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%
1 12.171990011995731995661993581991961993390.13
2 12.111992581992181992380.02
单位质量响应值RSD%判断
16379.5416452.350.32数据可信
供试品溶液-2025041711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%
5min1159255-15925577.99876.923.8778.0076.923.87
2161942-16194279.31479.31
3160373-16037378.54678.55
4161568-16156879.13179.13
5152101-15210174.49574.49
6147089-14708972.04072.04
10min1181717-18171789.00088.002.1689.1288.122.16
2181596-18159688.94089.06
3182269-18226989.27089.39
4182949-18294989.60389.72
5175498-17549885.95486.07
6174011-17401185.22585.33
15min1188395-18839592.27091.551.9692.5291.791.97
2187168-18716891.66991.92
3190856-19085693.47693.73
4189685-18968592.90293.16
5180990-18099088.64388.88
6184397-18439790.31290.55
20min1205609-205609100.70194.483.80101.0994.863.79
2189989-18998993.05193.44
3195210-19521095.60896.00
4193375-19337594.70995.10
5183982-18398290.10990.48
6189279-18927992.70393.07
30min1194899-19489995.45695.312.0296.0095.832.02
2195608-19560895.80396.33
3198408-19840897.17497.71
4198107-19810797.02797.56
5187902-18790292.02992.54
6192639-19263994.34994.86
45min1196164-19616496.07596.482.5196.7697.152.50
2197724-19772496.83997.51
3200487-20048798.19398.87
4203556-20355699.696100.38
5189271-18927192.69993.35
6194720-19472095.36896.02
极限1198375-19837597.15897.952.5697.9998.762.56
2201097-20109798.49199.31
3208132-208132101.937102.77
4202402-20240299.13099.96
5193470-19347094.75695.54
6196470-19647096.22597.02
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%
1 12.171997181998201997681997731996421997440.04
2 12.111990091999731994910.35
单位质量响应值RSD%判断
16412.8216473.250.26数据可信
供试品溶液-2025041711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%
5min1176957-17695786.52584.331.9686.5384.331.96
2169253-16925382.75882.76
3171919-17191984.06284.06
4170898-17089883.56383.56
5169504-16950482.88182.88
6176301-17630186.20586.20
10min1192255-19225594.00591.801.7694.1491.931.76
2183375-18337589.66489.79
3186520-18652091.20191.33
4187235-18723591.55191.68
5186103-18610390.99791.12
6190957-19095793.37193.50
15min1199769-19976997.68095.121.9197.9595.391.91
2189496-18949692.65692.92
3192600-19260094.17494.44
4194389-19438995.04995.31
5193196-19319694.46694.73
6197792-19779296.71396.98
20min1204386-20438699.93797.102.17100.3597.512.17
2193019-19301994.37994.78
3195944-19594495.80996.21
4198274-19827496.94997.35
5197009-19700996.33096.73
6202899-20289999.21099.62
30min1208611-208611102.00398.932.47102.5799.482.47
2196384-19638496.02496.56
3198482-19848297.05097.60
4202506-20250699.01899.57
5200132-20013297.85798.40
6207807-207807101.610102.17
45min1209740-209740102.55599.772.36103.28100.472.36
2197344-19734496.49497.18
3201139-20113998.34999.04
4204173-20417399.833100.53
5202545-20254599.03799.73
6209287-209287102.334103.05
极限1210853-210853103.099100.122.85103.97100.972.84
2197072-19707296.36197.19
3200547-20054798.06098.90
4205322-205322100.395101.24
5202824-20282499.173100.02
6211966-211966103.643104.51
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%
1 12.172005252011912002032012082007072007670.22
2 12.111991081982741986910.30
单位质量响应值RSD%判断
16496.8816407.180.39数据可信
供试品溶液-2025041711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%
5min1167681-16768181.94579.513.2981.9579.523.29
2152967-15296774.75574.75
3164678-16467880.47880.48
4166049-16604981.14881.15
5164432-16443280.35780.36
6160429-16042978.40178.40
10min1183556-18355689.70388.801.1689.8388.921.16
2179089-17908987.52087.63
3181249-18124988.57688.70
4184429-18442990.13090.25
5182146-18214689.01489.13
6179718-17971887.82887.95
15min1191380-19138093.52792.871.1393.7893.121.13
2189655-18965592.68492.93
3187408-18740891.58691.84
4193523-19352394.57494.83
5188677-18867792.20692.46
6189615-18961592.66492.91
20min1195413-19541395.49895.341.3395.9095.731.33
2194188-19418894.89995.28
3191965-19196593.81394.20
4198624-19862497.06797.47
5192877-19287794.25894.65
6197449-19744996.49396.88
30min1200282-20028297.87797.171.5298.4297.711.52
2198757-19875797.13297.66
3194011-19401194.81395.34
4202892-20289299.15399.70
5197230-19723096.38696.92
6199861-19986197.67198.20
45min1203882-20388299.63797.991.85100.3298.671.85
2200480-20048097.97498.64
3195859-19585995.71696.39
4205730-205730100.540101.23
5197946-19794696.73697.41
6199172-19917297.33598.01
极限1204783-204783100.07798.301.99100.9199.131.98
2201795-20179598.61799.43
3194843-19484395.21996.04
4205442-205442100.399101.24
5198368-19836896.94297.77
6201666-20166698.55499.38
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%
1 12.172006882007632007331999472006842005630.18
2 12.112015052010062012560.18
单位质量响应值RSD%判断
16480.1216618.990.60数据可信
供试品溶液-2025041711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%
5min1166362-16636280.82280.172.2880.8280.162.28
2170764-17076482.96182.96
3164406-16440679.87279.87
4165769-16576980.53480.53
5163393-16339379.38079.38
6159373-15937377.42777.43
10min1182433-18243388.63088.631.6088.7588.751.60
2185025-18502589.88990.01
3185183-18518389.96690.09
4183781-18378189.28589.41
5177711-17771186.33686.46
6180459-18045987.67187.79
15min1189486-18948692.05791.761.4092.3192.021.40
2191168-19116892.87493.13
3189553-18955392.08992.34
4191338-19133892.95693.21
5184394-18439489.58389.83
6187354-18735491.02191.27
20min1194011-19401194.25593.781.2394.6594.171.23
2193352-19335293.93594.33
3193190-19319093.85694.25
4195949-19594995.19695.59
5188742-18874291.69592.08
6192989-19298993.75894.14
30min1198424-19842496.39995.581.2096.9396.111.19
2197359-19735995.88196.42
3197001-19700195.70796.24
4199175-19917596.76497.30
5192564-19256493.55294.07
6195875-19587595.16095.69
45min1200986-20098697.64396.441.1698.3297.121.16
2197676-19767696.03596.72
3198910-19891096.63597.31
4200533-20053397.42398.11
5194616-19461694.54995.21
6198378-19837896.37697.04
极限1200531-20053197.42296.551.0098.2597.361.00
2198231-19823196.30597.13
3199137-19913796.74597.57
4200884-20088497.59498.42
5195413-19541394.93695.74
6198159-19815996.27097.08
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