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%
110.239486094244942919437494507944550.27
210.219507895172951250.07
单位质量响应值RSD%判断
9233.149316.850.64数据可信
供试品溶液-24090901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%
5min136743-3674335.29439.1515.0635.2939.1515.06
244002-4400242.26742.27
331086-3108629.86029.86
441516-4151639.87939.88
542377-4237740.70640.71
648817-4881746.89246.89
10min172278-7227869.42876.3111.4669.4976.3711.46
287220-8722083.78183.85
366553-6655363.92963.98
481813-8181378.58778.65
578010-7801074.93475.00
690767-9076787.18887.27
15min189619-8961986.08590.484.1686.2690.684.18
298304-9830494.42894.64
389294-8929485.77385.93
495592-9559291.82392.02
594598-9459890.86891.06
697767-9776793.91294.14
20min196615-9661592.80594.581.0993.1294.921.10
298783-9878394.88895.26
398711-9871194.81995.12
497949-9794994.08794.44
598984-9898495.08195.43
699712-9971295.78096.16
30min197702-9770293.85095.111.5994.3295.611.58
299168-9916895.25895.78
3101461-10146197.46097.92
498008-9800894.14494.65
597557-9755793.71094.21
6100201-10020196.25096.79
45min197108-9710893.27995.161.2693.9195.821.25
2100215-10021596.26496.95
3100544-10054496.58097.20
498454-9845494.57295.24
599028-9902895.12395.78
699075-9907595.16895.87
60min198177-9817794.30695.751.9195.0996.561.88
299557-9955795.63196.48
3103413-10341399.335100.12
499069-9906995.16395.98
598535-9853594.65095.47
699306-9930695.39096.25
极限199317-9931795.40196.491.3996.3497.461.37
2100194-10019496.24397.25
3103066-10306699.00299.95
499358-9935895.44096.42
5100022-10002296.07897.05
6100731-10073196.75997.78
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%
110.179205839152399178939233459223459198810.37
210.209237899220249229060.14
单位质量响应值RSD%判断
90450.4490480.980.03数据可信
供试品溶液-24090901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%
5min1450458-45045844.81450.7413.8444.8150.7413.84
2540161-54016153.73853.74
3407902-40790240.58040.58
4523873-52387352.11852.12
5531053-53105352.83252.83
6606814-60681460.36960.37
10min1827444-82744482.31888.359.2482.3988.449.24
2954238-95423894.93395.02
3769901-76990176.59476.66
4911163-91116390.64790.73
5873638-87363886.91487.00
6992183-99218398.70898.81
15min1979375-97937597.433100.533.0697.65100.763.07
21041021-1041021103.566103.81
3969361-96936196.43796.63
41020381-1020381101.513101.75
51009798-1009798100.460100.69
61043117-1043117103.775104.04
20min11029514-1029514102.421103.380.72102.80103.780.72
21038319-1038319103.297103.72
31045531-1045531104.015104.37
41034447-1034447102.912103.32
51037390-1037390103.205103.61
61049911-1049911104.451104.89
30min11040447-1040447103.509103.541.20104.05104.111.18
21039103-1039103103.375103.97
31060746-1060746105.529106.06
41035394-1035394103.006103.59
51022916-1022916101.765102.34
61045923-1045923104.054104.67
45min11031696-1031696102.638103.380.99103.36104.120.98
21040616-1040616103.526104.29
31058220-1058220105.277105.98
41032339-1032339102.702103.45
51031539-1031539102.623103.36
61040410-1040410103.505104.29
60min11032734-1032734102.742103.561.71103.63104.481.68
21034109-1034109102.879103.82
31076612-1076612107.107107.99
41036429-1036429103.109104.03
51028408-1028408102.311103.22
61037650-1037650103.231104.19
极限11034641-1034641102.931103.280.94103.99104.370.92
21033074-1033074102.776103.88
31057506-1057506105.206106.27
41034405-1034405102.908104.00
51031527-1031527102.622103.71
61037886-1037886103.254104.38
