二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.899297892919930709304693013930050.07
2 9.909321993030931240.15
单位质量响应值RSD%判断
9403.949406.460.02数据可信
供试品溶液-2024120321批-恩格列净-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%
5min143302-4330241.43637.4112.3341.4437.4112.33
237355-3735535.74635.75
337116-3711635.51735.52
431142-3114229.80029.80
543330-4333041.46341.46
642294-4229440.47240.47
10min183889-8388980.27573.929.3080.3473.989.31
275108-7510871.87271.93
372672-7267269.54169.60
466122-6612263.27363.32
581808-8180878.28378.35
683867-8386780.25480.32
15min1101568-10156897.19292.594.1597.4092.784.16
297395-9739593.19993.38
394552-9455290.47890.65
490248-9024886.36086.51
596957-9695792.78092.98
699858-9985895.55695.76
20min1102757-10275798.33096.750.9698.6997.090.97
2100846-10084696.50196.84
3101164-10116496.80697.13
499818-9981895.51895.82
5101310-10131096.94597.30
6100722-10072296.38396.74
30min1102730-10273098.30497.430.6098.8397.940.61
2101384-10138497.01697.51
3102238-10223897.83398.32
4101200-10120096.84097.30
5102010-10201097.61598.13
6101365-10136596.99897.52
45min1102417-10241798.00597.320.5398.7097.990.53
2101322-10132296.95797.61
3102294-10229497.88798.54
4101724-10172497.34197.96
5101254-10125496.89297.57
6101229-10122996.86897.55
60min1102079-10207997.68197.170.5598.5498.000.54
2101371-10137197.00497.82
3102358-10235897.94898.76
4101422-10142297.05297.83
5101057-10105796.70397.54
6101007-10100796.65597.50
极限1101721-10172197.33997.420.6198.3698.410.60
2101507-10150797.13498.11
3103024-10302498.58599.56
4101396-10139697.02897.97
5101734-10173497.35198.35
6101458-10145897.08798.09
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.998813598811268812198807618808938810720.03
210.088808318804738806520.03
单位质量响应值RSD%判断
88195.4087366.270.67数据可信
供试品溶液-2024120321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%
5min1483864-48386449.61145.7410.9549.6145.7410.95
2430567-43056744.14644.15
3422515-42251543.32143.32
4366253-36625337.55237.55
5490476-49047650.28950.29
6482795-48279549.50149.50
10min1845637-84563786.70381.737.9186.7981.817.92
2784932-78493280.47980.55
3754625-75462577.37277.44
4698641-69864171.63271.69
5836208-83620885.73785.82
6862920-86292088.47688.56
15min1987457-987457101.24498.393.44101.4798.603.45
2971860-97186099.64599.85
3940292-94029296.40896.61
4904285-90428592.71792.90
5961283-96128398.56198.79
6992478-992478101.759101.99
20min1994330-994330101.949101.850.58102.34102.230.60
2996259-996259102.147102.52
3992712-992712101.783102.14
4983057-983057100.793101.13
5993628-993628101.877102.27
61000343-1000343102.566102.97
30min1994943-994943102.012102.340.35102.58102.890.35
2999289-999289102.457103.00
31001734-1001734102.708103.24
4993309-993309101.844102.35
5998290-998290102.355102.92
61001271-1001271102.661103.23
45min1993950-993950101.910102.190.42102.65102.910.41
2997443-997443102.268102.98
31002813-1002813102.819103.52
4994864-994864102.004102.68
5991488-991488101.658102.39
6999564-999564102.486103.23
60min1989752-989752101.480102.050.46102.39102.940.45
2997345-997345102.258103.14
31002353-1002353102.772103.65
4992179-992179101.728102.57
5993141-993141101.827102.73
6997070-997070102.230103.14
极限1987454-987454101.244101.910.50102.32102.970.49
2994680-994680101.985103.04
31001717-1001717102.706103.75
4990817-990817101.589102.60
5992845-992845101.797102.87
