恩格列净二甲双胍片项目信息
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%
19.668850488687896618861888736888410.53
29.658838488546884650.13
单位质量响应值RSD%判断
9196.799167.360.23数据可信
中间条件6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%
5min138726-3872637.95837.0911.8237.9637.1011.82
231574-3157430.94830.95
338974-3897438.20138.20
434230-3423033.55133.55
539094-3909438.31938.32
644472-4447243.59043.59
10min174940-7494073.45473.556.0373.5273.626.03
267563-6756366.22366.28
377042-7704275.51575.58
475083-7508373.59473.65
574127-7412772.65772.72
681480-8148079.86579.94
15min192573-9257390.73891.922.9590.9292.102.95
289864-8986488.08288.24
395979-9597994.07694.27
496480-9648094.56794.75
591746-9174689.92790.11
696007-9600794.10394.31
20min197592-9759295.65797.602.5295.9997.942.52
298250-9825096.30296.61
3102390-102390100.360100.71
4103008-103008100.966101.30
597173-9717395.24695.58
699057-9905797.09397.46
30min198281-9828196.33298.212.2196.8398.712.21
299471-9947197.49997.97
3102772-102772100.734101.25
4103032-103032100.989101.49
597886-9788695.94596.44
699741-9974197.76398.29
45min198179-9817996.23298.222.2696.8998.882.25
299636-9963697.66198.29
3102829-102829100.790101.47
4103106-103106101.062101.73
597868-9786895.92896.58
699638-9963897.66298.35
60min198275-9827596.32798.172.3097.1499.002.29
299556-9955697.58298.38
3102978-102978100.936101.79
4102929-102929100.888101.73
597613-9761395.67896.49
699613-9961397.63898.49
极限198875-9887596.91598.632.1997.8999.622.19
2100176-10017698.19099.15
3103373-103373101.323102.34
4103222-103222101.175102.18
598126-9812696.18097.15
699983-9998398.00199.01
恩格列净二甲双胍片项目信息
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%
110.159586939603169630229631469635959617540.23
210.229619379611509615440.06
单位质量响应值RSD%判断
94754.0994084.540.51数据可信
中间条件6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%
5min1455540-45554043.42242.5310.4643.4242.5310.46
2380156-38015636.23736.24
3459847-45984743.83343.83
4409943-40994339.07639.08
5455742-45574243.44243.44
6515805-51580549.16749.17
10min1800996-80099676.35175.855.3076.4275.925.30
2725381-72538169.14469.20
3811722-81172277.37477.45
4794506-79450675.73375.80
5786682-78668274.98775.06
6855316-85531681.52981.61
15min1947701-94770190.33691.342.5690.5491.542.57
2923889-92388988.06688.24
3969375-96937592.40192.60
4977803-97780393.20593.40
5941951-94195189.78789.98
6988873-98887394.26094.48
20min1989141-98914194.28695.581.7994.6495.931.79
2991803-99180394.53994.86
31019693-101969397.19897.55
41028601-102860198.04798.39
5984143-98414393.80994.16
61002789-100278995.58795.96
30min1993861-99386194.73695.881.6195.2496.391.61
2998852-99885295.21195.69
31022481-102248197.46497.98
41028639-102863998.05198.56
5988349-98834994.21094.71
61003276-100327695.63396.17
45min1993997-99399794.74895.871.6495.4196.541.64
2999612-99961295.28495.92
31023138-102313897.52698.21
41027758-102775897.96798.64
5986198-98619894.00594.67
61003708-100370895.67496.37
60min1993852-99385294.73595.781.6595.5696.611.65
2998243-99824395.15395.95
31022405-102240597.45698.30
41027199-102719997.91398.75
5985217-98521793.91294.73
61002121-100212195.52396.38
极限1991550-99155094.51595.591.6395.5096.581.63
2996892-99689295.02495.98
31021306-102130697.35298.36
41023720-102372097.58298.58
5983229-98322993.72294.70
61000033-100003395.32496.34
恩格列净二甲双胍片项目信息
