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%
110.419812498096980049813398040980790.06
210.489913998776989580.26
单位质量响应值RSD%判断
9421.619442.560.16数据可信
供试品溶液-312163A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%
5min122032-2203221.02367.89164.3321.0267.89164.34
2309769-309769295.579295.58
325984-2598424.79424.79
425728-2572824.54924.55
522433-2243321.40521.41
620944-2094419.98519.98
10min149491-4949147.22448.3410.6847.2648.4510.42
243622-4362241.62442.12
353572-5357251.11851.16
459109-5910956.40156.44
551355-5135549.00249.04
646792-4679244.64944.68
15min172397-7239769.08171.488.5969.1971.678.44
267324-6732464.24064.80
377390-7739073.84573.97
485388-8538881.47681.61
576860-7686073.33973.46
670095-7009566.88466.99
20min188713-8871384.64986.585.2984.8886.895.19
285972-8597282.03482.70
390635-9063586.48386.73
499912-9991295.33595.61
590384-9038486.24486.48
688778-8877884.71184.93
30min1101113-10111396.48195.391.8696.8595.841.88
2100302-10030295.70796.51
397704-9770493.22893.62
4102174-10217497.49497.92
597726-9772693.24993.63
6100787-10078796.17096.53
45min1103677-10367798.92896.571.9099.4697.191.87
2100635-10063596.02596.99
398658-9865894.13994.69
4102991-10299198.27398.87
599761-9976195.19195.73
6101522-10152296.87197.39
60min1102955-10295598.23996.452.2098.9397.232.18
2100754-10075496.13997.26
398475-9847593.96494.67
4103331-10333198.59899.35
598446-9844693.93694.63
6102539-10253997.84298.52
极限1103038-10303898.31896.652.0599.1897.582.07
2101627-10162796.97298.26
399656-9965695.09195.95
4103407-10340798.67099.59
598030-9803093.53994.39
6101962-10196297.29198.14
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%
19.991065810106352410673341066710106685710660470.15
210.061070254107318510717200.20
单位质量响应值RSD%判断
106711.41106532.800.12数据可信
供试品溶液-312163A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%
5min1345252-34525229.14325.0549.5629.1425.0549.56
2-0.0000.00
3384082-38408232.42032.42
4380397-38039732.10932.11
5342040-34204028.87228.87
6328648-32864827.74127.74
10min1633512-63351253.47554.748.0753.5254.788.10
2579443-57944348.91148.91
3677776-67777657.21157.27
4728910-72891061.52861.58
5658703-65870355.60155.65
6612893-61289351.73451.78
15min1851964-85196471.91574.146.6072.0574.286.62
2806726-80672668.09668.18
3901328-90132876.08176.23
4968484-96848481.75081.91
5904108-90410876.31676.46
6837707-83770770.71170.84
20min11003307-100330784.68985.674.0084.9585.924.02
2967991-96799181.70881.90
31014573-101457385.64085.92
41090219-109021992.02692.32
51012639-101263985.47785.75
61000500-100050084.45384.70
30min11099296-109929692.79291.671.3093.1992.071.29
21089500-108950091.96592.30
31065774-106577489.96290.38
41099187-109918792.78393.23
51072139-107213990.50090.91
61090411-109041192.04292.43
45min11117533-111753394.33192.461.6794.8893.021.67
21086950-108695091.75092.23
31069631-106963190.28890.86
41113848-111384894.02094.62
51086195-108619591.68692.25
61098387-109838792.71593.26
60min11106442-110644293.39592.331.5594.1193.041.55
21092275-109227592.19992.84
31068184-106818490.16690.89
41109239-110923993.63194.39
51079658-107965891.13491.85
61107064-110706493.44894.15
极限11107727-110772793.50492.111.5594.3792.971.54
21092339-109233992.20593.00
31073598-107359890.62391.49
41107702-110770293.50194.41
51068360-106836090.18191.05
61097599-109759992.64993.50
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%
