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%
110.35420731342149584215727422127742148190.14
210.474171716417068541712000.02
单位质量响应值RSD%判断
407228.89398395.421.56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%
5min1174128-1741284.3234.454.534.324.454.54
2191703-1917034.7604.76
3180387-1803874.4794.48
4169204-1692044.2014.20
5184491-1844914.5814.58
6175156-1751564.3494.35
10min1347017-3470178.6168.764.188.648.784.18
2360279-3602798.9458.97
3332604-3326048.2588.28
4355334-3553348.8228.84
5346135-3461358.5948.62
6375951-3759519.3349.36
15min1487110-48711012.09412.362.5712.1612.432.54
2505958-50595812.56212.63
3488160-48816012.12012.18
4519873-51987312.90812.97
5494972-49497212.28912.36
6491271-49127112.19712.27
20min1597171-59717114.82715.122.2714.9515.242.27
2626544-62654415.55615.69
3599958-59995814.89615.02
4607451-60745115.08215.21
5625338-62533815.52615.65
6596489-59648914.81014.94
30min1867406-86740621.53620.423.1021.7420.623.08
2834919-83491920.73020.94
3800806-80080619.88320.08
4805350-80535019.99620.20
5821608-82160820.39920.60
6804818-80481819.98220.19
45min11057905-105790526.26626.571.7426.5726.881.72
21084054-108405426.91527.23
31080126-108012626.81827.12
41048103-104810326.02326.33
51094532-109453227.17627.48
61055884-105588426.21626.52
60min11260182-126018231.28831.661.9631.7332.101.93
21287497-128749731.96732.41
31270950-127095031.55631.99
41269222-126922231.51331.95
51317415-131741532.70933.15
61245450-124545030.92331.36
120min11881730-188173046.72048.092.7847.3248.692.76
21953061-195306148.49149.10
31949933-194993348.41449.00
41913031-191303147.49848.09
52029538-202953850.39051.00
61893694-189369447.01747.61
180min12382801-238280159.16159.571.3759.9960.411.37
22386301-238630159.24860.10
32419690-241969060.07760.91
42378477-237847759.05459.88
52456911-245691161.00161.86
62371607-237160758.88359.71
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12785551-278555169.16168.770.7070.2969.900.70
22767381-276738168.71069.86
32754377-275437768.38769.52
42756716-275671668.44569.57
52800241-280024169.52670.69
62754062-275406268.37969.50
360min13352348-335234883.23482.471.1084.7083.951.10
23304571-330457182.04783.54
33275633-327563381.32982.80
43338348-333834882.88684.35
53367382-336738283.60785.12
63291019-329101981.71183.17
480min13602031-360203189.43390.331.0591.3292.221.04
23633641-363364190.21892.12
33655178-365517890.75292.63
43587242-358724289.06690.95
53685639-368563991.50993.44
63665519-366551991.00992.88
600min13794456-379445694.21094.820.9196.5497.160.91
23838494-383849495.30497.65
33795077-379507794.22696.56
43778664-377866493.81896.15
53868242-386824296.04298.43
63839348-383934895.32597.65
720min13978372-397837298.77797.831.01101.58100.651.00
23936754-393675497.744100.57
33913931-391393197.17799.98
43879639-387963996.32599.12
53985015-398501598.942101.81
63948333-394833398.031100.83
极限13916256-391625697.23596.961.66100.53100.261.62
23917895-391789597.275100.59
33913970-391397097.178100.47
43785634-378563493.99197.27
53912072-391207297.131100.49
63984524-398452498.930102.22
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%
112.0028752290282909428752289060.63
212.022872028722287210.01
单位质量响应值RSD%判断
2408.832389.430.58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%
5min136188-3618897.02096.281.7697.0296.281.76
236808-3680898.68398.68
335540-3554095.28395.28
435633-3563395.53295.53
535039-3503993.94093.94
636260-3626097.21397.21
10min136970-3697099.11798.541.8799.6099.021.86
236522-3652297.91698.41
336939-3693999.03499.51
436002-3600296.52297.00
536187-3618797.01897.49
637901-37901101.613102.10
15min137480-37480100.48498.811.17101.4699.781.16
236712-3671298.42599.41
337099-3709999.463100.43
436526-3652697.92798.89
536297-3629797.31398.27
637011-3701199.227100.22
20min136663-3666398.29499.040.8399.78100.510.83
237000-3700099.197100.67
337294-3729499.986101.45
436527-3652797.92999.38
536924-3692498.994100.44
637239-3723999.838101.33
30min136928-3692899.00498.561.33100.98100.521.32