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%
19.668878788440889008885488522887010.24
29.658852388640885820.10
单位质量响应值RSD%判断
9182.309179.480.03数据可信
中间条件6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%
5min142754-4275441.91241.5212.3441.9141.5212.34
251077-5107750.07150.07
336512-3651235.79335.79
437701-3770136.95836.96
541728-4172840.90640.91
644345-4434543.47143.47
10min181262-8126279.66180.065.0779.7380.135.08
286870-8687085.15885.24
375863-7586374.36874.43
477974-7797476.43876.50
584211-8421182.55282.62
683828-8382882.17682.25
15min195948-9594894.05894.971.8094.2695.181.79
296904-9690494.99595.22
395330-9533093.45293.64
496971-9697195.06095.25
5100182-10018298.20898.41
695953-9595394.06294.27
20min198287-9828796.35097.041.3096.7197.401.29
298090-9809096.15796.54
399586-9958697.62497.96
498955-9895597.00597.35
5101235-10123599.24099.61
697771-9777195.84596.21
30min198332-9833296.39597.401.6496.9197.921.63
297745-9774595.81996.36
3100790-10079098.80499.31
499531-9953197.57098.08
5101741-10174199.736100.27
698004-9800496.07396.60
45min198288-9828896.35197.451.6497.0398.131.63
297935-9793596.00596.71
3100987-10098798.99799.66
499478-9947897.51898.19
5101736-10173699.732100.43
698020-9802096.08996.77
60min198225-9822596.29097.481.6097.1398.321.59
297796-9779695.86996.73
3100850-10085098.86399.69
499597-9959797.63598.47
5101746-10174699.741100.61
698414-9841496.47597.32
极限198012-9801296.08197.541.8197.0898.551.80
297622-9762295.69996.72
3101103-10110399.111100.11
4100009-10000998.03999.04
5101972-10197299.963101.00
698268-9826896.33297.34
恩格列净二甲双胍片项目信息
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%
110.159600349608259602859611179612339606990.06
210.229617859625919621880.06
单位质量响应值RSD%判断
94650.1594147.550.38数据可信
中间条件6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%
5min1493102-49310247.01346.9411.0347.0146.9411.02
2582803-58280355.56555.56
3432215-43221541.20841.21
4445349-44534942.46042.46
5483040-48304046.05346.05
6517501-51750149.33949.34
10min1854577-85457781.47681.594.5281.5581.674.52
2903151-90315186.10786.20
3798205-79820576.10276.17
4824496-82449678.60878.68
5876404-87640483.55783.63
6878002-87800283.70983.79
15min1978275-97827593.27093.831.6193.4894.041.61
2986692-98669294.07294.31
3964957-96495792.00092.20
4984441-98444193.85794.06
51012336-101233696.51796.73
6978085-97808593.25193.47
20min1994177-99417794.78695.320.8995.1695.700.88
2993228-99322894.69595.09
31002203-100220395.55195.90
41000467-100046795.38595.74
51015924-101592496.85997.24
6992953-99295394.66995.05
30min1993167-99316794.68995.501.1095.2296.031.09
2991956-99195694.57495.12
31008308-100830896.13396.64
41008016-100801696.10596.62
51017420-101742097.00297.54
6991434-99143494.52495.06
45min1992663-99266394.64195.371.0795.3396.051.06
2991252-99125294.50795.22
31008230-100823096.12596.79
41000986-100098695.43596.11
51017139-101713996.97597.67
6991305-99130594.51295.20
60min1992680-99268094.64395.391.0595.4996.241.04
2989932-98993294.38195.25
31009240-100924096.22297.05
41001887-100188795.52196.36
51016251-101625196.89097.75
6993392-99339294.71195.56
极限1989306-98930694.32195.181.1095.3296.181.08
2988479-98847994.24295.27
31006813-100681395.99096.98
4999868-99986895.32896.32
51014903-101490396.76297.78
6990299-99029994.41695.42
恩格列净二甲双胍片项目信息
