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%
112.354212406420746042149584215727422127742143660.12
212.474171716417068541712000.02
单位质量响应值RSD%判断
341244.21334498.801.42数据可信
供试品溶液-2025081521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%
5min1174128-1741285.1545.304.525.155.304.51
2191703-1917035.6745.67
3180387-1803875.3395.34
4169204-1692045.0085.01
5184491-1844915.4615.46
6175156-1751565.1855.18
10min1347017-34701710.27210.454.1810.3010.474.16
2360279-36027910.66410.69
3332604-3326049.8459.87
4355334-35533410.51810.54
5346135-34613510.24610.27
6375951-37595111.12811.15
15min1487110-48711014.41814.742.5614.5014.822.56
2505958-50595814.97615.06
3488160-48816014.45014.53
4519873-51987315.38815.47
5494972-49497214.65114.73
6491271-49127114.54214.62
20min1597171-59717117.67618.022.2817.8318.182.25
2626544-62654418.54618.70
3599958-59995817.75917.91
4607451-60745117.98118.14
5625338-62533818.51018.66
6596489-59648917.65617.81
30min1867406-86740625.67524.353.1025.9124.593.07
2834919-83491924.71424.96
3800806-80080623.70423.94
4805350-80535023.83824.08
5821608-82160824.32024.56
6804818-80481823.82324.07
45min11057905-105790531.31431.681.7431.6832.041.72
21084054-108405432.08832.46
31080126-108012631.97232.33
41048103-104810331.02431.39
51094532-109453232.39832.76
61055884-105588431.25431.62
60min11260182-126018237.30137.741.9637.8238.261.94
21287497-128749738.11038.64
31270950-127095037.62038.14
41269222-126922237.56938.09
51317415-131741538.99539.52
61245450-124545036.86537.38
120min11881730-188173055.69957.332.7856.4158.042.76
21953061-195306157.81158.53
31949933-194993357.71858.42
41913031-191303156.62657.33
52029538-202953860.07460.80
61893694-189369456.05356.76
180min12382801-238280170.53171.021.3771.5272.021.37
22386301-238630170.63571.65
32419690-241969071.62372.61
42378477-237847770.40371.39
52456911-245691172.72573.75
62371607-237160770.20071.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12785551-278555182.45281.980.7083.7983.340.70
22767381-276738181.91483.28
32754377-275437781.53082.88
42756716-275671681.59982.94
52800241-280024182.88784.27
62754062-275406281.52082.85
360min13352348-335234899.23098.321.10100.98100.081.09
23304571-330457197.81599.59
33275633-327563396.95998.72
43338348-333834898.815100.56
53367382-336738299.675101.48
63291019-329101997.41499.16
480min13602031-3602031106.620107.691.05108.87109.951.04
23633641-3633641107.556109.82
33655178-3655178108.193110.44
43587242-3587242106.182108.43
53685639-3685639109.095111.39
63665519-3665519108.499110.73
600min13794456-3794456112.316113.040.91115.10115.840.91
23838494-3838494113.619116.42
33795077-3795077112.334115.12
43778664-3778664111.848114.62
53868242-3868242114.500117.35
63839348-3839348113.645116.42
720min13978372-3978372117.760116.631.01121.10119.991.00
23936754-3936754116.528119.90
33913931-3913931115.852119.20
43879639-3879639114.837118.17
53985015-3985015117.956121.37
63948333-3948333116.871120.21
极限13916256-3916256115.921115.591.66119.85119.531.62
23917895-3917895115.970119.92
33913970-3913970115.854119.78
43785634-3785634112.055115.96
53912072-3912072115.797119.80
63984524-3984524117.942121.87
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%
112.002871829260290282909428752289700.80
212.022872028722287210.01
单位质量响应值RSD%判断
2414.172389.430.73数据可信
供试品溶液-2025081521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%
5min136188-3618896.91496.171.7696.9196.171.75
236808-3680898.57498.57
335540-3554095.17895.18
435633-3563395.42795.43
535039-3503993.83793.84
636260-3626097.10797.11
10min136970-3697099.00898.431.8799.4998.911.86
236522-3652297.80898.30
336939-3693998.92599.40
436002-3600296.41696.89
536187-3618796.91197.38
637901-37901101.501101.99
15min137480-37480100.37498.701.17101.3599.671.16
236712-3671298.31799.30
337099-3709999.353100.32
436526-3652697.81998.78
536297-3629797.20698.16
637011-3701199.118100.11
20min136663-3666398.18698.930.8399.67100.400.83
237000-3700099.088100.56
337294-3729499.876101.34
436527-3652797.82299.27
536924-3692498.885100.32
