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%
110.204066954407554040665534053994406648640659050.19
210.274128664413610741323860.13
单位质量响应值RSD%判断
398618.14402374.490.67数据可信
中间条件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%
5min1189574-1895744.7344.9715.684.734.9715.73
2165191-1651914.1254.12
3197653-1976534.9354.94
4174706-1747064.3624.36
5251440-2514406.2786.28
6216426-2164265.4045.40
10min1349516-3495168.7279.054.738.759.084.70
2347124-3471248.6688.69
3364137-3641379.0929.12
4388975-3889759.7139.73
5375926-3759269.3879.42
6349148-3491488.7188.75
15min1498410-49841012.44512.692.9712.5112.762.98
2492845-49284512.30612.37
3520077-52007712.98613.06
4531316-53131613.26713.34
5510180-51018012.73912.82
6496970-49697012.40912.48
20min1632080-63208015.78315.831.5815.9115.961.60
2614536-61453615.34515.47
3641710-64171016.02316.16
4638950-63895015.95416.09
5638989-63898915.95516.10
6636802-63680215.90116.03
30min1822784-82278420.54521.222.4720.7521.432.46
2876856-87685621.89522.10
3853959-85395921.32321.54
4852678-85267821.29121.51
5864113-86411321.57721.80
6827447-82744720.66120.87
45min11095628-109562827.35727.801.6427.6728.121.63
21104696-110469627.58427.90
31126258-112625828.12228.44
41142508-114250828.52828.85
51114398-111439827.82628.16
61097526-109752627.40527.72
60min11326478-132647833.12233.440.9633.5733.900.95
21355805-135580533.85434.30
31354663-135466333.82534.29
41329957-132995733.20833.67
51332978-133297833.28433.75
61335088-133508833.33733.79
120min11972906-197290649.26349.771.0149.8850.391.01
21997853-199785349.88650.50
31984189-198418949.54450.18
42023817-202381750.53451.17
52006018-200601850.08950.72
61973764-197376449.28449.90
180min12474212-247421261.78061.262.3762.6462.142.33
22550004-255000463.67264.54
32388068-238806859.62960.51
42410075-241007560.17961.06
52427433-242743360.61261.50
62471343-247134361.70862.57
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12824955-282495570.53870.810.8671.7171.990.85
22865139-286513971.54172.73
32842891-284289170.98672.16
42860314-286031471.42172.61
52810922-281092270.18871.38
62810088-281008870.16771.34
360min13357890-335789083.84584.101.2485.3785.641.23
23440528-344052885.90887.45
33311942-331194282.69884.23
43377040-337704084.32385.87
53358081-335808183.85085.39
63364115-336411584.00085.53
480min13659910-365991091.38692.271.1693.3394.231.15
23767756-376775694.07996.05
33711313-371131392.67094.62
43687796-368779692.08394.05
53698420-369842092.34894.31
63647596-364759691.07993.02
600min13897792-389779297.32697.300.3899.7299.710.37
23886573-388657397.04699.49
33883579-388357996.97199.38
43922627-392262797.946100.37
53887539-388753997.07099.49
63901622-390162297.42299.82
720min13951385-395138598.66498.811.17101.55101.711.15
24037006-4037006100.802103.73
33965744-396574499.023101.92
43953458-395345898.716101.63
53894420-389442097.242100.15
63940672-394067298.397101.28
极限13956116-395611698.78398.970.50102.16102.370.49
23978292-397829299.336102.77
33976357-397635799.288102.68
43985932-398593299.527102.93
53936007-393600798.280101.67
63949251-394925198.611101.99
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 12.613351033305332013336933134333040.45
2 12.743380833533336700.58
单位质量响应值RSD%判断
2641.082642.860.05数据可信
中间条件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%
5min136604-3660489.11490.111.3489.1190.111.34
236367-3636788.53788.54
337341-3734190.90990.91
437727-3772791.84891.85
536938-3693889.92789.93
637095-3709590.31090.31
10min137640-3764091.63692.040.7692.0892.490.77
237365-3736590.96791.41
337777-3777791.97092.42
438030-3803092.58693.05
538175-3817592.93993.39
637847-3784792.14092.59
15min138269-3826993.16892.641.5794.0793.561.56
237994-3799492.49893.40
338625-3862594.03494.95
438501-3850193.73394.65
536959-3695989.97990.89
637977-3797792.45793.37
20min138198-3819892.99592.441.1994.3693.821.17
237603-3760391.54692.91
338015-3801592.54993.93
438054-3805492.64494.04
