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DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99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%
110.059428594369942559412194033942130.15
210.019509594862949780.18
单位质量响应值RSD%判断
9374.439488.310.86数据可信
供试品溶液-F24707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%
5min159567-5956756.27051.6410.8356.2751.6410.83
246028-4602843.48143.48
351370-5137048.52748.53
458724-5872455.47455.47
560891-6089157.52157.52
651444-5144448.59748.60
10min1100400-10040094.84490.045.7794.9490.135.77
287169-8716982.34582.42
391952-9195286.86386.94
499903-9990394.37494.47
599730-9973094.21194.31
692736-9273687.60487.68
15min1104058-10405898.29998.000.3198.5598.240.31
2104114-10411498.35298.56
3103249-10324997.53597.76
4103571-10357197.83998.09
5103703-10370397.96498.22
6103756-10375698.01498.24
20min1104508-10450898.72498.350.6699.1498.740.65
2104911-10491199.10599.48
3103675-10367597.93798.33
4103340-10334097.62198.03
5103489-10348997.76298.18
6104718-10471898.92399.31
30min1103740-10374097.99998.230.5998.5898.790.58
2105123-10512399.30599.84
3103628-10362897.89398.44
4103645-10364597.90998.48
5104237-10423798.46899.05
6103540-10354097.81098.37
45min1103904-10390498.15498.140.5298.9098.870.51
2104507-10450798.72399.43
3103644-10364497.90898.62
4103105-10310597.39998.14
5104478-10447898.69699.44
6103723-10372397.98398.70
60min1103734-10373497.99397.820.7398.9098.710.71
2104847-10484799.04599.91
3103306-10330697.58998.47
4102878-10287897.18598.09
5102785-10278597.09798.00
6103747-10374798.00598.89
极限1103804-10380498.05997.840.7299.1398.900.70
2104747-10474798.95099.98
3103460-10346097.73498.77
4102760-10276097.07398.14
5102823-10282397.13398.20
6103859-10385998.11199.16
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20
标示量(mg)500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%
110.05 4902204902294902824904924898184902080.05
29.984935754934964935360.02
单位质量响应值RSD%判断
48776.9249452.510.98数据可信
供试品溶液-F24707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%
5min1350602-35060264.24960.099.2064.2560.099.20
2282848-28284851.83351.83
3311225-31122557.03357.03
4350673-35067364.26264.26
5359199-35919965.82465.82
6312840-31284057.32957.33
10min1518193-51819394.96191.564.4595.0791.664.45
2464255-46425585.07685.16
3486362-48636289.12789.22
4517784-51778494.88694.99
5517607-51760794.85394.96
6493504-49350490.43690.53
15min1523994-52399496.02496.080.4096.2996.330.39
2527356-52735696.64096.87
3522769-52276995.79996.04
4521805-52180595.62295.89
5523664-52366495.96396.23
6526093-52609396.40896.65
20min1523656-52365695.96296.100.6596.3996.520.63
2527666-52766696.69697.09
3522475-52247595.74596.15
4520858-52085895.44995.87
5522480-52248095.74696.17
6529420-52942097.01897.42
30min1522497-52249795.74995.940.6396.3396.520.62
2527653-52765396.69497.24
3521461-52146195.55996.12
4519619-51961995.22295.81
5527471-52747196.66197.25
6522623-52262395.77296.34
45min1520827-52082795.44395.790.6596.1996.520.65
2525429-52542996.28797.00
3520135-52013595.31696.04
4518918-51891895.09395.84
5527688-52768896.70097.45
6523326-52332695.90196.63
60min1519625-51962595.22395.340.4896.1396.230.47
2524560-52456096.12797.00
3519269-51926995.15896.04
4517582-51758294.84995.75
5518926-51892695.09596.00
6521634-52163495.59196.48
极限1518506-51850695.01895.120.5296.0896.170.50
2523902-52390296.00797.04
3517998-51799894.92595.96
4516332-51633294.61995.68
5517688-51768894.86895.94
6520002-52000295.29296.34
