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%
110.184252602423856842198264238813422067142340960.33
210.194291224430360642974150.21
单位质量响应值RSD%判断
415922.99421728.660.99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%
5min1161427-1614273.8543.648.703.853.648.72
2148644-1486443.5493.55
3136663-1366633.2633.26
4173684-1736844.1474.15
5152293-1522933.6363.64
6143204-1432043.4193.42
10min1345621-3456218.2537.937.518.277.947.51
2370823-3708238.8548.87
3297213-2972137.0977.11
4333645-3336457.9677.99
5324375-3243757.7457.76
6320096-3200967.6437.66
15min1466590-46659011.14111.074.1411.2011.134.13
2477846-47784611.41011.47
3441571-44157110.54410.60
4490287-49028711.70711.77
5443042-44304210.57910.64
6462249-46224911.03711.09
20min1597670-59767014.27114.114.6614.3914.224.66
2599395-59939514.31214.43
3567486-56748613.55013.65
4637409-63740915.22015.34
5561243-56124313.40113.51
6582596-58259613.91114.02
30min1793514-79351418.94719.062.9819.1319.242.99
2813488-81348819.42419.61
3777733-77773318.57018.74
4837597-83759720.00020.19
5774597-77459718.49518.67
6792348-79234818.91919.10
45min11102773-110277326.33125.482.3626.6125.762.37
21065937-106593725.45225.74
31040915-104091524.85425.12
41091624-109162426.06526.36
51044726-104472624.94525.21
61056728-105672825.23225.51
60min11301712-130171231.08230.442.9831.5030.842.98
21294348-129434830.90631.32
31264007-126400730.18130.57
41315353-131535331.40731.83
51210137-121013728.89529.29
61262592-126259230.14730.55
120min11953280-195328046.63946.601.6447.2147.161.64
21979329-197932947.26147.83
31942329-194232946.37846.92
41994720-199472047.62948.21
51931531-193153146.12046.66
61907400-190740045.54446.10
180min12492424-249242459.51358.361.2060.3259.151.21
22437543-243754358.20259.01
32443129-244312958.33659.11
42458440-245844058.70159.52
52426630-242663057.94258.71
62406951-240695157.47258.25
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12828394-282839467.53567.050.8668.6368.140.85
22813574-281357467.18168.28
32761089-276108965.92866.99
42809825-280982567.09168.21
52817528-281752867.27568.33
62818739-281873967.30468.37
360min13361532-336153280.26580.520.7081.7081.940.70
23382563-338256380.76782.20
33405403-340540381.31282.71
43385732-338573280.84382.29
53339382-333938279.73681.13
63358035-335803580.18181.58
480min13601510-360151085.99587.811.4187.8389.631.39
23741575-374157589.33991.18
33641787-364178786.95688.76
43715436-371543688.71590.57
53701016-370101688.37190.16
63663488-366348887.47589.28
600min13942032-394203294.12693.550.5296.3995.810.52
23919639-391963993.59195.87
33888409-388840992.84595.08
43926518-392651893.75596.05
53931234-393123493.86896.10
63900249-390024993.12895.37
720min13957603-395760394.49794.481.0797.2497.211.06
23964875-396487594.67197.42
33944096-394409694.17596.87
43998379-399837995.47198.24
53994260-399426095.37398.08
63882556-388255692.70595.41
极限14048480-404848096.66796.250.5099.8899.460.47
24008173-400817395.70598.93
34031812-403181296.26999.44
44007633-400763395.69298.94
54055910-405591096.845100.03
64034889-403488996.34399.51
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12500
标示量(mg)5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 12.653272832336323723260032290324650.59
2 12.623307333065330690.02
单位质量响应值RSD%判断
2566.402620.361.48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%
5min132838-3283881.45278.475.5581.4578.475.55
233010-3301081.87981.88
330386-3038675.37075.37
432803-3280381.36581.37
528651-2865171.06771.07
632123-3212379.67979.68
10min136920-3692091.57787.853.1691.9888.243.16
236579-3657990.73191.14
334640-3464085.92286.30
434786-3478686.28486.69
534138-3413884.67785.03
635432-3543287.88688.28
15min136809-3680991.30290.351.6892.1791.181.70
237316-3731692.56093.42
335791-3579188.77789.58
436427-3642790.35491.19
535713-3571388.58389.36
636502-3650290.54191.38
20min137632-3763293.34391.291.4994.6792.571.51
237033-3703391.85893.18
336614-3661490.81892.07
436661-3666190.93592.22
