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%
110.174103309409707340979544095881409288040974190.10
210.134093947409869540963210.09
单位质量响应值RSD%判断
402892.72404375.220.26数据可信
中间条件6月-供试品溶液-2025081621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%
5min1187220-1872204.6384.946.634.644.946.57
2219667-2196675.4425.44
3201651-2016514.9965.00
4188737-1887374.6764.68
5189519-1895194.6954.70
6209231-2092315.1845.18
10min1364091-3640919.0208.815.029.048.845.01
2361127-3611278.9478.97
3360732-3607328.9378.96
4323565-3235658.0168.04
5375529-3755299.3049.33
6349305-3493058.6548.68
15min1494922-49492212.26212.434.0912.3312.504.08
2483363-48336311.97512.05
3514526-51452612.74712.82
4474212-47421211.74911.81
5518690-51869012.85112.92
6524366-52436612.99113.06
20min1644206-64420615.96015.752.9716.0915.882.98
2627621-62762115.54915.68
3644914-64491415.97816.11
4605872-60587215.01015.13
5630217-63021715.61415.75
6660910-66091016.37416.51
30min1840036-84003620.81220.492.2021.0220.702.19
2816687-81668720.23320.44
3850326-85032621.06721.28
4801210-80121019.85020.05
5836067-83606720.71420.93
6818504-81850420.27820.49
45min11092431-109243127.06526.762.5827.3827.072.57
21079767-107976726.75127.06
31108961-110896127.47527.79
41032454-103245425.57925.88
51066358-106635826.41926.73
61100297-110029727.26027.58
60min11300707-130070732.22531.993.5132.6732.443.47
21293496-129349632.04632.49
31320764-132076432.72233.18
41277646-127764631.65432.08
51211187-121118730.00730.46
61343268-134326833.27933.73
120min11917743-191774347.51247.023.4548.1247.633.40
21902058-190205847.12347.73
31770123-177012343.85544.47
41921482-192148247.60548.19
51919545-191954547.55748.15
61957551-195755148.49849.12
180min12400962-240096259.48459.741.4160.3360.581.40
22378728-237872858.93359.77
32431403-243140360.23861.08
42431030-243103060.22961.05
52369504-236950458.70459.54
62456616-245661660.86361.73
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12761895-276189568.42668.350.8069.5769.480.79
22762954-276295468.45269.59
32741981-274198167.93369.07
42789593-278959369.11270.23
52726712-272671267.55468.68
62768866-276886668.59969.77
360min13242979-324297980.34581.090.9381.8382.570.93
23243623-324362380.36181.84
33286111-328611181.41382.89
43272044-327204481.06582.53
53268342-326834280.97382.44
63324476-332447682.36483.87
480min13620641-362064189.70188.661.3491.5990.541.32
23576306-357630688.60390.48
33501427-350142786.74888.63
43563499-356349988.28690.16
53572204-357220488.50190.37
63636654-363665490.09892.02
600min13744432-374443292.76893.721.3995.1196.051.37
23734108-373410892.51394.83
33794906-379490694.01996.34
43855451-385545195.51997.83
53736810-373681092.57994.89
63831878-383187894.93597.31
720min13857342-385734295.56695.451.2898.3798.251.27
23815370-381537094.52697.31
33852453-385245395.44598.24
43827114-382711494.81797.61
53817593-381759394.58197.36
63946277-394627797.769100.62
极限13853931-385393195.48194.741.1498.7698.021.13
23792738-379273893.96597.22
33800478-380047894.15797.42
43857624-385762495.57398.84
53765282-376528293.28596.54
63873883-387388395.97599.31
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%
1 12.613369033713337243372933625336960.13
2 12.693382333890338560.14
单位质量响应值RSD%判断
2672.162667.930.12数据可信
中间条件6月-供试品溶液-2025081621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%
5min138199-3819992.01991.781.5392.0291.781.53
238639-3863993.07993.08
337816-3781691.09791.10
437558-3755890.47590.48
537490-3749090.31190.31
638897-3889793.70193.70
10min138059-3805991.68288.992.6592.1489.452.64
236921-3692188.94189.41
337684-3768490.77991.23
435488-3548885.48985.94
537377-3737790.03990.49
636120-3612087.01187.48
15min136109-3610986.98589.913.2487.9090.813.21
236067-3606786.88487.79
337392-3739290.07590.98
436886-3688688.85689.74
538635-3863593.07093.97
638848-3884893.58394.49
20min138171-3817191.95292.110.9893.3193.460.97
237639-3763990.67092.01
338694-3869493.21294.57
438052-3805291.66592.99
