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%
110.059416394272942589416793965941650.14
210.029441394448944300.03
单位质量响应值RSD%判断
9369.659424.150.42数据可信
中间条件12月-供试品溶液-2024112921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%
5min131585-3158530.25139.3919.6430.2539.3919.64
234168-3416832.72532.73
354118-5411851.83351.83
445281-4528143.36943.37
541228-4122839.48739.49
640351-4035138.64738.65
10min165459-6545962.69576.6311.4062.7576.7011.40
272975-7297569.89369.95
387793-8779384.08684.17
488687-8868784.94285.01
584253-8425380.69580.76
680906-8090677.48977.55
15min187079-8707983.40292.095.1883.5692.295.20
293733-9373389.77589.95
398885-9888594.70994.94
499144-9914494.95795.17
5100228-10022895.99596.20
697833-9783393.70293.90
20min196966-9696692.87195.171.4493.1795.521.46
299692-9969295.48295.80
399996-9999695.77396.16
498467-9846794.30994.68
5100982-10098296.71897.08
6100092-10009295.86596.21
30min198387-9838794.23295.301.0494.6895.811.04
2100329-10032996.09296.57
399842-9984295.62696.17
498090-9809093.94894.48
5100561-10056196.31496.84
699830-9983095.61496.12
45min198407-9840794.25195.210.9894.8695.870.98
2100319-10031996.08396.72
399710-9971095.49996.20
498084-9808493.94294.63
5100427-10042796.18696.87
699483-9948395.28295.95
60min198215-9821594.06795.071.0594.8395.891.06
2100113-10011395.88596.69
399453-9945395.25396.12
497882-9788293.74894.59
5100544-10054496.29897.14
699335-9933595.14095.97
极限198905-9890594.72895.331.0095.6596.311.00
2100381-10038196.14297.10
399736-9973695.52496.55
497909-9790993.77494.77
5100587-10058796.33997.34
699667-9966795.45896.44
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%
19.939972029957839975419966839966659967750.07
29.949970109973579971840.03
单位质量响应值RSD%判断
100380.16100320.320.05数据可信
中间条件12月-供试品溶液-2024112921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%
5min1415664-41566437.27946.4416.1837.2846.4416.19
2444256-44425639.84339.84
3647554-64755458.07658.08
4565966-56596650.75950.76
5523292-52329246.93246.93
6509919-50991945.73345.73
10min1761595-76159568.30480.639.5968.3780.719.59
2830375-83037574.47374.54
3970772-97077287.06587.16
4979422-97942287.84087.92
5940703-94070384.36884.45
6911255-91125581.72781.80
15min1964066-96406686.46393.314.0086.6493.524.02
21022313-102231391.68791.88
31059839-105983995.05395.29
41065138-106513895.52895.76
51076699-107669996.56596.78
61054256-105425694.55294.76
20min11048117-104811794.00195.671.1194.3296.041.11
21075964-107596496.49996.84
31066457-106645795.64696.05
41059770-105977095.04695.44
51081011-108101196.95197.33
61068879-106887995.86396.23
30min11058744-105874494.95495.810.8595.4396.340.85
21077234-107723496.61397.12
31066062-106606295.61196.17
41057147-105714794.81195.36
51077696-107769696.65497.20
61072974-107297496.23196.76
45min11059299-105929995.00495.610.7995.6496.300.79
21075130-107513096.42497.09
31064936-106493695.51096.23
41055520-105552094.66595.37
51076585-107658596.55497.26
61064956-106495695.51296.20
60min11058539-105853994.93695.500.8395.7396.340.83
21075045-107504596.41697.24
31062998-106299895.33696.21
41053268-105326894.46395.33
51075109-107510996.42297.29
61063685-106368595.39896.25
极限11055252-105525294.64195.220.8295.5996.230.81
21071417-107141796.09197.08
31060346-106034695.09896.14
41050260-105026094.19495.22
51071764-107176496.12297.15
61061471-106147195.19996.21
