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200
标示量(mg)50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%
113.171680221680791672711680331679201678650.21
213.241677411677081677240.02
单位质量响应值RSD%判断
12746.0112667.980.44数据可信
供试品溶液-2022030601均一性1批-50mg规格-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%
5min1175959-17595996.94695.441.8896.9595.441.88
2177271-17727197.66997.67
3168373-16837392.76792.77
4171519-17151994.50094.50
5172010-17201094.77194.77
6174215-17421595.98595.99
10min1178970-17897098.60597.960.8098.7798.120.80
2179820-17982099.07499.24
3177526-17752697.81097.96
4176039-17603996.99097.15
5176658-17665897.33197.49
6177829-17782997.97798.14
15min1179707-17970799.01198.220.9499.3498.550.94
2180372-18037299.37899.71
3178452-17845298.32098.64
4175858-17585896.89197.21
5177062-17706297.55497.87
6178213-17821398.18898.51
20min1179680-17968098.99698.200.8999.4998.690.89
2180028-18002899.18899.68
3178371-17837198.27598.76
4176226-17622697.09397.57
5176537-17653797.26597.75
6178583-17858398.39298.88
30min1179615-17961598.96198.160.8499.6298.810.85
2179640-17964098.97499.63
3178563-17856398.38199.03
4176259-17625997.11297.75
5176430-17643097.20697.85
6178510-17851098.35299.00
45min1179372-17937298.82797.960.9099.6598.770.90
2179023-17902398.63499.46
3178401-17840198.29299.10
4175407-17540796.64297.45
5176227-17622797.09497.90
6178310-17831098.24299.06
极限1179824-17982499.07698.001.07100.0698.981.07
2179872-17987299.102100.09
3178085-17808598.11899.09
4175289-17528996.57797.54
5176054-17605496.99997.97
6178121-17812198.13899.12
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200
标示量(mg)50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%
113.171680321677911678861677361678261678540.07
213.241679511679721679620.01
单位质量响应值RSD%判断
12745.1812685.950.33数据可信
供试品溶液-2022030601均一性2批-50mg规格-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%
5min1178280-17828098.15997.361.0398.1697.361.03
2176136-17613696.97896.98
3179736-17973698.96098.96
4175011-17501196.35996.36
5175465-17546596.60996.61
6176345-17634597.09397.09
10min1181010-18101099.66299.290.8999.8399.450.89
2179562-17956298.86499.03
3182855-182855100.677100.84
4178102-17810298.06198.22
5179773-17977398.98199.14
6180661-18066199.46999.63
15min1181552-18155299.96099.610.92100.2999.940.92
2180176-18017699.20299.53
3183460-183460101.011101.34
4178567-17856798.31798.64
5180262-18026299.25099.58
6181463-18146399.911100.24
20min1181376-18137699.86399.430.94100.3699.920.94
2179438-17943898.79699.29
3182912-182912100.709101.21
4178106-17810698.06398.55
5180236-18023699.23599.73
6181445-18144599.901100.40
30min1181825-181825100.11099.500.91100.77100.160.91
2179943-17994399.07499.73
3182696-182696100.590101.26
4178047-17804798.03098.68
5180482-18048299.371100.03
6181357-18135799.853100.51
45min1179976-17997699.09299.300.8299.92100.120.82
2179981-17998199.09599.92
3182619-182619100.548101.38
4178322-17832298.18299.00
5179819-17981999.00699.83
6181396-18139699.874100.70
极限1181263-18126399.80199.260.86100.80100.250.87
2179369-17936998.75899.74
3182628-182628100.552101.56
4178288-17828898.16399.14
5179506-17950698.83499.82
6180647-18064799.462100.46
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