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%
110.529928899083993129953099486993400.18
210.439996999862999160.08
单位质量响应值RSD%判断
9442.979579.671.02数据可信
供试品溶液-206397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%
5min138079-3807936.03434.8912.2736.0334.8912.26
235873-3587333.94633.95
343102-4310240.78740.79
431099-3109929.42929.43
540240-4024038.07938.08
632842-3284231.07831.08
10min177673-7767373.50171.178.6873.5671.238.68
272063-7206368.19268.25
381854-8185477.45877.53
467123-6712363.51863.57
582788-8278878.34178.40
669754-6975466.00766.06
15min197077-9707791.86390.232.8292.0590.412.83
293540-9354088.51688.69
396686-9668691.49391.69
491904-9190486.96887.12
599057-9905793.73793.93
693835-9383588.79588.96
20min1103657-10365798.09096.911.3298.4397.241.30
2101141-10114195.70996.03
3100546-10054695.14695.50
4103364-10336497.81298.11
5102137-10213796.65197.00
6103610-10361098.04598.35
30min1104652-10465299.03197.231.9299.5397.721.90
2101541-10154196.08796.56
399507-9950794.16294.67
4104109-10410998.51798.98
5102576-10257697.06797.58
6104098-10409898.50798.98
45min1104262-10426298.66296.981.9099.3397.631.88
2101053-10105395.62596.26
399550-9955094.20394.87
4103872-10387298.29398.92
5101992-10199296.51497.19
6104149-10414998.55599.19
60min1103927-10392798.34596.992.1499.1797.802.12
2101119-10111995.68896.48
399039-9903993.72094.54
4103337-10333797.78798.58
5102341-10234196.84497.68
6105215-10521599.564100.37
极限1103808-10380898.23296.811.7599.2297.791.73
2100783-10078395.37096.33
399480-9948094.13795.12
4103352-10335297.80198.75
5102654-10265497.14098.14
6103773-10377398.19999.17
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%
110.181050209105115410534121057966105571010536900.31
210.161058231105799210581120.02
单位质量响应值RSD%判断
103505.89104144.880.44数据可信
供试品溶液-206397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%
5min1534782-53478246.35744.9410.1446.3644.9410.14
2498170-49817043.18443.18
3590350-59035051.17451.17
4455247-45524739.46339.46
5560355-56035548.57448.57
6471551-47155140.87640.88
10min1933137-93313780.88979.057.0380.9779.137.03
2883287-88328776.56876.64
3974901-97490184.50984.59
4834002-83400272.29572.36
5990147-99014785.83185.91
6856406-85640674.23774.31
15min11113265-111326596.50395.052.1896.7295.262.19
21078340-107834093.47693.68
31108491-110849196.08996.32
41066994-106699492.49292.68
51128831-112883197.85398.08
61083183-108318393.89694.09
20min11162833-1162833100.80099.581.18101.1799.941.17
21136704-113670498.53598.89
31128477-112847797.82298.21
41156229-1156229100.228100.57
51149010-114901099.60299.99
61159106-1159106100.477100.83
30min11165238-1165238101.00899.651.42101.55100.181.41
21134941-113494198.38298.90
31125358-112535897.55198.10
41162767-1162767100.794101.30
51149394-114939499.635100.19
61159975-1159975100.552101.07
45min11161907-1161907100.72099.411.55101.43100.111.53
21132195-113219598.14498.83
31119800-111980097.07097.78
41160154-1160154100.568101.24
51145164-114516499.26899.99
61161672-1161672100.699101.38
60min11159373-1159373100.50099.301.61101.38100.171.59
21129328-112932897.89698.74
31117773-111777396.89497.77
41158125-1158125100.392101.23
51145737-114573799.318100.20
61163117-1163117100.825101.68
极限11156324-1156324100.23699.061.44101.28100.091.43
21127250-112725097.71598.73
31118584-111858496.96498.00
41155355-1155355100.152101.16
51143080-114308099.088100.14