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%
110.059406794140945389450394265943030.23
210.029422194432943260.16
单位质量响应值RSD%判断
9383.389413.770.23数据可信
中间条件12月-供试品溶液-2024112921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%
5min143204-4320441.37239.1912.5641.3739.1912.56
237531-3753135.93935.94
345307-4530743.38643.39
432998-3299831.59931.60
539898-3989838.20638.21
646604-4660444.62844.63
10min186976-8697683.28875.838.9883.3675.908.98
272652-7265269.57169.63
384532-8453280.94781.02
470822-7082267.81967.87
575147-7514771.96072.02
685030-8503081.42481.50
15min1100530-10053096.26792.573.4196.4792.763.42
292899-9289988.96089.14
398715-9871594.52994.74
494328-9432890.32890.49
593979-9397989.99490.18
699543-9954395.32295.53
20min1102697-10269798.34296.081.7798.7196.431.78
298966-9896694.76995.09
3100714-10071496.44396.81
499926-9992695.68996.00
597932-9793293.77994.11
6101790-10179097.47497.84
30min1102643-10264398.29096.261.4598.8296.761.46
299416-9941695.20095.68
3100593-10059396.32796.85
4100619-10061996.35296.83
598501-9850194.32494.81
6101358-10135897.06097.59
45min1102680-10268098.32696.261.5099.0296.931.51
299469-9946995.25195.89
3100548-10054896.28496.97
4100410-10041096.15296.79
598448-9844894.27394.92
6101592-10159297.28497.98
60min1102364-10236498.02396.091.3398.8896.921.34
299502-9950295.28396.08
3100186-10018695.93896.78
4100429-10042996.17096.97
598502-9850294.32595.13
6101096-10109696.80997.66
极限1102469-10246998.12496.311.2599.1597.301.26
299265-9926595.05696.01
3100477-10047796.21697.22
4100734-10073496.46297.42
599183-9918394.97795.94
6101308-10130897.01298.03
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%
19.939950139948629945209944669951499948020.04
29.949970289975789973030.04
单位质量响应值RSD%判断
100181.47100332.290.11数据可信
中间条件12月-供试品溶液-2024112921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%
5min1534442-53444247.97745.9310.5147.9845.9310.50
2477729-47772942.88542.89
3554401-55440149.76849.77
4425101-42510138.16138.16
5507792-50779245.58445.58
6570181-57018151.18551.18
10min1960523-96052386.22679.517.3086.3179.597.31
2827121-82712174.25074.32
3931231-93123183.59683.68
4806137-80613772.36672.43
5854050-85405076.66876.74
6935236-93523683.95684.04
15min11076169-107616996.60793.422.6596.8393.632.66
21011441-101144190.79790.99
31055496-105549694.75194.97
41018885-101888591.46591.65
51018996-101899691.47591.68
61063270-106327095.44995.67
20min11091882-109188298.01896.061.2698.4096.431.27
21062325-106232595.36495.71
31069604-106960496.01896.40
41064274-106427495.53995.88
51054007-105400794.61894.97
61078622-107862296.82797.21
30min11091089-109108997.94696.161.1398.4996.691.14
21064799-106479995.58696.09
31069906-106990696.04596.59
41069269-106926995.98896.48
51055403-105540394.74395.26
61076898-107689896.67397.22
45min11088379-108837997.70396.001.1098.4196.681.11
21063880-106388095.50496.17
31065685-106568595.66696.37
41068030-106803095.87696.53
51054284-105428494.64295.31
61076196-107619696.61097.32
60min11086773-108677397.55995.941.0398.4396.791.04
21063163-106316395.44096.26
31066244-106624495.71696.58
41068348-106834895.90596.72
51054242-105424294.63995.47
61073749-107374996.39097.26
极限11084170-108417097.32595.691.0898.3696.701.09
21059027-105902795.06896.05
31063610-106361095.48096.50
41066363-106636395.72796.70
51050729-105072994.32395.31
