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%
110.109588896011958989573795663958390.15
210.149547695505954900.03
单位质量响应值RSD%判断
9489.019417.160.54数据可信
供试品溶液-2024120221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%
5min153083-5308350.53939.7120.4950.5439.7020.49
234801-3480133.13333.13
333062-3306231.47831.48
445708-4570843.51843.52
548748-4874846.41246.41
634823-3482333.15433.15
10min189742-8974285.44275.4911.9185.5375.5611.92
271284-7128467.86867.92
369939-6993966.58866.64
486181-8618182.05282.12
587601-8760183.40483.48
671011-7101167.60867.66
15min199984-9998495.19393.134.0695.4293.334.08
295379-9537990.80990.98
394532-9453290.00290.17
4100379-10037995.56995.78
5103346-10334698.39498.61
693313-9331388.84289.01
20min1101305-10130596.45197.091.9296.8497.441.93
2101550-10155096.68497.00
3101398-10139896.53996.85
4100728-10072895.90296.27
5105927-105927100.851101.23
6100962-10096296.12496.44
30min1101074-10107496.23197.191.5896.7897.701.58
2102472-10247297.56298.04
3101990-10199097.10397.58
4100697-10069795.87296.40
5105091-105091100.055100.60
6101158-10115896.31196.79
45min1101237-10123796.38697.231.4897.0997.901.48
2102609-10260997.69298.34
3102988-10298898.05398.69
4100539-10053995.72296.41
5104483-10448399.477100.19
6100888-10088896.05496.69
60min1100831-10083196.00096.961.5996.8797.801.58
2102098-10209897.20698.01
3102136-10213697.24298.04
4100222-10022295.42096.27
5104757-10475799.737100.62
6101021-10102196.18096.98
极限1101024-10102496.18397.311.5897.2198.301.58
2102781-10278197.85698.82
3102200-10220097.30398.26
4101106-10110696.26197.27
5105122-105122100.085101.13
6100994-10099496.15597.11
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%
110.101009817101463210163611017659101823710153410.34
210.031016473101705310167630.05
单位质量响应值RSD%判断
100528.81101372.180.60数据可信
供试品溶液-2024120221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%
5min1642183-64218357.25346.7017.0957.2546.7017.08
2452773-45277340.36740.37
3431350-43135038.45738.46
4566092-56609250.46950.47
5598058-59805853.31953.32
6452212-45221240.31740.32
10min11004628-100462889.56780.5110.2289.6680.5810.22
2823581-82358173.42673.49
3809566-80956672.17672.24
4971010-97101086.57086.65
5983815-98381587.71187.80
6825613-82561373.60773.67
15min11100015-110001598.07195.933.4298.3296.143.44
21049762-104976293.59193.78
31039576-103957692.68392.87
41096311-109631197.74197.97
51127304-1127304100.504100.74
61042760-104276092.96693.16
20min11106862-110686298.68198.961.5099.0999.331.51
21102922-110292298.33098.68
31102757-110275798.31598.65
41097180-109718097.81898.21
51142988-1142988101.902102.30
61107060-110706098.69999.04
30min11106727-110672798.66998.971.3399.2499.511.34
21110867-111086799.03899.55
31104300-110430098.45398.96
41094769-109476997.60398.16
51138195-1138195101.475102.05
61105742-110574298.58299.09
45min11106134-110613498.61698.841.2399.3599.541.24
21107960-110796098.77999.45
31109068-110906898.87899.54
41092052-109205297.36198.08
51133409-1133409101.048101.79
61103236-110323698.35899.03
60min11100444-110044498.10998.581.4499.0199.441.45
21106555-110655598.65499.49
31098087-109808797.89998.73
41091053-109105397.27298.15
51136415-1136415101.316102.23
61101658-110165898.21799.05
极限11099739-109973998.04698.511.4199.1199.541.41
21103697-110369798.39999.40
31096800-109680097.78498.78
41093788-109378897.51698.56
51135786-1135786101.260102.34
61099590-109959098.03399.03
