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%
110.204144906413784741399804118818411554441314190.33
210.274110740412414841174440.24
单位质量响应值RSD%判断
405041.08400919.570.73数据可信
加速6月-供试品溶液-2025081721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%
5min1173926-1739264.3164.6810.194.324.6810.16
2168730-1687304.1874.19
3212477-2124775.2735.27
4178573-1785734.4314.43
5186444-1864444.6274.63
6212327-2123275.2695.27
10min1356122-3561228.8379.192.868.869.212.85
2372282-3722829.2389.26
3380296-3802969.4379.46
4365676-3656769.0759.10
5363348-3633489.0179.04
6383900-3839009.5279.55
15min1532359-53235913.21113.041.5413.2813.111.54
2518995-51899512.87912.95
3529121-52912113.13113.20
4512304-51230412.71312.78
5531425-53142513.18813.26
6528903-52890313.12513.20
20min1641085-64108515.90916.233.3616.0416.363.35
2623298-62329815.46815.60
3673059-67305916.70216.84
4674472-67447216.73816.87
5639921-63992115.88016.01
6671627-67162716.66716.81
30min1859181-85918121.32121.621.6721.5321.841.68
2848359-84835921.05321.26
3885402-88540221.97222.19
4876904-87690421.76121.98
5875831-87583121.73421.95
6882610-88261021.90322.13
45min11125350-112535027.92627.961.8928.2428.281.89
21094408-109440827.15927.47
31144887-114488728.41128.74
41110180-111018027.55027.87
51135837-113583728.18728.51
61149438-114943828.52428.86
60min11342455-134245533.31433.351.1333.7733.821.13
21325574-132557432.89533.35
31351899-135189933.54834.02
41328386-132838632.96533.43
51365787-136578733.89334.36
61349173-134917333.48133.96
120min12011188-201118849.90949.830.6450.5350.460.62
22005135-200513549.75950.37
31998441-199844149.59350.24
42019605-201960550.11850.74
52023967-202396750.22650.86
61990101-199010149.38650.03
180min12495369-249536961.92461.850.5262.8062.730.53
22474062-247406261.39662.26
32509061-250906162.26463.15
42481417-248141761.57862.45
52493037-249303761.86762.75
62501552-250155262.07862.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12914060-291406072.31571.320.7573.5072.510.75
22856425-285642570.88472.05
32874780-287478071.34072.54
42869109-286910971.19972.38
52854506-285450670.83772.03
62875885-287588571.36772.57
360min13436406-343640685.27784.252.0586.8285.802.02
23405998-340599884.52286.05
33430846-343084685.13986.70
43261441-326144180.93582.48
53384923-338492383.99985.55
63450313-345031385.62287.18
480min13762593-376259393.37292.810.8895.3494.770.87
23679288-367928891.30493.25
33747992-374799293.00994.99
43772151-377215193.60995.55
53730809-373080992.58394.55
63745883-374588392.95794.94
600min14001043-400104399.28996.981.65101.7399.421.62
23831682-383168295.08697.49
33932505-393250597.588100.04
43861340-386134095.82298.24
53870350-387035096.04698.48
63951832-395183298.068100.52
720min14018909-401890999.73299.752.02102.67102.671.98
23920846-392084697.299100.18
34102961-4102961101.818104.76
43970384-397038498.528101.42
53977492-397749298.704101.61
64128340-4128340102.448105.39
极限14027014-402701499.93398.621.28103.37102.041.25
23880223-388022396.29199.66
33971572-397157298.558102.00
43997897-399789799.211102.60
53998279-399827999.220102.62
63970495-397049598.531101.98
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 12.613541935043350313495234878350650.60
2 12.743505134913349820.28
单位质量响应值RSD%判断
2780.732745.840.90数据可信
加速6月-供试品溶液-2025081721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%
5min137803-3780387.99686.871.5688.0086.861.56
236417-3641784.77084.77
336775-3677585.60385.60
437577-3757787.47087.47
537523-3752387.34487.34
637811-3781188.01588.01
10min138127-3812788.75088.131.2289.1988.561.22
236970-3697086.05786.48
337851-3785188.10888.54
438250-3825089.03789.47
537889-3788988.19688.63
638073-3807388.62589.06
15min139037-3903790.86988.022.0291.7588.892.00
237411-3741187.08487.94
337113-3711386.39087.26
437660-3766087.66388.55
538422-3842289.43790.31
637225-3722586.65187.53
20min138094-3809488.67487.751.2390.0189.061.22
237082-3708286.31887.61
338032-3803288.52989.83
437203-3720386.60087.92