61071953-107195396.22997.26
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%
110.059457694463947409469694795946540.15
210.029490694917949120.01
单位质量响应值RSD%判断
9418.319472.260.41数据可信
中间条件12月-供试品溶液-2024120221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%
5min156076-5607653.43341.4718.3553.4341.4718.35
247236-4723645.01045.01
344860-4486042.74542.75
442738-4273840.72440.72
536515-3651534.79434.79
633726-3372632.13632.14
10min191521-9152187.20778.299.8687.3078.369.87
289119-8911984.91884.99
382815-8281578.91178.98
484431-8443180.45180.52
573215-7321569.76469.82
671866-7186668.47968.53
15min1100085-10008595.36793.763.1795.6093.963.19
2101699-10169996.90597.12
396684-9668492.12792.33
4101659-10165996.86797.07
595362-9536290.86791.04
694928-9492890.45490.62
20min1100327-10032795.59896.632.0895.9996.982.08
2104184-10418499.27399.65
399674-9967494.97695.33
4103700-10370098.81299.18
5101355-10135596.57896.90
699190-9919094.51594.83
30min199988-9998895.27596.931.5495.8397.441.53
2102316-10231697.49398.04
399947-9994795.23695.75
4104064-10406499.15999.69
5102193-10219397.37697.86
6101816-10181697.01797.49
45min1100206-10020695.48397.101.8196.1997.781.80
2103990-10399099.08899.79
399821-9982195.11695.79
4103913-10391399.01599.71
5102531-10253197.69898.35
6100953-10095396.19596.83
60min1100039-10003995.32496.761.7096.1997.601.70
2103053-10305398.19699.07
399511-9951194.82095.65
4103891-10389198.99499.85
5101983-10198397.17697.99
6100832-10083296.07996.88
极限1100055-10005595.33996.771.6496.3797.771.64
2102729-10272997.88798.92
3100134-10013495.41496.40
4104004-10400499.102100.13
5102185-10218597.36898.34
6100226-10022695.50296.46
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%
19.939985989983209971819984959983079981800.06
29.94999828100069910002640.07
单位质量响应值RSD%判断
100521.65100630.180.08数据可信
中间条件12月-供试品溶液-2024120221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%
5min1669298-66929859.89248.1715.4859.8948.1715.48
2577541-57754151.68151.68
3553027-55302749.48749.49
4528414-52841447.28547.28
5464944-46494441.60541.61
6436696-43669639.07839.08
10min11000187-100018789.50181.788.1289.6081.868.13
2975836-97583687.32287.41
3924170-92417082.69982.78
4932152-93215283.41383.49
5832611-83261174.50674.58
6818116-81811673.20973.27
15min11071390-107139095.87394.432.3096.1294.652.32
21078193-107819396.48296.71
31042913-104291393.32593.55
41080635-108063596.70096.92
51030865-103086592.24792.44
61027553-102755391.95092.14
20min11071193-107119395.85596.581.2496.2696.951.25
21094940-109494097.98098.37
31070559-107055995.79996.17
41096110-109611098.08598.46
51078509-107850996.51096.86
61064329-106432995.24195.58
30min11068821-106882195.64396.740.9096.2197.270.89
21085102-108510297.10097.66
31071413-107141395.87596.41
41095134-109513497.99898.54
51081962-108196296.81997.33
61083783-108378396.98297.48
45min11072866-107286696.00596.780.9196.7397.470.91
21090990-109099097.62798.34
31071957-107195795.92496.62
41094343-109434397.92798.63
51084529-108452997.04997.72
61074241-107424196.12896.79
60min11067138-106713895.49296.541.0396.3897.401.03
21088086-108808697.36798.25
31068962-106896295.65696.51
41093674-109367497.86798.74
51083368-108336896.94597.78
61071533-107153395.88696.71
极限11066606-106660695.44596.210.9796.4997.220.96
21081466-108146696.77597.82
31063698-106369895.18596.20