637239-3723999.728101.22
30min136928-3692898.89598.451.33100.87100.421.32
236953-3695398.962100.93
337027-3702799.161101.13
436228-3622897.02198.96
536103-3610396.68698.62
637338-3733899.993101.98
45min136603-3660398.02598.461.39100.49100.911.37
236451-3645197.618100.08
337293-3729399.873102.34
436058-3605896.56698.99
536793-3679398.534100.95
637393-37393100.141102.63
60min136311-3631197.24398.211.33100.20101.161.28
236070-3607096.59899.55
337203-3720399.632102.59
436475-3647597.682100.59
537271-3727199.814102.72
636704-3670498.296101.28
120min135833-3583395.96398.702.0299.41102.141.95
236780-3678098.499101.93
337326-3732699.961103.42
436316-3631697.256100.65
537948-37948101.627105.04
636928-3692898.895102.37
180min136171-3617196.86897.791.39100.79101.721.36
235934-3593496.233100.16
336956-3695698.970102.93
436171-3617196.868100.75
536651-3665198.154102.07
637210-3721099.651103.62
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min136622-3662298.07697.110.92102.48101.530.89
235785-3578595.834100.24
336505-3650597.763102.22
436327-3632797.286101.65
535930-3593096.223100.63
636399-3639997.479101.95
360min136791-3679198.52997.211.01103.43102.110.96
235824-3582495.939100.83
336175-3617596.879101.82
436640-3664098.124102.98
536037-3603796.509101.40
636315-3631597.254102.21
480min135586-3558695.30296.441.34100.69101.831.31
235871-3587196.065101.43
336367-3636797.393102.82
435658-3565895.494100.84
535769-3576995.792101.16
636818-3681898.601104.05
600min135436-3543694.90095.620.72100.77101.490.69
235978-3597896.351102.20
335601-3560195.342101.26
435428-3542894.878100.70
535791-3579195.851101.70
635992-3599296.389102.33
720min135947-3594796.26895.960.91102.61102.310.89
235547-3554795.197101.53
335735-3573595.701102.09
435428-3542894.878101.17
536023-3602396.472102.80
636303-3630397.222103.64
极限135009-3500993.75694.451.92100.58101.281.83
235571-3557195.261102.07
335844-3584495.992102.86
434295-3429591.84498.61
534827-3482793.269100.08
636072-3607296.603103.51
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%
112.354211653421603342137004214721421300542138220.04
212.474353292435761843554550.08
单位质量响应值RSD%判断
341200.16349274.661.66数据可信
供试品溶液-2025081521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%
5min1205593-2055935.9565.4711.525.965.4711.54
2205828-2058285.9635.96
3204553-2045535.9265.93
4151281-1512814.3834.38
5177310-1773105.1375.14
6187766-1877665.4395.44
10min1357853-35785310.36710.475.8110.4010.505.82
2369228-36922810.69610.73
3356056-35605610.31510.34
4336135-3361359.7389.76
5398367-39836711.54111.57
6351636-35163610.18710.21
15min1509594-50959414.76314.782.4514.8414.862.45
2530131-53013115.35815.44
3508176-50817614.72214.80
4491087-49108714.22714.30
5508575-50857514.73314.82
6512517-51251714.84714.93
20min1643544-64354418.64318.383.2618.8018.543.28
2636155-63615518.42918.59
3645608-64560818.70318.86
4596230-59623017.27317.41
5655695-65569518.99519.15
6630255-63025518.25818.41
30min1840831-84083124.35824.282.4824.6124.522.48
2844227-84422724.45724.71
3840983-84098324.36324.61
4798031-79803123.11923.35
5858991-85899124.88525.14
6845347-84534724.48924.73
45min11083486-108348631.38831.681.6931.7632.041.69
21111450-111145032.19832.57
31111944-111194432.21332.58
41068527-106852730.95531.30
51104844-110484432.00732.38
61080319-108031931.29631.66
60min11282512-128251237.15437.721.0637.6838.241.05
21292359-129235937.43937.97
31311813-131181338.00338.53
41295672-129567237.53538.03
51317380-131738038.16438.70
61311568-131156837.99638.52
120min11949698-194969856.48256.680.8857.1957.390.87
21978026-197802657.30258.03
31952686-195268656.56857.29
41972805-197280557.15157.84
51954540-195454056.62257.35
61930716-193071655.93256.64
180min12443767-244376770.79570.950.7871.7971.940.77
22485732-248573272.01173.02
32441521-244152170.73071.73
42435555-243555570.55771.53
52436186-243618670.57571.59
62451463-245146371.01872.01
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12803535-280353581.21781.771.3582.5783.121.33
22868682-286868283.10484.47