538379-3837992.45393.82
638491-3849192.72394.09
30min138115-3811591.81790.841.7993.6392.651.76
236943-3694388.99490.79
338078-3807891.72893.55
437673-3767390.75292.53
538550-3855092.86594.69
636894-3689488.87690.71
45min137756-3775690.95290.951.4593.2293.221.44
237434-3743490.17792.42
338331-3833192.33794.62
436949-3694989.00891.24
537676-3767690.76093.05
638391-3839192.48294.76
60min137755-3775590.95090.493.1593.6893.223.06
237391-3739190.07392.77
338386-3838692.47095.22
437656-3765690.71193.39
535396-3539685.26788.01
638805-3880593.47996.22
120min137177-3717789.55789.023.7292.7492.193.57
236976-3697689.07392.22
334258-3425882.52685.73
437986-3798691.50694.64
537562-3756290.48593.66
637759-3775990.95994.17
180min137236-3723689.70090.741.5893.3394.361.52
237177-3717789.55793.15
337913-3791391.33094.95
438629-3862993.05596.65
537131-3713189.44793.07
637910-3791091.32394.99
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137072-3707289.30590.131.7293.3894.201.64
237246-3724689.72493.76
337379-3737990.04494.12
438668-3866893.14997.21
536842-3684288.75092.82
637272-3727289.78693.91
360min136584-3658488.12990.081.4092.6594.601.35
236931-3693188.96593.45
337760-3776090.96295.49
437816-3781691.09795.62
537448-3744890.21094.73
637814-3781491.09295.66
480min136727-3672788.47389.000.6693.4493.980.64
236935-3693588.97593.91
336648-3664888.28393.27
437028-3702889.19994.18
537027-3702789.19694.16
637318-3731889.89794.92
600min136167-3616787.12489.251.9492.5394.671.84
236570-3657088.09593.47
337595-3759590.56495.99
438111-3811191.80797.23
536700-3670088.40893.82
637157-3715789.50994.98
720min136377-3637787.63088.651.1293.4794.521.08
236366-3636687.60493.42
337248-3724889.72995.61
436798-3679888.64494.53
536698-3669888.40494.26
637309-3730989.87595.80
极限136245-3624587.31288.041.4293.5994.351.35
236117-3611787.00493.26
336744-3674488.51494.84
437264-3726489.76796.09
535964-3596486.63592.93
636950-3695089.01195.38
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%
110.174132703412800041241064128958411324141254020.19
210.134117842413084741243440.23
单位质量响应值RSD%判断
405644.25407141.560.27数据可信
中间条件6月-供试品溶液-2025081621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%
5min1187946-1879464.6254.664.184.624.664.22
2195391-1953914.8084.81
3175668-1756684.3234.32
4189469-1894694.6624.66
5198630-1986304.8884.89
6188507-1885074.6394.64
10min1376109-3761099.2559.134.329.289.164.29
2360582-3605828.8738.90
3352217-3522178.6678.69
4396206-3962069.7499.77
5361866-3618668.9048.93
6379614-3796149.3419.36
15min1526378-52637812.95212.732.6913.0212.802.69
2514844-51484412.66912.74
3496332-49633212.21312.28
4530591-53059113.05613.13
5506902-50690212.47312.54
6529735-52973513.03513.10
20min1662746-66274616.30815.783.0616.4415.923.06
2644250-64425015.85315.98
3613964-61396415.10815.23
4648048-64804815.94616.08
5621815-62181515.30115.43
6658119-65811916.19416.33
30min1856237-85623721.06920.742.0121.2820.952.02
2836955-83695520.59520.81
3816523-81652320.09220.29
4849129-84912920.89421.11
5834884-83488420.54420.75
6863138-86313821.23921.46
45min11145814-114581428.19527.572.5528.5227.882.55
21099523-109952327.05627.37
31088610-108861026.78727.09
41148080-114808028.25128.57
51095524-109552426.95727.27
61144561-114456128.16428.49
60min11348567-134856733.18432.591.6433.6533.041.65
21321485-132148532.51832.97
31297825-129782531.93532.37
41336827-133682732.89533.36
51299937-129993731.98732.43
61341128-134112833.00133.46
120min12011173-201117349.48948.871.4350.1249.491.43
21980213-198021348.72749.34
31975438-197543848.60949.20
41996645-199664549.13149.76
51938313-193831347.69648.30
62014482-201448249.57050.20
180min12528201-252820162.21161.111.3963.0961.981.40
22450939-245093960.31061.17
32456769-245676960.45361.29
42507600-250760061.70462.58
52451261-245126160.31861.16
62507122-250712261.69262.57
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12795160-279516068.78069.141.4669.9770.301.43
