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%
110.284293310429538242912304296624429483042942750.05
210.284341123434168443414040.01
单位质量响应值RSD%判断
417731.03422315.560.78数据可信
供试品溶液-2025081721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%
5min1183792-1837924.3763.7410.164.383.7410.18
2158493-1584933.7743.77
3134336-1343363.1983.20
4151179-1511793.5993.60
5156436-1564363.7253.72
6157448-1574483.7493.75
10min1377449-3774498.9878.2310.659.018.2510.67
2399797-3997979.5199.54
3313174-3131747.4567.47
4305174-3051747.2667.28
5343573-3435738.1808.20
6334317-3343177.9607.98
15min1495846-49584611.80611.454.2911.8711.514.31
2496288-49628811.81611.88
3460527-46052710.96511.02
4451816-45181610.75710.81
5501018-50101811.92911.99
6480147-48014711.43211.49
20min1621659-62165914.80114.503.8614.9314.623.88
2620418-62041814.77114.90
3584754-58475413.92214.03
4576655-57665513.73013.84
5637581-63758115.18015.30
6613547-61354714.60814.72
30min1830207-83020719.76619.602.2919.9719.792.33
2841235-84123520.02920.23
3812703-81270319.35019.53
4792027-79202718.85719.03
5840926-84092620.02220.22
6822800-82280019.59019.78
45min11088034-108803425.90525.941.7526.2026.231.77
21115548-111554826.56026.86
31085421-108542125.84326.12
41059193-105919325.21825.49
51103097-110309726.26426.56
61086378-108637825.86526.15
60min11307490-130749031.13031.342.2131.5631.762.21
21350298-135029832.14932.58
31328643-132864331.63432.04
41268373-126837330.19930.60
51337183-133718331.83732.26
61305885-130588531.09231.51
120min11961648-196164846.70546.521.6647.2947.101.64
21981047-198104747.16747.76
31988016-198801647.33247.89
41922691-192269145.77746.33
51906840-190684045.40045.99
61964063-196406346.76247.33
180min12449671-244967158.32458.850.7459.1459.660.74
22476632-247663258.96659.79
32484375-248437559.15059.95
42463020-246302058.64259.42
52499157-249915759.50260.31
62458691-245869158.53959.34
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12841089-284108967.64367.841.6868.7568.941.66
22824574-282457467.25068.37
32911767-291176769.32670.42
42829560-282956067.36968.44
52900942-290094269.06870.18
62787722-278772266.37367.47
360min13334817-333481779.39880.881.5180.8582.321.49
23392621-339262180.77582.23
33395213-339521380.83682.28
43387188-338718880.64582.05
53490813-349081383.11284.57
63381143-338114380.50181.93
480min13763019-376301989.59389.240.3891.4491.090.39
23754647-375464789.39491.26
33736089-373608988.95290.80
43732275-373227588.86190.67
53764007-376400789.61791.49
63740252-374025289.05190.88
600min13800345-380034590.48293.121.4692.7795.401.42
23915585-391558593.22695.54
33914226-391422693.19395.48
43932053-393205393.61895.87
53945925-394592593.94896.27
63957559-395755994.22596.50
720min14006907-400690795.40095.021.7398.1497.781.68
24093687-409368797.466100.24
33951370-395137094.07896.83
44005335-400533595.36398.09
53886115-388611592.52495.31
64003067-400306795.30998.06
极限14201680-4201680100.03794.972.86103.2698.202.77
23943170-394317093.88397.15
33985444-398544494.88998.12
43859111-385911191.88195.08
53963233-396323394.36097.61
63979402-397940294.74597.97
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 12.643204432124320343212831974320610.21
2 12.643229432117322060.39
单位质量响应值RSD%判断
2536.472547.940.32数据可信
供试品溶液-2025081721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%
5min135814-3581490.61389.444.2390.6189.434.23
236613-3661392.63492.63
334656-3465687.68387.68
432870-3287083.16483.16
535151-3515188.93588.94
636988-3698893.58393.58
10min137858-3785895.78493.012.5096.2493.462.50
237625-3762595.19595.66
336012-3601291.11491.55
435895-3589590.81891.23
535933-3593390.91491.36
637256-3725694.26194.73
15min137101-3710193.86993.161.4994.8094.081.50
237397-3739794.61895.56
335958-3595890.97791.87
436413-3641392.12893.00
536842-3684293.21494.11
637225-3722594.18395.12
20min137158-3715894.01393.481.6395.4194.861.64
237198-3719894.11595.53
335982-3598291.03892.39
436662-3666292.75894.09
