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%
112.181973201975971982091981571981071978780.21
212.161986091983081984580.11
单位质量响应值RSD%判断
16246.1416320.560.33数据可信
中间条件6月-供试品溶液-2025080321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%
5min1170845-17084584.35684.460.6084.3684.460.60
2172156-17215685.00385.00
3171401-17140184.63184.63
4170798-17079884.33384.33
5169262-16926283.57583.57
6171822-17182284.83984.84
10min1183954-18395490.82991.520.5990.9691.640.59
2186357-18635792.01592.14
3185508-18550891.59691.72
4184897-18489791.29491.42
5184581-18458191.13891.26
6186798-18679892.23392.36
15min1190129-19012993.87894.680.7594.1494.940.75
2193717-19371795.64995.91
3190782-19078294.20094.46
4191287-19128794.45094.71
5191338-19133894.47594.74
6193275-19327595.43195.70
20min1192688-19268895.14196.421.0595.5496.831.05
2197790-19779097.66098.07
3193674-19367495.62896.03
4195872-19587296.71397.12
5194407-19440795.99096.39
6197267-19726797.40297.81
30min1194755-19475596.16298.001.2396.7198.551.23
2201547-20154799.516100.07
3198083-19808397.80598.35
4197834-19783497.68298.23
5197838-19783897.68498.23
6200787-20078799.14099.70
45min1195017-19501796.29198.531.5396.9899.231.52
2203170-203170100.317101.02
3199399-19939998.45599.15
4199696-19969698.60299.30
5197591-19759197.56298.26
6202487-20248799.980100.68
极限1194790-19479096.17998.671.5997.0199.521.58
2203936-203936100.695101.55
3199678-19967898.59399.44
4199797-19979798.65199.50
5198549-19854998.03598.88
6202301-20230199.888100.74
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%
112.181991061995081995161992261993351993380.09
212.161975661975701975680.01
单位质量响应值RSD%判断
16366.0116247.370.52数据可信
中间条件6月-供试品溶液-2025080421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%
5min1175429-17542986.49685.540.8786.5085.540.87
2174088-17408885.83585.84
3173337-17333785.46585.46
4173139-17313985.36785.37
5173996-17399685.79085.79
6170915-17091584.27184.27
10min1188066-18806692.72791.990.5992.8692.120.59
2186178-18617891.79691.92
3185610-18561091.51691.64
4186616-18661692.01292.14
5187598-18759892.49692.62
6185344-18534491.38591.51
15min1194383-19438395.84295.090.5196.1195.360.51
2193016-19301695.16895.43
3191673-19167394.50594.77
4193161-19316195.23995.51
5193007-19300795.16395.43
6191941-19194194.63894.90
20min1198612-19861297.92796.800.6398.3497.210.63
2196218-19621896.74697.16
3194882-19488296.08896.49
4196103-19610396.69097.10
5196286-19628696.78097.19
6195904-19590496.59297.00
30min1201151-20115199.17998.270.6599.7498.830.65
2200454-20045498.83599.39
3197554-19755497.40597.96
4198782-19878298.01198.56
5198805-19880598.02298.58
6199152-19915298.19398.74
45min1202596-20259699.89198.281.39100.6098.981.38
2201143-20114399.17599.88
3198363-19836397.80498.50
4199147-19914798.19198.89
5200151-20015198.68699.39
6194605-19460595.95196.65
极限1202152-20215299.67298.521.05100.5399.371.04
2201941-20194199.568100.42
3196790-19679097.02897.87
4198269-19826997.75898.61
5199575-19957598.40299.25
6200160-20016098.69099.53
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%
112.181982911996872000631991291998741994090.36
212.161995141998211996680.11
单位质量响应值RSD%判断
16371.8416420.070.21数据可信
中间条件6月-供试品溶液-2025080521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%
5min1170707-17070783.70984.870.8683.7184.870.86
2173887-17388785.26885.27
3174340-17434085.49085.49
4173597-17359785.12685.13
5174139-17413985.39285.39
6171801-17180184.24584.25
10min1182677-18267789.57990.910.9189.7091.040.92
2187186-18718691.79091.92
3187002-18700291.69991.83
4185628-18562891.02691.15
5185438-18543890.93291.06
6184401-18440190.42490.55
15min1188699-18869992.53294.050.9992.7994.310.99
2193513-19351394.89295.16
3193431-19343194.85295.12
4192507-19250794.39994.66
5192223-19222394.26094.52
6190371-19037193.35193.61
20min1191468-19146893.88995.691.1794.2996.101.16
2197211-19721196.70697.11
3197213-19721396.70797.11
4195015-19501595.62996.03
5196301-19630196.25996.67
6193664-19366494.96695.37
30min1193718-19371894.99397.001.3195.5397.551.31
2200876-20087698.50399.06
3199559-19955997.85798.41
4198732-19873297.45198.00
5197971-19797197.07897.63
6196004-19600496.11496.66
45min1195478-19547895.85697.581.2496.5498.281.24
2202004-20200499.05699.76
3200974-20097498.55199.25
4199988-19998898.06798.76
5198477-19847797.32698.02
6197084-19708496.64397.33
极限1195072-19507295.65797.721.3796.4898.561.37
2202984-20298499.536100.39
3200508-20050898.32299.17
4200036-20003698.09198.93
5199670-19967097.91198.75
6197469-19746996.83297.67
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%
112.181986351991121992781991511990271990410.13
212.162018782013212016000.20
单位质量响应值RSD%判断
16341.6316578.951.02数据可信
中间条件6月-供试品溶液-WK2927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%
5min1173971-17397184.98074.6418.8284.9874.6418.82
2174060-17406085.02485.02
3152959-15295974.71674.72
4151731-15173174.11774.12
597628-9762847.68947.69
6166494-16649481.32881.33
10min1195335-19533595.41694.521.1895.5494.631.18
2189632-18963292.63092.76
3193686-19368694.61194.72
4196172-19617295.82595.94
5192908-19290894.23094.30
6193259-19325994.40294.52
15min1196642-19664296.05496.041.4496.3396.301.43
2191329-19132993.45993.73
3197239-19723996.34696.60
4199090-19909097.25097.51
5198969-19896997.19197.40
6196462-19646295.96796.23
20min1196894-19689496.17896.171.4596.5996.571.43
2191708-19170893.64494.05
3197367-19736796.40996.81
4199409-19940997.40697.81
5199494-19949497.44897.81
6196442-19644295.95796.36
30min1197256-19725696.35496.041.4696.9196.581.45
2191448-19144893.51794.06
3196726-19672696.09596.64
4199202-19920297.30597.85
5199172-19917297.29097.80
6195916-19591695.70096.25
45min1196654-19665496.06095.941.5496.7696.621.52
2191017-19101793.30793.99
3196333-19633395.90496.59
4199234-19923497.32198.01
5199258-19925897.33297.98
6195958-19595895.72096.42
极限1196477-19647795.97495.821.4496.8296.651.42
2191365-19136593.47794.30
3196231-19623195.85496.68
4198894-19889497.15497.99
5198938-19893897.17697.97
6195098-19509895.30096.14
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