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%
112.543550943550093551633548283554853551160.07
212.473557163551233554200.12
单位质量响应值RSD%判断
28318.6628502.000.46数据可信
供试品溶液-2025041011批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1318645-31864578.36085.607.8078.3685.607.80
2366214-36621490.05890.06
3362097-36209789.04589.05
4309053-30905376.00176.00
5373553-37355391.86291.86
6359061-35906188.29988.30
10min1378524-37852493.08592.243.3993.2292.383.39
2373384-37338491.82191.97
3375098-37509892.24292.39
4352352-35235286.64986.78
5380291-38029193.51993.67
6390818-39081896.10896.26
15min1382395-38239594.03793.282.1794.3293.582.17
2373872-37387291.94192.24
3375900-37590092.44092.74
4370550-37055091.12491.40
5379415-37941593.30493.61
6393774-39377496.83597.14
20min1382548-38254894.07493.961.8794.5294.411.86
2374069-37406991.98992.45
3376600-37660092.61293.07
4383504-38350494.31094.73
5381097-38109793.71894.18
6394599-39459997.03897.51
30min1382419-38241994.04394.281.8194.6494.891.81
2376100-37610092.48993.10
3378248-37824893.01793.63
4386643-38664395.08295.66
5381427-38142793.79994.42
6395463-39546397.25097.88
45min1384480-38448094.55094.591.8795.3195.361.86
2376897-37689792.68593.45
3378209-37820993.00793.77
4388191-38819195.46296.20
5383601-38360194.33395.11
6396558-39655897.52098.31
极限1385777-38577794.86995.291.8995.7896.211.89
2380345-38034593.53394.45
3381751-38175193.87894.80
4390064-39006495.92396.82
5386347-38634795.00995.94
6400647-40064798.52599.48
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%
112.543545383537363537723535343538493538860.11
212.473544503540963542730.08
单位质量响应值RSD%判断
28220.5728410.020.48数据可信
供试品溶液-2025041011批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1352855-35285587.06486.423.3487.0686.423.34
2361223-36122389.12989.13
3328606-32860681.08181.08
4358323-35832388.41388.41
5346853-34685385.58385.58
6353619-35361987.25287.25
10min1366098-36609890.33192.081.5990.4892.221.59
2374581-37458192.42592.57
3379213-37921393.56793.70
4373823-37382392.23792.38
5366095-36609590.33190.47
6379222-37922293.57093.72
15min1372589-37258991.93393.942.0392.2394.242.03
2382635-38263594.41294.71
3391816-39181696.67796.97
4380606-38060693.91194.21
5371549-37154991.67691.97
6385252-38525295.05795.36
20min1376731-37673192.95594.752.1293.4095.212.11
2385746-38574695.17995.64
3396847-39684797.91898.37
4383604-38360494.65195.11
5374061-37406192.29692.74
6387160-38716095.52895.99
30min1380637-38063793.91996.062.1494.5296.682.14
2390038-39003896.23896.86
3402329-40232999.27199.89
4387943-38794395.72196.34
5380677-38067793.92994.53
6394356-39435697.30497.92
45min1383346-38334694.58796.812.3195.3597.592.30
2391417-39141796.57997.36
3407018-407018100.428101.21
4391035-39103596.48497.26
5383436-38343694.60995.37
6397951-39795198.19198.97
极限1389003-38900395.98397.741.9596.9098.671.95
2396305-39630597.78598.72
3407796-407796100.620101.57
4393422-39342297.07398.01
5387944-38794495.72296.64
6402194-40219499.238100.18
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%
112.543532543538443535173537273532693535220.08
212.473544803542043543420.06
单位质量响应值RSD%判断
28191.5528415.560.56数据可信
供试品溶液-2025041111批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1347373-34737385.74784.969.0285.7584.969.01
2368385-36838590.93490.93
3306009-30600975.53775.54
4376146-37614692.85092.85
5306138-30613875.56975.57
6361133-36113389.14489.14
10min1382734-38273494.47694.431.5894.6294.571.58
2381065-38106594.06494.22
3383367-38336794.63294.76
4393603-39360397.15997.31
5377198-37719893.10993.24
6377320-37732093.13993.29
15min1386303-38630395.35795.321.4395.6695.621.42
2380796-38079693.99794.31
3387574-38757495.67195.95
4394435-39443597.36497.68
5388416-38841695.87896.16
6379331-37933193.63693.94
20min1386281-38628195.35196.091.3795.8196.541.36
2381418-38141894.15194.62
3389208-38920896.07496.52
4394964-39496497.49597.97
5388317-38831795.85496.29
6395348-39534897.59098.05
30min1387704-38770495.70395.691.5196.3296.311.50
2382290-38229094.36694.99
3387770-38777095.71996.32
4397374-39737498.09098.73
5389687-38968796.19296.79
6381197-38119794.09694.72
45min1388802-38880295.97495.781.4896.7596.561.48
2382911-38291194.52095.30
3388738-38873895.95896.72
4397299-39729998.07198.88
5389278-38927896.09196.85
6381056-38105694.06294.84
极限1391696-39169696.68896.881.4497.6397.821.44
2387952-38795295.76496.70
3393382-39338297.10498.03
4402172-40217299.274100.24
5393668-39366897.17598.10
6386000-38600095.28296.22
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%
112.543524613552723554643547993554673546930.36
212.473558893562723560800.08
单位质量响应值RSD%判断
28284.9328554.930.68数据可信
供试品溶液-2025041111批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1324997-32499779.89685.085.6279.9085.085.62
2351588-35158886.43386.43
3350880-35088086.25986.26
4323137-32313779.43979.44
5375079-37507992.20892.21
6350759-35075986.22986.23
10min1369006-36900690.71591.633.0690.8591.773.06
2379837-37983793.37793.52
3357704-35770487.93688.08
4363860-36386089.45089.58
5388908-38890895.60795.76
6377043-37704392.69192.83
15min1381421-38142193.76793.122.8494.0593.412.84
2381201-38120193.71394.01
3358783-35878388.20288.49
4377777-37777792.87193.15
5391012-39101296.12596.44
6382481-38248194.02794.33
20min1384517-38451794.52893.563.0794.9794.003.07
2382017-38201793.91394.37
3357834-35783487.96888.41
4384586-38458694.54594.98
5391835-39183596.32796.80
6382568-38256894.04994.50
30min1386234-38623494.95093.843.0495.5594.453.03
2383174-38317494.19894.81
3359384-35938488.34988.93
4387522-38752295.26795.86
5392494-39249496.48997.12
6381618-38161893.81594.43
45min1386431-38643194.99894.123.1395.7594.883.12
2384231-38423194.45895.23
3359494-35949488.37689.11
4388297-38829795.45796.21
5393945-39394596.84697.64
6384761-38476194.58895.36
极限1390495-39049595.99895.223.0296.9196.143.01
2387603-38760395.28796.21
3364684-36468489.65290.53
4393167-39316796.65497.57
5398131-39813197.87598.83
6390025-39002595.88296.81
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