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%
1 12.813644103643113648123648803648243646470.08
2 12.853633213632983633100.01
单位质量响应值RSD%判断
28465.8128273.150.49数据可信
供试品溶液-2025030122批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1353636-35363687.27190.752.3787.2790.752.37
2366388-36638890.41890.42
3380528-38052893.90793.91
4367899-36789990.79190.79
5371431-37143191.66291.66
6366612-36661290.47390.47
10min1365186-36518690.12193.572.1390.2793.722.13
2377665-37766593.20193.35
3389741-38974196.18196.34
4378852-37885293.49493.64
5382963-38296394.50894.66
6380522-38052293.90694.06
15min1370793-37079391.50594.822.0491.8095.132.04
2385601-38560195.15995.47
3393918-39391897.21297.53
4382875-38287594.48694.79
5389315-38931596.07696.39
6382834-38283494.47694.78
20min1374102-37410292.32195.622.0492.7796.092.04
2385445-38544595.12195.59
3397503-39750398.09698.58
4387984-38798495.74796.21
5392690-39269096.90997.38
6387097-38709795.52895.99
30min1377636-37763693.19497.332.6893.8097.952.67
2390659-39065996.40797.03
3400444-40044498.82299.46
4408116-408116100.715101.34
5398917-39891798.44599.08
6390577-39057796.38797.01
45min1379335-37933593.61397.362.1794.3798.142.17
2392426-39242696.84397.63
3404082-40408299.720100.53
4395898-39589897.70098.49
5400610-40061098.86399.66
6394643-39464397.39198.18
极限1381832-38183294.22997.862.1295.1498.812.12
2393528-39352897.11598.06
3404953-40495399.935100.91
4397656-39765698.13499.09
5403778-40377899.645100.61
6397568-39756898.11299.06
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%
1 12.813640593638733641543636793636043638740.07
2 12.853638183636423637300.04
单位质量响应值RSD%判断
28405.4628305.840.25数据可信
供试品溶液-2025030222批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1369022-36902291.11190.900.9791.1190.900.97
2366675-36667590.53290.53
3363627-36362789.77989.78
4374406-37440692.44192.44
5367908-36790890.83690.84
6367470-36747090.72890.73
10min1383916-38391694.78994.250.9694.9494.400.96
2381184-38118494.11494.27
3375757-37575792.77492.92
4386775-38677595.49595.65
5381510-38151094.19594.35
6381322-38132294.14894.30
15min1389272-38927296.11195.590.9896.4295.900.98
2386529-38652995.43495.74
3381118-38111894.09894.40
4392566-39256696.92497.24
5387148-38714895.58795.90
6386428-38642895.40995.72
20min1391073-39107396.55696.301.0397.0396.771.03
2389046-38904696.05596.52
3383377-38337794.65695.12
4395733-39573397.70698.18
5391252-39125296.60097.07
6389710-38971096.21996.69
30min1393677-39367797.19997.231.1497.8397.861.14
2393012-39301297.03597.66
3386722-38672295.48296.10
4400737-40073798.94299.58
5393961-39396197.26997.90
6394668-39466897.44398.07
45min1395809-39580997.72598.081.2498.5298.871.24
2396494-39649497.89498.68
3389383-38938396.13996.92
4404369-40436999.839100.64
5399269-39926998.57999.37
6398221-39822198.32199.11
极限1401242-40124299.06798.711.15100.0299.661.15
2398189-39818998.31399.26
3391936-39193696.76997.71
4405799-405799100.192101.16
5400630-40063098.91599.87
6401008-40100899.00999.96
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%
1 12.813640873639593632443636973636623637300.09
2 12.853635673637003636340.03
单位质量响应值RSD%判断
28394.2228298.370.24数据可信
供试品溶液-2025030322批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1367819-36781990.84490.860.7890.8490.860.78
2370628-37062891.53891.54
3367008-36700890.64490.64
4368773-36877391.08091.08
5370303-37030391.45891.46
6362858-36285889.61989.62
10min1378937-37893793.59093.860.7893.7494.010.78
2382552-38255294.48394.64
3379741-37974193.78993.94
4382084-38208494.36894.52
5382098-38209894.37194.52
6374775-37477592.56292.71
15min1383702-38370294.76795.030.6595.0795.340.65
2386593-38659395.48195.79
3384251-38425194.90395.21
4387141-38714195.61795.93
5386288-38628895.40695.72
6380548-38054893.98894.29
20min1386673-38667395.50195.810.6895.9796.280.67
2390151-39015196.36096.83
3387803-38780395.78096.25
4389726-38972696.25596.72
5389858-38985896.28896.76
6383420-38342094.69795.16
30min1391024-39102496.57696.780.6497.2097.400.64
2394773-39477397.50198.13
3391257-39125796.63397.26
4392976-39297697.05897.69
5393370-39337097.15597.78
6387644-38764495.74196.36
45min1395957-39595797.79497.870.5698.5898.650.56
2398250-39825098.36099.15
3394949-39494997.54598.33
4397203-39720398.10298.89
5398441-39844198.40799.20
6392696-39269696.98897.77
极限1401040-40104099.04998.820.51100.0099.770.51
2401901-40190199.262100.22
3398845-39884598.50799.46
4399681-39968198.71499.67
5402198-40219899.335100.29
6396884-39688498.02398.96
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