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100
标示量(mg)100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%
112.813117903119693124803132043133983125680.23
212.853131923136303134110.10
单位质量响应值RSD%判断
24400.3124389.960.04数据可信
供试品溶液-2025030122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%
5min1338075-33807597.02297.280.7297.0297.280.72
2336661-33666196.61696.62
3339967-33996797.56597.56
4339784-33978497.51297.51
5336495-33649596.56896.57
6342888-34288898.40398.40
10min1340772-34077297.79698.200.7897.9698.360.78
2339114-33911497.32097.48
3343880-34388098.68898.85
4343010-34301098.43898.60
5340158-34015897.61997.78
6346182-34618299.34899.51
15min1340374-34037497.68198.190.8998.0198.520.89
2339062-33906297.30597.63
3344267-34426798.79999.13
4343062-34306298.45398.78
5339483-33948397.42697.75
6346698-34669899.49699.83
20min1340393-34039397.68798.090.8798.1798.580.87
2338638-33863897.18397.67
3343866-34386698.68499.18
4342699-34269998.34998.84
5339023-33902397.29497.78
6346162-34616299.34299.84
30min1338891-33889197.25697.840.9597.9198.500.95
2337004-33700496.71497.36
3343229-34322998.50199.16
4342462-34246298.28198.94
5338697-33869797.20097.85
6345342-34534299.10799.77
45min1338319-33831997.09297.570.9197.9098.390.91
2336777-33677796.64997.46
3342042-34204298.16098.98
4340304-34030497.66198.48
5337612-33761296.88997.70
6344961-34496198.99899.82
极限1338119-33811997.03497.550.9198.0198.530.91
2336274-33627496.50597.47
3341676-34167698.05599.04
4341802-34180298.09199.07
5337483-33748396.85297.82
6344223-34422398.78699.78
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100
标示量(mg)100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%
112.813131653133693129543134523126933131270.10
212.853128423129323128870.03
单位质量响应值RSD%判断
24443.9524349.180.28数据可信
供试品溶液-2025030222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%
5min1337245-33724596.77895.931.1896.7895.931.18
2333744-33374495.77395.77
3326662-32666293.74193.74
4336128-33612896.45896.46
5335281-33528196.21596.21
6336681-33668196.61696.62
10min1340830-34083097.80797.261.0397.9797.421.03
2338123-33812397.03097.19
3332262-33226295.34895.50
4340059-34005997.58697.75
5340770-34077097.79097.95
6341536-34153698.00998.17
15min1340620-34062097.74797.131.0198.0797.451.02
2337347-33734796.80797.13
3332016-33201695.27895.59
4339570-33957097.44597.77
5340901-34090197.82798.15
6340405-34040597.68598.01
20min1339526-33952697.43396.970.9797.9297.460.97
2337699-33769996.90897.39
3331516-33151695.13495.61
4338702-33870297.19697.68
5339692-33969297.48097.97
6340381-34038197.67898.17
30min1339793-33979397.50996.961.0698.1697.601.06
2336824-33682496.65797.30
3331048-33104895.00095.63
4339292-33929297.36698.01
5339896-33989697.53998.19
6340440-34044097.69598.34
45min1338624-33862497.17496.731.0997.9997.541.09
2335832-33583296.37397.18
3330238-33023894.76795.56
4338078-33807897.01797.83
5339619-33961997.45998.27
6340125-34012597.60598.42
极限1337936-33793696.97696.521.0197.9597.491.01
2335741-33574196.34797.31
3329785-32978594.63795.59
4337387-33738796.81997.79
5338790-33879097.22198.20
6338487-33848797.13598.11
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100
标示量(mg)100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%
112.813140093134713134663134893130813135030.11
212.853134253139143136700.12
单位质量响应值RSD%判断
24473.3024410.120.19数据可信
供试品溶液-2025030322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%
5min1335646-33564696.14196.591.1196.1496.581.12
2336662-33666296.43296.43
3335506-33550696.10196.10
4342236-34223698.02998.03
5340943-34094397.65897.66
6332194-33219495.15295.15
10min1339309-33930997.19097.701.0897.3597.861.08
2339375-33937597.20997.37
3339932-33993297.36997.53
4346187-34618799.16099.32
5344898-34489898.79198.95
6336737-33673796.45496.61
15min1339811-33981197.33497.831.1097.6698.151.10
2340374-34037497.49597.82
3339552-33955297.26097.58
4346660-34666099.29699.62
5345648-34564899.00699.33
6337183-33718396.58196.90
20min1338399-33839996.93097.601.0597.4198.091.05
2339930-33993097.36897.85
3339033-33903397.11197.60
4346111-34611199.13999.63
5344079-34407998.55799.05
6336946-33694696.51496.99
30min1338393-33839396.92897.601.1797.5798.251.17
2339277-33927797.18197.83
3339165-33916597.14997.80
4346719-34671999.31399.97
5344487-34448798.67499.33
6336408-33640896.35997.00
45min1337060-33706096.54697.331.2097.3598.141.20
2338696-33869697.01597.82
3338087-33808796.84097.65
4345922-34592299.08599.91
5343583-34358398.41599.24
6335513-33551396.10396.90
极限1337436-33743696.65497.201.2297.6298.181.22
2338052-33805296.83097.80
3338029-33802996.82497.79
4344724-34472498.74199.73
5343877-34387798.49999.48
6333978-33397895.66396.63
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