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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3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%
112.543299893295953296303296423300403297790.07
212.473299053289433294240.21
单位质量响应值RSD%判断
26298.1726417.320.32数据可信
供试品溶液-2025041211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%
5min1395316-395316104.78498.704.34104.7898.704.34
2358866-35886695.12395.12
3363850-36385096.44496.44
4390051-390051103.389103.39
5367103-36710397.30697.31
6358903-35890395.13295.13
10min1397151-397151105.271100.583.65105.45100.753.65
2383271-383271101.592101.75
3365833-36583396.96997.13
4393598-393598104.329104.50
5369149-36914997.84898.01
6367749-36774997.47797.64
15min1396570-396570105.117100.553.51105.47100.883.51
2382754-382754101.455101.78
3365902-36590296.98897.31
4392731-392731104.099104.45
5369527-36952797.94998.27
6368519-36851997.68198.00
20min1395771-395771104.905100.333.54105.43100.833.54
2382553-382553101.401101.90
3364652-36465296.65697.14
4391678-391678103.820104.34
5367541-36754197.42297.91
6368863-36886397.77398.26
30min1395554-395554104.847100.063.64105.55100.733.64
2381927-381927101.235101.90
3363875-36387596.45097.10
4390471-390471103.500104.19
5365729-36572996.94297.59
6367389-36738997.38298.03
45min1393648-393648104.34299.863.57105.22100.693.58
2381074-381074101.009101.84
3363642-36364296.38997.19
4390450-390450103.494104.36
5365924-36592496.99397.81
6365651-36565196.92197.73
极限1392686-392686104.08799.693.44105.14100.693.45
2379273-379273100.532101.53
3362274-36227496.02696.99
4389343-389343103.201104.24
5365893-36589396.98597.96
6367112-36711297.30898.28
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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3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%
112.543300683297623301583300663303043300720.07
212.473306303303463304880.07
单位质量响应值RSD%判断
26321.5326502.650.49数据可信
供试品溶液-2025041211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%
5min1370501-37050198.00598.041.9798.0198.041.97
2381094-381094100.807100.81
3360697-36069795.41295.41
4365703-36570396.73696.74
5376310-37631099.54299.54
6369396-36939697.71397.71
10min1373024-37302498.673100.742.0598.84100.902.05
2383452-383452101.431101.60
3390777-390777103.369103.53
4376106-37610699.48899.65
5388433-388433102.749102.91
6373283-37328398.74198.90
15min1372574-37257498.554100.782.2298.88101.112.22
2382937-382937101.295101.63
3392768-392768103.895104.23
4376061-37606199.47699.80
5388474-388474102.760103.10
6373123-37312398.69999.03
20min1372335-37233598.490100.662.1498.98101.152.14
2382638-382638101.216101.72
3391938-391938103.676104.18
4375659-37565999.37099.86
5387540-387540102.512103.02
6372998-37299898.66699.16
30min1371512-37151298.273100.562.1898.93101.232.18
2382192-382192101.098101.77
3391335-391335103.516104.19
4375481-37548199.32399.98
5387889-387889102.605103.28
6372605-37260598.56299.22
45min1371127-37112798.171100.272.2898.99101.102.27
2381574-381574100.934101.78
3390955-390955103.416104.27
4373964-37396498.92199.75
5386469-386469102.229103.08
6370192-37019297.92498.74
极限1371606-37160698.298100.262.1599.28101.262.15
2381067-381067100.800101.81
3389392-389392103.002104.02
4373775-37377598.87199.86
5387387-387387102.472103.49
6370822-37082298.09099.07
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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3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%
112.543296033297333294443295143298723296330.06
212.473302873297663300260.12
单位质量响应值RSD%判断
26286.5226465.600.49数据可信
供试品溶液-2025041211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%
5min1363961-36396196.40798.891.6696.4198.891.66
2381736-381736101.115101.12
3369932-36993297.98897.99
4376675-37667599.77599.77
5371612-37161298.43398.43
6376119-37611999.62799.63
10min1368571-36857197.62899.931.5697.79100.101.56
2384719-384719101.905102.07
3373184-37318498.85099.01
4380693-380693100.839101.01
5375977-37597799.59099.75
6380444-380444100.773100.94
15min1369730-36973097.93599.941.4798.26100.281.47
2384244-384244101.779102.12
3373296-37329698.87999.21
4381158-381158100.962101.30
5374957-37495799.31999.65
6380518-380518100.792101.13
20min1368825-36882597.69599.851.5198.18100.341.51
2384240-384240101.778102.29
3372606-37260698.69799.19
4380614-380614100.818101.32
5375629-37562999.49799.99
6379750-379750100.589101.09
30min1369146-36914697.78099.751.4998.43100.421.49
2383352-383352101.543102.22
3371881-37188198.50599.16
4381190-381190100.970101.64
5374660-37466099.24199.90
6379357-379357100.485101.15
45min1368003-36800397.47799.621.4398.29100.451.43
2383218-383218101.508102.35
3373183-37318398.85099.67
4379348-379348100.483101.32
5374419-37441999.177100.00
6378427-378427100.239101.08
极限1368905-36890597.71699.371.3298.69100.371.32
2382293-382293101.263102.28
3371522-37152298.41099.40
4378204-378204100.180101.19
5372917-37291798.77999.77
6377115-37711599.891100.90
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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3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%
112.543297023297443299593295063295743296970.06
212.473302243300673301460.04
单位质量响应值RSD%判断
26291.6326475.220.50数据可信
供试品溶液-2025041211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%
5min1376306-37630699.64997.623.4899.6597.623.48
2386061-386061102.232102.23
3367198-36719897.23797.24
4352588-35258893.36893.37
5355621-35562194.17194.17
6374167-37416799.08399.08
10min1381216-381216100.94999.123.59101.1299.293.59
2389926-389926103.256103.43
3381503-381503101.025101.19
4356618-35661894.43594.59
5359074-35907495.08695.24
6377578-37757899.986100.15
15min1380869-380869100.85799.103.53101.1999.423.53
2389957-389957103.264103.61
3380362-380362100.723101.05
4357217-35721794.59494.91
5358896-35889695.03995.35
6378033-378033100.106100.44
20min1380581-380581100.78198.933.56101.2899.433.56
2389164-389164103.054103.57
3380292-380292100.705101.20
4355997-35599794.27194.74
5358581-35858194.95595.43
6377035-37703599.842100.34
30min1379953-379953100.61598.833.53101.2999.483.53
2388806-388806102.959103.65
3379711-379711100.551101.22
4356462-35646294.39495.02
5357663-35766394.71295.34
6376580-37658099.722100.39
45min1378461-378461100.22098.633.57101.0699.453.56
2388406-388406102.853103.71
3379470-379470100.487101.32
4355694-35569494.19194.98
5356751-35675194.47195.26
6375974-37597499.561100.39
极限1377606-37760699.99398.393.47101.0099.373.47
2386861-386861102.444103.47
3378368-378368100.195101.20
4355191-35519194.05895.00
5356254-35625494.33995.29
6374939-37493999.287100.28
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