236953-3695399.071101.04
337027-3702799.270101.24
436228-3622897.12899.07
536103-3610396.79398.73
637338-37338100.104102.09
45min136603-3660398.13398.571.39100.60101.021.37
236451-3645197.726100.19
337293-3729399.983102.45
436058-3605896.67299.10
536793-3679398.642101.06
637393-37393100.251102.74
60min136311-3631197.35098.321.33100.31101.271.28
236070-3607096.70499.66
337203-3720399.742102.71
436475-3647597.790100.70
537271-3727199.924102.84
636704-3670498.404101.40
120min135833-3583396.06998.812.0299.52102.251.95
236780-3678098.608102.05
337326-37326100.071103.54
436316-3631697.364100.76
537948-37948101.739105.15
636928-3692899.004102.49
180min136171-3617196.97597.901.39100.90101.831.36
235934-3593496.339100.27
336956-3695699.079103.04
436171-3617196.975100.86
536651-3665198.262102.18
637210-3721099.760103.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min136622-3662298.18497.220.92102.60101.640.89
235785-3578595.940100.35
336505-3650597.870102.33
436327-3632797.393101.76
535930-3593096.329100.74
636399-3639997.586102.06
360min136791-3679198.63797.311.01103.54102.220.96
235824-3582496.045100.94
336175-3617596.986101.93
436640-3664098.232103.09
536037-3603796.616101.51
636315-3631597.361102.33
480min135586-3558695.40696.551.34100.80101.941.31
235871-3587196.171101.54
336367-3636797.500102.93
435658-3565895.600100.95
535769-3576995.897101.27
636818-3681898.709104.16
600min135436-3543695.00495.720.72100.88101.600.69
235978-3597896.457102.31
335601-3560195.447101.37
435428-3542894.983100.81
535791-3579195.956101.81
635992-3599296.495102.44
720min135947-3594796.37496.060.91102.72102.420.89
235547-3554795.302101.64
335735-3573595.806102.20
435428-3542894.983101.28
536023-3602396.578102.92
636303-3630397.329103.76
极限135009-3500993.86094.561.92100.69101.401.83
235571-3557195.366102.18
335844-3584496.098102.98
434295-3429591.94598.72
534827-3482793.372100.19
636072-3607296.709103.62
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%
110.354211653421603342137004214721421300542138220.04
210.474351023435514743530850.07
单位质量响应值RSD%判断
407132.56415767.431.49数据可信
供试品溶液-2025081521批-二甲双胍
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1205593-2055934.9974.5911.525.004.5911.49
2205828-2058285.0035.00
3204553-2045534.9724.97
4151281-1512813.6773.68
5177310-1773104.3104.31
6187766-1877664.5644.56
10min1357853-3578538.6988.795.818.728.815.78
2369228-3692288.9759.00
3356056-3560568.6558.68
4336135-3361358.1708.19
5398367-3983679.6839.70
6351636-3516368.5478.57
15min1509594-50959412.38712.402.4512.4612.462.46
2530131-53013112.88612.96
3508176-50817612.35212.42
4491087-49108711.93712.00
5508575-50857512.36212.43
6512517-51251712.45812.52
20min1643544-64354415.64315.423.2615.7715.553.27
2636155-63615515.46315.60
3645608-64560815.69315.82
4596230-59623014.49314.61
5655695-65569515.93816.07
6630255-63025515.32015.45
30min1840831-84083120.43820.372.4820.6520.582.48
2844227-84422720.52120.73
3840983-84098320.44220.65
4798031-79803119.39819.59
5858991-85899120.87921.09
6845347-84534720.54820.75
45min11083486-108348626.33626.581.6926.6526.891.69
21111450-111145027.01627.33
31111944-111194427.02827.34
41068527-106852725.97326.26
51104844-110484426.85527.17
61080319-108031926.25926.57
60min11282512-128251231.17431.641.0631.6232.081.05
21292359-129235931.41331.86
31311813-131181331.88632.33
41295672-129567231.49431.91
51317380-131738032.02232.47
61311568-131156831.88032.32
120min11949698-194969847.39147.550.8847.9948.160.86
21978026-197802648.08048.69
31952686-195268647.46448.07
41972805-197280547.95348.53
51954540-195454047.50948.12
61930716-193071646.93047.53
180min12443767-244376759.40159.530.7860.2460.370.78
22485732-248573260.42161.27
32441521-244152159.34660.19
42435555-243555559.20160.02
52436186-243618659.21660.06
62451463-245146359.58860.42
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12803535-280353568.14568.611.3569.2869.741.33
22868682-286868269.72970.88
32783536-278353667.65968.80
