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%
110.158966790232899309019789668899390.31
210.108998589613897990.30
单位质量响应值RSD%判断
8860.998890.990.24数据可信
供试品溶液-24090201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%
5min148302-4830248.48242.3314.5648.4842.3314.55
235146-3514635.27735.28
343974-4397444.13844.14
442853-4285343.01343.01
534438-3443834.56734.57
648327-4832748.50748.51
10min186331-8633186.65377.827.6686.7377.897.66
269509-6950969.76969.83
378526-7852678.81978.89
477529-7752977.81877.89
572658-7265872.92972.99
680621-8062180.92281.00
15min198492-9849298.86095.542.5199.0895.742.52
291418-9141891.75991.93
393955-9395594.30694.51
495635-9563595.99296.19
595151-9515195.50695.69
696437-9643796.79797.01
20min1100024-100024100.39799.080.84100.7999.440.85
297907-9790798.27398.60
398130-9813098.49698.86
499059-9905999.42999.79
599097-9909799.46799.81
698051-9805198.41798.79
30min199789-99789100.16299.700.54100.72100.230.54
299166-9916699.536100.03
398731-9873199.10099.63
499182-9918299.552100.08
5100153-100153100.527101.03
698957-9895799.32699.87
45min199392-9939299.76399.660.55100.49100.360.55
298931-9893199.30099.96
398615-9861598.98399.67
499633-99633100.005100.70
5100120-100120100.494101.17
699061-9906199.431100.14
60min199610-9961099.98299.490.82100.87100.340.81
299017-9901799.387100.21
397875-9787598.24099.10
499197-9919799.567100.43
5100259-100259100.633101.47
698745-9874599.11499.99
极限1100943-100943101.320100.500.62102.38101.530.63
299823-99823100.196101.18
399475-9947599.846100.87
4100855-100855101.232102.26
599746-99746100.118101.13
699929-99929100.302101.34
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DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9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%
19.668694008706208735618703588743258716530.25
29.708745878719838732850.22
单位质量响应值RSD%判断
90233.2390029.380.16数据可信
供试品溶液-24090201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%
5min1580898-58089857.94751.7711.9657.9551.7711.97
2448249-44824944.71544.71
3535819-53581953.45053.45
4527658-52765852.63652.64
5440103-44010343.90243.90
6580901-58090157.94857.95
10min1934771-93477193.24885.266.2293.3485.356.22
2786134-78613478.42078.50
3862698-86269886.05886.15
4855709-85570985.36185.45
5807656-80765680.56780.64
6881300-88130087.91488.01
15min11014582-1014582101.20999.331.44101.4699.561.45
2974129-97412997.17497.38
3987672-98767298.52598.76
41003180-1003180100.072100.30
5991313-99131398.88899.10
61003312-1003312100.085100.33
20min11023100-1023100102.059101.470.35102.48101.860.36
21015190-1015190101.270101.64
31015369-1015369101.288101.68
41019914-1019914101.741102.14
51015590-1015590101.310101.68
61014134-1014134101.165101.57
30min11019408-1019408101.691101.420.36102.28101.980.36
21017594-1017594101.510102.05
31011217-1011217100.874101.44
41018902-1018902101.640102.21
51019885-1019885101.738102.28
61013069-1013069101.058101.64
45min11016756-1016756101.426101.190.50102.19101.920.49
21017574-1017574101.508102.21
31004374-1004374100.191100.92
41016682-1016682101.419102.15
51015974-1015974101.348102.06
61014751-1014751101.226101.97
60min11012979-1012979101.049100.910.39101.98101.810.38
21017601-1017601101.510102.38
31008327-1008327100.585101.49
41008947-1008947100.647101.55
51013901-1013901101.141102.02
61007640-1007640100.517101.43
极限11017716-1017716101.522101.020.62102.62102.090.61
21016825-1016825101.433102.48
31009213-1009213100.674101.74
41018681-1018681101.618102.69
51011125-1011125100.864101.91
