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%
112.813425633424513416623420953418913421320.12
212.853410383415163412770.10
单位质量响应值RSD%判断
26708.2026558.520.40数据可信
供试品溶液-2025030122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%
5min1372946-37294698.03598.001.2598.0498.001.25
2369003-36900396.99997.00
3370617-37061797.42397.42
4381589-381589100.307100.31
5369455-36945597.11897.12
6373334-37333498.13798.14
10min1375177-37517798.62299.001.1998.7999.161.19
2373752-37375298.24798.41
3374333-37433398.40098.56
4385472-385472101.328101.50
5374277-37427798.38598.55
6376668-37666899.01499.18
15min1374914-37491498.55398.741.2398.8899.081.23
2371829-37182997.74298.07
3373734-37373498.24298.57
4384768-384768101.143101.48
5373813-37381398.26398.59
6374816-37481698.52798.86
20min1374765-37476598.51398.711.2799.0199.211.27
2371902-37190297.76198.25
3374131-37413198.34798.84
4385035-385035101.213101.72
5373342-37334298.13998.63
6373965-37396598.30398.80
30min1374123-37412398.34598.471.2599.0099.131.25
2371279-37127997.59798.25
3373773-37377398.25398.91
4383861-383861100.904101.58
5371882-37188297.75698.41
6372773-37277397.99098.65
45min1372832-37283298.00598.191.1998.8399.011.19
2369794-36979497.20798.02
3372379-37237997.88698.70
4382225-382225100.474101.32
5370989-37098997.52198.34
6372974-37297498.04398.86
极限1372593-37259397.94298.131.2798.9399.121.26
2369249-36924997.06398.04
3371910-37191097.76398.74
4382570-382570100.565101.57
5370901-37090197.49898.48
6372603-37260397.94598.93
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%
112.813409703411213418513411313424513415050.19
212.853403993404903404440.02
单位质量响应值RSD%判断
26659.2526493.700.45数据可信
供试品溶液-2025030222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%
5min1379303-37930399.92098.920.9299.9298.920.91
2374890-37489098.75798.76
3378213-37821399.63399.63
4376790-37679099.25899.26
5374033-37403398.53298.53
6369795-36979597.41597.42
10min1380993-380993100.36599.380.86100.5399.550.86
2377355-37735599.40799.57
3379797-379797100.050100.22
4378130-37813099.61199.78
5375215-37521598.84399.01
6372091-37209198.02098.18
15min1380223-380223100.16299.230.82100.5099.560.82
2375824-37582499.00399.33
3379804-379804100.052100.38
4377410-37741099.42199.75
5374601-37460198.68199.01
6372291-37229198.07398.40
20min1379221-37922199.89899.020.85100.4099.510.84
2375465-37546598.90999.40
3378765-37876599.778100.28
4377167-37716799.35799.85
5373503-37350398.39298.89
6371090-37109097.75698.25
30min1378910-37891099.81698.740.90100.4899.400.91
2374291-37429198.60099.26
3377530-37753099.453100.12
4376075-37607599.07099.73
5372305-37230598.07698.73
6369859-36985997.43298.08
45min1377158-37715899.35598.480.77100.1999.300.77
2372794-37279498.20599.03
3376574-37657499.201100.03
4374493-37449398.65399.48
5372458-37245898.11798.94
6369496-36949697.33698.15
极限1377541-37754199.45698.680.81100.4599.670.81
2374606-37460698.68399.67
3377437-37743799.428100.43
4375459-37545998.90799.90
5373117-37311798.29099.27
6369478-36947897.33298.31
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%
112.813419883414973411843413343412113414430.10
212.853402123405213403660.07
单位质量响应值RSD%判断
26654.4126487.630.45数据可信
供试品溶液-2025030322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%
5min1373161-37316198.32295.214.3898.3295.214.38
2366867-36686796.66496.66
3361520-36152095.25595.25
4330343-33034387.04087.04
5364470-36447096.03296.03
6371794-37179497.96297.96
10min1375478-37547898.93397.711.1999.1097.871.19
2369673-36967397.40397.56
3366360-36636096.53096.69
4373089-37308998.30398.45
5365381-36538196.27296.43
6375138-37513898.84399.01
15min1375718-37571898.99697.581.1799.3297.901.16
2368835-36883597.18297.51
3365184-36518496.22096.54
4372503-37250398.14998.46
5366067-36606796.45396.77
6373773-37377398.48398.81
20min1374324-37432498.62997.481.1899.1297.971.18
2369131-36913197.26097.75
3365012-36501296.17596.65
4371782-37178297.95998.43
5364960-36496096.16196.64
6374682-37468298.72399.21
30min1374190-37419098.59397.231.1799.2597.871.17
2367835-36783596.91997.57
3364462-36446296.03096.67
4370540-37054097.63198.27
5363975-36397595.90296.54
6373022-37302298.28598.94
45min1372139-37213998.05396.971.1398.8897.781.13
2366598-36659896.59397.40
3363718-36371895.83496.63
4368977-36897797.22098.02
5363530-36353095.78496.59
6373251-37325198.34699.17
极限1373001-37300198.28096.941.1799.2797.921.18
2365637-36563796.34097.31
3363379-36337995.74596.70
4369264-36926497.29598.26
5363750-36375095.84296.80
6372571-37257198.16799.15
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