538103-3810388.69590.02
637666-3766687.67788.99
30min137949-3794988.33687.860.9290.1289.610.91
237853-3785388.11389.83
337141-3714186.45588.20
438041-3804188.55090.30
537957-3795788.35590.12
637527-3752787.35489.11
45min137888-3788888.19487.760.8390.4289.960.83
237333-3733386.90289.06
337620-3762087.57089.75
437429-3742987.12689.32
537756-3775687.88790.10
638185-3818588.88591.08
60min138259-3825989.05887.391.8991.7290.021.85
237296-3729686.81689.41
336926-3692685.95588.57
437176-3717686.53789.17
538598-3859889.84792.50
637005-3700586.13988.77
120min137545-3754587.39686.541.2790.5189.611.24
237563-3756387.43890.47
336595-3659585.18488.23
437486-3748687.25890.32
537306-3730686.83989.94
636562-3656285.10788.17
180min137371-3737186.99186.881.0990.5490.381.05
237778-3777887.93891.41
336949-3694986.00889.48
437613-3761387.55491.06
537498-3749887.28690.82
636731-3673185.50188.99
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min138239-3823989.01186.582.0592.9990.511.98
237755-3775587.88491.79
336861-3686185.80389.70
437234-3723486.67290.61
537042-3704286.22590.19
636026-3602683.86087.78
360min138255-3825589.04885.902.9793.4790.272.84
237295-3729586.81491.16
336664-3666485.34589.67
434997-3499781.46585.84
537439-3743987.14991.55
636776-3677685.60689.94
480min137722-3772287.80886.281.3492.6891.081.31
237186-3718686.56091.34
336491-3649184.94289.70
437244-3724486.69591.47
537286-3728686.79391.63
636463-3646384.87789.64
600min138064-3806488.60486.021.6893.9191.241.64
236692-3669285.41090.62
336275-3627584.43989.62
436748-3674885.54090.75
537203-3720386.60091.87
636735-3673585.51090.70
720min137019-3701986.17185.370.9591.9291.030.91
236018-3601883.84189.48
336802-3680285.66691.27
436705-3670585.44091.08
536659-3665985.33391.04
636853-3685385.78591.40
极限137342-3734286.92384.732.0393.1190.821.96
236002-3600283.80489.86
335739-3573983.19289.22
436738-3673885.51791.59
537028-3702886.19292.32
635545-3554582.74088.79
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%
110.204133915411746741176924113755412311741211890.20
210.274139313413899641391540.01
单位质量响应值RSD%判断
404038.14403033.500.18数据可信
加速6月-供试品溶液-2025081721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%
5min1174136-1741364.3154.517.204.324.517.18
2179183-1791834.4404.44
3189462-1894624.6954.70
4170250-1702504.2194.22
5173245-1732454.2934.29
6204727-2047275.0735.07
10min1364814-3648149.0408.974.739.068.994.74
2380661-3806619.4339.46
3379342-3793429.4009.42
4338616-3386168.3918.41
5345907-3459078.5728.59
6362226-3622268.9769.00
15min1516372-51637212.79612.563.7212.8612.623.73
2534328-53432813.24113.31
3511092-51109212.66512.74
4479424-47942411.88111.94
5494755-49475512.26112.32
6504134-50413412.49312.56
20min1650420-65042016.11815.942.9816.2516.063.00
2652383-65238316.16716.30
3647007-64700716.03316.17
4619050-61905015.34115.46
5621287-62128715.39615.52
6668109-66810916.55616.69
30min1849524-84952421.05221.022.0721.2621.232.03
2850282-85028221.07121.29
3859708-85970821.30421.52
4872993-87299321.63421.83
5826757-82675720.48820.69
6830459-83045920.58020.80
45min11105383-110538327.39227.241.5427.7127.561.53
21103031-110303127.33427.66
31124370-112437027.86328.18
41075405-107540526.65026.96
51101851-110185127.30527.61
61086088-108608826.91427.23
60min11347488-134748833.39233.141.1633.8533.591.16
21348766-134876633.42433.88
31342713-134271333.27433.73
41309110-130911032.44132.88
51345872-134587233.35233.79
61329207-132920732.93933.39
120min11972505-197250548.88149.011.1949.5049.631.18
22001716-200171649.60450.23
32009935-200993549.80850.43
41973299-197329948.90049.50
51954245-195424548.42849.04
61954657-195465748.43849.06
180min12456570-245657060.87661.211.9461.7462.071.92
22512754-251275462.26963.14
32491454-249145461.74162.62
42464608-246460861.07561.92
52509892-250989262.19863.05
62384212-238421259.08359.94
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12833157-283315770.20869.852.9771.3871.022.91
