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%
112.683642503637863635373641973642473640030.09
212.723634803630153632480.10
单位质量响应值RSD%判断
28706.8628557.230.37数据可信
供试品溶液-2025060411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%
5min1421855-421855103.151102.200.64103.15102.200.64
2416048-416048101.731101.73
3416726-416726101.897101.90
4420576-420576102.838102.84
5415239-415239101.533101.53
6417427-417427102.068102.07
10min1422597-422597103.332102.320.75103.50102.490.75
2416203-416203101.769101.94
3417283-417283102.033102.20
4422297-422297103.259103.43
5415529-415529101.604101.77
6416936-416936101.948102.12
15min1421350-421350103.027102.200.74103.37102.540.74
2415409-415409101.575101.91
3416900-416900101.939102.28
4422269-422269103.252103.60
5415384-415384101.569101.91
6416429-416429101.824102.16
20min1421159-421159102.981102.400.90103.50102.920.90
2417514-417514102.089102.60
3422747-422747103.369103.88
4422188-422188103.232103.75
5413898-413898101.205101.71
6415280-415280101.543102.05
30min1420099-420099102.721101.861.01103.41102.541.00
2413407-413407101.085101.76
3414878-414878101.445102.13
4423426-423426103.535104.22
5413829-413829101.188101.86
6413908-413908101.208101.89
45min1418833-418833102.412101.730.88103.27102.580.88
2412462-412462100.854101.70
3416206-416206101.770102.62
4421674-421674103.107103.97
5412915-412915100.965101.81
6414171-414171101.272102.12
极限1418286-418286102.278101.421.03103.31102.451.03
2411158-411158100.535101.55
3413466-413466101.100102.12
4421716-421716103.117104.15
5411893-411893100.715101.73
6412257-412257100.804101.82
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%
112.683635683634613635293634703634213634900.02
212.723633703625113629400.17
单位质量响应值RSD%判断
28666.4028533.020.33数据可信
供试品溶液-2025060411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%
5min1427640-427640104.683101.842.14104.68101.842.14
2401716-40171698.33798.34
3416884-416884102.050102.05
4413861-413861101.310101.31
5422656-422656103.463103.46
6413483-413483101.218101.22
10min1421922-421922103.284101.881.69103.46102.051.69
2402835-40283598.61198.78
3417318-417318102.157102.33
4416482-416482101.952102.12
5422058-422058103.317103.49
6416391-416391101.930102.10
15min1421575-421575103.199102.502.49103.55102.842.48
2402962-40296298.64298.97
3416331-416331101.915102.26
4415001-415001101.589101.93
5421873-421873103.272103.62
6434648-434648106.399106.74
20min1421253-421253103.120101.671.75103.64102.181.75
2401938-40193898.39298.88
3416513-416513101.960102.47
4413998-413998101.344101.85
5421884-421884103.274103.79
6416504-416504101.957102.47
30min1419231-419231102.625101.341.68103.32102.021.67
2401195-40119598.21098.87
3415186-415186101.635102.31
4413385-413385101.194101.87
5420785-420785103.005103.69
6414078-414078101.364102.05
45min1418373-418373102.415101.561.92103.28102.411.92
2399764-39976497.86098.68
3414489-414489101.464102.31
4422440-422440103.410104.26
5419102-419102102.593103.45
6415133-415133101.622102.48
极限1418131-418131102.356101.291.77103.39102.311.77
2400143-40014397.95298.94
3412284-412284100.924101.94
4418837-418837102.528103.55
5419570-419570102.708103.74
6413687-413687101.268102.29
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%
112.683631003630903628993630983632603630890.04
212.723626783630873628820.08
单位质量响应值RSD%判断
28634.7828528.460.27数据可信
供试品溶液-2025060412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%
5min1406579-40657999.59199.910.6499.5999.910.64
2411915-411915100.898100.90
3405366-40536699.29399.29
4407732-40773299.87399.87
5410038-410038100.438100.44
6405740-40574099.38599.39
10min1408787-408787100.131100.810.60100.30100.980.60
2415573-415573101.794101.96
3409503-409503100.307100.47
4412932-412932101.147101.31
5410903-410903100.650100.82
6411717-411717100.849101.01
15min1410284-410284100.498100.860.54100.83101.190.54
2415428-415428101.758102.10
3410995-410995100.672101.00
4412508-412508101.043101.38
5412147-412147100.954101.29
6409105-409105100.209100.54
20min1408362-408362100.027100.770.66100.53101.270.66
2415120-415120101.683102.19
3409548-409548100.318100.82
4412864-412864101.130101.63
5413165-413165101.204101.71
6409260-409260100.247100.75
30min1408257-408257100.002100.730.68100.67101.400.68
2413941-413941101.394102.07
3408424-408424100.043100.71
4413222-413222101.218101.89
5413951-413951101.396102.07
6409546-409546100.317100.99
45min1412889-412889101.136100.590.65101.97101.430.65
2413678-413678101.329102.18
3408615-408615100.089100.92
4412244-412244100.978101.82
5409639-409639100.340101.18
6406975-40697599.688100.52
极限1407369-40736999.784100.300.72100.79101.300.72
2413537-413537101.295102.31
3406217-40621799.502100.50
4412467-412467101.033102.04
5409143-409143100.219101.23
6408090-40809099.961100.96
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%
112.683625433634323620303629703625473627040.15
212.723633673635093634380.03
单位质量响应值RSD%判断
28604.4228572.170.08数据可信
供试品溶液-2025060412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%
5min1413758-413758101.325100.491.99101.33100.491.99
2423057-423057103.602103.60
3401595-40159598.34798.35
4405742-40574299.36299.36
5414283-414283101.454101.45
6403587-40358798.83498.83
10min1417781-417781102.310100.851.43102.48101.021.43
2415806-415806101.827102.00
3405510-40551099.30599.47
4409405-409405100.259100.42
5417264-417264102.184102.35
6405099-40509999.20599.37
15min1417255-417255102.181100.701.46102.52101.031.46
2416152-416152101.911102.25
3404802-40480299.13299.46
4408724-408724100.092100.43
5415934-415934101.858102.20
6404294-40429499.00799.34
20min1421975-421975103.337100.701.72103.85101.201.72
2414119-414119101.414101.93
3403835-40383598.89599.39
4406996-40699699.669100.17
5415089-415089101.651102.16
6405162-40516299.22099.72
30min1415756-415756101.814100.331.29102.50101.001.29
2413770-413770101.328102.01
3403266-40326698.75699.42
4407304-40730499.745100.41
5413368-413368101.230101.91
6404652-40465299.09599.76
45min1416879-416879102.089100.311.52102.94101.151.52
2413670-413670101.304102.15
3402809-40280998.64499.47
4405973-40597399.419100.25
5414848-414848101.592102.44
6403551-40355198.82699.65
极限1414521-414521101.512100.201.33102.53101.201.33
2412977-412977101.134102.15
3402864-40286498.65799.65
4410143-410143100.440101.44
5412517-412517101.021102.04
6401946-40194698.43299.42
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