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%
110.109589496094957679601995796959140.15
210.149592996098960140.13
单位质量响应值RSD%判断
9496.449468.840.21数据可信
供试品溶液-2024120221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%
5min139545-3954537.53238.808.9237.5338.808.93
238987-3898737.00337.00
340325-4032538.27338.27
436910-3691035.03135.03
547482-4748245.06545.07
642056-4205639.91639.92
10min179152-7915275.12476.706.7975.1976.776.78
277319-7731973.38473.45
378193-7819374.21374.28
474918-7491871.10571.16
587604-8760483.14583.22
687701-8770183.23783.30
15min198592-9859293.57493.372.4593.7693.562.46
296609-9660991.69291.88
396130-9613091.23791.42
496443-9644391.53591.71
5100733-10073395.60695.82
6101771-10177196.59196.80
20min1100533-10053395.41695.721.1095.7696.071.10
2100961-10096195.82396.16
398851-9885193.82094.16
4101149-10114996.00196.33
5101648-10164896.47596.85
6101960-10196096.77197.14
30min1103030-10303097.78696.191.3698.2996.701.36
2100558-10055895.44095.94
399087-9908794.04494.54
4101828-10182896.64597.13
5101504-10150496.33896.87
6102108-10210896.91197.44
45min1103014-10301497.77196.261.2998.4496.931.28
2100696-10069695.57196.23
399295-9929594.24194.89
4102241-10224197.03797.69
5101444-10144496.28196.98
6101839-10183996.65697.34
60min1102879-10287997.64396.141.2598.4796.971.25
2100575-10057595.45696.27
399239-9923994.18895.00
4101978-10197896.78897.60
5101280-10128096.12596.98
6101816-10181696.63497.48
极限1102901-10290197.66496.251.3298.6697.241.32
2100501-10050195.38696.36
399424-9942494.36495.33
4102255-10225597.05198.02
5100953-10095395.81596.83
6102413-10241397.20198.21
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%
110.101018104101925810188011019611101934410190240.06
210.031019622101856710190940.08
单位质量响应值RSD%判断
100893.47101604.590.50数据可信
供试品溶液-2024120221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%
5min1496634-49663444.14645.687.8944.1545.687.89
2496782-49678244.15944.16
3506346-50634645.01045.01
4469597-46959741.74341.74
5587736-58773652.24452.24
6526181-52618146.77346.77
10min1899823-89982379.98681.415.7880.0681.485.78
2883164-88316478.50578.58
3890715-89071579.17679.25
4857923-85792376.26176.33
5983351-98335187.41187.50
6979855-97985587.10087.18
15min11077169-107716995.75095.582.0595.9695.792.06
21062860-106286094.47994.68
31055604-105560493.83494.04
41053042-105304293.60693.80
51098624-109862497.65897.89
61104159-110415998.15098.37
20min11111123-111112398.76997.641.1699.1498.011.16
21095643-109564397.39397.75
31076296-107629695.67396.04
41095186-109518697.35297.70
51104083-110408398.14398.54
61108400-110840098.52798.91
30min11112515-111251598.89297.761.1699.4298.291.16
21095354-109535497.36797.89
31076941-107694195.73096.25
41101331-110133197.89898.41
51103712-110371298.11098.67
61108927-110892798.57399.12
45min11109229-110922998.60097.641.0699.3098.341.06
21092830-109283097.14397.83
31077499-107749995.78096.46
41102603-110260398.01198.69
51103533-110353398.09498.82
61104894-110489498.21598.93
60min11108231-110823198.51297.511.0499.3798.361.04
21091094-109109496.98897.84
31077461-107746195.77696.62
41099789-109978997.76198.60
51098732-109873297.66798.55
61106241-110624198.33599.21
极限11104269-110426998.15997.290.9999.1898.320.99
21091347-109134797.01198.02
31074542-107454295.51796.52
41097175-109717597.52998.53
51097352-109735297.54598.59
61102524-110252498.00499.05
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%
