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%
112.543396613403633404733405243407983403640.13
212.473392213396713394460.10
单位质量响应值RSD%判断
27142.2627221.010.21数据可信
供试品溶液-2025041011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%
5min1386782-38678299.414100.111.5699.41100.111.56
2391955-391955100.744100.74
3396085-396085101.806101.81
4378781-37878197.35897.36
5390636-390636100.405100.40
6392695-392695100.934100.93
10min1388342-38834299.815100.581.4999.98100.741.50
2393217-393217101.068101.24
3397578-397578102.189102.36
4381205-38120597.98198.14
5392325-392325100.839101.01
6395174-395174101.571101.74
15min1387253-38725399.535100.301.5199.87100.641.51
2391608-391608100.655100.99
3396549-396549101.925102.26
4380095-38009597.69698.02
5391638-391638100.663101.00
6394310-394310101.349101.69
20min1386797-38679799.418100.211.4799.92100.721.46
2390961-390961100.489100.99
3396461-396461101.902102.41
4380180-38018097.71798.21
5391796-391796100.703101.21
6393114-393114101.042101.55
30min1385156-38515698.99699.821.4999.66100.491.49
2389164-389164100.027100.70
3395116-395116101.556102.24
4378652-37865297.32597.98
5390535-390535100.379101.05
6391628-391628100.660101.33
45min1384992-38499298.95499.791.4899.78100.621.48
2389434-389434100.096100.93
3394951-394951101.514102.36
4378586-37858697.30898.12
5389829-389829100.198101.04
6391637-391637100.662101.50
极限1384487-38448798.82599.561.5199.82100.561.51
2388005-38800599.729100.73
3394224-394224101.327102.35
4377526-37752697.03598.01
5388676-38867699.901100.91
6391202-391202100.550101.56
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%
112.543403063404763402993401463400823402620.05
212.473401963402313402140.01
单位质量响应值RSD%判断
27134.1327282.600.39数据可信
供试品溶液-2025041011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%
5min1378929-37892997.30197.133.2597.3097.133.25
2379993-37999397.57497.57
3393086-393086100.936100.94
4355913-35591391.39191.39
5377935-37793597.04697.05
6383757-38375798.54198.54
10min1381632-38163297.99599.371.9498.1699.531.94
2382430-38243098.20098.36
3397286-397286102.014102.18
4378293-37829397.13797.29
5393738-393738101.103101.27
6388505-38850599.76099.92
15min1380868-38086897.79999.581.7198.1299.901.71
2382265-38226598.15798.48
3395783-395783101.629101.97
4384573-38457398.75099.06
5395885-395885101.655101.98
6387443-38744399.48799.82
20min1379960-37996097.56699.401.7998.0599.891.78
2380127-38012797.60898.10
3395622-395622101.587102.09
4385232-38523298.91999.40
5394978-394978101.422101.92
6386737-38673799.30699.80
30min1380497-38049797.70399.341.6598.35100.001.65
2381065-38106597.84998.50
3394928-394928101.409102.09
4385152-38515298.89999.54
5394428-394428101.281101.95
6385192-38519298.90999.57
45min1378820-37882097.27399.111.6798.0999.941.67
2380068-38006897.59398.41
3393535-393535101.051101.90
4384476-38447698.72599.53
5393737-393737101.103101.94
6385220-38522098.91699.74
极限1378354-37835497.15398.911.6698.1399.901.66
2379069-37906997.33798.32
3392903-392903100.889101.90
4383061-38306198.36299.33
5392651-392651100.824101.83
6385219-38521998.91699.91
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%
112.543399513402253398023399103399363399650.05
212.473391363391373391360.01
单位质量响应值RSD%判断
27110.4527196.150.23数据可信
供试品溶液-2025041111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%
5min1367074-36707494.44795.012.8494.4595.012.84
2364693-36469393.83593.83
3361305-36130592.96392.96
4376916-37691696.98096.98
5386492-38649299.44499.44
6359043-35904392.38192.38
10min1370837-37083795.41697.363.6395.5797.523.63
2365726-36572694.10194.26
3364839-36483993.87294.03
4380435-38043597.88598.05
5390437-390437100.459100.62
6398199-398199102.456102.61
15min1370210-37021095.25497.544.0795.5797.864.06
2365508-36550894.04494.36
3364655-36465593.82594.14
4380960-38096098.02098.34
5389788-389788100.292100.62
6403537-403537103.829104.15
20min1369479-36947995.06697.394.0095.5497.873.99
2365702-36570294.09494.56
3363947-36394793.64394.11
4380234-38023497.83398.32
5389546-389546100.229100.73
6402144-402144103.471103.97
30min1368632-36863294.84897.123.9995.4897.773.98
2364213-36421393.71194.34
3363557-36355793.54294.17
4379348-37934897.60598.26
5387588-38758899.726100.39
6401536-401536103.314103.98
45min1368262-36826294.75397.094.0895.5497.894.07
2363700-36370093.57994.36
3363365-36336593.49394.27
4378961-37896197.50698.32
5387794-38779499.779100.61
6401946-401946103.420104.26
极限1368068-36806894.70397.094.0095.6598.064.00
2364565-36456593.80294.74
3362867-36286793.36594.30
4379400-37940097.61998.60
5388136-38813699.867100.87
6400984-400984103.172104.19
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%
112.543395953394753394933394243394583394890.02
212.473390653391903391280.03
单位质量响应值RSD%判断
27072.4927195.510.33数据可信
供试品溶液-2025041111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%
5min1385841-38584199.34799.572.3099.3599.572.31
2402657-402657103.677103.68
3382908-38290898.59298.59
4384455-38445598.99098.99
5375851-37585196.77596.77
6388440-388440100.016100.02
10min1388305-38830599.981100.392.30100.15100.562.30
2406310-406310104.617104.79
3386381-38638199.48699.65
4388158-38815899.944100.11
5379298-37929897.66297.82
6390961-390961100.665100.83
15min1387549-38754999.787100.362.21100.12100.692.21
2405596-405596104.433104.78
3386663-38666399.55999.89
4387997-38799799.902100.23
5379726-37972697.77298.10
6391029-391029100.683101.02
20min1387104-38710499.672100.202.15100.17100.702.15
2404707-404707104.205104.73
3385669-38566999.30399.80
4386664-38666499.559100.06
5380118-38011897.87398.36
6390652-390652100.586101.09
30min1385999-38599999.38899.942.17100.05100.612.17
2403156-403156103.805104.50
3384772-38477299.07299.73
4386408-38640899.493100.16
5377958-37795897.31797.97
6390534-390534100.555101.23
45min1385800-38580099.33699.782.20100.17100.612.20
2402839-402839103.724104.59
3383918-38391898.85299.68
4385216-38521699.186100.02
5377467-37746797.19198.00
6389788-389788100.363101.20
极限1384903-38490399.10599.732.16100.10100.742.16
2402536-402536103.646104.69
3383244-38324498.67899.67
4383806-38380698.82399.82
5378939-37893997.57098.54
6390653-390653100.586101.59
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