536903-3690393.36894.73
637772-3777295.56796.98
30min137201-3720194.12293.901.0995.9995.751.11
237488-3748894.84896.73
336819-3681993.15694.96
436608-3660892.62294.42
536923-3692393.41995.25
637647-3764795.25197.14
45min137101-3710193.86994.071.7996.2196.391.79
237997-3799796.13698.49
336272-3627291.77294.04
436804-3680493.11895.38
537008-3700893.63495.93
637905-3790595.90398.27
60min136961-3696193.51594.051.3796.3396.841.36
238186-3818696.61499.45
337061-3706193.76896.50
436767-3676793.02495.75
537066-3706693.78196.55
636992-3699293.59396.44
120min136800-3680093.10892.842.1696.3996.102.11
237120-3712093.91797.24
337227-3722794.18897.39
436575-3657592.53895.73
535179-3517989.00692.24
637269-3726994.29497.61
180min136596-3659692.59193.810.7896.3497.530.75
237295-3729594.36098.15
336879-3687993.30796.98
437353-3735394.50798.16
537167-3716794.03697.72
637172-3717294.04997.83
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min136345-3634591.95692.881.0696.1697.070.97
236763-3676393.01497.28
337093-3709393.84997.98
437063-3706393.77397.90
536863-3686393.26797.42
636142-3614291.44395.70
360min135895-3589590.81892.901.5095.4997.561.42
236870-3687093.28598.01
336359-3635991.99296.60
436921-3692193.41498.01
537512-3751294.90999.53
636759-3675993.00497.71
480min136357-3635791.98792.601.1897.1197.711.15
237025-3702593.67798.87
336394-3639492.08097.14
436923-3692393.41998.48
535952-3595290.96296.05
636937-3693793.45498.63
600min134657-3465787.68691.362.1793.2796.942.06
236490-3649092.32397.99
335989-3598991.05696.58
436707-3670792.87298.40
536055-3605591.22396.77
636757-3675792.99998.64
720min135832-3583290.65891.152.7596.6897.192.62
237145-3714593.980100.10
335559-3555989.96895.95
436749-3674992.97998.97
534394-3439487.02093.02
636476-3647692.28898.40
极限137025-3702593.67790.991.80100.1597.481.70
236024-3602491.14497.74
335885-3588590.79397.22
435130-3513088.88295.34
535520-3552089.86996.31
636189-3618991.56298.13
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%
110.284296791430248643009194292290429924142983450.10
210.284299791429889642993440.02
单位质量响应值RSD%判断
418126.95418224.120.02数据可信
供试品溶液-2025081721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%
5min1137911-1379113.2983.819.513.303.809.46
2156841-1568413.7513.75
3162012-1620123.8743.87
4180832-1808324.3244.32
5148449-1484493.5503.55
6168890-1688904.0394.04
10min1314438-3144387.5198.315.857.548.335.83
2359207-3592078.5908.61
3341932-3419328.1778.20
4371667-3716678.8888.91
5338818-3388188.1028.12
6359349-3593498.5938.61
15min1454156-45415610.86011.624.5110.9111.684.51
2511589-51158912.23412.30
3477631-47763111.42211.48
4475132-47513211.36211.43
5509029-50902912.17312.23
6487575-48757511.66011.72
20min1626653-62665314.98514.892.4415.0915.012.41
2614855-61485514.70314.83
3605927-60592714.49014.61
4625629-62562914.96115.08
5614455-61445514.69414.81
6649491-64949115.53215.65
30min1795056-79505619.01219.362.1919.2019.552.17
2837270-83727020.02220.22
3812513-81251319.43019.62
4821779-82177919.65219.85
5795672-79567219.02719.22
6794437-79443718.99819.20
45min11038919-103891924.84425.732.5425.1226.022.53
21064974-106497425.46725.76
31089320-108932026.04926.34
41119744-111974426.77727.07
51078127-107812725.78226.07
61065091-106509125.47025.76
60min11265562-126556230.26430.951.3930.6731.371.39
21305351-130535131.21531.64
31291803-129180330.89131.31
41304437-130443731.19431.62
51315277-131527731.45331.87
61283589-128358930.69531.12
120min11942788-194278846.45946.631.9647.0147.211.94
21964547-196454746.97947.56
31976368-197636847.26247.83
41975739-197573947.24747.83
51964785-196478546.98547.56
61876477-187647744.87345.45
180min12407030-240703057.56058.711.4458.3559.521.43
22445277-244527758.47559.29
32435540-243554058.24259.05
42477179-247717959.23860.06
52508947-250894759.99760.81
62456744-245674458.74959.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12815976-281597667.34067.681.0968.4168.781.09
