
极限135914-3591487.59889.891.5591.1593.501.52
236922-3692290.05793.70
336926-3692690.06693.72
436531-3653189.10392.70
537418-3741891.26694.90
637409-3740991.24494.84
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%
110.204310349430837643088654309013430615043085510.04
210.244346171434684243465060.02
单位质量响应值RSD%判断
422406.96424463.480.35数据可信
供试品溶液-2025081521批-达格列净
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1275179-2751796.4997.044.316.507.044.31
2307371-3073717.2597.26
3292927-2929276.9186.92
4296797-2967977.0097.01
5309090-3090907.3007.30
6306052-3060527.2287.23
30min1525265-52526512.40512.963.0212.4413.003.01
2551821-55182113.03213.07
3531120-53112012.54312.58
4562971-56297113.29513.33
5563075-56307513.29813.33
6558113-55811313.18113.22
45min1716414-71641416.91917.983.1417.0118.083.15
2774774-77477418.29718.40
3751940-75194017.75817.86
4772861-77286118.25218.35
5772198-77219818.23718.34
6778976-77897618.39718.50
60min1863241-86324120.38721.993.8420.5722.183.83
2932525-93252522.02322.22
3926850-92685021.88922.08
4947847-94784722.38522.58
5960496-96049622.68422.88
6955769-95576922.57222.77
75min11005274-100527423.74125.353.7424.0225.653.74
21052228-105222824.85025.15
31073563-107356325.35425.65
41091913-109191325.78726.09
51103774-110377426.06726.37
61114410-111441026.31826.63
90min11144332-114433227.02528.613.4727.4229.033.47
21220530-122053028.82529.25
31175411-117541127.75928.18
41243039-124303929.35629.79
51243334-124333429.36329.80
61241780-124178029.32729.76
105min11250958-125095829.54331.203.1530.0831.773.16
21316936-131693631.10131.67
31298188-129818830.65931.22
41351332-135133231.91432.49
51357579-135757932.06132.65
61351822-135182231.92532.51
120min11389068-138906832.80534.162.5833.4934.892.60
21449017-144901734.22134.95
31414458-141445833.40534.12
41467076-146707634.64735.39
51478059-147805934.90735.65
61481219-148121934.98135.73
极限11494086-149408635.28536.392.2236.1337.292.24
21546786-154678636.53037.43
31502974-150297435.49536.38
41569800-156980037.07337.99
51560122-156012236.84537.76
61571676-157167637.11738.04
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%
112.713369933565335303370933524336050.28
212.753369533647336710.11
单位质量响应值RSD%判断
2643.982640.860.09数据可信
供试品溶液-2025081521批-二甲双胍
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min136748-3674889.44990.001.0689.4590.001.06
236373-3637388.53788.54
337187-3718790.51890.52
436840-3684089.67389.67
537362-3736290.94490.94
637340-3734090.89090.89
30min137706-3770691.78190.651.6692.2391.101.65
236367-3636788.52288.96
336667-3666789.25289.70
437956-3795692.39092.84
537501-3750191.28291.74
637244-3724490.65791.11
45min137009-3700990.08591.661.0590.9992.561.04
237423-3742391.09391.98
338047-3804792.61193.51
438023-3802392.55393.46
537657-3765791.66292.57
637781-3778191.96492.87
60min136155-3615588.00691.212.2389.3692.582.21
236731-3673189.40890.75
338248-3824893.10194.46
437996-3799692.48793.86
537958-3795892.39593.76
637751-3775191.89193.26
75min136059-3605987.77290.262.6689.5792.082.63
235628-3562886.72388.51
337800-3780092.01093.84
437439-3743991.13192.97
537624-3762491.58293.41
637946-3794692.36694.19
90min136116-3611687.91190.161.8490.1592.431.82
236476-3647688.78791.01
336785-3678589.54091.83
437738-3773891.85994.15
537704-3770491.77694.07
637412-3741291.06693.35
105min135501-3550186.41488.681.7989.0991.401.78
235774-3577487.07989.74
336906-3690689.83492.57
436892-3689289.80092.55
537050-3705090.18592.93
636462-3646288.75391.50
120min136353-3635388.48889.381.1491.6092.551.15
236077-3607787.81690.92
336747-3674789.44792.63
437100-3710090.30693.51
537008-3700890.08293.28
637036-3703690.15093.34
极限136372-3637288.53489.300.7392.0892.910.75
236455-3645588.73692.28
336650-3665089.21192.84
