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%
110.159114891082914299096891199911650.19
210.069111191402912560.23
单位质量响应值RSD%判断
8981.779071.170.71数据可信
供试品溶液-2024120321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%
5min138719-3871938.60636.616.8838.6136.616.88
233679-3367933.58133.58
336088-3608835.98335.98
437767-3776737.65737.66
534107-3410734.00834.01
639925-3992539.80939.81
10min177518-7751877.29375.216.2977.3675.286.29
270495-7049570.29070.35
378379-7837978.15178.21
478227-7822777.99978.06
568378-6837868.17968.24
679602-7960279.37079.44
15min196572-9657296.29195.513.6396.4895.693.63
294100-9410093.82694.00
399357-9935799.06899.26
495979-9597995.70095.89
589891-8989189.63089.80
698806-9880698.51998.72
20min1101764-101764101.468100.271.46101.82100.621.46
2100044-10004499.753100.08
3101419-101419101.124101.48
499031-9903198.74399.10
598855-9885598.56798.89
6102285-102285101.988102.35
30min1102529-102529102.231100.941.13102.75101.461.14
2100800-100800100.507101.00
3101263-101263100.968101.49
499610-9961099.32099.84
5100686-100686100.393100.88
6102549-102549102.251102.78
45min1102635-102635102.336100.941.25103.03101.631.25
2100519-100519100.227100.89
3101363-101363101.068101.76
499496-9949699.20799.89
5100719-100719100.426101.08
6102701-102701102.402103.11
60min1102352-102352102.054100.631.26102.92101.481.26
2100099-10009999.808100.64
3101243-101243100.949101.81
499283-9928398.99499.84
5100220-10022099.929100.75
6102328-102328102.030102.90
极限1102833-102833102.534101.151.22103.57102.161.22
2100196-10019699.905100.90
3101290-101290100.995102.02
499794-9979499.504100.52
5102128-102128101.831102.82
6102401-102401102.103103.15
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%
110.078569988576338573028560898561078568260.09
29.988584648587758586200.03
单位质量响应值RSD%判断
85086.9986034.070.79数据可信
供试品溶液-2024120321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%
5min1406059-40605942.71440.235.8742.7140.235.87
2357508-35750837.60737.61
3374195-37419539.36239.36
4392099-39209941.24641.25
5358237-35823737.68437.68
6406654-40665442.77742.78
10min1717251-71725175.44973.585.1975.5273.655.19
2665708-66570870.02770.09
3721576-72157675.90475.97
4724617-72461776.22476.29
5641948-64194867.52867.59
6725835-72583576.35276.42
15min1857927-85792790.24789.502.9890.4489.692.98
2844746-84474688.86089.04
3875223-87522392.06692.26
4854076-85407689.84290.04
5804115-80411584.58684.76
6869040-86904091.41691.61
20min1893110-89311093.94892.961.0794.3093.301.08
2883706-88370692.95993.29
3887991-88799193.40993.76
4876411-87641192.19192.54
5869046-86904691.41791.73
6891923-89192393.82394.17
30min1897003-89700394.35793.390.7694.8693.880.76
2887400-88740093.34793.83
3888238-88823893.43593.94
4880778-88077892.65193.15
5880064-88006492.57693.04
6893078-89307893.94594.45
45min1897218-89721894.38093.280.8895.0493.930.88
2887486-88748693.35693.99
3886669-88666993.27093.93
4878012-87801292.36093.01
5878157-87815792.37593.00
6892998-89299893.93694.60
60min1896529-89652994.30893.050.9295.1393.860.93
2884155-88415593.00693.80
3884506-88450693.04393.86
4875984-87598492.14692.95
5875775-87577592.12492.90
6890475-89047593.67194.49
极限1893855-89385594.02693.060.7895.0094.020.77
2880282-88028292.59993.55
3881737-88173792.75293.72
4875076-87507692.05193.01
5887902-88790293.40094.33
6888885-88888593.50494.48
