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%
110.184199740417926141905664187386418470241883310.19
210.194227580422248942250340.09
单位质量响应值RSD%判断
411427.41414625.520.55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%
5min1169088-1690884.0944.477.724.094.477.75
2197080-1970804.7724.77
3184729-1847294.4734.47
4184039-1840394.4564.46
5169082-1690824.0944.09
6204027-2040274.9404.94
10min1354821-3548218.5918.802.958.618.822.95
2346368-3463688.3868.41
3372562-3725629.0209.04
4372674-3726749.0239.05
5369520-3695208.9478.97
6363676-3636768.8058.83
15min1491507-49150711.90012.262.0811.9612.332.09
2497816-49781612.05312.12
3519147-51914712.57012.64
4504653-50465312.21912.29
5511589-51158912.38712.45
6514301-51430112.45212.52
20min1627019-62701915.18115.121.8115.3015.251.80
2608463-60846314.73214.86
3633775-63377515.34515.48
4631229-63122915.28315.41
5612296-61229614.82514.95
6634072-63407215.35215.48
30min1814227-81422719.71420.081.5519.9120.291.55
2834395-83439520.20220.40
3851288-85128820.61120.82
4827136-82713620.02720.23
5829744-82974420.09020.29
6820255-82025519.86020.07
45min11073067-107306725.98126.330.9126.2826.640.91
21085192-108519226.27526.58
31099916-109991626.63126.94
41081312-108131226.18126.49
51096275-109627526.54326.84
61090158-109015826.39526.70
60min11312840-131284031.78631.751.2432.2132.191.23
21303376-130337631.55731.99
31323809-132380932.05232.50
41329727-132972732.19532.63
51284200-128420031.09331.53
61315184-131518431.84332.28
120min11926974-192697446.65647.921.6647.2448.511.65
21981816-198181647.98448.57
31997720-199772048.36948.97
42025503-202550349.04149.64
51969683-196968347.69048.28
61973148-197314847.77448.37
180min12445747-244574759.21659.890.7960.0460.730.79
22457850-245785059.50960.34
32499432-249943260.51661.36
42472060-247206059.85360.70
52482511-248251160.10660.93
62484391-248439160.15260.99
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12808569-280856968.00168.830.7369.1269.960.73
22854888-285488869.12270.25
32863884-286388469.34070.49
42851315-285131569.03670.18
52850846-285084669.02470.15
62827447-282744768.45869.60
360min13336305-333630580.77881.981.1182.2383.451.09
23443424-344342483.37284.84
33368295-336829581.55383.05
43406747-340674782.48483.97
53393274-339327482.15883.63
63366518-336651881.51082.99
480min13707167-370716789.75889.590.7291.6291.480.70
23734375-373437590.41692.31
33686969-368696989.26891.17
43726313-372631390.22192.12
53674331-367433188.96290.85
63673123-367312388.93390.82
600min13924426-392442695.01893.101.3197.3395.441.26
23796614-379661491.92394.27
33805936-380593692.14994.50
43887112-388711294.11496.46
53832423-383242392.79095.12
63824395-382439592.59694.93
720min13899034-389903494.40395.481.5397.1998.281.49
24050823-405082398.078100.88
33946767-394676795.55998.37
43913604-391360494.75697.58
53963189-396318995.95698.75
63886441-388644194.09896.89
极限13921537-392153794.94895.111.2798.2098.381.23
23953901-395390195.73199.02
33857384-385738493.39596.68
44004230-400423096.950100.24
53932878-393287895.22298.50
63898987-389898794.40297.67
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 12.653222932042321283214632157321400.21
2 12.623235232363323580.03
单位质量响应值RSD%判断
2540.712564.030.65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%
5min136346-3634691.59492.331.0591.5992.331.05
236524-3652492.04392.04
336975-3697593.17993.18
436211-3621191.25491.25
536553-3655392.11692.12
637212-3721293.77793.78
10min137343-3734394.10793.931.0494.5694.391.04
237108-3710893.51593.97
337781-3778195.21195.68
436909-3690993.01393.47
536845-3684592.85293.31
637642-3764294.86095.33
15min137082-3708293.44994.490.9194.3895.420.91
237614-3761494.79095.72
337809-3780995.28196.22
437403-3740394.25895.18
537149-3714993.61894.54
637905-3790595.52396.47
20min136987-3698793.21093.741.0594.6195.151.05
236933-3693393.07494.48
337406-3740694.26695.68
437151-3715193.62395.02
536836-3683692.82994.22