61156181-1156181100.223101.24
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%
110.529884998804991959916098787989590.21
210.439833997921981300.31
单位质量响应值RSD%判断
9406.759408.440.02数据可信
供试品溶液-311952B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%
5min114993-1499314.34316.8512.5114.3416.8512.51
218473-1847317.67317.67
318326-1832617.53217.53
414903-1490314.25714.26
520416-2041619.53119.53
618580-1858017.77517.78
10min133568-3356832.11436.9210.3732.1436.9510.37
241174-4117439.39039.42
339892-3989238.16438.19
433939-3393932.46932.49
543479-4347941.59541.63
639518-3951837.80637.84
15min150449-5044948.26354.458.8748.3454.548.87
260895-6089558.25758.35
357017-5701754.54754.64
451578-5157849.34349.42
563137-6313760.40260.50
658429-5842955.89855.99
20min166171-6617163.30469.916.5663.4670.096.57
275367-7536772.10272.29
371056-7105667.97768.16
471345-7134568.25468.41
580406-8040676.92277.12
674125-7412570.91371.10
30min191697-9169787.72488.544.1187.9988.834.12
291959-9195987.97588.29
390141-9014186.23686.53
489444-8944485.56985.84
599987-9998795.65595.99
692042-9204288.05488.36
45min1103732-10373299.23896.002.3099.6596.442.29
298061-9806193.81294.27
398767-9876794.48894.93
499993-9999395.66196.08
5102603-10260398.15898.65
698902-9890294.61795.07
60min1104296-10429699.77796.541.91100.3597.141.89
299227-9922794.92895.54
399726-9972695.40596.00
4100812-10081296.44497.02
5101844-10184497.43298.09
699552-9955295.23995.85
极限1104160-10416099.64796.771.77100.3997.541.76
299423-9942395.11595.89
3100310-10031095.96496.72
4100451-10045196.09996.84
5102449-10244998.01098.83
6100125-10012595.78796.55
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%
110.181045900104682110497341050389104781610481320.19
210.161059819105927410595460.04
单位质量响应值RSD%判断
102959.92104286.020.91数据可信
供试品溶液-311952B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%
5min1258029-25802922.41225.399.7222.4125.399.72
2310160-31016026.94026.94
3301062-30106226.14926.15
4256543-25654322.28322.28
5324805-32480528.21228.21
6303635-30363526.37326.37
10min1484235-48423542.05947.088.3942.1047.128.39
2577320-57732050.14450.19
3553502-55350248.07548.12
4490923-49092342.64042.68
5596335-59633551.79651.84
6549655-54965547.74147.79
15min1668211-66821158.03964.197.2558.1564.317.25
2788150-78815068.45668.58
3735136-73513663.85263.98
4687519-68751959.71659.82
5802906-80290669.73869.87
6752154-75215465.33065.45
20min1825919-82591971.73777.395.9571.9477.625.96
2932718-93271881.01381.26
3871388-87138875.68675.92
4847648-84764873.62473.83
5966321-96632183.93284.18
6902174-90217478.36078.59
30min11070582-107058292.98793.793.3193.3194.153.31
21088541-108854194.54794.92
31050014-105001491.20191.56
41054053-105405391.55291.88
51147109-114710999.634100.02
61068763-106876392.82993.19
45min11167978-1167978101.44799.421.60101.9399.941.59
21137653-113765398.81399.35
31123055-112305597.54598.05
41144505-114450599.40899.89
51164487-1164487101.144101.70
61130370-113037098.18098.70
60min11171840-1171840101.78299.741.33102.43100.421.31
21147171-114717199.640100.34
31131589-113158998.28698.96
41153398-1153398100.181100.83
51154027-1154027100.235100.96
61132219-113221998.34199.02
极限11161194-1161194100.85899.620.99101.68100.460.99
21148089-114808999.719100.59
31136043-113604398.67399.51
41147008-114700899.626100.44
51156948-1156948100.489101.38
61132135-113213598.33499.18