537339-3733990.90492.27
638612-3861294.00395.38
30min137009-3700990.10091.871.2091.9393.701.17
238336-3833693.33195.15
337807-3780792.04393.89
437609-3760991.56193.42
538030-3803092.58694.40
637619-3761991.58593.43
45min137488-3748891.26692.300.9793.5594.600.95
237918-3791892.31394.60
338413-3841393.51895.83
438275-3827593.18295.49
537631-3763191.61593.90
637759-3775991.92694.23
60min137480-3748091.24791.951.7793.9994.711.72
238563-3856393.88496.63
338626-3862694.03796.81
437615-3761591.57694.35
537053-3705390.20792.95
637279-3727990.75893.52
120min137430-3743091.12590.880.7594.3294.100.73
237062-3706290.22993.44
337116-3711690.36193.61
437684-3768491.74494.98
537080-3708090.27393.46
637605-3760591.55194.77
180min137261-3726190.71490.522.2894.3794.192.19
238591-3859193.95297.62
336724-3672489.40693.10
436606-3660689.11992.81
536273-3627388.30891.95
637639-3763991.63495.31
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min136788-3678889.56290.711.2893.6794.841.25
237478-3747891.24295.38
337808-3780892.04596.19
437693-3769391.76595.91
536660-3666089.25193.33
637139-3713990.41794.55
360min136792-3679289.57290.330.8194.1394.900.78
237449-3744991.17195.76
336777-3677789.53594.14
437422-3742291.10695.70
536973-3697390.01394.54
637198-3719890.56095.14
480min136152-3615288.01490.141.4593.0295.171.38
237672-3767291.71496.76
337328-3732890.87795.93
436920-3692089.88494.94
537319-3731990.85595.83
636762-3676289.49994.54
600min137440-3744091.15090.391.1496.5995.871.08
236872-3687289.76795.27
337325-3732590.87096.38
437699-3769991.78097.28
536622-3662289.15894.59
636811-3681189.61895.10
720min136470-3647088.78889.411.4294.6995.341.37
237151-3715190.44696.40
337232-3723290.64396.60
437102-3710290.32796.29
535925-3592587.46193.34
636467-3646788.78194.71
极限136714-3671489.38289.130.8995.7295.510.86
236874-3687489.77296.18
337048-3704890.19596.61
436424-3642488.67695.09
536172-3617288.06394.38
636435-3643588.70395.08
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%
110.204067741406953040671994061224406292440657240.09
210.274108575410319241058840.10
单位质量响应值RSD%判断
398600.39399793.960.22数据可信
中间条件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%
5min1257707-2577076.4566.428.696.466.428.69
2288535-2885357.2287.23
3232212-2322125.8175.82
4265862-2658626.6606.66
5262932-2629326.5876.59
6229524-2295245.7505.75
10min1414618-41461810.38610.527.8610.4210.567.83
2414765-41476510.39010.43
3400182-40018210.02510.05
4471353-47135311.80811.84
5377080-3770809.4469.48
6442825-44282511.09311.12
15min1537602-53760213.46713.994.6013.5514.074.55
2539916-53991613.52513.61
3598053-59805314.98115.06
4535781-53578113.42113.51
5559260-55926014.01014.09
6579245-57924514.51014.59
20min1694632-69463217.40117.154.1117.5517.304.07
2709665-70966517.77717.93
3638125-63812515.98516.14
4713571-71357117.87518.03
5680554-68055417.04817.20
6670140-67014016.78716.94
30min1870212-87021221.79921.871.6822.0422.111.68
2874133-87413321.89722.14
3847035-84703521.21921.45
4879729-87972922.03822.29
5874877-87487721.91622.15
6891193-89119322.32522.57
45min11093635-109363527.39628.282.4827.7428.632.47
21173448-117344829.39529.75
31113002-111300227.88128.22
41146013-114601328.70829.07
51130218-113021828.31228.66
61118063-111806328.00828.36
60min11317299-131729932.99933.691.4633.4834.181.44
21355845-135584533.96434.47
31355177-135517733.94834.43
41322000-132200033.11733.62
51357741-135774134.01234.50
61360179-136017934.07334.57
120min11956520-195652049.01150.714.0549.6651.374.01
22168165-216816554.31354.98
32072493-207249351.91752.57
41961969-196196949.14849.82
51983239-198323949.68150.34
62003791-200379150.19650.86
180min12449567-244956761.36261.311.0462.2662.231.04
22489793-248979362.37063.31
32412495-241249560.43461.34
42455098-245509861.50162.41
52437129-243712961.05161.96
62441706-244170661.16662.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12802116-280211670.19469.311.4671.4070.531.45