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%
110.239384894003941379365794187939660.24
210.219455694899947280.26
单位质量响应值RSD%判断
9185.349277.960.71数据可信
供试品溶液-24091002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%
5min140516-4051639.10141.746.7639.1041.746.75
241377-4137739.93239.93
345027-4502743.45543.45
447167-4716745.52045.52
540201-4020138.79738.80
645206-4520643.62843.63
10min175527-7552772.89076.945.1772.9677.015.17
278872-7887276.11876.18
384103-8410381.16781.24
483223-8322380.31780.39
574386-7438671.78971.85
682258-8225879.38679.46
15min193614-9361490.34593.142.5990.5393.342.60
295911-9591192.56292.76
398988-9898895.53295.74
499410-9941095.93996.15
593836-9383690.56090.74
697304-9730493.90794.11
20min198383-9838394.94896.961.5995.2997.321.59
2101542-10154297.99798.34
3101411-10141197.87098.24
4102233-10223398.66499.03
5100596-10059697.08497.42
698669-9866995.22495.59
30min198950-9895095.49597.551.6895.9998.071.67
2102461-10246198.88499.39
3101099-10109997.56998.10
4103063-10306399.465100.00
5101713-10171398.16298.66
699213-9921395.74996.27
45min199600-9960096.12297.761.4496.7898.441.44
2102416-10241698.84099.52
3101287-10128797.75198.44
4103254-10325499.649100.35
5101498-10149897.95498.61
699720-9972096.23896.92
60min199753-9975396.27097.661.4097.0898.501.40
2101995-10199598.43499.27
3101342-10134297.80498.66
4102678-10267899.09399.96
5102228-10222898.65999.48
699190-9919095.72796.57
极限199518-9951896.04397.561.2597.0298.561.25
2102385-10238598.81099.81
3100897-10089797.37498.39
4102317-10231798.74599.78
5101719-10171998.16799.16
699716-9971696.23497.23
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%
110.179116809165169153269126189142509140780.22
210.209240719212959226830.22
单位质量响应值RSD%判断
89879.8490459.120.46数据可信
供试品溶液-24091002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%
5min1438382-43838243.75648.467.5043.7648.467.50
2465095-46509546.42346.42
3508821-50882150.78750.79
4528370-52837052.73852.74
5457949-45794945.70945.71
6514418-51441851.34651.35
10min1795066-79506679.35883.304.6879.4383.384.68
2818296-81829681.67781.75
3878618-87861887.69887.78
4864107-86410786.24986.34
5788055-78805578.65878.73
6862975-86297586.13686.22
15min1954396-95439695.26198.012.2795.4798.242.28
2980101-98010197.82798.04
31004996-1004996100.312100.54
41002214-1002214100.034100.27
5956581-95658195.47995.69
6993572-99357299.17199.40
20min1995680-99568099.382101.181.2999.75101.571.29
21024635-1024635102.272102.65
31024202-1024202102.229102.63
41025615-1025615102.370102.77
51010289-1010289100.840101.21
61002019-1002019100.015100.41
30min1996435-99643599.457101.731.5699.99102.281.55
21034341-1034341103.241103.79
31021958-1021958102.005102.57
41033654-1033654103.172103.74
51025587-1025587102.367102.90
61003487-1003487100.161100.72
45min11002408-1002408100.053101.731.37100.75102.461.37
21036113-1036113103.418104.14
31020060-1020060101.815102.55
41033409-1033409103.148103.89
51018292-1018292101.639102.34
61005222-1005222100.334101.06
60min11004930-1004930100.305101.811.25101.17102.701.25
21027038-1027038102.512103.40
31019117-1019117101.721102.63
41032040-1032040103.011103.92
51032285-1032285103.036103.91
61004611-1004611100.273101.17
极限1998646-99864699.678101.391.15100.71102.451.14
21028678-1028678102.676103.74
31019226-1019226101.732102.81
41020754-1020754101.885102.97
51022744-1022744102.083103.13
