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200
标示量(mg)50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%
112.813412413419883422933422653421883419950.13
212.853416203411373413780.11
单位质量响应值RSD%判断
26697.5026566.380.35数据可信
中间条件36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%
5min1282805-28280574.34478.094.6774.3478.094.68
2299044-29904478.61378.61
3321306-32130684.46584.47
4292378-29237876.86176.86
5285727-28572775.11275.11
6301007-30100779.12979.13
10min1324716-32471685.36287.902.6685.4988.032.66
2328202-32820286.27886.41
3345018-34501890.69990.84
4339997-33999789.37989.51
5326463-32646385.82185.95
6341820-34182089.85889.99
15min1339203-33920389.17090.861.8889.4491.141.88
2339641-33964189.28589.56
3352277-35227792.60792.90
4351736-35173692.46592.74
5340428-34042889.49289.76
6350497-35049792.13992.42
20min1347650-34765091.39092.441.5891.8192.871.58
2344640-34464090.59991.02
3357402-35740293.95494.40
4356286-35628693.66194.09
5347833-34783391.43991.86
6356008-35600893.58894.02
30min1354463-35446393.18194.271.3093.7594.861.30
2352878-35287892.76593.34
3363763-36376395.62696.23
4361659-36165995.07395.66
5356275-35627593.65894.23
6362669-36266995.33995.93
45min1361074-36107494.91995.951.2695.6496.691.27
2359374-35937494.47295.20
3369316-36931697.08697.85
4369191-36919197.05397.80
5362250-36225095.22895.95
6368742-36874296.93597.69
极限1367051-36705196.49197.151.1897.3798.051.18
2363698-36369895.60996.50
3371508-37150897.66298.59
4373426-37342698.16699.07
5366946-36694696.46397.35
6374807-37480798.52999.44
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200
标示量(mg)50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%
112.813412813412553412913412963408823412010.06
212.853414303413623413960.02
单位质量响应值RSD%判断
26635.5226567.780.19数据可信
中间条件36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%
5min1295207-29520777.69277.269.9877.6977.269.98
2326452-32645285.91585.92
3322565-32256584.89284.89
4296555-29655578.04778.05
5268928-26892870.77670.78
6251728-25172866.24966.25
10min1336974-33697488.68487.685.0288.8187.815.03
2347911-34791191.56391.71
3349062-34906291.86692.01
4336314-33631488.51188.64
5324246-32424685.33585.45
6304493-30449380.13680.25
15min1345651-34565190.96890.332.8391.2590.602.85
2346404-34640491.16691.46
3355346-35534693.52093.81
4345710-34571090.98491.26
5340123-34012389.51389.77
6326125-32612585.82986.07
20min1350171-35017192.15892.092.0692.5992.522.07
2350979-35097992.37092.82
3360036-36003694.75495.20
4351760-35176092.57693.01
5348875-34887591.81692.23
6337683-33768388.87189.26
30min1357121-35712193.98794.281.4394.5794.861.44
2357265-35726594.02594.63
3366970-36697096.57997.19
4358939-35893994.46595.05
5357995-35799594.21794.78
6351092-35109292.40092.94
45min1362637-36263795.43896.362.6996.1897.102.69
2363026-36302695.54196.30
3384964-384964101.314102.08
4365433-36543396.17496.92
5364875-36487596.02796.75
6355937-35593793.67594.36
极限1367716-36771696.77597.231.1797.6798.121.17
2365058-36505896.07696.99
3376484-37648499.083100.02
4369239-36923997.17698.08
5372218-37221897.96098.84
6365839-36583996.28197.13
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200
标示量(mg)50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%
112.813407313407223402953407913407703406620.07
212.853396773399413398090.06
单位质量响应值RSD%判断
26593.4426444.280.40数据可信
中间条件36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%
5min1284125-28412575.01074.3613.0275.0174.3613.02
2286470-28647075.62975.63
3281370-28137074.28274.28
4213838-21383856.45456.45
5322860-32286085.23685.24
6301410-30141079.57379.57
10min1328066-32806686.61085.786.6386.7485.906.64
2333443-33344388.03088.16
3330267-33026787.19187.31
4282410-28241074.55774.65
5343818-34381890.76990.91
6331523-33152387.52387.66
15min1342017-34201790.29389.804.2190.5690.074.22
2348101-34810191.89992.17
3347634-34763491.77692.05
4312234-31223482.43082.65
5351045-35104592.67792.97
6339965-33996589.75190.03
20min1347449-34744991.72791.573.0492.1591.983.06
2353153-35315393.23393.66
3354077-35407793.47793.90
4327751-32775186.52786.88
5355832-35583293.94094.39
6342790-34279090.49790.93
30min1356164-35616494.02893.552.6594.6094.122.67
2360102-36010295.06895.65
3360401-36040195.14795.72
4337257-33725789.03789.54
5361943-36194395.55496.16
6350252-35025292.46793.05
45min1372901-37290198.44795.932.2899.1896.652.30
2367261-36726196.95897.70
3366179-36617996.67297.41
4351145-35114592.70393.35
5367240-36724096.95297.72
6355374-35537493.81994.55
极限1366649-36664996.79696.502.0497.6997.382.06
2371818-37181898.16199.06
3369873-36987397.64798.54
4352600-35260093.08793.89
5371088-37108897.96898.89
6361099-36109995.33196.22
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101546-202101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200
标示量(mg)50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%
112.813409403410963411053408143411333410180.05
212.853412623413393413000.02
单位质量响应值RSD%判断
26621.2326560.310.17数据可信
中间条件36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%
5min1240977-24097763.44659.965.4363.4559.965.43
2242540-24254063.85763.86
3230594-23059460.71260.71
4216617-21661757.03257.03
5222153-22215358.49058.49
6213438-21343856.19556.20
10min1297804-29780478.40874.853.5778.5174.953.57
2294025-29402577.41377.52
3286832-28683275.51975.62
4277227-27722772.99073.09
5276395-27639572.77172.87
6273413-27341371.98672.08
15min1321406-32140684.62281.982.5784.8682.212.57
2317922-31792283.70583.94
3314694-31469482.85583.08
4309440-30944081.47181.69
5302895-30289579.74879.97
6301927-30192779.49379.71
20min1333509-33350987.80886.261.8588.1986.621.86
2332571-33257187.56187.94
3331825-33182587.36587.73
4327138-32713886.13186.48
5320347-32034784.34384.69
6320303-32030384.33184.68
30min1348457-34845791.74490.980.8092.2791.490.81
2345509-34550990.96891.49
3348962-34896291.87792.39
4345262-34526290.90391.40
5342150-34215090.08390.58
6343011-34301190.31090.80
45min1357237-35723794.05693.930.9594.7394.590.94
2352138-35213892.71393.39
3357404-35740494.10094.76
4354752-35475293.40194.05
5362360-36236095.40496.05
6356677-35667793.90894.55
极限1368176-36817696.93696.620.7697.7797.430.75
2364408-36440895.94496.77
3367011-36701196.62997.45
4363731-36373195.76596.57
5371434-37143497.79498.59
6367088-36708896.64997.44
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