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%
19.668840188088883928851288159883100.21
29.658896289138890500.14
单位质量响应值RSD%判断
9141.829227.980.67数据可信
中间条件6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%
5min140103-4010339.29742.3316.5539.3042.3316.55
248241-4824147.27147.27
337845-3784537.08437.08
445040-4504044.13444.13
534298-3429833.60833.61
653651-5365152.57252.57
10min177028-7702875.47977.837.8275.5477.907.83
280429-8042978.81278.89
373753-7375372.27072.33
482276-8227680.62180.70
573281-7328171.80771.86
689809-8980988.00388.09
15min194503-9450392.60392.982.8992.7993.182.90
295536-9553693.61593.82
391303-9130389.46789.65
495423-9542393.50493.71
593140-9314091.26791.44
699432-9943297.43297.67
20min199386-9938697.38797.120.6097.7397.480.61
299153-9915397.15997.53
398711-9871196.72697.06
498191-9819196.21696.58
599380-9938097.38297.71
699885-9988597.87698.27
30min1100095-10009598.08297.680.7098.5998.200.69
299743-9974397.73798.27
399815-9981597.80898.30
498414-9841496.43596.96
5100457-10045798.43798.93
699599-9959997.59698.16
45min199995-9999597.98497.620.7198.6698.300.69
299584-9958497.58198.27
399911-9991197.90298.56
498402-9840296.42397.11
5100446-10044698.42699.08
699416-9941697.41798.14
60min1100085-10008598.07297.620.7898.9198.460.77
299659-9965997.65598.51
399459-9945997.45998.28
498293-9829396.31697.16
5100619-10061998.59699.41
699600-9960097.59798.48
极限1100155-10015598.14197.710.6999.1498.720.66
299623-9962397.62098.64
399791-9979197.78498.77
498725-9872596.74097.75
5100694-10069498.66999.65
699322-9932297.32598.37
恩格列净二甲双胍片项目信息
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%
110.159575109578179579419575989562619574250.08
210.229621829613169617490.07
单位质量响应值RSD%判断
94327.5994104.600.17数据可信
中间条件6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%
5min1466229-46622944.53747.8014.0144.5447.8014.01
2551942-55194252.72452.72
3446829-44682942.68342.68
4517771-51777149.46049.46
5416573-41657339.79339.79
6603069-60306957.60857.61
10min1809653-80965377.34279.806.6277.4279.886.62
2852335-85233581.41981.51
3779232-77923274.43674.51
4860593-86059382.20882.29
5785554-78555475.04075.11
6924990-92499088.36088.46
15min1957045-95704591.42292.322.5491.6392.542.55
2979608-97960893.57793.80
3928193-92819388.66688.86
4972339-97233992.88393.10
5960564-96056491.75891.95
61001204-100120495.64095.88
20min1996846-99684695.22495.350.7795.5895.720.78
21003369-100336995.84796.23
3987351-98735194.31794.66
4991416-99141694.70595.08
51006898-100689896.18496.53
61003380-100338095.84896.25
30min11001418-100141895.66195.610.8496.1796.140.83
21003025-100302595.81496.35
3994483-99448394.99895.50
4990560-99056094.62395.16
51014925-101492596.95197.46
61001041-100104195.62596.19
45min11003571-100357195.86695.570.7096.5496.250.69
21003457-100345795.85596.55
3992480-99248094.80795.47
4992472-99247294.80695.50
51010112-101011296.49197.16
61000517-100051795.57596.30
60min1998662-99866295.39795.440.8196.2396.280.80
21001687-100168795.68696.55
3990952-99095294.66195.48
4991418-99141894.70595.55
51012777-101277796.74697.57
6998928-99892895.42396.30
极限1998141-99814195.34895.200.7096.3496.200.69
2999852-99985295.51196.53
3990343-99034394.60395.58
4988925-98892594.46795.47
51007717-100771796.26297.25
6994414-99441494.99296.03
恩格列净二甲双胍片项目信息
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%