436986-3698690.02993.68
537020-3702090.11293.76
636631-3663189.16592.80
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%
110.204353256435238543514454351180435120143518930.03
210.244380388438337943818840.05
单位质量响应值RSD%判断
426656.18427918.360.21数据可信
供试品溶液-2025081521批-达格列净
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1190724-1907244.4644.504.484.464.504.49
2205802-2058024.8164.82
3190144-1901444.4504.45
4198772-1987724.6524.65
5181847-1818474.2564.26
6186714-1867144.3704.37
30min1404204-4042049.4609.342.869.489.372.85
2415168-4151689.7169.74
3397923-3979239.3139.34
4400697-4006979.3789.40
5380159-3801598.8978.92
6397494-3974949.3039.32
45min1520342-52034212.17813.414.9112.2513.484.88
2602457-60245714.10014.17
3588637-58863713.77613.84
4581453-58145313.60813.68
5573136-57313613.41313.48
6572650-57265013.40213.47
60min1750952-75095217.57517.182.1717.7117.322.16
2753761-75376117.64117.78
3724914-72491416.96617.10
4737817-73781717.26817.41
5714635-71463516.72516.86
6723380-72338016.93017.07
75min1790149-79014918.49219.593.0618.7119.813.04
2863830-86383020.21720.45
3835656-83565619.55719.78
4855335-85533520.01820.24
5840075-84007519.66119.88
6837090-83709019.59119.81
90min1983509-98350923.01822.313.0323.3322.643.00
2985984-98598423.07523.41
3908835-90883521.27021.59
4943377-94337722.07822.40
5943035-94303522.07022.39
6956094-95609422.37622.69
105min11058873-105887324.78125.342.1525.2125.772.14
21097292-109729225.68026.13
31061275-106127524.83825.26
41086550-108655025.42925.86
51072497-107249725.10025.53
61119309-111930926.19626.63
120min11177529-117752927.55827.622.1728.1128.182.14
21218044-121804428.50729.08
31185422-118542227.74328.29
41185848-118584827.75328.32
51175188-117518827.50428.05
61138529-113852926.64627.21
极限11293071-129307130.26229.762.2630.9530.462.24
21312690-131269030.72231.44
31241248-124124829.05029.74
41272221-127222129.77430.48
51239329-123932929.00529.69
61271454-127145429.75630.45
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%
112.713368533907335843357033835337160.45
212.753355133609335800.13
单位质量响应值RSD%判断
2652.712633.730.51数据可信
供试品溶液-2025081521批-二甲双胍
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min133542-3354281.62279.529.8681.6279.529.86
235695-3569586.86186.86
334994-3499485.15585.16
434466-3446683.87083.87
527790-2779067.62567.62
629590-2959072.00572.01
30min136627-3662789.12985.697.3689.5486.087.37
237382-3738290.96691.40
337061-3706190.18590.61
436286-3628688.29988.72
531232-3123276.00176.34
632685-3268579.53779.90
45min133002-3300280.30887.196.6881.1688.016.67
238546-3854693.79994.69
338233-3823393.03793.91
437008-3700890.05690.92
533975-3397582.67683.39
634208-3420883.24384.00
60min138011-3801192.49789.134.9093.7590.394.92
238199-3819992.95494.31
337451-3745191.13492.48
437332-3733290.84592.16
533929-3392982.56483.70
634832-3483284.76185.94
75min133576-3357681.70585.854.6483.4287.564.66
237333-3733390.84792.67
336288-3628888.30490.10
436570-3657088.99090.76
533794-3379482.23583.78
634113-3411383.01184.61
90min136934-3693489.87686.044.1992.0088.184.18
237284-3728490.72893.01
334543-3454384.05886.30
435411-3541186.17088.38
533587-3358781.73283.69
634393-3439383.69385.71
105min135766-3576687.03487.882.8789.6190.452.93
237134-3713490.36393.09
336397-3639788.56991.23
437031-3703190.11292.75
534302-3430283.47185.84
636050-3605087.72590.16
120min136057-3605787.74287.554.1090.7590.564.12
237905-3790592.23995.42
336816-3681689.58992.69
436518-3651888.86491.96
534749-3474984.55987.34
633829-3382982.32085.19
极限137296-3729690.75788.414.0794.2191.864.08
238208-3820892.97696.62
336185-3618588.05491.60
436930-3693089.86693.40
534118-3411883.02486.23
635253-3525385.78689.07
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