达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
112.312000702003191999111999131998932000210.10
212.292005412004422004920.04
单位质量响应值RSD%判断
16248.6616313.430.29数据可信
供试品溶液-WA3063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%
5min1139670-13967068.97372.158.4668.9772.158.46
2142454-14245470.34870.35
3153781-15378175.94175.94
4161827-16182779.91579.91
5151926-15192675.02575.03
6126920-12692062.67762.68
10min1163059-16305980.52386.104.5380.6386.214.53
2171857-17185784.86884.97
3175148-17514886.49386.61
4182131-18213189.94190.06
5184123-18412390.92591.04
6169808-16980883.85683.95
15min1172493-17249385.18289.673.6485.4189.903.64
2178926-17892688.35988.59
3180897-18089789.33289.58
4187584-18758492.63492.89
5190744-19074494.19594.44
6178787-17878788.29088.51
20min1175943-17594386.88691.253.5887.2491.623.58
2181694-18169489.72690.09
3184802-18480291.26091.64
4190399-19039994.02494.42
5194227-19422795.91596.30
6181659-18165989.70890.06
30min1182095-18209589.92493.323.1490.4193.833.14
2186084-18608491.89392.39
3188625-18862593.14893.66
4193885-19388595.74696.28
5197966-19796697.76198.30
6185208-18520891.46191.95
45min1185493-18549391.60295.012.8192.2295.662.81
2190593-19059394.12094.76
3192402-19240295.01395.67
4196220-19622096.89997.58
5200654-20065499.08999.77
6188998-18899893.33293.96
极限1199878-19987898.70598.961.7899.4699.751.77
2195479-19547996.53397.31
3202293-20229399.898100.69
4197168-19716897.36798.19
5204706-204706101.090101.92
6202848-202848100.172100.94
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
112.312010072011812010002010182011542010720.05
212.292020322019122019720.05
单位质量响应值RSD%判断
16334.0416433.850.44数据可信
供试品溶液-WA3063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%
5min1154497-15449775.81670.3113.4975.8270.3113.49
2154755-15475575.94375.94
3149729-14972973.47673.48
4149817-14981773.52073.52
5146432-14643271.85871.86
6104374-10437451.21951.22
10min1170336-17033683.58982.2711.2283.7082.3811.22
2175671-17567186.20786.32
3179993-17999388.32888.44
4176313-17631386.52286.63
5173748-17374885.26385.37
6129830-12983063.71163.79
15min1175738-17573886.24085.5210.4986.4885.7510.49
2180546-18054688.59988.84
3186714-18671491.62691.87
4182970-18297089.78990.03
5181988-18198889.30789.54
6137702-13770267.57467.75
20min1179623-17962388.14687.359.5488.5187.709.55
2182827-18282789.71890.09
3189369-18936992.92993.31
4186007-18600791.27991.65
5186138-18613891.34391.71
6144010-14401070.67070.94
30min1183509-18350990.05389.508.3590.5589.988.36
2185863-18586391.20891.72
3192573-19257394.50195.02
4190034-19003493.25593.77
5190221-19022193.34793.85
6152047-15204774.61474.99
45min1188077-18807792.29591.647.3192.9392.267.33
2189283-18928392.88793.53
3196662-19666296.50897.17
4193510-19351094.96195.61
5193323-19332394.86995.52
6159634-15963478.33778.83
极限1201727-20172798.99398.260.8199.7799.020.84
2200457-20045798.37099.16
3201806-20180699.03299.84
4200787-20078798.53299.33
5197873-19787397.10297.89
6198721-19872197.51898.13
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
112.312010512011462011122010982007872010390.08
212.292043082037472040280.20
单位质量响应值RSD%判断
16331.3616601.141.16数据可信
供试品溶液-WC2484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%
5min1128002-12800262.50464.6517.4562.5064.6517.45
2137153-13715366.97266.97
3130390-13039063.67063.67
4161690-16169078.95478.95
5144884-14488470.74770.75
692292-9229245.06745.07
10min1168587-16858782.32283.429.7482.4283.529.75
2180834-18083488.30288.40
3162848-16284879.51979.61
4186957-18695791.29291.41
5183256-18325689.48589.59
6142532-14253269.59969.67
15min1178842-17884287.32987.408.4487.5587.628.45
2188254-18825491.92592.16
3171310-17131083.65183.87
4192410-19241093.95594.21
5190321-19032192.93593.17
6152783-15278374.60574.78
20min1184071-18407189.88389.077.8290.2389.427.83
2190703-19070393.12193.49
3175162-17516285.53285.87
4194650-19465095.04895.44
5192659-19265994.07694.46
6157191-15719176.75777.04
30min1187925-18792591.76590.687.0992.2591.167.11
2193076-19307694.28094.79
3179574-17957487.68788.16
4196441-19644195.92396.46
5195206-19520695.32095.84
6161953-16195379.08279.48
45min1190183-19018392.86792.106.2593.4992.726.27
2195369-19536995.40096.05
3183764-18376489.73390.33
4198582-19858296.96897.65
5196590-19659095.99696.66
6167166-16716681.62882.15
极限1193883-19388394.67497.201.7395.4397.961.74
2204198-20419899.711100.51
3197164-19716496.27697.01
4200508-20050897.90998.74
5199357-19935797.34798.15
6199255-19925597.29797.94
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
112.312034512030972034902032372032162032980.09
212.292027192025402026300.07
单位质量响应值RSD%判断
16514.8716487.390.12数据可信
供试品溶液-WC2484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%
5min1137426-13742666.95965.049.3966.9665.049.38
2133612-13361265.10165.10
3138111-13811167.29367.29
4111517-11151754.33654.34
5149513-14951372.84972.85
6130737-13073763.70063.70
10min1181193-18119388.28486.234.3788.3886.334.37
2176209-17620985.85685.95
3175715-17571585.61585.72
4163653-16365379.73879.82
5178137-17813786.79586.90
6186953-18695391.09191.19
15min1190782-19078292.95790.513.4093.1990.743.40
2184826-18482690.05590.28
3185418-18541890.34390.57
4175483-17548385.50285.70
5184319-18431989.80890.05
6193786-19378694.42094.65
20min1192799-19279993.93992.132.9894.3192.492.98
2188372-18837291.78292.14
3190321-19032192.73293.10
4179534-17953487.47687.81
5187463-18746391.33991.71
6196036-19603695.51795.89
30min1195750-19575095.37793.802.6095.8994.302.60
2191457-19145793.28593.78
3194457-19445794.74795.25
4184043-18404389.67390.13
5190924-19092493.02693.54
6198405-19840596.67197.19
45min1198054-19805496.50095.122.1197.1695.762.12
2193663-19366394.36095.00
3197993-19799396.47097.12
4188272-18827291.73492.33
5194029-19402994.53995.19
6199332-19933297.12297.78
极限1199094-19909497.00796.701.1797.8197.481.18
2195676-19567695.34196.12
3201312-20131298.08798.88
4196615-19661595.79996.53
5197259-19725996.11296.90
6200802-20080297.83998.65
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