41090259-109025997.56198.59
51079957-107995796.64097.63
61068784-106878495.64096.62
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%
110.059515195244952789506695525952530.19
210.029501695052950340.03
单位质量响应值RSD%判断
9477.919484.430.05数据可信
中间条件12月-供试品溶液-2024120221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%
5min145702-4570243.38338.9212.6243.3838.9212.61
239990-3999037.96137.96
338514-3851436.55936.56
448702-4870246.23046.23
538156-3815636.22036.22
634919-3491933.14733.15
10min185389-8538981.05674.636.5381.1374.706.53
277999-7799974.04174.10
375354-7535471.53071.59
481910-8191077.75377.83
580267-8026776.19376.25
670806-7080667.21367.27
15min199039-9903994.01391.352.1294.2291.542.13
296597-9659791.69591.88
394926-9492690.10990.29
496124-9612491.24691.45
597535-9753592.58592.77
693183-9318388.45488.62
20min1100769-10076995.65595.130.9596.0295.470.95
2101398-10139896.25296.59
3100829-10082995.71296.04
499326-9932694.28594.64
599988-9998894.91495.26
698967-9896793.94494.26
30min1100855-10085595.73795.630.7596.2696.130.74
2101384-10138496.23996.74
3101761-10176196.59797.09
499918-9991894.84795.36
599963-9996394.89095.39
6100559-10055995.45695.93
45min1101501-10150196.35095.791.0297.0396.451.01
2101495-10149596.34497.00
3102145-10214596.96197.61
499326-9932694.28594.96
5100194-10019495.10995.77
6100830-10083095.71396.34
60min1100737-10073795.62595.591.0796.4796.411.06
2101742-10174296.57997.40
3101979-10197996.80497.62
499207-9920794.17295.00
599815-9981594.74995.57
6100733-10073395.62196.41
极限1100950-10095095.82795.681.1196.8396.661.09
2101508-10150896.35697.34
3102139-10213996.95597.93
498932-9893293.91194.90
5100244-10024495.15796.13
6100986-10098695.86196.81
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%
19.931003274100265010029761002791100260910028600.03
29.941003408100281810031130.05
单位质量响应值RSD%判断
100992.95100916.800.06数据可信
中间条件12月-供试品溶液-2024120221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%
5min1566323-56632350.48745.8011.1950.4945.8011.19
2497876-49787644.38544.39
3484763-48476343.21643.22
4601094-60109453.58753.59
5482517-48251743.01643.02
6450056-45005640.12240.12
10min1944337-94433784.18678.395.6584.2778.465.65
2865714-86571477.17777.25
3844799-84479975.31375.38
4914695-91469581.54481.63
5898234-89823480.07680.15
6807968-80796872.02972.10
15min11064114-106411494.86492.341.9095.0992.541.91
21033096-103309692.09992.30
31023651-102365191.25791.45
41036897-103689792.43892.66
51049158-104915893.53193.74
61007674-100767489.83390.02
20min11078322-107832296.13195.300.6496.5195.660.65
21073077-107307795.66396.02
31070790-107079095.46095.81
41064575-106457594.90695.28
51068219-106821995.23095.59
61058746-105874694.38694.72
30min11075798-107579895.90695.540.4296.4596.060.42
21073688-107368895.71896.23
31077265-107726596.03796.55
41068779-106877995.28095.82
51066946-106694695.11795.64
61067554-106755495.17195.67
45min11080684-108068496.34295.520.6697.0496.200.66
21072963-107296395.65396.33
31077255-107725596.03696.70
41061228-106122894.60795.30
51067156-106715695.13695.81
61069551-106955195.34996.00
60min11072998-107299895.65695.310.5396.5296.140.52
21071636-107163695.53596.37
31075886-107588695.91496.74
41060260-106026094.52195.37
51066655-106665595.09195.93
61066972-106697295.11995.93
极限11070118-107011895.40095.020.6296.4296.020.62