6996443-996443102.166103.25
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.899330193338929859345693544933250.23
2 9.909316093363932620.16
单位质量响应值RSD%判断
9436.309420.400.12数据可信
供试品溶液-2024120321批-恩格列净-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136319-3631934.66939.3519.5334.6739.3519.53
252392-5239250.01250.01
345630-4563043.55743.56
437609-3760935.90035.90
530019-3001928.65528.66
645358-4535843.29743.30
10min172442-7244269.15175.2712.2969.2175.3412.30
289952-8995285.86585.95
384909-8490981.05181.12
473445-7344570.10870.17
565578-6557862.59962.65
686796-8679682.85382.92
15min194742-9474290.43892.974.7790.6193.164.79
2103036-10303698.35598.58
3100960-10096096.37396.58
496611-9661192.22292.40
590105-9010586.01186.16
698924-9892494.43094.64
20min1101848-10184897.22196.831.5097.5497.171.52
2102923-10292398.24798.64
3101928-10192897.29797.67
4101872-10187297.24497.57
598487-9848794.01394.31
6101561-10156196.94797.31
30min1101934-10193497.30397.290.6997.7997.800.72
2102975-10297598.29798.85
3101766-10176697.14397.67
4102306-10230697.65898.15
5100862-10086296.28096.73
6101695-10169597.07597.60
45min1101748-10174897.12597.350.4797.7798.020.50
2102763-10276398.09498.81
3101762-10176297.13997.83
4102354-10235497.70498.36
5101463-10146396.85397.47
6101833-10183397.20797.90
60min1101508-10150896.89697.170.4097.7198.010.42
2102570-10257097.91098.79
3101554-10155496.94097.79
4101913-10191397.28398.10
5101631-10163197.01497.79
6101620-10162097.00397.86
极限1101949-10194997.31797.420.3398.2998.410.35
2102668-10266898.00499.05
3101825-10182597.19998.21
4101825-10182597.19998.18
5101872-10187297.24498.18
6102181-10218197.53998.55
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.998823078822798819118816838816398819640.04
210.088813988816988815480.03
单位质量响应值RSD%判断
88284.6887455.160.67数据可信
供试品溶液-2024120321批-二甲双胍-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1401687-40168741.14346.4216.6341.1446.4216.63
2555663-55566356.91556.91
3496165-49616550.82050.82
4422030-42203043.22743.23
5349551-34955135.80335.80
6494033-49403350.60250.60
10min1730513-73051374.82480.7210.5474.8980.7910.55
2882087-88208790.34990.44
3842936-84293686.33986.42
4739906-73990675.78675.86
5676781-67678169.32069.38
6855988-85598887.67687.76
15min1913199-91319993.53696.183.8493.7396.393.86
2983665-983665100.753101.00
3969849-96984999.33899.57
4931338-93133895.39495.59
5886966-88696690.84991.02
6949039-94903997.20797.44
20min1968570-96857099.20799.320.9699.5699.700.98
2981660-981660100.548100.96
3974125-97412599.776100.17
4972656-97265699.62699.98
5953947-95394797.70998.04
6967236-96723699.07199.46
30min1966936-96693699.04099.680.4799.55100.220.49
2980690-980690100.449101.03
3974499-97449999.814100.37
4973200-97320099.681100.20
5971391-97139199.49699.99
6972658-97265899.626100.18
45min1964257-96425798.76599.550.5399.44100.250.54
2979087-979087100.284101.03
3972646-97264699.625100.35
4972650-97265099.625100.31
5974548-97454899.819100.47
6968330-96833099.18399.91
60min1962207-96220798.55599.350.5099.40100.220.51
2975686-97568699.936100.85
3970496-97049699.404100.30
4969451-96945199.297100.15
5974257-97425799.790100.61
6967729-96772999.121100.01
极限1960407-96040798.37199.100.5399.38100.140.54
2974330-97433099.797100.88
3967423-96742399.090100.15
4966371-96637198.982100.00
5972153-97215399.574100.56
6964430-96443098.78399.84