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%
110.521015771016281015811014901012911015130.14
210.431010171008901009540.09
单位质量响应值RSD%判断
9649.529679.190.22数据可信
供试品溶液-301793A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%
5min127837-2783725.92326.9412.9725.9226.9412.97
236509-3650933.99934.00
327863-2786325.94825.95
426485-2648524.66424.66
527216-2721625.34525.35
627654-2765425.75325.75
10min158085-5808554.09255.9412.8654.1455.9912.86
275579-7557970.38470.44
358113-5811354.11854.16
454325-5432550.59150.63
557402-5740253.45653.50
656917-5691753.00453.05
15min180591-8059175.05176.767.3275.1876.907.33
294441-9444187.94988.12
381814-8181476.19076.32
477824-7782472.47472.60
580228-8022874.71374.84
679655-7965574.17974.31
20min193684-9368487.24488.503.4387.5088.773.44
2100819-10081993.88994.21
394236-9423687.75888.02
490984-9098484.73084.98
595706-9570689.12789.38
694798-9479888.28188.54
30min1101761-10176194.76695.710.9995.1796.120.99
2103242-10324296.14596.62
3104359-10435997.18597.59
4102229-10222995.20295.59
5101849-10184994.84895.25
6103188-10318896.09596.50
45min1103758-10375896.62697.070.9497.1997.640.93
2104241-10424197.07597.71
3104695-10469597.49898.07
4105940-10594098.65899.20
5103320-10332096.21896.78
6103466-10346696.35496.92
60min1104311-10431197.14197.320.5897.8698.060.58
2104390-10439097.21498.01
3104488-10448897.30598.04
4104722-10472297.52398.23
5105496-10549698.24498.97
6103640-10364096.51697.24
极限1104951-10495197.73796.990.6898.6297.890.68
2104356-10435697.18298.14
3104340-10434097.16898.06
4103878-10387896.73797.61
5104492-10449297.30998.20
6102910-10291095.83696.72
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%
110.189180689181529188439181119172679180880.07
210.169152409136879144640.13
单位质量响应值RSD%判断
90185.4690006.300.15数据可信
供试品溶液-301793A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%
5min1352327-35232735.19536.2811.0435.2036.2811.04
2443732-44373244.32644.33
3351938-35193835.15635.16
4333767-33376733.34133.34
5346440-34644034.60734.61
6351060-35106035.06935.07
10min1629484-62948462.88165.3210.8862.9465.3810.88
2796760-79676079.59179.67
3641865-64186564.11864.18
4603045-60304560.24060.30
5624909-62490962.42462.48
6627312-62731262.66562.72
15min1828237-82823782.73684.406.0082.9084.566.01
2944370-94437094.33794.54
3841901-84190184.10184.27
4799611-79961179.87680.03
5826961-82696182.60882.77
6828036-82803682.71682.88
20min1930516-93051692.95393.962.7993.2594.272.80
2987954-98795498.69099.05
3948060-94806094.70595.01
4910280-91028090.93191.22
5934059-93405993.30793.61
6932838-93283893.18593.49
30min1965814-96581496.47997.551.0196.9398.011.02
2981823-98182398.07898.61
3989726-98972698.86799.33
4966552-96655296.55296.99
5971872-97187297.08497.54
6983218-98321898.21798.67
45min1972065-97206597.10398.070.6997.7298.700.68
2981797-98179798.07598.77
3987346-98734698.63099.26
4989355-98935598.83099.43
5975800-97580097.47698.09
6984151-98415198.31098.93
60min1976466-97646697.54397.820.2598.3298.610.26
2979957-97995797.89298.75
3981500-98150098.04698.84
4977380-97738097.63498.40
5977734-97773497.66998.45
6982298-98229898.12598.91
极限1976134-97613497.51097.510.3998.4598.470.40
2977416-97741697.63898.66
3980567-98056797.95298.91
4969192-96919296.81697.75
5976070-97607097.50398.45
6977381-97738197.63498.58
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