21070881-107088195.46896.46
31072394-107239495.60396.59
41054997-105499794.05295.06
51062497-106249794.72095.72
61064220-106422094.87495.84
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%
110.059347693690933239362893470935170.16
210.029283692929928820.08
单位质量响应值RSD%判断
9305.179269.660.28数据可信
中间条件12月-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%
5min153668-5366852.00742.8214.3352.0142.8214.33
241841-4184140.54640.55
338426-3842637.23737.24
444906-4490643.51643.52
549021-4902147.50447.50
637274-3727436.12136.12
10min189108-8910886.35179.158.6586.4479.228.66
276903-7690374.52374.59
374741-7474172.42872.49
486680-8668083.99884.07
588328-8832885.59585.67
674325-7432572.02572.09
15min198836-9883695.77893.663.2196.0193.863.22
296491-9649193.50593.70
391862-9186289.01989.20
497186-9718694.17994.39
5100706-10070697.59097.81
694811-9481191.87792.06
20min199449-9944996.37296.361.5296.7696.721.53
299965-9996596.87297.22
397423-9742394.40894.74
498203-9820395.16495.53
5101757-10175798.60898.99
699821-9982196.73297.07
30min199303-9930396.23096.651.2796.7897.171.27
2100699-10069997.58398.09
398098-9809895.06395.55
498636-9863695.58496.11
5101347-10134798.21198.76
6100317-10031797.21397.71
45min199505-9950596.42696.581.2297.1497.261.22
2100597-10059797.48498.16
398096-9809695.06195.71
498529-9852995.48096.17
5101252-10125298.11998.83
6100004-10000496.91097.57
60min199264-9926496.19296.481.1897.0697.321.18
2100450-10045097.34298.18
398008-9800894.97595.78
498526-9852695.47796.32
5101065-10106597.93898.81
6100037-10003796.94297.76
极限199700-9970096.61596.861.1497.6597.861.14
2100920-10092097.79798.79
398309-9830995.26796.23
499100-9910096.03497.04
5101283-10128398.14999.19
6100402-10040297.29598.27
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%
19.938767338764568765438767288767008766320.02
29.948728768735968732360.06
单位质量响应值RSD%判断
88281.1787850.700.35数据可信
中间条件12月-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%
5min1572932-57293258.55249.6612.0758.5549.6612.07
2458984-45898446.90746.91
3435423-43542344.49944.50
4495502-49550250.63950.64
5531626-53162654.33054.33
6421326-42132643.05843.06
10min1874165-87416589.33782.957.1889.4383.037.18
2768313-76831378.51978.60
3756755-75675577.33877.41
4854826-85482687.36087.44
5863985-86398588.29688.39
6751996-75199676.85276.92
15min1948877-94887796.97294.962.5597.2295.182.56
2925809-92580994.61594.82
3892451-89245191.20691.41
4934203-93420395.47395.70
5958197-95819797.92598.16
6915829-91582993.59593.79
20min1951801-95180197.27196.971.0897.6897.351.09
2949091-94909196.99497.36
3934816-93481695.53595.89
4940465-94046596.11296.50
5963994-96399498.51798.92
6953190-95319097.41397.77
30min1951401-95140197.23097.090.8497.8097.630.84
2953008-95300897.39497.92
3939336-93933695.99796.51
4941905-94190596.26096.81
5960173-96017398.12798.69
6954284-95428497.52598.04
45min1949560-94956097.04296.920.7697.7797.620.76
2951559-95155997.24697.94
3938719-93871995.93496.61
4940975-94097596.16596.87
5957615-95761597.86598.59
6951733-95173397.26497.94
60min1947015-94701596.78296.720.7897.6897.590.78
2949110-94911096.99697.85
3936991-93699195.75796.59
4938677-93867795.93096.80
5955961-95596197.69698.59
6950767-95076797.16598.01
极限1944829-94482996.55896.570.8297.6197.590.83
2947986-94798696.88197.90
3934735-93473595.52796.52
4937447-93744795.80496.83
