磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.813225823230943235613236583244013234590.21
212.853244323236883240600.17
单位质量响应值RSD%判断
25250.5125218.680.09数据可信
供试品溶液-2025030122批-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%
5min1350245-35024597.17197.721.7897.1797.721.78
2347754-34775496.47996.48
3354741-35474198.41898.42
4349723-34972397.02697.03
5363726-363726100.911100.91
6347157-34715796.31496.31
10min1353519-35351998.07998.521.7698.2498.681.76
2349548-34954896.97797.14
3357876-35787699.28899.45
4353184-35318497.98698.15
5366292-366292101.623101.79
6350175-35017597.15197.31
15min1352729-35272997.86098.441.7898.1998.771.77
2349001-34900196.82597.15
3358205-35820599.37999.71
4353322-35332298.02498.35
5365804-365804101.487101.82
6349838-34983897.05897.38
20min1352709-35270997.85498.321.7698.3498.811.76
2348773-34877396.76297.25
3357406-35740699.15799.65
4352893-35289397.90598.39
5365386-365386101.371101.88
6349172-34917296.87397.36
30min1351643-35164397.55898.121.7498.2198.781.74
2348271-34827196.62397.27
3356826-35682698.99699.66
4351928-35192897.63798.29
5364528-364528101.133101.81
6348811-34881196.77397.42
45min1351313-35131397.46797.901.8498.2898.721.84
2346812-34681296.21897.02
3355859-35585998.72899.55
4350990-35099097.37798.19
5364409-364409101.100101.94
6347946-34794696.53397.34
极限1350562-35056297.25897.751.7198.2498.741.72
2347118-34711896.30397.27
3354929-35492998.47099.46
4350818-35081897.33098.31
5363193-363193100.763101.78
6347420-34742096.38797.35
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.813236823238393239103232743227703234950.15
212.853230363233543231950.07
单位质量响应值RSD%判断
25253.3225151.360.29数据可信
供试品溶液-2025030222批-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%
5min1352801-35280198.00596.202.3598.0196.202.35
2351160-35116097.54997.55
3330954-33095491.93691.94
4348567-34856796.82996.83
5343824-34382495.51295.51
6350492-35049297.36497.36
10min1356144-35614498.93497.402.1599.1097.562.15
2355188-35518898.66898.83
3336137-33613793.37693.53
4352677-35267797.97198.13
5349101-34910196.97797.14
6354420-35442098.45598.62
15min1356379-35637998.99997.412.0699.3397.742.06
2354421-35442198.45598.78
3336746-33674693.54593.85
4352824-35282498.01298.34
5349435-34943597.07097.39
6354203-35420398.39598.72
20min1355616-35561698.78797.232.0299.2897.712.03
2353748-35374898.26898.76
3336258-33625893.41093.87
4351125-35112597.54098.03
5349580-34958097.11197.59
6353684-35368498.25198.74
30min1355211-35521198.67597.212.1099.3397.862.10
2354387-35438798.44699.10
3335831-33583193.29193.91
4351874-35187497.74898.40
5348531-34853196.81997.46
6353840-35384098.29498.95
45min1354657-35465798.52196.962.1199.3497.772.10
2353619-35361998.23399.05
3334787-33478793.00193.78
4350202-35020297.28398.10
5348597-34859796.83797.64
6352458-35245897.91098.73
极限1354253-35425398.40996.782.1099.4097.752.10
2352149-35214997.82498.81
3334099-33409992.81093.74
4350101-35010197.25598.23
5348096-34809696.69897.67
6351607-35160797.67498.65
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.813237663236973243243235053233173237220.12
212.853237253235943236600.03
单位质量响应值RSD%判断
25271.0425187.550.24数据可信
供试品溶液-2025030322批-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%
5min1351404-35140497.51397.641.0497.5197.641.04
2348009-34800996.57196.57
3351221-35122197.46297.46
4350063-35006397.14197.14
5358784-35878499.56199.56
6351760-35176097.61297.61
10min1354846-35484698.46898.951.2298.6399.111.22
2352390-35239097.78697.95
3355644-35564498.68998.85
4355881-35588198.75598.92
5364997-364997101.285101.45
6355736-35573698.71598.88
15min1355838-35583898.74398.891.3099.0799.221.30
2351854-35185497.63897.96
3354951-35495198.49798.82
4355263-35526398.58498.91
5365326-365326101.376101.71
6355032-35503298.52098.85
20min1355478-35547898.64398.831.2699.1399.321.26
2351372-35137297.50497.99
3354788-35478898.45298.94
4355795-35579598.73199.22
5364675-364675101.195101.70
6354826-35482698.46298.95
30min1355089-35508998.53598.771.2699.1999.421.25
2351423-35142397.51898.17
3354998-35499898.51099.17
4354420-35442098.35099.01
5364542-364542101.159101.83
6355037-35503798.52199.18
45min1354166-35416698.27998.511.3199.1099.331.31
2350859-35085997.36298.17
3353427-35342798.07498.89
4353651-35365198.13698.96
5364134-364134101.045101.89
6353681-35368198.14598.96
极限1353769-35376998.16998.391.2599.1599.381.25
2350411-35041197.23798.21
3352737-35273797.88398.87
4353531-35353198.10399.09
5363169-363169100.778101.79
6353852-35385298.19299.18
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