22750212-275021267.67468.83
32837713-283771369.82770.97
42865947-286594770.52271.70
52821291-282129169.42370.57
62787929-278792968.60269.79
360min13375561-337556183.06283.170.9784.5984.680.96
23338309-333830982.14583.64
33406553-340655383.82485.31
43423253-342325384.23585.77
53349621-334962182.42383.92
63386729-338672983.33784.86
480min13713647-371364791.38191.410.9193.3393.330.91
23694868-369486890.91992.83
33730280-373028091.79093.70
43768816-376881692.73994.69
53669030-366903090.28392.19
63711186-371118691.32093.26
600min13887238-388723895.65395.590.6398.0697.980.63
23842034-384203494.54096.90
33897644-389764495.90998.28
43915478-391547896.34798.77
53885791-388579195.61797.97
63879996-387999695.47497.88
720min13923326-392332696.54197.491.1299.42100.351.10
23957130-395713097.372100.21
33960805-396080597.463100.31
44046302-404630299.567102.47
53954750-395475097.314100.15
63928646-392864696.67199.55
极限13921655-392165596.49997.942.7499.86101.292.65
23924990-392499096.58199.90
34198294-4198294103.307106.64
43970421-397042197.699101.10
53952632-395263297.262100.58
63913064-391306496.28899.65
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%
1 12.613405834294338273439933995341150.68
2 12.693407033962340160.23
单位质量响应值RSD%判断
2705.392680.540.66数据可信
中间条件6月-供试品溶液-2025081621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%
5min137021-3702188.42588.882.8088.4288.882.80
238476-3847691.90091.90
335391-3539184.53184.53
437874-3787490.46290.46
537342-3734289.19189.19
637176-3717688.79588.79
10min137942-3794290.62491.822.5091.0792.262.50
238277-3827791.42591.88
337241-3724188.95089.37
440119-4011995.82496.28
538396-3839691.70992.15
638671-3867192.36692.81
15min138424-3842491.77692.261.5092.6793.171.51
238999-3899993.14994.07
337811-3781190.31191.18
439460-3946094.25095.18
538307-3830791.49692.40
638769-3876992.60093.51
20min138476-3847691.90091.821.8393.2593.181.83
238972-3897293.08594.47
337546-3754689.67991.00
439493-3949394.32995.73
537988-3798890.73492.10
638181-3818191.19592.56
30min138023-3802390.81891.531.6392.6393.351.64
238706-3870692.44994.30
337492-3749289.55091.32
439298-3929893.86395.74
538339-3833991.57393.39
638059-3805990.90492.73
45min138474-3847491.89592.321.8994.1694.601.88
238756-3875692.56994.88
338122-3812291.05493.27
440062-4006295.68898.03
538348-3834891.59493.87
638157-3815791.13893.42
60min138132-3813291.07891.311.7193.8194.061.70
238605-3860592.20894.98
337792-3779290.26692.94
439364-3936494.02196.84
537653-3765389.93492.67
637837-3783790.37493.11
120min138235-3823591.32491.591.2294.5194.791.22
238548-3854892.07295.31
338152-3815291.12694.25
439053-3905393.27896.57
537650-3765089.92793.11
638430-3843091.79094.98
180min138692-3869292.41692.051.3396.0595.711.33
238295-3829591.46795.16
337999-3799990.76094.34
439408-3940894.12697.88
538150-3815091.12194.75
638699-3869992.43296.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137183-3718388.81190.251.8692.9194.371.82
237565-3756589.72493.88
337993-3799390.74694.78
438989-3898993.12597.35
537937-3793790.61294.70
637050-3705088.49492.60
360min137677-3767789.99191.081.4194.5495.651.41
238267-3826791.40196.00
337967-3796790.68495.17
439155-3915593.52298.22
537847-3784790.39794.94
637887-3788790.49395.04
480min137738-3773890.13791.381.3695.1396.411.36
238734-3873492.51697.57
337911-3791190.55095.49
439010-3901093.17598.34
538316-3831691.51896.51
637852-3785290.40995.41
600min137406-3740689.34490.091.4794.7995.571.46
237722-3772290.09995.62
337352-3735289.21594.61
438754-3875492.56498.19
537800-3780090.28595.73
637265-3726589.00794.46
720min136566-3656687.33889.572.4293.2395.502.36
238177-3817791.18697.16
337036-3703688.46094.30
438950-3895093.03299.12
537448-3744889.44495.34
636822-3682287.94993.85
极限136819-3681987.94289.752.7094.2796.132.54
237711-3771190.07396.50
339202-3920293.63499.91
438249-3824991.35897.91
536904-3690488.14594.49
636573-3657387.35593.69
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