637878-3787895.45596.88
30min136798-3679892.73393.530.5894.6095.400.57
237155-3715593.63395.50
337457-3745794.39496.28
437080-3708093.44495.30
537145-3714593.60895.46
637059-3705993.39195.29
45min137155-3715593.63393.760.8195.9696.100.80
237037-3703793.33695.67
337350-3735094.12496.49
436735-3673592.57594.90
537381-3738194.20396.53
637580-3758094.70497.07
60min137200-3720093.74693.591.4296.5496.401.39
237271-3727193.92596.73
337422-3742294.30697.14
437280-3728093.94896.74
536094-3609490.95993.76
637555-3755594.64197.48
120min136630-3663092.31093.661.2695.5796.941.24
237024-3702493.30396.57
337456-3745694.39297.70
437574-3757494.68997.95
536638-3663892.33095.58
637669-3766994.92898.24
180min136719-3671992.53493.981.1996.2697.721.17
237312-3731294.02997.77
337738-3773895.10298.88
436999-3699993.24096.97
537111-3711193.52297.23
637866-3786695.42599.21
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min136927-3692793.05893.780.7697.2597.990.75
237397-3739794.24398.45
337522-3752294.55898.81
436995-3699593.23097.43
536959-3695993.13997.32
637474-3747494.43798.70
360min136629-3662992.30793.540.9596.9698.220.93
237499-3749994.50099.18
337279-3727993.94698.67
437180-3718093.69698.36
536751-3675192.61597.26
637373-3737394.18298.92
480min136817-3681792.78192.851.1297.8998.001.09
237322-3732294.05499.21
336939-3693993.08998.28
436717-3671792.52997.66
536134-3613491.06096.17
637147-3714793.61398.82
600min136864-3686492.90091.580.9298.4897.200.87
236134-3613491.06096.68
336196-3619691.21696.88
436369-3636991.65297.25
535930-3593090.54696.11
636550-3655092.10897.78
720min135679-3567989.91391.351.9395.9697.431.82
237480-3748094.452100.53
336523-3652392.04098.16
435554-3555489.59895.65
536108-3610890.99597.01
636157-3615791.11897.25
极限135816-3581690.25990.810.8696.7597.340.82
236391-3639191.70898.26
335694-3569489.95196.53
436298-3629891.47397.98
535767-3576790.13596.61
636242-3624291.33297.92
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%
110.184210494420772342068324195539420934642059870.15
210.194245426422759042365080.30
单位质量响应值RSD%判断
413161.79415751.520.45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%
5min180197-801971.9352.7526.591.942.7526.52
2106043-1060432.5592.56
384447-844472.0382.04
4127420-1274203.0743.07
5123460-1234602.9792.98
6161210-1612103.8903.89
10min1187600-1876004.5265.7113.934.545.7213.94
2227149-2271495.4815.49
3217321-2173215.2445.25
4257795-2577956.2206.24
5249860-2498606.0296.04
6280694-2806946.7736.79
15min1309355-3093557.4648.4614.097.508.5014.10
2337313-3373138.1398.18
3283948-2839486.8516.89
4383122-3831229.2449.29
5373105-3731059.0029.05
6416243-41624310.04310.10
20min1378027-3780279.12110.7613.349.1910.8413.34
2454268-45426810.96111.04
3369123-3691238.9068.98
4479075-47907511.55911.65
5478004-47800411.53311.62
6516313-51631312.45812.56
30min1552304-55230413.32614.9012.2213.4415.0412.25
2583147-58314714.07014.21
3524193-52419312.64812.76
4665533-66553316.05816.21
5662289-66228915.98016.13
6717554-71755417.31317.48
45min1732106-73210617.66419.698.7617.8519.908.80
2801086-80108619.32919.53
3734454-73445417.72117.90
4865231-86523120.87621.11
5899884-89988421.71321.94
6862398-86239820.80821.06
60min1921235-92123522.22824.258.7122.5024.568.75
2966851-96685123.32823.63
3897478-89747821.65521.92
41079075-107907526.03626.37
51101178-110117826.56926.91
61064537-106453725.68526.04
120min11436338-143633834.65638.6011.0635.0439.0411.04
21506445-150644536.34836.77
31386437-138643733.45233.83
41768700-176870042.67643.14
51775999-177599942.85243.32
61725342-172534241.62942.11
180min11839727-183972744.38949.4310.9744.9450.0610.97
21901474-190147445.87946.48
31797529-179752943.37143.91
42253502-225350254.37355.05
52269827-226982754.76755.45
62230922-223092253.82854.52
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12186955-218695552.76758.2310.4353.5459.1010.43
22243938-224393854.14254.97
32127680-212768051.33752.10