22664394-266439466.02667.21
32859987-285998770.87372.06
42829899-282989970.12871.28
52913761-291376172.20673.37
62811831-281183169.68070.84
360min13406159-340615984.40883.790.8285.9385.300.81
23347408-334740882.95284.47
33388035-338803583.95985.50
43410929-341092984.52686.03
53385983-338598383.90885.43
63347842-334784282.96384.47
480min13703363-370336391.77392.261.4693.7294.201.44
23692077-369207791.49393.42
33746843-374684392.85094.81
43694326-369432691.54993.47
53822862-382286294.73496.68
63679007-367900791.16993.09
600min13919832-391983297.13796.421.0999.5498.821.08
23875853-387585396.04798.43
33921069-392106997.16899.59
43870649-387064995.91898.30
53935464-393546497.52599.94
63823549-382354994.75197.13
720min13979246-397924698.61097.930.98101.50100.810.96
23888482-388848296.36099.23
33952294-395229497.942100.85
43953598-395359897.974100.84
54000586-400058699.138102.04
63935797-393579797.533100.38
极限13969875-396987598.37796.991.10101.76100.361.07
23899267-389926796.62899.98
33869660-386966095.89499.29
43938942-393894297.611100.96
53940568-394056897.651101.05
63863873-386387395.75199.09
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 12.613467534821347023465734429346570.42
2 12.743514035177351580.08
单位质量响应值RSD%判断
2748.372759.650.29数据可信
加速6月-供试品溶液-2025081721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%
5min135921-3592183.89484.722.8183.8984.722.81
236895-3689586.16986.17
337311-3731187.14087.14
434576-3457680.75380.75
535915-3591583.88083.88
637042-3704286.51286.51
10min136872-3687286.11587.471.7486.5387.891.74
237585-3758587.78088.21
338109-3810989.00489.44
436497-3649785.23985.64
537565-3756587.73388.15
638078-3807888.93289.36
15min137959-3795988.65487.951.8889.5088.811.88
238020-3802088.79689.67
337513-3751387.61288.49
436428-3642885.07885.91
537515-3751587.61788.47
638510-3851089.94090.82
20min137484-3748487.54487.651.6588.8488.951.65
237617-3761787.85589.17
337701-3770188.05189.37
436731-3673185.78687.04
537091-3709186.62687.92
638551-3855190.03691.36
30min136829-3682986.01487.301.5287.7589.041.52
238169-3816989.14490.90
337654-3765487.94189.70
436826-3682686.00787.69
537018-3701886.45688.19
637783-3778388.24390.02
45min137098-3709886.64387.031.3188.8089.211.31
237263-3726387.02889.23
337341-3734187.21089.41
436425-3642585.07187.19
537819-3781988.32790.49
637640-3764087.90990.13
60min137513-3751387.61287.791.4890.2190.401.48
238125-3812589.04191.68
337160-3716086.78889.42
436842-3684286.04588.58
537599-3759987.81390.42
638300-3830089.45092.11
120min136284-3628484.74286.341.4087.7789.391.39
237342-3734287.21390.29
337349-3734987.22990.30
436772-3677285.88188.85
536514-3651485.27988.32
637552-3755287.70390.81
180min136724-3672485.76987.071.7489.2390.551.69
238152-3815289.10492.62
337372-3737287.28390.79
436702-3670285.71889.12
537940-3794088.60992.08
636792-3679285.92889.47
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min136228-3622884.61185.212.6888.5089.132.56
234851-3485181.39585.36
336958-3695886.31690.26
436234-3623484.62588.45
537739-3773988.14092.05
636893-3689386.16490.14
360min136544-3654485.34986.441.2189.6690.781.18
236594-3659485.46689.83
337151-3715186.76791.14
436805-3680585.95890.21
537696-3769688.03992.39
637273-3727387.05191.46
480min136708-3670885.73286.701.6090.4791.471.56
237161-3716186.79091.58
336978-3697886.36291.17
436412-3641285.04189.72
538131-3813189.05593.85
637333-3733387.19292.03
600min136363-3636384.92685.521.0090.0990.731.00
236679-3667985.66490.89
336538-3653885.33590.57
436175-3617584.48789.59
537242-3724286.97992.22
636707-3670785.73091.00
720min135766-3576683.53284.871.8289.1290.511.74
235838-3583883.70089.36
336049-3604984.19389.86
436088-3608884.28489.81
537401-3740187.35093.02
636898-3689886.17691.88
极限135790-3579083.58883.730.8789.5989.790.83
235964-3596483.99490.07
335407-3540782.69388.78
435759-3575983.51589.47
536354-3635484.90591.01
635829-3582983.67989.81
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