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%
112.561854291854921855481855031854281854800.03
212.731851531852801852160.05
单位质量响应值RSD%判断
14767.5214549.571.06数据可信
供试品溶液-2022030401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%
5min1191022-19102291.23889.482.2791.2489.482.27
2187753-18775389.67789.68
3185877-18587788.78188.78
4189750-18975090.63090.63
5190124-19012490.80990.81
6179548-17954885.75885.76
10min1198312-19831294.72093.241.7194.8793.391.71
2194982-19498293.12993.28
3193055-19305592.20992.36
4197599-19759994.37994.53
5197612-19761294.38694.54
6189745-18974590.62890.77
15min1202325-20232596.63794.801.7596.9595.101.75
2198144-19814494.64094.94
3196177-19617793.70094.00
4200566-20056695.79696.10
5200653-20065395.83896.15
6192960-19296092.16492.46
20min1204419-20441997.63795.771.7098.1196.231.71
2200290-20029095.66596.13
3197878-19787894.51394.97
4202651-20265196.79297.26
5202523-20252396.73197.20
6195312-19531293.28793.73
30min1206166-20616698.47196.821.6699.1097.441.66
2202188-20218896.57197.19
3200730-20073095.87596.49
4204872-20487297.85398.48
5205039-20503997.93398.56
6197215-19721594.19694.80
45min1207251-20725198.98997.451.7399.7998.231.73
2203198-20319897.05497.84
3202915-20291596.91897.69
4206555-20655598.65799.45
5206354-20635498.56199.35
6197864-19786494.50695.27
极限1209066-20906699.85698.101.50100.8299.051.50
2204725-20472597.78398.73
3203717-20371797.30198.24
4207477-20747799.097100.05
5206865-20686598.80599.76
6200506-20050695.76896.69
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%
112.561852621851621852211852301852621852270.03
212.731848981849641849310.03
单位质量响应值RSD%判断
14747.3714527.181.07数据可信
供试品溶液-2022030401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%
5min1191993-19199391.83590.331.5891.8490.331.58
2186219-18621989.07389.07
3190415-19041591.08091.08
4184445-18444588.22588.22
5188847-18884790.33090.33
6191192-19119291.45291.45
10min1199915-19991595.62494.151.4495.7894.301.44
2194903-19490393.22793.38
3198744-19874495.06495.22
4192493-19249392.07492.22
5196166-19616693.83193.98
6198821-19882195.10195.25
15min1203068-20306897.13295.861.3197.4496.161.31
2198635-19863595.01295.32
3202300-20230096.76597.08
4196541-19654194.01094.31
5199340-19934095.34995.66
6202522-20252296.87197.18
20min1204720-20472097.92396.661.3698.4097.121.36
2200463-20046395.88696.35
3204071-20407197.61298.08
4197848-19784894.63695.09
5201045-20104596.16596.63
6204318-20431897.73098.20
30min1207106-20710699.06497.821.3499.7098.451.34
2202554-20255496.88797.51
3206181-20618198.62299.26
4200452-20045295.88196.50
5203678-20367897.42498.05
6207059-20705999.04199.68
45min1207532-20753299.26898.221.34100.0799.011.34
2202976-20297697.08897.87
3207051-20705199.03899.84
4201268-20126896.27297.05
5205049-20504998.08098.87
6208135-20813599.556100.36
极限1207438-20743899.22398.391.28100.1999.351.28
2203398-20339897.29098.24
3206623-20662398.83399.80
4201836-20183696.54397.48
5205982-20598298.52699.48
6208908-20890899.926100.89
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%
112.561854911855661855721857121857151856110.06
212.731854141854181854160.01
单位质量响应值RSD%判断
14777.9514565.281.03数据可信
供试品溶液-2022030501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%
5min1187852-18785289.64489.450.7989.6489.450.79
2189041-18904190.21190.21
3186375-18637588.93988.94
4188992-18899290.18890.19
5185349-18534988.44988.45
6187032-18703289.25289.25
10min1196723-19672393.87793.580.3294.0393.730.33
2196473-19647393.75893.91
3195191-19519193.14693.29
4196692-19669293.86294.01
5195682-19568293.38093.53
6195829-19582993.45093.60
15min1200322-20032295.59495.230.3395.9095.540.33
2199827-19982795.35895.66
3198624-19862494.78495.09
4200062-20006295.47095.78
5199577-19957795.23995.54
6198969-19896994.94995.25
20min1202462-20246296.61696.180.3997.0896.640.38
2201593-20159396.20196.67
3200238-20023895.55496.02
4201981-20198196.38696.85
5201789-20178996.29496.76
6201173-20117396.00096.46
30min1204358-20435897.52097.090.3398.1597.710.33
2203434-20343497.07997.71
3202332-20233296.55497.17
4203703-20370397.20897.83
5203612-20361297.16497.79
6203264-20326496.99897.62
45min1205151-20515197.89997.540.5398.6998.320.53
2203733-20373397.22298.01
3202593-20259396.67897.46
4205298-20529897.96998.76
5205205-20520597.92598.71
6204368-20436897.52598.31
极限1205867-20586798.24097.860.4399.1998.810.43
2205984-20598498.29699.25
3203638-20363897.17798.12
4205213-20521397.92898.88
5205095-20509597.87298.82
6204629-20462997.65098.60
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%
112.561851181852221851451851691851671851640.03
212.731857661857631857640.01
单位质量响应值RSD%判断
14742.3614592.620.73数据可信
供试品溶液-2022030501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%
5min1183965-18396587.81188.781.3687.8188.781.36
2185919-18591988.74488.74
3184987-18498788.29988.30
4183831-18383187.74787.75
5186651-18665189.09389.09
6190625-19062590.99090.99
10min1191669-19166991.48892.841.1391.6392.981.13
2194597-19459792.88693.03
3195409-19540993.27493.42
4192671-19267191.96792.11
5194759-19475992.96393.11
6197895-19789594.46094.61
15min1195831-19583193.47594.641.0393.7794.941.03
2197934-19793494.47994.78
3199293-19929395.12895.43
4196654-19665493.86894.17
5198349-19834994.67794.98
6201563-20156396.21196.52
20min1198212-19821294.61295.571.0195.0796.041.01
2199185-19918595.07695.54
3202070-20207096.45396.91
4198508-19850894.75395.21
5200214-20021495.56796.03
6203170-20317096.97897.45
30min1199453-19945395.20496.551.1895.8297.171.18
2202050-20205096.44497.06
3204529-20452997.62798.25
4199838-19983895.38896.00
5202384-20238496.60397.22
6205344-20534498.01698.65
45min1201743-20174396.29797.191.0197.0797.981.01
2202824-20282496.81397.59
3205835-20583598.25099.03
4201142-20114296.01096.78
5204251-20425197.49498.28
6205944-20594498.30299.10
极限1203131-20313196.96097.551.0397.8998.491.03
2203638-20363897.20298.14
3205538-20553898.10899.06
4201467-20146796.16597.10
5204875-20487597.79298.74
6207501-20750199.045100.00
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