535978-3597889.24190.46
636906-3690691.54392.83
30min137160-3716092.17392.320.6993.9694.060.71
237605-3760593.27695.06
337165-3716592.18593.89
437295-3729592.50794.25
536822-3682291.33493.00
637277-3727792.46394.21
45min138969-3896996.66093.412.1198.9195.612.08
237361-3736192.67194.92
337342-3734292.62494.79
436680-3668090.98293.19
537456-3745692.90795.03
638135-3813594.59196.80
60min138120-3812094.55492.732.2797.2995.402.25
237506-3750693.03195.75
337905-3790594.02196.65
437282-3728292.47595.14
535766-3576688.71591.30
637739-3773993.60996.29
120min138014-3801494.29193.400.9497.5096.530.92
237698-3769893.50796.69
338066-3806694.42097.52
437388-3738892.73895.86
537603-3760393.27196.30
637164-3716492.18395.33
180min138414-3841495.28393.511.7098.9697.111.64
237083-3708391.98295.63
338301-3830195.00398.57
436828-3682891.34994.94
537858-3785893.90497.40
637711-3771193.53997.15
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137962-3796294.16292.841.8798.3296.911.80
236743-3674391.13895.25
337282-3728292.47596.52
436549-3654990.65794.70
537716-3771693.55297.52
638330-3833095.07599.15
360min137772-3777293.69193.341.4598.3197.871.40
237419-3741992.81597.38
338525-3852595.558100.07
436871-3687191.45695.95
537460-3746092.91797.35
637737-3773793.60498.16
480min136629-3662990.85692.121.1195.9597.121.02
237251-3725192.39897.43
337403-3740392.77597.76
436658-3665890.92795.88
537642-3764293.36898.27
637246-3724692.38697.41
600min137766-3776693.67692.941.2399.2298.401.18
236972-3697291.70697.20
337824-3782493.82099.27
436802-3680291.28596.69
537670-3767093.43898.81
637789-3778993.73399.22
720min136913-3691391.56091.180.9297.5897.100.84
236427-3642790.35496.30
337005-3700591.78897.71
436876-3687691.46897.33
537076-3707691.96497.80
636258-3625889.93595.89
极限137312-3731292.55092.631.5999.0299.001.48
236684-3668490.99297.39
337738-3773893.60699.98
436585-3658590.74697.07
537987-3798794.224100.52
637753-3775393.644100.05
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%
110.184237164422726742283494202340424982842289900.42
210.194276513427133942739260.09
单位质量响应值RSD%判断
415421.41419423.550.68数据可信
供试品溶液-WK2171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%
5min1123402-1234022.9562.6910.312.962.6910.29
2108465-1084652.5992.60
3111249-1112492.6652.67
4126132-1261323.0223.02
5109130-1091302.6142.61
694223-942232.2572.26
10min1254076-2540766.0876.334.426.106.344.38
2283462-2834626.7916.80
3263929-2639296.3236.34
4266125-2661256.3766.39
5267003-2670036.3976.41
6250188-2501885.9946.01
15min1379258-3792589.0869.415.389.139.465.37
2403917-4039179.6779.72
3420212-42021210.06710.11
4410047-4100479.8249.87
5375183-3751838.9889.03
6369074-3690748.8428.88
20min1518424-51842412.42012.092.7912.5112.182.79
2510565-51056512.23212.33
3501609-50160912.01712.11
4519451-51945112.44512.54
5491994-49199411.78711.88
6485303-48530311.62611.71
30min1661434-66143415.84616.392.7816.0016.542.76
2715204-71520417.13417.29
3690047-69004716.53216.69
4681677-68167716.33116.49
5667701-66770115.99616.15
6687949-68794916.48116.62
45min1887886-88788621.27121.951.9321.5022.181.93
2942160-94216022.57122.81
3918131-91813121.99622.23
4922576-92257622.10222.34
5910054-91005421.80222.03
6917226-91722621.97422.20
60min11089375-108937526.09826.743.1226.4427.083.10
21179631-117963128.26128.62
31133219-113321927.14927.50
41097000-109700026.28126.63
51100648-110064826.36826.71
61096635-109663526.27226.61
120min11693366-169336640.56841.511.9941.0441.991.99
21785938-178593842.78643.28
31761535-176153542.20142.69
41710704-171070440.98341.47
51722405-172240541.26441.73
61722436-172243641.26541.73
180min12139186-213918651.24952.822.4951.9253.502.48
22280047-228004754.62355.33
32258368-225836854.10454.80
42183147-218314752.30252.99
52164106-216410651.84652.52
62202813-220281352.77353.45
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12514929-251492960.25061.451.6261.1862.401.63
22617013-261701362.69663.68
32610536-261053662.54163.51
