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%
112.713526063548093537823546073529233537450.28
212.643516323519513517920.07
单位质量响应值RSD%判断
27832.0227831.650.01数据可信
长期24月-供试品溶液-2022030701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%
5min1286975-28697572.18774.237.7572.1974.237.75
2324658-32465881.66681.67
3297334-29733474.79374.79
4261340-26134065.73965.74
5315540-31554079.37379.37
6284697-28469771.61471.61
10min1345473-34547386.90286.903.6287.0287.023.63
2356244-35624489.61289.75
3341883-34188385.99986.12
4323717-32371781.43081.54
5358767-35876790.24690.38
6346582-34658287.18187.30
15min1361981-36198191.05590.832.0891.3291.102.10
2369482-36948292.94293.23
3360054-36005490.57090.84
4347164-34716487.32887.57
5363966-36396691.55491.84
6363836-36383691.52191.79
20min1367613-36761392.47192.511.4892.8992.931.49
2376150-37615094.61995.06
3366084-36608492.08792.51
4360581-36058190.70391.09
5364658-36465891.72892.16
6371425-37142593.43093.85
30min1358616-35861690.20893.291.9890.7893.871.98
2379834-37983495.54696.14
3370395-37039593.17193.74
4368360-36836092.65993.20
5371654-37165493.48894.08
6376452-37645294.69595.27
45min1377373-37737394.92795.471.5195.6596.201.51
2387883-38788397.57098.33
3375566-37556694.47295.20
4374255-37425594.14294.84
5376559-37655994.72295.47
6385556-38555696.98597.72
极限1388460-38846097.71597.611.2398.6098.501.23
2392026-39202698.61299.53
3383537-38353796.47797.36
4384776-38477696.78997.64
5384160-38416096.63497.54
6395213-39521399.414100.31
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%
112.713512933514333537243526443528363523860.29
212.643522543502673512600.40
单位质量响应值RSD%判断
27725.1027789.560.17数据可信
长期24月-供试品溶液-2022030801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%
5min1265713-26571367.01868.077.8667.0268.077.86
2303505-30350576.55076.55
3281308-28130870.95270.95
4241337-24133760.87060.87
5257444-25744464.93364.93
6270007-27000768.10268.10
10min1327367-32736782.56982.013.9882.6882.123.99
2344887-34488786.98887.12
3330619-33061983.38983.51
4305778-30577877.12477.23
5319621-31962180.61580.72
6322571-32257181.35981.47
15min1341565-34156586.15086.872.0286.4087.122.03
2354341-35434189.37289.64
3349362-34936288.11788.37
4333995-33399584.24184.47
5343375-34337586.60686.85
6343783-34378386.70986.96
20min1357261-35726190.10989.691.0590.5090.081.06
2361299-36129991.12791.55
3355147-35514789.57689.98
4349985-34998588.27488.64
5354328-35432889.36989.76
6355588-35558889.68790.08
30min1367041-36704192.57692.030.6993.1292.580.70
2366044-36604492.32492.90
3363263-36326391.62392.18
4360568-36056890.94391.46
5365528-36552892.19492.73
6366847-36684792.52793.07
45min1371713-37171393.75493.540.6694.4594.240.66
2369243-36924393.13193.86
3372964-37296494.06994.78
4366687-36668792.48693.16
5371904-37190493.80294.49
6372732-37273294.01194.71
极限1383550-38355096.73996.120.8297.5996.970.82
2379990-37999095.84296.72
3379389-37938995.69096.55
4377218-37721895.14295.97
5380519-38051995.97596.82
6385912-38591297.33598.19
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101546-202101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%
112.713508593514913482063521353524243510230.49
212.643542543540433541480.05
单位质量响应值RSD%判断
27617.8628018.041.02数据可信
长期24月-供试品溶液-2022030901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%
5min1278851-27885170.18267.548.6170.1867.548.61
2249355-24935562.75962.76
3306865-30686577.23377.23
4271217-27121768.26168.26
5260899-26089965.66465.66
6242897-24289761.13361.13
10min1328982-32898282.80082.144.6582.9282.264.66
2309849-30984977.98478.09
3351785-35178588.53988.67
4329765-32976582.99783.11
5326079-32607982.06982.18
6311788-31178878.47278.57
15min1343322-34332286.40986.861.9586.6687.111.95
2334188-33418884.11084.34
3352296-35229688.66788.94
4350560-35056088.23088.48
5348403-34840387.68887.93
6342003-34200386.07786.31
20min1350004-35000488.09189.132.3088.4989.532.30
2343086-34308686.34986.72
3359678-35967890.52590.95
4361155-36115590.89791.30
5362769-36276991.30391.70
6348184-34818487.63288.01
30min1360542-36054290.74391.811.5691.2992.351.57
2355675-35567589.51890.04
3368322-36832292.70193.28
4368530-36853092.75393.30
5370617-37061793.27893.82
6365014-36501491.86892.39
45min1365094-36509491.88893.461.7092.5994.151.69
2362203-36220391.16191.83
3373248-37324893.94194.67
4377416-37741694.99095.69
5376954-37695494.87395.57
6373078-37307893.89894.57
极限1377941-37794195.12295.901.7595.9796.751.75
2370057-37005793.13893.96
3381585-38158596.03996.92
4384314-38431496.72697.59
5389848-38984898.11998.98
6382410-38241096.24797.08
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%
112.713491833512993496073513543484753499840.37
212.643551823542123546970.20
单位质量响应值RSD%判断
27536.1128061.471.34数据可信
长期24月-供试品溶液-U011530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%
5min1236675-23667559.61162.839.8259.6162.839.82
2245660-24566061.87461.87
3271546-27154668.39468.39
4236423-23642359.54759.55
5220570-22057055.55455.55
6285892-28589272.00772.01
10min1302069-30206976.08178.026.8976.1878.136.89
2308648-30864877.73877.84
3330447-33044783.22983.34
4295407-29540774.40374.50
5283014-28301471.28271.37
6339131-33913185.41685.54
15min1329956-32995683.10584.123.6683.3384.363.68
2334323-33432384.20584.44
3344953-34495386.88287.14
4329634-32963483.02483.25
5315388-31538879.43679.65
6349653-34965388.06688.33
20min1346817-34681787.35287.912.3487.7288.282.35
2350216-35021688.20888.58
3358794-35879490.36890.77
4346559-34655987.28787.65
5335788-33578884.57484.92
6355976-35597689.65990.07
30min1362777-36277791.37291.121.5291.8891.641.54
2360501-36050190.79891.32
3369615-36961593.09493.64
4358582-35858290.31590.82
5353826-35382689.11789.60
6365330-36533092.01592.57
45min1374692-37469294.37393.341.4495.0494.021.46
2366894-36689492.40993.08
3377909-37790995.18395.89
4366524-36652492.31592.97
5364632-36463291.83992.47
6372922-37292293.92794.64
极限1389299-38929998.05296.041.1598.8796.881.14
2379912-37991295.68796.51
3383006-38300696.46797.33
4377407-37740795.05695.87
5380240-38024095.77096.56
6378129-37812995.23896.11
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