61002732-1002732100.027101.11
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%
110.159330293798937929374993647936580.23
210.109205192373922120.25
单位质量响应值RSD%判断
9227.399129.900.76数据可信
供试品溶液-24090201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%
5min143059-4305941.79641.007.3541.8041.007.34
245817-4581744.47344.47
336486-3648635.41635.42
442016-4201640.78340.78
542758-4275841.50441.50
643328-4332842.05742.06
10min177165-7716574.90175.323.5574.9775.393.55
282367-8236779.95080.02
374451-7445172.26772.33
475484-7548473.26973.34
578356-7835676.05776.13
677783-7778375.50175.57
15min193919-9391991.16392.761.8791.3692.961.86
297981-9798195.10695.31
396522-9652293.69093.87
494501-9450191.72891.92
596826-9682693.98594.18
693653-9365390.90591.10
20min197383-9738394.52696.071.1194.8796.421.10
299187-9918796.27796.64
3100049-10004997.11497.45
498920-9892096.01896.36
5100197-10019797.25797.61
698132-9813295.25395.60
30min197953-9795395.07996.601.1495.5897.111.14
2100186-10018697.24797.77
3100368-10036897.42397.92
498880-9888095.97996.48
5100894-10089497.93498.45
698851-9885195.95196.46
45min196871-9687194.02995.851.3194.6996.521.30
299205-9920596.29496.98
399957-9995797.02497.68
498092-9809295.21495.88
5100243-10024397.30297.98
698096-9809695.21895.88
60min198055-9805595.17896.301.0896.0097.131.08
299176-9917696.26697.12
3100154-10015497.21698.04
499417-9941796.50097.32
5100532-10053297.58298.42
697908-9790895.03595.86
极限197931-9793195.05896.981.2996.0497.971.28
299766-9976696.83997.85
3101711-10171198.72799.71
499311-9931196.39797.38
5100779-10077997.82298.82
699963-9996397.03098.01
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DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9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%
19.668784408733458759328767638763118761580.22
29.708655968650058653000.05
单位质量响应值RSD%判断
90699.5989206.191.18数据可信
供试品溶液-24090201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%
5min1531901-53190153.16852.256.4753.1752.256.47
2560096-56009655.98755.99
3458975-45897545.87945.88
4523180-52318052.29752.30
5527647-52764752.74352.74
6534656-53465653.44453.44
10min1847969-84796984.76285.202.9484.8585.292.95
2897246-89724689.68889.78
3825313-82531382.49882.57
4833812-83381283.34783.43
5857862-85786285.75185.84
6851987-85198785.16485.25
15min1981606-98160698.12199.491.3698.3599.711.36
21012199-1012199101.179101.42
31004911-1004911100.450100.66
4985388-98538898.49998.72
51004832-1004832100.442100.67
6982669-98266998.22798.46
20min1995857-99585799.545101.391.1799.94101.781.16
21014716-1014716101.430101.84
31026781-1026781102.636103.02
41012421-1012421101.201101.59
51027087-1027087102.667103.07
61008766-1008766100.835101.23
30min11000009-100000999.960101.410.84100.52101.980.84
21017346-1017346101.693102.27
31018212-1018212101.780102.33
41011194-1011194101.078101.64
51025274-1025274102.486103.05
61015181-1015181101.477102.04
45min1993915-99391599.351100.821.05100.08101.561.04
21011790-1011790101.138101.89
31024431-1024431102.401103.12
41003624-1003624100.321101.05
51014361-1014361101.395102.13
61003842-1003842100.343101.08
60min1995547-99554799.514100.921.02100.41101.821.01
21010463-1010463101.005101.92
31024496-1024496102.408103.30
41012733-1012733101.232102.13
51013482-1013482101.307102.22
61000910-1000910100.050100.95
极限1989685-98968598.928100.911.1499.99101.981.13
21005146-1005146100.474101.56
31022756-1022756102.234103.30
41008802-1008802100.839101.90
51016304-1016304101.589102.67