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%
110.159194991739918129187791971918700.11
210.069192391974919480.04
单位质量响应值RSD%判断
9051.239139.960.69数据可信
供试品溶液-2024120321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%
5min141394-4139440.96038.609.4640.9638.609.46
237177-3717736.78736.79
343560-4356043.10343.10
440739-4073940.31240.31
533148-3314832.80032.80
638031-3803137.63237.63
10min183528-8352882.65277.618.2582.7277.678.25
273043-7304372.27772.34
385535-8553584.63884.71
481851-8185180.99381.06
568868-6886868.14668.20
677740-7774076.92576.99
15min1104420-104420103.32597.164.78103.5397.364.78
294474-9447493.48393.67
3102488-102488101.413101.63
496871-9687195.85596.06
592128-9212891.16291.33
698755-9875597.71997.91
20min1104966-104966103.865100.473.39104.24100.833.39
298623-9862397.58997.93
3105138-105138104.035104.42
497187-9718796.16896.53
599797-9979798.75099.07
6103527-103527102.441102.80
30min1104351-104351103.257101.112.90103.81101.642.90
2100384-10038499.33199.83
3105647-105647104.539105.09
497499-9749996.47797.00
5101699-101699100.633101.12
6103521-103521102.435102.96
45min1104169-104169103.077100.852.80103.80101.542.80
2100286-10028699.23499.90
3104722-104722103.624104.35
497178-9717896.15996.84
5101716-101716100.649101.30
6103455-103455102.370103.07
60min1103954-103954102.864100.532.85103.76101.392.85
299632-9963298.58799.42
3104401-104401103.306104.21
496899-9689995.88396.73
5101507-101507100.443101.26
6103167-103167102.085102.95
极限1104083-104083102.992100.592.80104.06101.622.80
299500-9950098.45799.45
3104882-104882103.782104.86
497378-9737896.35797.36
5101429-101429100.365101.35
6102679-102679101.602102.64
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%
110.078588528606968590878596538597258596030.09
29.988608228615018611620.06
单位质量响应值RSD%判断
85362.7686288.780.77数据可信
供试品溶液-2024120321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%
5min1425341-42534144.60442.297.9344.6042.297.93
2388307-38830740.72040.72
3436037-43603745.72645.73
4426118-42611844.68644.69
5351603-35160336.87136.87
6391984-39198441.10641.11
10min1761343-76134379.83975.836.7779.9175.896.77
2686651-68665172.00772.07
3770582-77058280.80880.88
4757807-75780779.46979.54
5648009-64800967.95568.02
6714009-71400974.87674.94
15min1908434-90843495.26491.003.4995.4791.203.50
2845443-84544388.65988.85
3894943-89494393.85094.06
4865664-86566490.77990.99
5826823-82682386.70686.88
6865309-86530990.74290.94
20min1907520-90752095.16993.232.0995.5393.582.10
2873567-87356791.60891.94
3911051-91105195.53995.91
4867096-86709690.92991.29
5878256-87825692.10092.42
6896753-89675394.03994.38
30min1907042-90704295.11893.571.8895.6494.071.88
2884048-88404892.70793.20
3911922-91192295.63096.16
4865836-86583690.79791.31
5888140-88814093.13693.61
6896529-89652994.01694.52
45min1904483-90448394.85093.401.7795.5394.061.77
2886933-88693393.01093.65
3907494-90749495.16695.85
4863758-86375890.57991.24
5887382-88738293.05793.68
6893744-89374493.72494.38
60min1903082-90308294.70393.131.8495.5493.951.84
2878329-87832992.10792.91
3906268-90626895.03795.88
4862608-86260890.45991.27
5885707-88570792.88193.66
6892611-89261193.60594.42
极限1900670-90067094.45092.871.7595.4593.841.75
2875999-87599991.86392.81
3903380-90338094.73495.74
4862535-86253590.45191.41
5882084-88208492.50193.44
6889131-88913193.24094.21
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