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1000
标示量(mg)12.5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%
114.422699092698512695602694732693902696370.09
214.442703612703432703520.01
单位质量响应值RSD%判断
18698.8218722.440.09数据可信
供试品溶液-24021601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%
5min160072-6007222.88329.5617.2822.8829.5617.29
280342-8034230.60430.60
369665-6966526.53726.54
493789-9378935.72635.73
591740-9174034.94634.95
669930-6993026.63826.64
10min1134217-13421751.12662.1912.5151.1662.2412.52
2168432-16843264.15964.21
3148903-14890356.72056.76
4188418-18841871.77271.83
5181823-18182369.26069.32
6157802-15780260.11060.15
15min1193535-19353573.72283.717.4373.8583.867.44
2223436-22343685.11285.27
3208137-20813779.28479.42
4236991-23699190.27590.45
5233484-23348488.93989.11
6222932-22293284.92085.06
20min1229051-22905187.25092.132.9487.5092.422.96
2244037-24403792.95993.26
3238164-23816490.72290.99
4247500-24750094.27894.61
5246117-24611793.75194.07
6246279-24627993.81394.10
30min1244864-24486493.27494.440.7293.6794.880.74
2247259-24725994.18694.64
3249196-24919694.92495.35
4249149-24914994.90695.39
5247488-24748894.27494.75
6249549-24954995.05995.50
45min1245621-24562193.56294.540.7094.1195.140.71
2247194-24719494.16294.77
3250292-25029295.34295.92
4249492-24949295.03795.68
5247512-24751294.28394.92
6249031-24903194.86195.46
60min1246662-24666293.95994.690.7294.6695.450.72
2246743-24674393.99094.76
3251016-25101695.61796.36
4249608-24960895.08195.88
5247871-24787194.41995.21
6249622-24962295.08695.85
极限1245964-24596493.69395.111.2594.5596.031.25
2246826-24682694.02194.95
3254304-25430496.87097.77
4250917-25091795.58096.54
5248727-24872794.74595.70
6251377-25137795.75596.67
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20
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%
119.178378148380518375208368738363188373150.09
219.178393748392658393200.01
单位质量响应值RSD%判断
43678.4043782.990.17数据可信
供试品溶液-24021601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%
5min1311834-31183432.08939.3814.1732.0939.3814.16
2393092-39309240.45040.45
3351168-35116836.13636.14
4448621-44862146.16446.16
5439737-43973745.25045.25
6351660-35166036.18736.19
10min1590840-59084060.79971.1610.2660.8571.2210.27
2707457-70745772.79972.87
3641840-64184066.04766.11
4781042-78104280.37180.45
5754325-75432577.62277.70
6673477-67347769.30369.36
15min1790609-79060981.35689.585.7381.5189.765.75
2876261-87626190.17090.36
3835912-83591286.01886.19
4925093-92509395.19595.41
5911362-91136293.78293.99
6883738-88373890.93991.11
20min1896410-89641092.24395.792.1892.5396.122.20
2929927-92992795.69296.03
3920317-92031794.70395.02
4951550-95155097.91798.29
5941070-94107096.83997.20
6945734-94573497.31997.65
30min1934259-93425996.13897.110.8896.5897.600.90
2933817-93381796.09296.59
3949105-94910597.66598.14
4952767-95276798.04298.58
5942110-94211096.94697.47
6950191-95019197.77798.27
45min1937682-93768296.49097.110.8697.0997.770.87
2931601-93160195.86496.52
3949639-94963997.72098.35
4951972-95197297.96098.66
5941790-94179096.91397.60
6949846-94984697.74298.39
60min1937988-93798896.52197.130.8797.2997.950.87
2931847-93184795.89096.71
3950123-95012397.77098.57
4952573-95257398.02298.88
5941478-94147896.88197.73
6949407-94940797.69798.51
极限1924847-92484795.16996.751.1696.1097.731.17
2929705-92970595.66996.65
3949302-94930297.68698.65
4950368-95036897.79598.82
5939366-93936696.66397.67
6947666-94766697.51798.50
