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 12.813379023376703376523375963376393376920.04
2 12.853373863377023375440.07
单位质量响应值RSD%判断
26361.5926268.020.26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%
5min1345460-34546091.90991.780.8891.9191.780.87
2344844-34484491.74591.75
3349800-34980093.06493.06
4341107-34110790.75190.75
5346036-34603692.06292.06
6342639-34263991.15891.16
10min1356031-35603194.72194.791.0294.8794.941.02
2355877-35587794.68094.83
3363144-36314496.61496.77
4353031-35303193.92394.07
5356221-35622194.77294.93
6353518-35351894.05394.20
15min1360370-36037095.87696.000.8396.1996.310.83
2359687-35968795.69496.00
3366464-36646497.49797.81
4358049-35804995.25895.57
5361241-36124196.10796.42
6359118-35911895.54395.85
20min1364098-36409896.86896.750.7997.3497.220.79
2362833-36283396.53197.00
3368579-36857998.06098.54
4359996-35999695.77696.24
5364000-36400096.84197.31
6362368-36236896.40796.88
30min1368074-36807497.92597.820.5698.5698.450.56
2366479-36647997.50198.13
3370895-37089598.67699.32
4365406-36540697.21697.84
5368945-36894598.15798.79
6366217-36621797.43198.06
45min1371350-37135098.79798.790.8399.5999.590.83
2369393-36939398.27699.07
3375877-375877100.001100.81
4367416-36741697.75098.54
5373708-37370899.424100.22
6370289-37028998.51599.31
极限1373978-37397899.49699.240.77100.46100.200.77
2370781-37078198.64699.60
3376117-376117100.065101.04
4369109-36910998.20199.15
5376039-376039100.044101.01
6372110-37211098.99999.95
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 12.813376973377983377633375393373643376320.06
2 12.853368533372363370440.09
单位质量响应值RSD%判断
26356.9126229.110.35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%
5min1341565-34156590.94890.451.2590.9590.451.25
2340244-34024490.59790.60
3333023-33302388.67488.67
4338443-33844390.11790.12
5338988-33898890.26290.26
6345924-34592492.10992.11
10min1353824-35382494.21293.930.9194.3694.080.91
2353850-35385094.21994.37
3350279-35027993.26993.42
4349726-34972693.12193.27
5350709-35070993.38393.53
6358175-35817595.37195.52
15min1358025-35802595.33195.170.9395.6495.480.93
2359074-35907495.61095.92
3354502-35450294.39394.70
4354519-35451994.39894.70
5355436-35543694.64294.95
6362915-36291596.63396.95
20min1360803-36080396.07195.980.9696.5496.440.96
2361788-36178896.33396.80
3358111-35811195.35495.81
4357221-35722195.11795.58
5358267-35826795.39595.86
6366472-36647297.58098.05
30min1365055-36505597.20397.141.0797.8397.771.07
2367551-36755197.86898.50
3362604-36260496.55097.17
4360261-36026195.92696.55
5362555-36255596.53797.16
6370966-37096698.77799.41
45min1368314-36831498.07197.961.0998.8698.751.09
2369309-36930998.33699.13
3365771-36577197.39498.17
4363622-36362296.82197.60
5365519-36551997.32698.11
6374926-37492699.831100.63
极限1371894-37189499.02498.681.0899.9899.631.08
2372203-37220399.106100.06
3367717-36771797.91298.85
4365754-36575497.38998.33
5369120-36912098.28599.23
6376980-376980100.378101.35
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 12.813373543374073372963372953373823373470.02
2 12.853368613370463369540.04
单位质量响应值RSD%判断
26334.6626222.100.31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%
5min1338454-33845490.17089.144.7090.1789.144.70
2344773-34477391.85391.85
3302836-30283680.68180.68
4339900-33990090.55590.56
5340460-34046090.70490.70
6341217-34121790.90690.91
10min1348600-34860092.87394.210.8193.0294.360.81
2356671-35667195.02395.18
3355844-35584494.80394.94
4354519-35451994.45094.60
5352829-35282994.00094.15
6353344-35334494.13794.29
15min1352647-35264793.95195.561.1694.2695.861.15
2360819-36081996.12896.44
3365039-36503997.25397.55
4358838-35883895.60195.91
5357114-35711495.14195.45
6357593-35759395.26995.58
20min1355239-35523994.64296.301.2295.1096.771.22
2363735-36373596.90597.38
3368353-36835398.13698.59
4361731-36173196.37196.84
5359293-35929395.72296.19
6360444-36044496.02896.50
30min1359919-35991995.88997.571.2096.5198.191.19
2367401-36740197.88298.52
3372712-37271299.29799.91
4368583-36858398.19798.83
5364025-36402596.98297.61
6364679-36467997.15797.78
45min1363885-36388596.94598.631.1497.7299.421.13
2371835-37183599.06399.86
3376620-376620100.338101.12
4369140-36914098.34599.14
5371125-37112598.87499.66
6368668-36866898.21999.01
极限1367386-36738697.87899.371.1198.82100.321.10
2374021-37402199.646100.61
3380036-380036101.248102.20
4371624-37162499.00799.96
5372050-37205099.120100.07
6372732-37273299.302100.26
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