32783536-278353680.63882.00
42829020-282902081.95583.28
52864634-286463482.98784.35
62785449-278544980.69382.04
360min13322575-332257596.25397.491.4098.0199.251.37
23368983-336898397.59899.38
33340888-334088896.78498.54
43442092-344209299.716101.45
53394757-339475798.345100.12
63323042-332304296.26798.02
480min13662317-3662317106.096106.690.88108.33108.940.86
23671812-3671812106.371108.64
33653395-3653395105.837108.08
43728742-3728742108.020110.25
53717883-3717883107.705109.98
63662899-3662899106.112108.34
600min13819724-3819724110.656112.081.45113.42114.861.43
23870581-3870581112.129114.93
33820704-3820704110.684113.46
43874817-3874817112.252115.02
53972102-3972102115.070117.88
63854432-3854432111.661114.42
720min13888597-3888597112.651114.411.44115.97117.751.41
24024448-4024448116.586119.95
34007914-4007914116.107119.43
43918150-3918150113.507116.84
53956065-3956065114.605117.99
63900991-3900991113.010116.33
极限13979330-3979330115.279115.490.99119.16119.400.98
23986997-3986997115.501119.45
33981884-3981884115.353119.26
44005532-4005532116.038119.94
54042928-4042928117.122121.08
63922046-3922046113.620117.51
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%
112.002914528712289582893328887289270.54
212.022978729650297180.33
单位质量响应值RSD%判断
2410.582472.381.79数据可信
供试品溶液-2025081521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%
5min136468-3646896.08994.692.4996.0994.692.49
236601-3660196.44096.44
336251-3625195.51795.52
434199-3419990.11190.11
535816-3581694.37194.37
636278-3627895.58895.59
10min136799-3679996.96197.112.4797.4497.582.47
237878-3787899.804100.29
336691-3669196.67797.15
435223-3522392.80993.26
537423-3742398.60599.08
637121-3712197.81098.29
15min137666-3766699.24697.691.66100.2198.651.66
237529-3752998.88599.87
337519-3751998.85899.82
436175-3617595.31796.23
536509-3650996.19797.16
637054-3705497.63398.60
20min137301-3730198.28497.712.0599.7599.152.04
237252-3725298.15599.63
337929-3792999.939101.39
436012-3601294.88896.28
536320-3632095.69997.15
637674-3767499.267100.72
30min137999-37999100.12398.351.82102.08100.291.82
237235-3723598.110100.08
337960-37960100.020101.98
436224-3622495.44697.31
536947-3694797.35199.28
637601-3760199.074101.03
45min136939-3693997.33097.021.4899.7899.451.48
237212-3721298.049100.51
337492-3749298.787101.24
436183-3618395.33897.68
536156-3615695.26797.68
636943-3694397.34199.79
60min136494-3649496.15896.441.4899.1099.351.47
236978-3697897.433100.38
336457-3645796.06099.01
436199-3619995.38098.20
536002-3600294.86197.75
637476-3747698.745101.68
120min137220-3722098.07196.621.35101.49100.011.34
236740-3674096.806100.24
337197-3719798.010101.44
436440-3644096.01599.31
535928-3592894.66698.03
636482-3648296.12699.55
180min137253-3725398.15796.591.92102.07100.461.90
237180-3718097.965101.88
337078-3707897.696101.62
435744-3574494.18197.96
535781-3578194.27998.11
636903-3690397.235101.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137014-3701497.52896.281.22101.93100.641.22
236856-3685697.111101.52
336439-3643996.013100.42
435819-3581994.37998.63
536299-3629995.64499.95
636805-3680596.977101.37
360min136406-3640695.92696.090.66100.82100.930.65
236727-3672796.772101.67
336545-3654596.292101.18
436657-3665796.587101.31
536050-3605094.98899.77
636421-3642195.965100.84
480min136735-3673596.79395.570.92102.16100.900.92
236142-3614295.230100.61
336397-3639795.902101.27
435948-3594894.71999.92
535900-3590094.59299.85
636510-3651096.200101.56
600min135854-3585494.47194.671.04100.32100.481.04
236207-3620795.401101.26
336141-3614195.227101.08
435240-3524092.85398.53
535919-3591994.643100.38
636223-3622395.444101.28
720min135707-3570794.08494.022.13100.41100.302.07
236781-3678196.914103.24
336251-3625195.517101.84
434680-3468091.37897.52
535105-3510592.49898.70
635583-3558393.757100.07
极限136299-3629995.64494.831.26102.44101.571.26
236483-3648396.129102.94
336262-3626295.546102.35
435242-3524292.85999.46
535852-3585294.466101.13
635799-3579994.326101.11
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