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D5551-23-012对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)19.2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%
112.151974911971651972441973921971001972780.09
212.211981511982411981960.04
单位质量响应值RSD%判断
16236.8716232.270.03数据可信
供试品溶液-25030601批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1168914-16891483.90186.121.9683.9086.121.96
2176970-17697087.90287.90
3174179-17417986.51686.52
4169530-16953084.20784.21
5176151-17615187.49687.50
6174571-17457186.71186.71
10min1184910-18491091.84693.441.6491.9793.571.64
2189780-18978094.26594.40
3191331-19133195.03695.17
4190815-19081594.77994.91
5184048-18404891.41891.55
6187799-18779993.28193.41
15min1186048-18604892.41293.441.2992.6893.711.29
2191058-19105894.90095.17
3189667-18966794.20994.48
4189759-18975994.25594.52
5184847-18484791.81592.08
6187312-18731293.03993.31
20min1186718-18671892.74494.061.2193.1594.471.21
2191595-19159595.16795.58
3190627-19062794.68695.10
4190821-19082194.78295.19
5186243-18624392.50892.91
6190229-19022994.48894.90
30min1188274-18827493.51794.651.2594.0695.201.25
2193224-19322495.97696.53
3192772-19277295.75196.31
4191884-19188495.31095.86
5187666-18766693.21593.76
6189560-18956094.15694.71
45min1189357-18935794.05595.701.3594.7496.401.35
2195653-19565397.18297.88
3195184-19518496.94997.65
4193634-19363496.18096.87
5190218-19021894.48395.17
6192020-19202095.37896.07
60min1190270-19027094.50996.881.6195.3397.721.60
2199300-19930098.99499.84
3197236-19723697.96998.81
4195347-19534797.03097.87
5193353-19335396.04096.87
6194771-19477196.74497.58
极限1204776-204776101.714101.890.78102.68102.880.78
2206208-206208102.425103.42
3207663-207663103.148104.14
4205001-205001101.826102.81
5203236-203236100.949101.92
6203943-203943101.300102.28
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D5551-23-012对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)19.2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%
112.151974721974841975801975441974691975100.03
212.211989341987531988440.07
单位质量响应值RSD%判断
16255.9716285.340.13数据可信
供试品溶液-25030601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%
5min1186655-18665592.50795.492.3092.5195.492.30
2190681-19068194.50394.50
3197312-19731297.78997.79
4195941-19594197.11097.11
5196274-19627497.27597.27
6189159-18915993.74893.75
10min1198614-19861498.43499.791.0998.5799.931.09
2199986-19998699.11499.26
3203470-203470100.841100.99
4203766-203766100.988101.13
5202532-202532100.376100.52
6199698-19969898.97299.11
15min1199618-19961898.932100.570.9599.22100.860.95
2201752-20175299.990100.28
3203224-203224100.719101.02
4204604-204604101.403101.70
5204466-204466101.335101.63
6203816-203816101.013101.30
20min1202843-202843100.530100.810.48100.97101.250.48
2203898-203898101.053101.49
3203466-203466100.839101.29
4204343-204343101.274101.72
5204116-204116101.161101.61
6201756-20175699.992100.43
30min1201456-20145699.843100.740.65100.43101.340.65
2204521-204521101.362101.95
3203316-203316100.765101.37
4204074-204074101.140101.74
5204394-204394101.299101.90
6201885-201885100.056100.65
45min1200676-20067699.456100.490.70100.19101.240.70
2203625-203625100.918101.66
3203167-203167100.691101.44
4203529-203529100.870101.62
5204240-204240101.223101.97
6201357-20135799.794100.53
60min1200324-20032499.282100.370.87100.17101.270.87
2204216-204216101.211102.11
3202862-202862100.540101.44
4203110-203110100.663101.57
5204210-204210101.208102.11
6200445-20044599.342100.23
极限1200136-20013699.189100.310.99100.22101.360.98
2205486-205486101.840102.89
3202271-202271100.247101.30
4202443-202443100.332101.39
5203607-203607100.909101.96
6200491-20049199.365100.40
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D5551-23-012对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)19.2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%
112.151981771979991982671980351981171981190.06
212.211978781978541978660.01
单位质量响应值RSD%判断
16306.0916205.240.44数据可信
供试品溶液-25030601批-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%
5min1163990-16399081.35083.193.4481.3583.193.44
2171827-17182785.23885.24
3170957-17095784.80684.81
4160092-16009279.41779.42
5175120-17512086.87186.87
6164226-16422681.46781.47
10min1181674-18167490.12390.751.9090.2490.871.90
2185005-18500591.77591.90
3183712-18371291.13491.26
4177859-17785988.23088.35
5187966-18796693.24493.37
6181359-18135989.96690.09
15min1183962-18396291.25891.881.8391.5192.141.83
2188516-18851693.51793.78
3184687-18468791.61791.88
4181179-18117989.87790.13
5189980-18998094.24394.51
6182939-18293990.75091.01
20min1184918-18491891.73292.311.3692.1392.711.36
2187265-18726592.89693.30
3185473-18547392.00792.41
4182989-18298990.77591.16
5190385-19038594.44494.86
6185436-18543691.98992.38
30min1191673-19167395.08393.451.4095.6193.981.39
2188737-18873793.62694.17
3186321-18632192.42892.97
4184680-18468091.61492.14
5190698-19069894.59995.15
6188123-18812393.32293.85
45min1191685-19168595.08994.081.0795.7694.761.07
2189999-18999994.25294.94
3187534-18753493.03093.71
4187244-18724492.88693.55
5192058-19205895.27495.97
6189389-18938993.95094.62
60min1190468-19046894.48594.100.9095.3094.920.90
2190269-19026994.38695.21
3188426-18842693.47294.29
4187602-18760293.06393.86
5192338-19233895.41396.25
6189034-18903493.77494.59
极限1204660-204660101.525100.300.84102.48101.260.83
2202998-202998100.701101.67
3200254-20025499.340100.30
4203199-203199100.801101.74
5200919-20091999.670100.65
6201109-20110999.764100.72
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