61004533-1004533100.266101.33
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%
110.239341793800939779352193453936340.27
210.219390794378941420.36
单位质量响应值RSD%判断
9152.889220.570.53数据可信
供试品溶液-24090902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%
5min139267-3926738.08139.8829.2038.0839.8829.21
229997-2999729.09129.09
360980-6098059.13859.14
433678-3367832.66132.66
532924-3292431.92931.93
649881-4988148.37448.37
10min174093-7409371.85575.5017.6671.9275.5717.67
264982-6498263.01963.07
397424-9742494.48194.58
468980-6898066.89666.95
568890-6889066.80966.86
692770-9277089.96890.05
15min193522-9352290.69790.704.8790.8890.894.90
287948-8794885.29185.44
397506-9750694.56194.82
491048-9104888.29888.46
590960-9096088.21288.38
6100146-10014697.12197.35
20min197939-9793994.98195.041.2495.3195.381.26
297719-9771994.76795.06
397858-9785894.90295.32
497579-9757994.63194.94
596647-9664793.72894.04
6100274-10027497.24597.64
30min198109-9810995.14595.641.2795.6496.141.28
298871-9887195.88496.34
397607-9760794.65995.23
497844-9784494.88895.36
598288-9828895.31995.79
6101005-10100597.95498.51
45min198646-9864695.66696.201.1296.3296.861.12
299999-9999996.97897.59
398262-9826295.29496.02
499505-9950596.49997.13
597933-9793394.97595.60
6100820-10082097.77598.49
60min198554-9855495.57796.161.2496.3996.981.24
299815-9981596.80097.57
397851-9785194.89595.78
499587-9958796.57997.37
598069-9806995.10795.89
6101068-10106898.01598.90
极限1100526-10052697.48998.221.0498.4699.211.01
2103077-10307799.963100.90
3100227-10022797.19998.25
4101051-10105197.99998.95
5100928-10092897.87998.82
6101897-10189798.81999.86
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%
110.175013175012834998845016615013295010950.14
210.205017255033265025260.23
单位质量响应值RSD%判断
49271.8849267.250.01数据可信
供试品溶液-24090902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%
5min1251391-25139145.92149.7225.4245.9249.7225.41
2208329-20832938.05538.06
3384985-38498570.32570.32
4232129-23212942.40342.40
5228073-22807341.66241.66
6328155-32815559.94459.94
10min1449475-44947582.10585.0714.8382.1885.1514.85
2401211-40121173.28973.35
3566378-566378103.459103.58
4420537-42053776.81976.89
5419391-41939176.61076.68
6537129-53712998.11798.22
15min1538483-53848398.36498.313.3398.5898.533.36
2513446-51344693.79093.98
3558335-558335101.990102.28
4530439-53043996.89597.09
5529191-52919196.66796.86
6559179-559179102.144102.41
20min1555419-555419101.458102.121.22101.83102.511.25
2557873-557873101.906102.25
3560270-560270102.344102.80
4556621-556621101.677102.04
5552273-552273100.883101.24
6571830-571830104.455104.89
30min1556880-556880101.724101.720.57102.27102.280.57
2560481-560481102.382102.89
3554688-554688101.324101.95
4555576-555576101.486102.02
5552867-552867100.991101.52
6560569-560569102.398103.01
45min1553077-553077101.030101.810.82101.75102.540.81
2564700-564700103.153103.84
3558514-558514102.023102.82
4557722-557722101.878102.58
5552050-552050100.842101.54
6558022-558022101.933102.71
60min1553619-553619101.129101.540.61102.01102.440.59
2561458-561458102.561103.42
3552597-552597100.942101.91
4557242-557242101.791102.66
5553373-553373101.084101.95
6556887-556887101.726102.67
极限1551262-551262100.698101.330.88101.75102.400.86
2563821-563821102.992104.02
3551312-551312100.707101.84
4555051-555051101.390102.43
5551483-551483100.739101.77
6555530-555530101.478102.60
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%