110.109563095969959029595195774958450.15
210.149626296656964590.29
单位质量响应值RSD%判断
9489.609512.720.18数据可信
供试品溶液-2024120321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%
5min151360-5136048.65138.1816.1148.6538.1816.11
239834-3983437.73337.73
339295-3929537.22237.22
442743-4274340.48840.49
536496-3649634.57134.57
632137-3213730.44230.44
10min190502-9050285.72873.8010.5685.8173.8710.57
277397-7739773.31573.38
375021-7502171.06471.13
484007-8400779.57679.64
573211-7321169.34969.41
667328-6732863.77763.83
15min1104184-10418498.68992.164.2798.9192.344.28
298544-9854493.34693.53
395207-9520790.18590.37
498627-9862793.42593.62
594879-9487989.87490.05
692300-9230087.43287.59
20min1104664-10466499.14396.541.7699.5396.881.77
2100171-10017194.88795.23
3101923-10192396.54796.88
4101225-10122595.88696.24
5100194-10019494.90995.23
6103327-10332797.87798.18
30min1104274-10427498.77497.432.0799.3397.932.06
2100392-10039295.09795.60
3103151-10315197.71098.20
4101841-10184196.46996.98
5101295-10129595.95296.43
6106172-106172100.572101.04
45min1104203-10420398.70797.411.9399.4398.081.92
2100271-10027194.98295.64
3103097-10309797.65998.31
4102032-10203296.65097.33
5101605-10160596.24696.89
6105819-105819100.237100.87
60min1103883-10388398.40497.272.1699.2998.092.15
2100111-10011194.83195.65
3103390-10339097.93798.75
4101110-10111095.77796.61
5101452-10145296.10196.90
6106152-106152100.553101.35
极限1104092-10409298.60297.662.1099.6598.652.08
2100237-10023794.95095.92
3103772-10377298.29899.28
4101737-10173796.37197.37
5102314-10231496.91797.88
6106444-106444100.829101.80
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%
110.101015772101621210197631016618101670710170140.16
210.031018063101789810179800.02
单位质量响应值RSD%判断
100694.46101493.520.56数据可信
供试品溶液-2024120321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%
5min1618333-61833355.04944.8813.5355.0544.8713.54
2501806-50180644.67544.67
3496744-49674444.22444.22
4526673-52667346.88846.89
5467847-46784741.65141.65
6412936-41293636.76336.76
10min11000597-100059789.08178.628.9889.1778.708.99
2882953-88295378.60778.68
3855757-85575776.18676.26
4943035-94303583.95684.03
5840260-84026074.80674.88
6776038-77603869.08969.15
15min11117333-111733399.47394.613.3099.7194.823.32
21080125-108012596.16196.37
31047005-104700593.21293.41
41071438-107143895.38795.61
51044336-104433692.97593.17
61015915-101591590.44490.62
20min11121201-112120199.81898.311.00100.2298.681.00
21095870-109587097.56397.93
31105096-110509698.38498.74
41096428-109642897.61297.99
51094118-109411897.40797.76
61113152-111315299.10199.43
30min11120249-112024999.73398.871.43100.3199.391.42
21092318-109231897.24697.77
31116311-111631199.38299.90
41098247-109824797.77498.31
51101594-110159498.07298.58
61134374-1134374100.990101.48
45min11118192-111819299.55098.931.43100.2999.621.41
21091091-109109197.13797.83
31116905-111690599.435100.12
41099875-109987597.91998.62
51105308-110530898.40399.08
61135735-1135735101.112101.77
60min11114439-111443999.21698.721.50100.1299.571.49
21089513-108951396.99797.85
31117407-111740799.480100.33
41095115-109511597.49598.36
51101789-110178998.08998.93
61134656-1134656101.016101.84
极限11114141-111414199.18998.531.61100.2699.551.59
21084927-108492796.58897.60
31113864-111386499.164100.18
41091481-109148197.17298.20
51102050-110205098.11399.12
61133907-1133907100.949101.95
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%