61014251-1014251101.384102.45
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%
110.159259892570926659316493061928120.31
210.109219792371922840.14
单位质量响应值RSD%判断
9144.049137.030.06数据可信
供试品溶液-24090201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%
5min138646-3864637.66838.994.4037.6738.994.39
241757-4175740.70040.70
340652-4065239.62339.62
438091-3809137.12737.13
538676-3867637.69737.70
642169-4216941.10141.10
10min180126-8012678.09776.522.0078.1676.592.00
278813-7881376.81776.89
378528-7852876.54076.61
478153-7815376.17476.24
575698-7569873.78173.84
679747-7974777.72877.80
15min197043-9704394.58693.261.0994.7893.451.08
294022-9402291.64191.84
395752-9575293.32893.52
495362-9536292.94793.14
595451-9545193.03493.22
696440-9644093.99894.20
20min199270-9927096.75796.280.6797.1196.620.67
297563-9756395.09395.44
398625-9862596.12896.48
499375-9937596.85997.20
598762-9876296.26196.60
699075-9907596.56696.92
30min199003-9900396.49697.192.0297.0197.702.00
297402-9740294.93695.44
3100116-10011697.58198.09
498702-9870296.20396.71
5103327-103327100.711101.21
699755-9975597.22997.74
45min198821-9882196.31996.230.3996.9996.900.39
298371-9837195.88096.55
398515-9851596.02196.69
499133-9913396.62397.29
598333-9833395.84396.51
699188-9918896.67797.35
60min199035-9903596.52796.390.7897.3697.220.77
297478-9747895.01095.84
398826-9882696.32497.16
499082-9908296.57397.40
599775-9977597.24998.08
699169-9916996.65897.50
极限1100196-10019697.65997.620.6898.6598.610.67
299507-9950796.98897.97
3101440-10144098.87299.86
499763-9976397.23798.22
599929-9992997.39998.39
6100110-10011097.57598.58
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DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9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%
19.668729708731368741898753198752298741690.13
29.708652558665698659120.11
单位质量响应值RSD%判断
90493.6989269.280.97数据可信
供试品溶液-24090201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%
5min1486050-48605048.62349.723.7448.6249.723.74
2512803-51280351.29951.30
3505965-50596550.61550.61
4476067-47606747.62447.62
5480474-48047448.06548.06
6520625-52062552.08152.08
10min1873828-87382887.41585.221.8687.5085.301.86
2856280-85628085.65985.74
3851664-85166485.19785.28
4851129-85112985.14485.22
5824698-82469882.50082.58
6853917-85391785.42385.51
15min1996518-99651899.68898.610.6699.9198.830.66
2976208-97620897.65697.88
3984372-98437298.47398.70
4986160-98616098.65298.87
5986085-98608598.64498.86
6985115-98511598.54798.78
20min11008374-1008374100.874100.350.45101.27100.740.44
2996750-99675099.711100.10
31001366-1001366100.173100.56
41007972-1007972100.834101.22
51002685-1002685100.305100.69
61001498-1001498100.186100.58
30min11006339-1006339100.671100.470.63101.23101.030.63
2996120-99612099.648100.21
31013765-1013765101.413101.97
4999168-99916899.953100.51
51007521-1007521100.789101.34
61003025-1003025100.339100.90
45min11000869-1000869100.12399.860.41100.85100.580.41
21000448-1000448100.081100.80
31001851-1001851100.222100.95
4998564-99856499.893100.61
5990745-99074599.11199.83
6997032-99703299.739100.47
60min11004577-1004577100.49499.790.39101.39100.680.39
2993863-99386399.422100.31
3998250-99825099.861100.75
4997504-99750499.787100.67
5996880-99688099.724100.61
6994217-99421799.458100.35
极限11002269-1002269100.26399.780.63101.33100.840.62
2992242-99224299.260100.32
31007495-1007495100.786101.85
4995180-99518099.554100.61
5995850-99585099.621100.67
6991749-99174999.211100.27
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