42530893-253089360.63361.58
52553302-255330261.17062.11
62563562-256356261.41562.35
360min13024436-302443672.45774.582.0473.6975.842.03
23219942-321994277.14078.44
33095972-309597274.17075.45
43118358-311835874.70775.96
53124101-312410174.84476.09
63095068-309506874.14975.39
480min13508359-350835984.05083.431.2485.6485.061.23
23520878-352087884.35086.03
33529758-352975884.56386.21
43423411-342341182.01583.64
53450791-345079182.67184.29
63461597-346159782.93084.55
600min13651857-365185787.48888.661.7389.5090.711.72
23784453-378445390.66492.77
33765021-376502190.19992.27
43656849-365684987.60789.64
53632695-363269587.02989.06
63714973-371497389.00091.03
720min13758754-375875490.04990.100.9892.5092.590.97
23799703-379970391.03093.59
33752741-375274189.90592.43
43698058-369805888.59591.07
53759577-375957790.06992.53
63795686-379568690.93493.41
极限13760966-376096690.10289.701.8593.0092.641.81
23855111-385511192.35795.37
33639325-363932587.18890.16
43726395-372639589.27492.19
53741403-374140389.63392.55
63741605-374160589.63892.57
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12500
标示量(mg)5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 12.653237032214323913227632370323240.24
2 12.623287332627327500.54
单位质量响应值RSD%判断
2555.262595.091.10数据可信
供试品溶液-WK2171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%
5min122484-2248456.16256.802.7856.1656.802.78
221886-2188654.66854.67
323299-2329958.19758.20
422441-2244156.05456.05
522709-2270956.72456.72
623630-2363059.02459.02
10min133393-3339383.41184.583.7383.6984.863.72
234841-3484187.02787.30
334507-3450786.19386.48
433044-3304482.53982.82
532009-3200979.95480.24
635365-3536588.33688.63
15min135378-3537888.36988.453.0689.0789.163.05
236839-3683992.01892.73
335362-3536288.32989.05
434421-3442185.97886.67
534060-3406085.07785.76
636411-3641190.94991.69
20min136824-3682491.98190.702.6893.1291.852.68
236571-3657191.34992.52
335922-3592289.72890.89
435212-3521287.95489.08
535495-3549588.66189.77
637850-3785094.54395.74
30min135916-3591689.71390.462.9691.3192.072.95
236689-3668991.64393.27
336535-3653591.25992.87
435298-3529888.16989.73
534953-3495387.30788.86
637912-3791294.69896.36
45min136178-3617890.36790.922.8692.4292.972.85
236478-3647891.11693.20
336171-3617190.35092.42
435398-3539888.41990.42
535787-3578789.39091.38
638376-3837695.85798.00
60min136461-3646191.07491.002.9893.5793.512.97
236945-3694592.28394.82
336667-3666791.58994.11
434958-3495887.32089.77
535527-3552788.74191.18
638039-3803995.01697.63
120min136389-3638990.89490.722.9393.8593.692.92
236452-3645291.05294.05
336239-3623990.51993.50
435116-3511687.71490.60
535529-3552988.74691.63
638201-3820195.42098.51
180min135829-3582989.49590.463.0892.9193.883.06
236673-3667391.60495.06
336422-3642290.97794.41
435637-3563789.01692.34
534722-3472286.73090.05
638010-3801094.94398.51
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min135750-3575089.29889.323.1293.1693.203.10
235614-3561488.95892.87
336246-3624690.53794.42
434695-3469586.66390.43
534618-3461886.47090.23
637637-3763794.01198.06
360min135493-3549388.65688.912.7792.9693.232.75
236209-3620990.44594.80
334884-3488487.13591.47
434995-3499587.41291.61
534720-3472086.72590.91
637272-3727293.10097.61
480min136147-3614790.29088.613.0495.0493.383.02
235476-3547688.61493.42
335424-3542488.48493.26
434190-3419085.40190.04
534494-3449486.16190.78
637127-3712792.73897.72
600min135423-3542388.48188.663.5593.6893.863.51
235965-3596589.83595.09
335625-3562588.98694.20
434466-3446686.09191.15
533943-3394384.78489.84
637546-3754693.78499.23
720min135305-3530588.18687.223.5693.8392.873.50
234950-3495087.30093.00
334312-3431285.70691.37
433654-3365484.06389.56
534143-3414385.28490.76
637148-3714892.79098.70
极限135215-3521587.96286.263.0994.0492.353.03
235019-3501987.47293.61
333261-3326183.08189.17
433789-3378984.40090.31
533862-3386284.58290.49
636065-3606590.08596.46
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