42633310-263331063.53764.49
52649757-264975763.93464.89
62637929-263792963.64964.61
360min12720464-272046465.64071.339.2066.6872.509.23
22739516-273951666.10067.20
32670404-267040464.43265.45
43249199-324919978.39779.67
53193742-319374277.05978.34
63164322-316432276.34977.63
480min13035418-303541873.23981.058.3274.6182.578.36
23230702-323070277.95179.38
33068200-306820074.03075.37
43615419-361541987.23488.89
53590914-359091486.64288.30
63614079-361407987.20188.86
600min13447830-344783083.19087.186.4384.9289.106.50
23408905-340890582.25184.07
33355515-335551580.96382.67
43858788-385878893.10695.20
53777358-377735891.14193.24
63829626-382962692.40294.50
720min13757584-375758490.66492.464.5992.8194.824.69
23643974-364397487.92390.16
33629485-362948587.57389.69
43993163-399316396.34898.91
53974879-397487995.90798.46
63993467-399346796.35598.92
极限13727646-372764689.94192.123.5192.5594.943.65
23683929-368392988.88791.56
33685341-368534188.92191.47
43917602-391760294.52597.57
53906361-390636194.25497.28
63985581-398558196.16599.21
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 12.653230932309323303222532278322900.13
2 12.623261332513325630.22
单位质量响应值RSD%判断
2552.572580.270.77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%
5min123571-2357159.07665.419.0559.0865.429.05
229504-2950473.94673.95
325786-2578664.62764.63
424766-2476662.07162.07
524523-2452361.46261.46
628451-2845171.30671.31
10min136166-3616690.64290.522.7090.9490.852.71
236649-3664991.85392.22
336259-3625990.87691.20
434540-3454086.56786.88
535665-3566589.38789.69
637431-3743193.81394.17
15min137228-3722893.30491.921.7894.0592.701.77
236190-3619090.70391.53
337162-3716293.13993.92
435637-3563789.31790.06
536657-3665791.87392.63
637186-3718693.19994.02
20min136788-3678892.20192.491.7193.4293.731.72
236680-3668091.93193.21
337389-3738993.70894.95
435970-3597090.15191.34
536795-3679592.21993.43
637799-3779994.73596.03
30min137067-3706792.90193.062.0494.5894.762.04
236799-3679992.22993.97
337904-3790494.99896.71
435864-3586489.88691.53
537291-3729193.46295.14
637854-3785494.87396.64
45min137473-3747393.91893.462.1996.0695.632.18
237264-3726493.39495.60
338153-3815395.62297.81
435749-3574989.59791.69
537444-3744493.84595.99
637660-3766094.38796.63
60min137791-3779194.71593.541.5197.3396.181.51
237268-3726893.40496.07
337976-3797695.17997.84
436357-3635791.12193.66
537269-3726993.40796.02
637275-3727593.42296.13
120min137871-3787194.91693.601.4198.0096.701.39
236880-3688092.43295.57
337506-3750694.00197.14
436549-3654991.60294.60
537806-3780694.75397.83
637470-3747093.91197.09
180min137776-3777694.67893.591.4098.2497.161.38
236617-3661791.77395.37
337585-3758594.19997.81
436735-3673592.06995.52
537662-3766294.39297.94
637683-3768394.44498.09
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137812-3781294.76893.401.6198.8097.441.59
236665-3666591.89395.95
337642-3764294.34298.42
436361-3636191.13195.04
537514-3751494.02198.04
637601-3760194.23998.36
360min138004-3800495.24993.191.8299.7597.691.74
236103-3610390.48595.00
337802-3780294.74399.30
437081-3708192.93697.30
537118-3711893.02897.52
636982-3698292.68897.28
480min136806-3680692.24692.571.6597.2397.541.63
237062-3706292.88897.86
337806-3780694.75399.78
435999-3599990.22495.06
536674-3667491.91696.87
637252-3725293.36498.42
600min136743-3674392.08991.181.4097.5396.611.39
235733-3573389.55794.99
336941-3694192.58598.09
436014-3601490.26195.54
536040-3604090.32795.75
636805-3680592.24497.77
720min137183-3718393.19192.091.6199.0997.981.57
235894-3589489.96195.84
336836-3683692.32298.29
436222-3622290.78396.52
536860-3686092.38298.25
637468-3746893.90699.89
极限136370-3637091.15490.941.7297.5297.291.70
235981-3598190.17996.51
336656-3665691.87198.30
435404-3540488.73394.92
536078-3607890.42296.75
637219-3721993.28299.73
点击查看处理图标(人工保存)
 
原始图谱下载图谱(姜进硙 于 2026-01-26 11:37:16 完成)
生成报告数据部分(等待生成报告)
Current page cost:60 ms