110.419790798658983919790397966981650.35
210.489823198338982840.08
单位质量响应值RSD%判断
9429.889378.240.39数据可信
供试品溶液-312163A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%
5min124610-2461023.55327.3214.8923.5527.3214.90
226968-2696825.80925.81
335250-3525033.73633.74
424037-2403723.00423.00
531069-3106929.73429.73
629376-2937628.11428.11
10min157197-5719754.74059.9613.7354.7860.0013.72
258073-5807355.57855.62
376139-7613972.86872.92
453196-5319650.91150.95
569488-6948866.50366.55
661795-6179559.14059.19
15min181611-8161178.10581.628.4778.2481.778.47
281039-8103977.55877.69
395562-9556291.45791.63
476211-7621172.93773.06
591665-9166587.72787.89
685629-8562981.95082.10
20min194826-9482690.75291.623.9891.0191.904.00
291881-9188187.93488.20
399880-9988095.58995.92
491005-9100587.09587.34
599628-9962895.34895.65
697174-9717492.99993.28
30min1100163-10016395.86096.281.3796.2796.711.40
2100164-10016495.86196.27
3102501-10250198.09898.59
498537-9853794.30494.69
5101653-10165397.28697.75
6100592-10059296.27196.71
45min199948-9994895.65497.061.3196.2397.661.33
2101244-10124496.89597.47
3102918-10291898.49799.15
4101103-10110396.76097.31
5103090-10309098.66199.29
6100214-10021495.90996.51
60min199647-9964795.36696.340.5696.1097.100.58
2100647-10064796.32397.06
3100916-10091696.58197.40
4100638-10063896.31597.02
5101301-10130196.94997.74
6100865-10086596.53297.29
极限199736-9973695.45196.470.8996.3497.390.89
2101416-10141697.05997.95
3100242-10024295.93696.91
4100956-10095696.61997.49
5102176-10217697.78798.74
6100293-10029395.98496.90
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%
19.991065930106964710647771066460106377310661170.21
210.061066276106679710665360.04
单位质量响应值RSD%判断
106718.42106017.500.47数据可信
供试品溶液-312163A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%
5min1382129-38212932.33336.8612.4832.3336.8612.48
2414866-41486635.10335.10
3516404-51640443.69443.69
4377736-37773631.96131.96
5473014-47301440.02340.02
6449892-44989238.06738.07
10min1754910-75491063.87568.4211.2963.9368.4811.29
2756120-75612063.97764.04
3945441-94544179.99680.07
4703943-70394359.56359.62
5888009-88800975.13775.20
6803100-80310067.95368.02
15min1996715-99671584.33586.726.7184.5086.906.72
2984002-98400283.25983.42
31113824-111382494.24494.45
4929980-92998078.68878.84
51089206-108920692.16192.35
61035813-103581387.64387.82
20min11109453-110945393.87494.183.0194.1794.503.03
21082394-108239491.58491.89
31139293-113929396.39996.76
41065210-106521090.13090.41
51148481-114848197.17697.52
61133369-113336995.89896.22
30min11156882-115688297.88797.631.0898.3498.111.10
21157855-115785597.96998.43
31154308-115430897.66998.19
41129484-112948495.56996.00
51164934-116493498.56899.08
61159600-115960098.11798.60
45min11149231-114923197.24097.790.7897.8698.430.80
21157518-115751897.94198.56
31161561-116156198.28398.97
41146252-114625296.98897.58
51169708-116970898.97299.64
61150080-115008097.31297.96
60min11146977-114697797.04997.560.6797.8398.360.66
21158433-115843398.01898.80
31142721-114272196.68997.54
41149425-114942597.25698.01
51158926-115892698.06098.90
61161389-116138998.26899.08
极限11148831-114883197.20697.350.7398.1598.310.73
21154086-115408697.65198.60
31138442-113844296.32797.34
41144388-114438896.83097.75
51161838-116183898.30699.31
61155407-115540797.76298.73
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