42829020-282902068.76569.88
52864634-286463469.63170.77
62785449-278544967.70668.84
360min13322575-332257580.76281.801.4082.2383.281.37
23368983-336898381.89083.39
33340888-334088881.20782.68
43442092-344209283.66785.12
53394757-339475782.51684.01
63323042-332304280.77382.24
480min13662317-366231789.02089.520.8890.9091.410.86
23671812-367181289.25191.16
33653395-365339588.80390.69
43728742-372874290.63492.51
53717883-371788390.37092.28
63662899-366289989.03490.91
600min13819724-381972492.84694.041.4595.1796.371.43
23870581-387058194.08296.44
33820704-382070492.87095.20
43874817-387481794.18596.51
53972102-397210296.55098.91
63854432-385443293.69096.01
720min13888597-388859794.52096.001.4497.3198.801.41
24024448-402444897.822100.65
34007914-400791497.420100.21
43918150-391815095.23898.04
53956065-395606596.16099.00
63900991-390099194.82197.61
极限13979330-397933096.72596.900.9999.98100.180.98
23986997-398699796.912100.22
33981884-398188496.788100.07
44005532-400553297.362100.64
54042928-404292898.271101.59
63922046-392204695.33398.59
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%
112.002914528712289582893328887289270.54
212.022927929186292320.23
单位质量响应值RSD%判断
2410.582431.950.63数据可信
供试品溶液-2025081521批-达格列净
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136468-3646896.87895.462.4996.8895.462.49
236601-3660197.23197.23
336251-3625196.30196.30
434199-3419990.85090.85
535816-3581695.14695.15
636278-3627896.37396.37
10min136799-3679997.75797.912.4798.2498.382.47
237878-37878100.623101.11
336691-3669197.47097.95
435223-3522393.57094.02
537423-3742399.41599.89
637121-3712198.61299.09
15min137666-37666100.06098.491.66101.0399.461.66
237529-3752999.696100.69
337519-3751999.670100.64
436175-3617596.09997.02
536509-3650996.98797.96
637054-3705498.43499.41
20min137301-3730199.09198.512.05100.5699.972.04
237252-3725298.960100.45
337929-37929100.759102.23
436012-3601295.66697.07
536320-3632096.48597.94
637674-37674100.082101.55
30min137999-37999100.94599.161.82102.91101.111.82
237235-3723598.915100.90
337960-37960100.841102.81
436224-3622496.23098.11
536947-3694798.150100.09
637601-3760199.888101.86
45min136939-3693998.12997.821.48100.60100.261.48
237212-3721298.854101.33
337492-3749299.598102.07
436183-3618396.12198.48
536156-3615696.04998.48
636943-3694398.140100.61
60min136494-3649496.94797.231.4899.91100.171.47
236978-3697898.233101.20
336457-3645796.84999.82
436199-3619996.16399.01
536002-3600295.64098.55
637476-3747699.556102.51
120min137220-3722098.87597.411.35102.32100.831.34
236740-3674097.600101.06
337197-3719798.814102.27
436440-3644096.803100.13
535928-3592895.44398.83
636482-3648296.915100.37
180min137253-3725398.96397.381.92102.91101.291.90
237180-3718098.769102.72
337078-3707898.498102.45
435744-3574494.95498.76
535781-3578195.05398.92
636903-3690398.033101.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137014-3701498.32897.071.22102.77101.461.22
236856-3685697.908102.35
336439-3643996.801101.24
435819-3581995.15499.44
536299-3629996.429100.77
636805-3680597.773102.20
360min136406-3640696.71396.880.67101.64101.760.65
236727-3672797.566102.50
336545-3654597.082102.01
436657-3665797.380102.14
536050-3605095.767100.59
636421-3642196.753101.67
480min136735-3673597.58796.360.92103.00101.720.92
236142-3614296.012101.43
336397-3639796.689102.10
435948-3594895.496100.74
535900-3590095.369100.67
636510-3651096.989102.39
600min135854-3585495.24795.451.04101.15101.301.04
236207-3620796.184102.09
336141-3614196.009101.91
435240-3524093.61699.34
535919-3591995.419101.20
636223-3622396.227102.11
720min135707-3570794.85694.802.13101.23101.122.07
236781-3678197.709104.09
336251-3625196.301102.68
434680-3468092.12898.32
535105-3510593.25799.51
635583-3558394.527100.90
极限136299-3629996.42995.611.26103.28102.401.26
236483-3648396.918103.79
336262-3626296.331103.19
435242-3524293.621100.27
535852-3585295.241101.96
635799-3579995.101101.94
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