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.899364293685933969352692922934340.33
2 9.909369493566936300.10
单位质量响应值RSD%判断
9447.329457.580.08数据可信
供试品溶液-2024120321批-恩格列净-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%
5min139684-3968437.78539.656.3937.7839.656.39
241241-4124139.26739.27
337896-3789636.08236.08
444672-4467242.53442.53
541890-4189039.88539.88
644488-4448842.35942.36
10min177259-7725973.56177.385.1873.6277.455.18
280218-8021876.37876.44
377152-7715273.45973.52
486630-8663082.48382.55
580178-8017876.34076.41
686197-8619782.07182.14
15min195252-9525290.69392.711.8590.8892.901.85
297110-9711092.46292.65
395844-9584491.25691.44
499769-9976994.99495.20
597049-9704992.40492.60
699197-9919794.44994.66
20min1100968-10096896.13596.290.8496.4796.640.83
2101553-10155396.69297.04
3102249-10224997.35597.69
4101137-10113796.29696.66
599692-9969294.92095.27
6101194-10119496.35096.72
30min1102409-10240997.50796.711.2898.0097.221.27
2101479-10147996.62297.13
3103323-10332398.37798.87
4100627-10062795.81096.34
599675-9967594.90495.41
6101915-10191597.03797.56
45min1102370-10237097.47096.881.1798.1397.551.16
2101675-10167596.80897.48
3103572-10357298.61499.28
4101021-10102196.18696.87
5100070-10007095.28095.94
6101787-10178796.91597.60
60min1102369-10236997.46996.851.1698.2997.681.15
2101375-10137596.52397.35
3103461-10346198.50999.33
4100960-10096096.12896.97
5100091-10009195.30096.12
6102062-10206297.17798.03
极限1102846-10284697.92396.811.2398.9197.801.22
2101588-10158896.72597.72
3103216-10321698.27699.26
4100842-10084296.01597.02
599855-9985595.07596.06
6101704-10170496.83697.85
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.998800478805768802098800688784488798700.10
210.088809528813348811430.04
单位质量响应值RSD%判断
88075.0887414.980.54数据可信
供试品溶液-2024120321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%
5min1435910-43591044.71246.855.1444.7146.855.14
2456957-45695746.87146.87
3423259-42325943.41443.41
4482690-48269049.51049.51
5463045-46304547.49547.50
6478681-47868149.09949.10
10min1767905-76790578.76582.614.2678.8482.684.26
2801624-80162482.22482.30
3769972-76997278.97779.05
4847455-84745586.92587.01
5802084-80208482.27182.35
6843108-84310886.47986.56
15min1910851-91085193.42795.611.5393.6395.831.53
2939742-93974296.39196.61
3919135-91913594.27794.48
4945777-94577797.01097.24
5933586-93358695.75995.98
6943909-94390996.81897.04
20min1955935-95593598.05298.520.8798.4198.890.87
2974925-97492599.999100.38
3965111-96511198.99399.35
4954545-95454597.90998.30
5952668-95266897.71698.09
6959584-95958498.42698.81
30min1961496-96149698.62298.700.8999.1599.240.88
2970128-97012899.507100.05
3973474-97347499.851100.38
4952973-95297397.74898.30
5952881-95288197.73898.28
6962419-96241998.71799.27
45min1961830-96183098.65698.510.8399.3599.210.82
2967452-96745299.23399.94
3970514-97051499.547100.24
4951065-95106597.55298.27
5951991-95199197.64798.35
6959347-95934798.40299.12
60min1960813-96081398.55298.380.9199.4199.250.90
2966773-96677399.163100.04
3969463-96946399.439100.30
4948235-94823597.26298.14
5949799-94979997.42298.29
6959917-95991798.46099.34
极限1959385-95938598.40598.170.8999.4299.200.88
2965250-96525099.007100.05
3966020-96602099.086100.11
4947227-94722797.15898.20
5946752-94675297.11098.14
6957699-95769998.23299.28
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