110.109588795979964409588296069960510.24
210.149770897300975040.30
单位质量响应值RSD%判断
9510.009615.780.79数据可信
供试品溶液-2024120321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%
5min136992-3699234.81635.8010.1334.8235.8010.13
232332-3233230.43030.43
338852-3885236.56636.57
442458-4245839.96039.96
541879-4187939.41539.42
635682-3568233.58333.58
10min172321-7232168.06670.997.8868.1271.057.88
267156-6715663.20563.26
375326-7532670.89470.96
482819-8281977.94778.01
581665-8166576.86076.93
673273-7327368.96269.02
15min192843-9284387.38189.883.2087.5590.063.21
291638-9163886.24786.40
394936-9493689.35189.53
499522-9952293.66793.86
598324-9832492.53992.73
695725-9572590.09390.26
20min199833-9983393.96094.600.5494.2894.920.55
299891-9989194.01494.31
3100724-10072494.79895.13
4100695-10069594.77195.12
5101181-10118195.22895.58
6100736-10073694.80995.13
30min1104350-10435098.21195.871.3098.6896.351.28
2101252-10125295.29595.75
3102054-10205496.05096.54
4100565-10056594.64895.16
5101662-10166295.68196.19
6101265-10126595.30795.79
45min1104121-10412197.99595.731.3298.6396.381.31
2100986-10098695.04595.66
3102372-10237296.34997.00
4100618-10061894.69895.37
5101423-10142395.45696.12
6100759-10075994.83195.47
60min1103780-10378097.67495.881.2498.4896.681.22
2101686-10168695.70396.48
3102542-10254296.50997.32
4100188-10018894.29495.12
5102091-10209196.08596.91
6100948-10094895.00995.80
极限1104079-10407997.95696.240.9798.9297.210.96
2102388-10238896.36497.30
3102020-10202096.01896.99
4101308-10130895.34896.33
5102245-10224596.23097.22
6101507-10150795.53596.49
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%
110.101015824101628710159611015968101643410160950.03
210.031023587102177010226780.13
单位质量响应值RSD%判断
100603.47101961.910.95数据可信
供试品溶液-2024120321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%
5min1471874-47187441.93342.708.6041.9342.708.60
2423084-42308437.59737.60
3485157-48515743.11343.11
4531733-53173347.25247.25
5520667-52066746.26946.27
6450419-45041940.02640.03
10min1860859-86085976.50076.986.4276.5777.066.42
2786626-78662669.90369.97
3858441-85844176.28576.36
4933869-93386982.98883.07
5924202-92420282.12882.21
6833685-83368574.08574.15
15min11056535-105653593.88893.542.1794.0993.742.18
21019371-101937190.58690.76
31042588-104258892.64992.85
41082678-108267896.21196.43
51071988-107198895.26195.48
61042556-104255692.64692.84
20min11129472-1129472100.37097.741.37100.7298.101.36
21093269-109326997.15297.48
31095684-109568497.36797.72
41094781-109478197.28797.66
51098873-109887397.65098.02
61087291-108729196.62196.97
30min11141120-1141120101.40598.391.62101.9398.911.61
21106238-110623898.30598.80
31107596-110759698.42698.94
41095002-109500297.30697.85
51102384-110238497.96298.50
61090795-109079596.93397.44
45min11141312-1141312101.42298.331.72102.1199.011.71
21105814-110581498.26798.92
31111618-111161898.78399.46
41094172-109417297.23397.93
51098356-109835697.60598.30
61087934-108793496.67897.35
60min11140105-1140105101.31598.411.60102.1799.261.58
21108223-110822398.48199.30
31108032-110803298.46499.31
41091460-109146096.99297.86
51104369-110436998.13999.00
61092635-109263597.09697.92
极限11140769-1140769101.37498.141.74102.4099.151.73
21105783-110578398.26599.25
31103289-110328998.04399.05
41088273-108827396.70997.73
51098690-109869097.63498.66
61089513-108951396.81997.81
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