19.668858988859882448836988577885280.27
29.658900088894889470.09
单位质量响应值RSD%判断
9164.399217.310.41数据可信
中间条件6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%
5min139806-3980638.98041.1413.8938.9841.1413.89
238924-3892438.11638.12
351547-5154750.47750.48
434689-3468933.96933.97
541736-4173640.87040.87
645355-4535544.41444.41
10min176671-7667175.08079.549.1175.1479.619.11
283314-8331481.58581.65
392606-9260690.68490.77
470725-7072569.25769.31
580141-8014178.47878.55
683921-8392182.17982.25
15min193175-9317591.24195.224.8391.4395.424.83
2102894-102894100.758100.96
3101496-10149699.38999.62
490820-9082088.93589.11
596539-9653994.53594.73
698507-9850796.46296.67
20min198308-9830896.26798.492.6496.6198.852.65
2104746-104746102.572102.94
3101647-10164799.53799.94
497213-9721395.19595.52
5100666-10066698.57698.93
6100886-10088698.79299.16
30min199138-9913897.08098.901.7197.5899.431.73
2103460-103460101.312101.85
3102418-102418100.292100.86
499220-9922097.16197.64
5101188-10118899.08899.61
6100578-10057898.49099.03
45min199558-9955897.49199.041.7798.1699.731.78
2103426-103426101.279101.99
3103183-103183101.041101.78
499422-9942297.35898.00
5101095-10109598.99799.68
6100136-10013698.05798.76
60min198766-9876696.71698.821.7597.5499.681.76
2103656-103656101.504102.38
3101199-10119999.098100.00
499496-9949697.43198.23
5101927-10192799.811100.66
6100473-10047398.38799.25
极限199524-9952497.45899.202.0898.45100.222.08
2105323-105323103.137104.18
3101626-10162699.517100.58
4100106-10010698.02898.99
5101029-10102998.93299.95
6100213-10021398.13399.16
恩格列净二甲双胍片项目信息
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%
110.159568369586309574279576479574619576000.07
210.229638489638159638320.01
单位质量响应值RSD%判断
94344.8394308.410.03数据可信
中间条件6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%
5min1474426-47442645.26646.5111.5245.2746.5111.52
2455713-45571343.48143.48
3578327-57832755.18055.18
4415491-41549139.64339.64
5480435-48043545.84045.84
6520347-52034749.64849.65
10min1817590-81759078.00980.977.3278.0881.057.33
2859055-85905581.96582.04
3946948-94694890.35190.44
4760416-76041672.55472.62
5835131-83513179.68279.76
6872784-87278483.27583.36
15min1957420-95742091.35093.693.3791.5693.913.38
21019431-101943197.26797.48
31015440-101544096.88697.13
4935283-93528389.23889.43
5972898-97289892.82793.04
6991220-99122094.57594.80
20min1997045-99704595.13196.181.5795.4996.551.58
21032688-103268898.53298.90
31015117-101511796.85697.26
4986564-98656494.13194.47
51006302-100630296.01496.38
61010610-101061096.42596.80
30min11004243-100424395.81896.230.7196.3396.760.73
21018519-101851997.18097.72
31016826-101682697.01997.58
41002441-100244195.64696.14
51004993-100499395.89096.41
61004218-100421895.81696.36
45min11006382-100638296.02296.371.0496.7097.061.05
21018804-101880497.20797.90
31026874-102687497.97798.70
41001984-100198495.60296.25
51005126-100512695.90296.59
61001163-100116395.52496.22
60min1998607-99860795.28096.120.7596.1296.970.76
21015846-101584696.92597.78
31009738-100973896.34297.23
41002071-100207195.61196.42
51016105-101610596.95097.79
61002313-100231395.63496.49
极限11002516-100251695.65396.021.1596.6597.041.14
21028991-102899198.17999.20
31007294-100729496.10997.16
41000755-100075595.48596.46
51000847-100084795.49496.50
6997957-99795795.21896.24
恩格列净二甲双胍片项目信息