22869781-286978168.62669.73
32788702-278870266.68767.79
42834497-283449767.78268.90
52860687-286068768.40969.52
62812560-281256067.25868.35
360min13282112-328211278.48680.441.9579.9081.881.93
23477441-347744183.15784.61
33377521-337752180.76882.20
43326700-332670079.55381.01
53370500-337050080.60082.05
63348570-334857080.07681.51
480min13624321-362432186.67088.290.9988.4790.130.99
23707781-370778188.66690.53
33717735-371773588.90490.74
43700261-370026188.48690.34
53721837-372183789.00290.86
63680830-368083088.02189.85
600min13838306-383830691.78791.380.8794.0293.660.83
23760540-376054089.92792.24
33857749-385774992.25294.53
43822857-382285791.41893.71
53831094-383109491.61493.91
63818284-381828491.30893.58
720min13865656-386565692.44193.480.8795.1496.220.86
23932669-393266994.04396.80
33942729-394272994.28497.03
43883402-388340292.86595.62
53941449-394144994.25397.01
63888742-388874292.99395.72
极限13875886-387588692.68692.942.3395.8496.152.26
23889960-388996093.02296.25
33925301-392530193.86797.08
43937063-393706394.14997.37
53974798-397479895.05198.28
63716904-371690488.88492.08
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 12.643197532126321613202331965320500.28
2 12.643220631956320810.56
单位质量响应值RSD%判断
2535.602538.050.07数据可信
供试品溶液-2025081721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%
5min133234-3323484.26390.923.9684.2690.923.96
236527-3652792.61292.61
336625-3662592.86192.86
437290-3729094.54794.55
535900-3590091.02391.02
635570-3557090.18690.19
10min135229-3522989.32193.502.3789.7493.952.38
237087-3708794.03294.50
337488-3748895.04995.51
437688-3768895.55696.03
536986-3698693.77694.23
636775-3677593.24193.69
15min135715-3571590.55493.491.9291.4294.421.92
236957-3695793.70394.64
336410-3641092.31693.26
437215-3721594.35795.31
537265-3726594.48495.41
637679-3767995.53396.45
20min135062-3506288.89893.182.3890.2294.572.37
236771-3677193.23194.63
336956-3695693.70095.10
437231-3723194.39795.82
536946-3694693.67595.07
637546-3754695.19696.59
30min137023-3702393.87092.782.3895.6494.632.34
237034-3703493.89895.77
336774-3677493.23995.11
437462-3746294.98396.88
535011-3501188.76990.63
636247-3624791.90293.77
45min136177-3617791.72593.621.3793.9695.941.38
236802-3680293.31095.65
336895-3689593.54595.88
437741-3774195.69098.06
536866-3686693.47295.78
637060-3706093.96496.29
60min136379-3637992.23793.991.7594.9396.781.74
237687-3768795.55498.36
336937-3693793.65296.46
437921-3792196.14798.99
537135-3713594.15496.93
636366-3636692.20495.00
120min136922-3692293.61493.712.6196.7796.972.54
237412-3741294.85698.14
337535-3753595.16898.44
437914-3791496.12999.46
536794-3679493.28996.54
635179-3517989.19592.46
180min136465-3646592.45594.031.3896.0897.751.38
237026-3702693.87897.63
336630-3663092.87496.62
437894-3789496.07899.89
537231-3723194.39798.11
637260-3726094.47198.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min136929-3692993.63293.650.9497.7297.850.92
237367-3736794.74298.97
336429-3642992.36496.58
437278-3727894.51798.81
536823-3682393.36397.55
636796-3679693.29497.47
360min135696-3569690.50593.012.2195.0697.672.15
238106-3810696.616101.31
336887-3688793.52598.20
436574-3657492.73297.49
536210-3621091.80996.46
636632-3663292.87997.52
480min135732-3573290.59792.331.1695.6097.461.17
236595-3659592.78597.97
336588-3658892.76797.91
436934-3693493.64498.87
536135-3613591.61996.73
636500-3650092.54497.65
600min135878-3587890.96790.450.9396.4396.040.88
235476-3547689.94895.59
336035-3603591.36596.97
435873-3587390.95496.65
535135-3513589.08394.65
635658-3565890.40995.98
720min134955-3495588.62790.421.2494.5496.461.23
236074-3607491.46497.56
336060-3606091.42897.49
435923-3592391.08197.23
535489-3548989.98196.00
635467-3546789.92595.95
极限135369-3536989.67689.962.6796.0396.452.53
235467-3546789.92596.48
336101-3610191.53298.05
436441-3644192.39499.00
535770-3577090.69397.16
633733-3373385.52892.00
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