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1000
标示量(mg)12.5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%
114.422696362695042696782688972694862694400.12
214.442694702702252698480.20
单位质量响应值RSD%判断
18685.1618687.530.01数据可信
供试品溶液-24021602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%
5min169096-6909626.35428.889.6726.3528.889.66
270837-7083727.01827.02
370886-7088627.03727.04
484034-8403432.05232.05
573536-7353628.04828.05
685840-8584032.74132.74
10min1145032-14503255.31859.037.4655.3659.087.46
2144137-14413754.97655.02
3150658-15065857.46357.51
4168783-16878364.37764.43
5150244-15024457.30657.35
6169710-16971064.73064.78
15min1204192-20419277.88280.253.5878.0280.403.59
2203241-20324177.51977.66
3209046-20904679.73479.87
4215982-21598282.37982.54
5207247-20724779.04779.19
6222659-22265984.92685.09
20min1238629-23862991.01791.860.7191.2892.140.73
2239493-23949391.34791.61
3240988-24098891.91792.19
4242338-24233892.43292.73
5240431-24043191.70491.98
6243140-24314092.73893.04
30min1249458-24945895.14795.280.7195.5795.720.71
2251675-25167595.99396.41
3248244-24824494.68495.11
4252262-25226296.21796.67
5249198-24919895.04895.48
6248002-24800294.59295.05
45min1250182-25018295.42495.500.7996.0096.090.79
2252588-25258896.34196.92
3248557-24855794.80495.39
4252573-25257396.33596.95
5250510-25051095.54996.13
6247837-24783794.52995.15
60min1251028-25102895.74695.660.7696.4896.410.75
2252681-25268196.37797.12
3249987-24998795.34996.09
4252815-25281596.42897.20
5250607-25060795.58696.33
6247710-24771094.48195.25
极限1252127-25212796.16596.180.7997.0697.090.78
2254363-25436397.01897.92
3251322-25132295.85896.76
4254427-25442797.04397.98
5251511-25151195.93096.83
6249278-24927895.07996.01
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20
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%
119.178356108366208361888353288359918359470.07
219.178368658397368383000.25
单位质量响应值RSD%判断
43607.0443729.790.20数据可信
供试品溶液-24021602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%
5min1349799-34979936.04738.197.7936.0538.207.79
2354590-35459036.54036.54
3345036-34503635.55635.56
4403996-40399641.63241.63
5359904-35990437.08837.09
6410444-41044442.29642.30
10min1623641-62364164.26667.165.8464.3367.225.84
2621359-62135964.03164.09
3629679-62967964.88864.95
4698674-69867471.99872.07
5634768-63476865.41365.47
6702158-70215872.35772.43
15min1815436-81543684.03085.592.4284.2085.772.43
2815279-81527984.01484.18
3819948-81994884.49584.66
4845005-84500587.07787.27
5823021-82302184.81284.98
6864864-86486489.12489.31
20min1915289-91528994.32094.580.4594.6394.900.45
2924637-92463795.28395.59
3913005-91300594.08594.39
4917235-91723594.52194.86
5920084-92008494.81495.13
6916391-91639194.43494.77
30min1938769-93876996.74096.601.0197.2097.081.00
2951754-95175498.07898.54
3927182-92718295.54696.01
4940556-94055696.92497.42
5939777-93977796.84497.31
6926540-92654095.47995.98
45min1939389-93938996.80496.521.0397.4397.161.02
2950431-95043197.94198.57
3925797-92579795.40396.03
4939190-93919096.78397.44
5939911-93991196.85797.49
6925363-92536395.35896.01
60min1941941-94194197.06796.691.0597.8597.491.04
2952141-95214198.11898.91
3928549-92854995.68796.47
4940931-94093196.96297.78
5940872-94087296.95697.75
6925440-92544095.36696.18
极限1941134-94113496.98396.581.0197.9397.541.00
2951582-95158298.06099.02
3927383-92738395.56696.51
4938812-93881296.74497.72
5938035-93803596.66497.62
6926090-92609095.43396.41
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