110.239382893539937559337493740936470.20
210.219447294318943950.12
单位质量响应值RSD%判断
9154.159245.350.71数据可信
供试品溶液-24091001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%
5min143425-4342542.05442.8424.5242.0542.8424.52
249139-4913947.58847.59
329699-2969928.76128.76
444824-4482443.40943.41
536867-3686735.70335.70
661483-6148359.54259.54
10min180022-8002277.49677.7914.8677.5777.8614.87
284973-8497382.29082.37
363260-6326061.26361.31
483091-8309180.46880.54
572208-7220869.92869.99
698374-9837495.26895.37
15min197673-9767394.59093.895.6194.7994.095.63
2101295-10129598.09798.31
386742-8674284.00484.15
499505-9950596.36496.57
595615-9561592.59692.77
6100897-10089797.71297.97
20min199571-9957196.42897.781.0896.7898.141.08
2102166-10216698.94199.32
3100871-10087197.68797.98
499881-9988196.72897.09
5102099-10209998.87699.21
6101221-10122198.02598.45
30min199620-9962096.47598.171.3096.9998.691.27
2101873-10187398.65799.20
3103084-10308499.830100.28
4100182-10018297.01997.55
5102322-10232299.09299.59
6101135-10113597.94298.53
45min198972-9897295.84797.921.5296.5398.611.49
2101686-10168698.47699.19
3102821-10282199.575100.19
499634-9963496.48997.18
5102399-10239999.16699.83
6101173-10117397.97998.73
60min199246-9924696.11397.841.3896.9598.691.36
2101338-10133898.13999.01
3102860-10286099.613100.40
499644-9964496.49897.35
5102104-10210498.88199.71
6100972-10097297.78498.70
极限199948-9994896.79397.781.3297.7998.791.27
2101107-10110797.91598.95
3103053-10305399.800100.75
499794-9979496.64497.66
5101940-10194098.72299.71
699949-9994996.79497.87
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%
110.174990704984425023275011915018625005780.35
210.205092775053685073220.55
单位质量响应值RSD%判断
49221.0449737.450.74数据可信
供试品溶液-24091001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%
5min1262500-26250047.74949.1821.1047.7549.1821.10
2289869-28986952.72752.73
3192536-19253635.02235.02
4277203-27720350.42350.42
5236970-23697043.10543.10
6363129-36312966.05366.05
10min1475775-47577586.54384.3013.0786.6284.3813.08
2478744-47874487.08387.17
3373922-37392268.01668.07
4474702-47470286.34886.43
5423601-42360177.05377.12
6554083-554083100.787100.90
15min1548738-54873899.81598.464.71100.0498.684.73
2558361-558361101.566101.80
3492169-49216989.52589.70
4556070-556070101.149101.38
5535603-53560397.42697.63
6556702-556702101.264101.54
20min1555284-555284101.006101.480.71101.40101.860.68
2558183-558183101.533101.94
3559097-559097101.699102.02
4553430-553430100.669101.07
5564695-564695102.718103.08
6556504-556504101.228101.67
30min1558756-558756101.637101.660.79102.20102.220.76
2557913-557913101.484102.06
3563871-563871102.568103.06
4552321-552321100.467101.03
5563779-563779102.551103.08
6556762-556762101.275101.89
45min1554938-554938100.943101.560.81101.67102.290.78
2558910-558910101.665102.41
3562134-562134102.252102.91
4553631-553631100.705101.44
5565035-565035102.780103.48
6555396-555396101.026101.81
60min1551990-551990100.407101.370.75101.30102.260.73
2554208-554208100.810101.72
3562819-562819102.376103.21
4555115-555115100.975101.87
5559083-559083101.697102.57
6560405-560405101.937102.89
极限1553675-553675100.713101.170.95101.78102.230.91
2553224-553224100.631101.71
3565312-565312102.830103.83
4552265-552265100.457101.52
5559863-559863101.839102.88
6552692-552692100.534101.66
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