5955500-95550097.64998.70
6948879-94887996.97297.98
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%
110.059353493589935769365993690936100.07
210.029358393627936050.04
单位质量响应值RSD%判断
9314.439341.820.21数据可信
中间条件12月-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%
5min141366-4136639.91138.7910.8939.9138.7910.90
232643-3264331.49531.49
344213-4421342.65842.66
439213-3921337.83437.83
539210-3921037.83137.83
644594-4459443.02543.03
10min178314-7831475.55975.127.6675.6375.197.66
268368-6836865.96366.02
387040-8704083.97884.05
477703-7770374.97075.03
576681-7668173.98474.05
679065-7906576.28476.36
15min195950-9595092.57591.882.2592.7792.072.26
292757-9275789.49489.66
398675-9867595.20495.42
495837-9583792.46692.65
593287-9328790.00690.19
694884-9488491.54791.75
20min199258-9925895.76796.041.6896.1196.381.68
2101066-10106697.51197.82
3101441-10144197.87398.24
499023-9902395.54095.88
596776-9677693.37293.71
699695-9969596.18896.54
30min199696-9969696.18996.561.9696.7097.061.95
2101943-10194398.35798.83
3101593-10159398.02098.55
4100987-10098797.43597.94
596573-9657393.17693.67
699669-9966996.16396.68
45min199496-9949695.99696.232.0396.6696.892.02
2102191-10219198.59799.23
3101555-10155597.98398.68
498835-9883595.35996.02
596544-9654493.14893.80
699808-9980896.29796.97
60min199208-9920895.71995.951.9796.5596.781.97
2101744-10174498.16598.97
3101260-10126097.69898.56
498685-9868595.21496.04
596299-9629992.91293.71
699501-9950196.00196.83
极限199392-9939295.89696.161.9196.8897.151.90
2101820-10182098.23999.20
3101578-10157898.00599.03
498784-9878495.30996.29
596685-9668593.28494.24
699764-9976496.25597.25
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%
19.938767358772018761648762578758618764440.07
29.948772938772528772720.01
单位质量响应值RSD%判断
88262.2488256.740.01数据可信
中间条件12月-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%
5min1465449-46544947.46345.999.3147.4645.999.31
2376475-37647538.39038.39
3485621-48562149.52049.52
4443301-44330145.20445.20
5442966-44296645.17045.17
6492417-49241750.21350.21
10min1792469-79246980.81079.866.2980.8979.946.30
2701280-70128071.51171.57
3855037-85503787.19087.27
4785258-78525880.07480.15
5773254-77325478.85078.93
6791675-79167580.72980.81
15min1932995-93299595.13993.861.9295.3594.071.93
2897624-89762491.53391.72
3943486-94348696.20996.44
4928455-92845594.67694.89
5904388-90438892.22292.43
6915538-91553893.35993.58
20min1957909-95790997.68097.061.2098.0597.431.20
2960170-96017097.91098.25
3960542-96054297.94898.34
4951437-95143797.02097.39
5930252-93025294.86095.22
6950899-95089996.96597.34
30min1958282-95828297.71897.331.3998.2597.861.39
2963513-96351398.25198.75
3963417-96341798.24298.79
4961260-96126098.02298.55
5929096-92909694.74295.26
6951557-95155797.03297.57
45min1957499-95749997.63897.041.4498.3497.731.43
2965636-96563698.46899.13
3960592-96059297.95498.67
4948624-94862496.73397.42
5926943-92694394.52295.20
6950407-95040796.91597.61
60min1954977-95497797.38196.721.4298.2497.581.41
2960380-96038097.93298.76
3958076-95807697.69798.58
4947085-94708596.57697.43
5923673-92367394.18995.02
6946914-94691496.55997.42
极限1953242-95324297.20496.611.3698.2397.621.35
2958734-95873497.76498.75
3956886-95688697.57698.62
4946045-94604596.47097.48
5923697-92369794.19195.18
6946024-94602496.46897.49
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