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%
19.668838187991882038881888491883770.36
29.658899089246891180.21
单位质量响应值RSD%判断
9148.769235.030.67数据可信
中间条件6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%
5min136827-3682736.05942.3319.3036.0642.3319.30
238186-3818637.39037.39
355397-5539754.24254.24
437152-3715236.37736.38
552331-5233151.24051.24
639509-3950938.68538.69
10min173402-7340271.87177.9611.4371.9378.0311.44
274477-7447772.92472.99
396074-9607494.07094.16
475028-7502873.46373.52
584709-8470982.94283.03
674034-7403472.49072.55
15min194110-9411092.14793.652.8492.3393.862.86
294437-9443792.46892.65
399525-9952597.44997.70
496170-9617094.16494.35
597673-9767395.63695.86
691972-9197290.05490.24
20min199454-9945497.38097.390.5297.7197.750.51
299060-9906096.99497.33
399216-9921697.14797.56
4100409-10040998.31598.66
599575-9957597.49897.88
699066-9906697.00097.34
30min1100744-10074498.64397.980.8999.1498.500.86
2100500-10050098.40498.90
399346-9934697.27497.85
4100310-10031098.21898.72
598632-9863296.57597.12
6100890-10089098.78699.28
45min1102013-10201399.88698.701.04100.5599.381.01
2100461-10046198.36699.03
399283-9928397.21297.95
4101610-10161099.491100.16
5100056-10005697.96998.68
6101396-10139699.28199.94
60min1102480-102480100.34398.121.20101.1798.971.17
299973-9997397.88898.72
399238-9923897.16898.06
4100279-10027998.18899.02
599235-9923597.16598.04
6100055-10005597.96898.80
极限1103145-103145100.99498.911.29101.9999.921.26
2100980-10098098.87499.86
399548-9954897.47298.53
4100830-10083098.72799.72
599900-9990097.81798.85
6101687-10168799.566100.56
恩格列净二甲双胍片项目信息
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%
110.159273959280899287779299839292419286970.11
210.229358479326449342460.25
单位质量响应值RSD%判断
91497.2491413.500.07数据可信
中间条件6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%
5min1421501-42150141.47948.0616.5641.4848.0616.56
2444897-44489743.78243.78
3607398-60739859.77359.77
4427011-42701142.02242.02
5573903-57390356.47756.48
6455463-45546344.82244.82
10min1763607-76360775.14680.719.8275.2180.799.83
2781897-78189776.94577.02
3965630-96563095.02695.13
4782079-78207976.96377.03
5864106-86410685.03685.13
6763797-76379775.16475.24
15min1942360-94236092.73693.652.3692.9393.862.38
2944671-94467192.96493.17
3984303-98430396.86497.12
4954532-95453293.93494.13
5965599-96559995.02395.26
6918416-91841690.38090.58
20min1979519-97951996.39396.640.2096.7497.010.22
2981198-98119896.55896.91
3983771-98377196.81297.23
4984518-98451896.88597.24
5982570-98257096.69397.09
6980843-98084396.52396.87
30min1994327-99432797.85097.040.7398.3697.580.70
2988130-98813097.24197.76
3982001-98200196.63797.22
4988690-98869097.29697.81
5973905-97390595.84196.40
6989650-98965097.39097.90
45min1993909-99390997.80997.250.6098.4897.940.57
2990173-99017397.44298.12
3981650-98165096.60397.34
4989071-98907197.33398.01
5980585-98058596.49897.21
6993914-99391497.81098.48
60min1997784-99778498.19196.950.8699.0397.800.83
2980189-98018996.45997.30
3980522-98052296.49297.39
4979647-97964796.40697.25
5978878-97887896.33097.21
6993827-99382797.80198.64
极限1996779-99677998.09297.090.8699.0998.100.82
2987145-98714597.14498.15
3978386-97838696.28297.35
4985967-98596797.02898.03
5976050-97605096.05297.09
6994973-99497397.91498.91
恩格列净二甲双胍片项目信息
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%