22805395-280539570.27671.53
32801270-280127070.17371.38
42728940-272894068.36169.58
52744021-274402168.73969.95
62719066-271906668.11469.33
360min13240690-324069081.18082.131.3882.7383.701.37
23331599-333159983.45885.06
33337128-333712883.59685.16
43264608-326460881.78083.34
53232282-323228280.97082.52
63265274-326527481.79683.36
480min13522861-352286188.24989.742.2690.2191.712.22
23588401-358840189.89191.91
33593560-359356090.02092.00
43503679-350367987.76889.74
53554225-355422589.03590.99
63730839-373083993.45995.43
600min13639834-363983491.17992.661.2393.5895.081.22
23739772-373977293.68396.15
33717859-371785993.13495.56
43693532-369353292.52494.94
53652165-365216591.48893.89
63749380-374938093.92396.36
720min13775520-377552094.57894.730.8997.4397.620.89
23797164-379716495.12098.06
33801698-380169895.23498.13
43737391-373739193.62396.50
53750925-375092593.96296.82
63826922-382692295.86698.77
极限13740265-374026593.69594.631.9597.0297.991.91
23869389-386938996.929100.35
33787935-378793594.88998.26
43669379-366937991.91995.26
53751972-375197293.98897.32
63845657-384565796.33599.72
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%
1 12.613332033621333013346333435334280.39
2 12.743385433907338800.12
单位质量响应值RSD%判断
2650.912659.340.23数据可信
中间条件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%
5min136529-3652988.49189.221.6188.4989.221.61
236977-3697789.57689.58
336527-3652788.48688.49
436965-3696589.54789.55
536133-3613387.53287.53
637849-3784991.68991.69
10min137438-3743890.69390.670.9991.1491.110.99
237435-3743590.68691.13
337969-3796991.98092.42
437505-3750590.85591.30
536811-3681189.17489.61
637408-3740890.62091.08
15min137587-3758791.05490.590.8091.9591.490.79
237546-3754690.95591.86
337685-3768591.29292.19
437475-3747590.78391.68
537162-3716290.02590.91
636910-3691089.41490.33
20min137890-3789091.78890.611.5693.1491.961.53
237590-3759091.06192.42
337049-3704989.75191.11
437790-3779091.54692.90
537719-3771991.37492.71
636380-3638088.13089.49
30min137713-3771391.35990.850.6193.1792.650.61
237483-3748390.80292.61
337397-3739790.59492.40
437837-3783791.66093.47
537320-3732090.40792.20
637264-3726490.27292.07
45min136638-3663888.75589.700.7791.0291.960.75
237185-3718590.08092.35
336749-3674989.02491.28
437395-3739590.58992.86
537088-3708889.84592.09
637119-3711989.92092.17
60min136429-3642988.24989.921.5090.9692.621.45
236684-3668488.86791.58
338026-3802692.11894.82
437055-3705589.76592.49
537184-3718490.07892.77
637328-3732890.42793.13
120min137215-3721590.15391.912.8893.3095.072.79
239910-3991096.68299.84
338547-3854793.38096.55
437210-3721090.14193.31
537442-3744290.70393.85
637315-3731590.39593.55
180min136802-3680289.15289.421.2692.7693.041.22
236888-3688889.36193.00
336623-3662388.71992.35
437825-3782591.63195.26
536765-3676589.06392.66
636562-3656288.57192.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137040-3704089.72988.091.9293.7892.151.84
235803-3580386.73290.82
337080-3708089.82693.90
436775-3677589.08793.17
536053-3605387.33891.38
635428-3542885.82489.87
360min136280-3628087.88888.001.9992.3992.501.90
235963-3596387.12091.64
337572-3757291.01895.54
436518-3651888.46492.99
536217-3621787.73592.21
635402-3540285.76190.24
480min135706-3570686.49786.941.2291.4391.881.14
235482-3548285.95590.91
336057-3605787.34892.33
435491-3549185.97790.95
535951-3595187.09192.01
636639-3663988.75893.66
600min134571-3457183.74885.171.2789.1290.551.21
234993-3499384.77090.16
335378-3537885.70391.12
435881-3588186.92192.32
534960-3496084.69090.04
635166-3516685.18990.54
720min135263-3526385.42484.641.1691.2190.441.10
234511-3451183.60389.42
335158-3515885.17091.02
435296-3529685.50491.34
535045-3504584.89690.67
634356-3435683.22789.00
极限134718-3471884.10484.790.7990.3291.020.75
235364-3536485.66991.90
335233-3523385.35291.62
434740-3474084.15790.42
534819-3481984.34990.55
635123-3512385.08591.28
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