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DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99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%
110.059479494599946329460894521946310.11
210.019431594313943140.01
单位质量响应值RSD%判断
9416.029421.980.05数据可信
供试品溶液-F24707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%
5min145083-4508342.64246.249.0942.6446.249.10
247852-4785245.26245.26
354337-5433751.39551.40
448998-4899846.34546.35
543362-4336241.01541.01
653676-5367650.77050.77
10min185559-8555980.92785.435.7381.0085.505.73
286488-8648881.80681.88
395772-9577290.58790.67
491625-9162586.66586.74
585618-8561880.98381.05
696851-9685191.60891.69
15min1102790-10279097.22597.860.8097.4398.080.80
2102643-10264397.08697.30
3103447-10344797.84798.08
4102975-10297597.40097.62
5104391-10439198.74098.94
6104523-10452398.86599.10
20min1104479-10447998.82398.570.7499.1998.950.73
2103554-10355497.94898.32
3103720-10372098.10598.50
4103492-10349297.88998.27
5105424-10542499.717100.08
6104613-10461398.95099.35
30min1104317-10431798.67098.490.8799.2099.040.86
2103667-10366798.05598.59
3103073-10307397.49398.06
4103407-10340797.80998.36
5105357-10535799.653100.19
6104931-10493199.25199.82
45min1104182-10418298.54298.300.8199.2499.020.80
2103260-10326097.67098.37
3103342-10334297.74898.47
4103109-10310997.52798.24
5105222-10522299.526100.23
6104467-10446798.81299.54
60min1103877-10387798.25498.050.8399.1198.930.82
2102980-10298097.40598.27
3103112-10311297.53098.42
4102851-10285197.28398.16
5105084-10508499.395100.26
6104095-10409598.46099.36
极限1104095-10409598.46097.900.8999.4898.940.88
2102775-10277597.21198.24
3102640-10264097.08498.13
4102826-10282697.26098.29
5104952-10495299.270100.30
6103738-10373898.12299.18
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20
标示量(mg)500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%
110.05 4915734917344914924911664917694915470.05
29.984921734920804921260.02
单位质量响应值RSD%判断
48910.1549311.220.58数据可信
供试品溶液-F24707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%
5min1278009-27800950.94954.627.7950.9554.627.79
2290750-29075053.28453.28
3326223-32622359.78459.78
4300276-30027655.02955.03
5269779-26977949.44049.44
6323370-32337059.26259.26
10min1461375-46137584.55387.774.5084.6487.864.50
2460192-46019284.33684.42
3500961-50096191.80791.91
4484222-48422288.74088.83
5459942-45994284.29084.37
6506846-50684692.88692.98
15min1526135-52613596.42196.000.8096.6596.240.79
2520467-52046795.38295.61
3520755-52075595.43595.69
4519674-51967495.23795.48
5530032-53003297.13597.36
6525962-52596296.38996.64
20min1527362-52736296.64696.020.8897.0396.420.87
2520508-52050895.39095.78
3520038-52003895.30395.72
4519352-51935295.17895.58
5530398-53039897.20297.59
6525906-52590696.37996.79
30min1526182-52618296.42995.860.8896.9896.420.87
2519998-51999895.29695.84
3518531-51853195.02795.60
4518647-51864795.04995.61
5529132-52913296.97097.52
6525833-52583396.36696.94
45min1525150-52515096.24095.680.9096.9596.400.89
2518169-51816994.96195.67
3518151-51815194.95895.69
4517625-51762594.86195.58
5528468-52846896.84897.56
6525049-52504996.22296.96
60min1522996-52299695.84695.380.9096.7196.260.89
2517159-51715994.77695.64
3516733-51673394.69895.59
4515547-51554794.48095.35
5527151-52715196.60797.48
6523166-52316695.87796.77
极限1523102-52310295.86595.150.9196.8996.180.90
2515869-51586994.53995.56
3515342-51534294.44395.49
4514048-51404894.20695.24
5525216-52521696.25297.28
6521637-52163795.59796.65
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