19.668889589257888468901189106890230.19
29.658961189079893450.43
单位质量响应值RSD%判断
9215.639258.550.33数据可信
中间条件6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%
5min140320-4032039.28544.5513.1339.2944.5513.13
240604-4060439.56239.56
354240-5424052.84852.85
450036-5003648.75248.75
548483-4848347.23947.24
640637-4063739.59439.59
10min179678-7967877.63381.886.4977.7081.966.49
277149-7714975.16975.24
390171-9017187.85787.95
484139-8413981.98082.06
590534-9053488.21188.29
682542-8254280.42480.49
15min198005-9800595.49096.493.4695.6896.703.46
293202-9320290.81091.00
3101518-10151898.91399.15
498391-9839195.86696.08
5102979-102979100.336100.56
6100119-10011997.55097.75
20min1101542-10154298.93698.711.9299.2999.081.92
298256-9825695.73596.08
3102844-102844100.205100.60
499669-9966997.11197.49
5102747-102747100.110100.50
6102820-102820100.181100.54
30min1101984-10198499.36798.552.0899.8999.092.09
297959-9795995.44595.95
3102191-10219199.569100.13
499050-9905096.50897.05
5102855-102855100.216100.78
6102829-102829100.190100.72
45min1100903-10090398.31498.822.0899.0099.522.09
298093-9809395.57696.24
3103147-103147100.500101.23
4100185-10018597.61498.31
5103665-103665101.005101.73
6102521-10252199.890100.59
60min1101496-10149698.89198.601.5299.7499.461.53
298746-9874696.21297.03
3101530-10153098.92599.82
4100221-10022197.64998.51
5103156-103156100.509101.40
6102048-10204899.429100.29
极限1101871-10187199.25798.701.60100.2799.731.60
299031-9903196.49097.47
3100363-10036397.78798.85
4100468-10046897.89098.92
5103143-103143100.496101.56
6102931-102931100.290101.32
恩格列净二甲双胍片项目信息
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%
110.159306029282829317819335429332789314970.24
210.229338629326479332540.10
单位质量响应值RSD%判断
91773.1091316.440.36数据可信
中间条件6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%
5min1455593-45559344.79149.9510.9944.7949.9510.99
2467866-46786645.99746.00
3585723-58572357.58457.58
4552987-55298754.36654.37
5529942-52994252.10052.10
6456239-45623944.85444.85
10min1811390-81139079.77083.754.9379.8483.834.94
2799015-79901578.55478.63
3895191-89519188.00988.11
4863692-86369284.91285.00
5899572-89957288.44088.53
6842407-84240782.82082.89
15min1966315-96631595.00195.892.6695.2196.122.66
2929711-92971191.40391.61
3996808-99680897.99998.24
4975701-97570195.92496.16
51001244-100124498.43598.67
6982596-98259696.60296.81
20min1990358-99035897.36597.361.2597.7397.741.26
2970804-97080495.44395.80
3996914-99691498.01098.42
4981436-98143696.48896.88
5997558-99755898.07398.47
61004789-100478998.78499.16
30min1987059-98705997.04196.961.5397.5797.511.53
2960545-96054594.43494.95
3994576-99457697.78098.35
4981814-98181496.52597.08
5988036-98803697.13797.70
61005654-100565498.86999.41
45min1976979-97697996.05097.171.3996.7497.881.39
2970382-97038295.40196.08
3996368-99636897.95698.69
4982882-98288296.63097.34
5998506-99850698.16698.89
61005142-100514298.81999.52
60min1988414-98841497.17497.111.2398.0297.981.23
2968663-96866395.23296.07
3987325-98732597.06797.96
4981305-98130596.47597.35
5999175-99917598.23299.12
61001687-100168798.47999.35
极限1985137-98513796.85296.830.8597.8697.860.85
2974184-97418495.77596.77
3986135-98613596.95098.01
4976599-97659996.01397.05
5995151-99515197.83698.89
6992170-99217097.54398.58
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