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%
112.711903151905491908421902741906361905230.13
212.641899381902621901000.13
单位质量响应值RSD%判断
14990.0115039.560.24数据可信
中间条件24月-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%
5min1170051-17005179.29082.528.2079.2982.528.20
2188895-18889588.07788.08
3184145-18414585.86285.86
4188207-18820787.75687.76
5150954-15095470.38670.39
6179578-17957883.73283.73
10min1194873-19487390.86489.682.3991.0089.822.39
2197020-19702091.86592.01
3190859-19085988.99389.14
4196848-19684891.78591.93
5186603-18660387.00887.13
6187739-18773987.53887.68
15min1194611-19461190.74290.511.5591.0390.801.55
2197629-19762992.14992.45
3190665-19066588.90289.19
4196502-19650291.62491.92
5190370-19037088.76589.03
6194940-19494090.89591.18
20min1197719-19771992.19192.091.8192.6392.531.81
2197891-19789192.27192.72
3192935-19293589.96190.40
4202014-20201494.19494.65
5193909-19390990.41590.82
6200529-20052993.50193.94
30min1201731-20173194.06293.401.1294.6593.991.13
2200748-20074893.60494.21
3197013-19701391.86292.45
4202142-20214294.25394.86
5198054-19805492.34792.91
6202216-20221694.28894.88
45min1204653-20465395.42494.781.2096.1795.521.20
2203130-20313094.71495.48
3200031-20003193.26994.01
4204628-20462895.41396.18
5200846-20084693.64994.36
6206298-20629896.19196.94
极限1206085-20608596.09295.641.1497.0096.541.14
2205433-20543395.78896.71
3201331-20133193.87594.77
4205565-20556595.85096.77
5203929-20392995.08795.96
6208301-20830197.12598.04
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%
112.711901741902831901701901451900481901640.05
212.641897851902741900300.19
单位质量响应值RSD%判断
14961.7615034.020.35数据可信
中间条件24月-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%
5min1160813-16081375.06880.887.7775.0780.887.77
2185941-18594186.79786.80
3183586-18358685.69885.70
4180787-18078784.39184.39
5152746-15274671.30271.30
6175685-17568582.01082.01
10min1182742-18274285.30487.922.5585.4388.062.56
2194283-19428390.69190.84
3190941-19094189.13189.27
4192399-19239989.81289.95
5184120-18412085.94786.07
6185638-18563886.65686.79
15min1193135-19313590.15590.691.4090.4290.971.41
2198343-19834392.58792.88
3194249-19424990.67590.97
4196054-19605491.51891.81
5193483-19348390.31890.58
6190359-19035988.86089.14
20min1197494-19749492.19091.961.3192.6192.391.31
2200200-20020093.45393.90
3196211-19621191.59192.03
4198518-19851892.66893.11
5196990-19699091.95592.37
6192562-19256289.88890.32
30min1202164-20216494.37093.931.4594.9494.511.45
2204622-20462295.51896.12
3199408-19940893.08493.68
4202630-20263094.58895.19
5202119-20211994.34994.92
6196333-19633391.64892.23
45min1206452-20645296.37295.301.5697.1096.041.55
2206614-20661496.44797.21
3201876-20187694.23694.99
4205506-20550695.93096.69
5205744-20574496.04196.76
6198738-19873892.77193.50
极限1209499-20949997.79496.061.8898.6896.961.87
2208175-20817597.17698.10
3203213-20321394.86095.77
4205623-20562395.98596.90
5208724-20872497.43298.32
6199476-19947693.11594.00
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%
112.711908511903921905551907231903291905700.12
212.641899551901031900290.06
单位质量响应值RSD%判断
14993.7115033.940.19数据可信
中间条件24月-供试品溶液-2022030601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%
5min1174370-17437081.30978.819.9781.3178.819.97
2173538-17353880.92180.92
3187116-18711687.25387.25
4150047-15004769.96769.97
5146604-14660468.36268.36
6182363-18236385.03685.04
10min1189421-18942188.32887.184.4288.4687.314.42
2190994-19099489.06189.20
3196109-19610991.44691.59
4176180-17618082.15382.27
5177257-17725782.65582.77
6191814-19181489.44389.59
15min1192863-19286389.93390.072.6390.2290.342.64
2195035-19503590.94591.23
3200542-20054293.51393.81
4186481-18648186.95787.21
5188590-18859087.94088.19
6195410-19541091.12091.41
20min1195104-19510490.97891.572.2491.4192.002.25
2198046-19804692.34992.78
3203506-20350694.89595.35
4191349-19134989.22789.63
5192597-19259789.80990.21
6197625-19762592.15392.60
30min1198653-19865392.63293.141.9193.2293.721.92
2200818-20081893.64294.23
3206018-20601896.06796.68
4194592-19459290.73991.29
5197883-19788392.27392.82
6200490-20049093.48994.09
45min1201778-20177894.09094.551.5694.8395.281.58
2204738-20473895.47096.21
3207941-20794196.96497.74
4198884-19888492.74093.44
5201078-20107893.76394.47
6202167-20216794.27195.02
极限1204631-20463195.42096.021.3896.3296.921.39
2207419-20741996.72097.62
3210645-21064598.22499.16
4202480-20248094.41795.27
5205788-20578895.96096.82
6204565-20456595.38996.30
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%
112.711904081906141903941905921904381904890.06
212.641906611907701907160.05
单位质量响应值RSD%判断
14987.3315088.290.48数据可信
中间条件24月-供试品溶液-U028516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%
5min1133008-13300861.92468.8011.3261.9268.8011.32
2142916-14291666.53666.54
3137158-13715863.85663.86
4148195-14819568.99468.99
5179976-17997683.79083.79
6145377-14537767.68267.68
10min1165965-16596577.26781.415.8277.3781.525.83
2170057-17005779.17279.28
3168153-16815378.28678.39
4180678-18067884.11784.23
5192867-19286789.79289.93
6171439-17143979.81679.93
15min1179756-17975683.68887.293.4383.9287.553.44
2185522-18552286.37286.62
3184111-18411185.71585.95
4193336-19333690.01090.27
5197074-19707491.75092.04
6185216-18521686.23086.48
20min1187499-18749987.29390.272.3887.6690.662.39
2193687-19368790.17490.56
3191962-19196289.37189.75
4198208-19820892.27892.68
5200087-20008793.15393.60
6191857-19185789.32289.71
30min1195079-19507990.82293.201.8991.3493.751.91
2199598-19959892.92693.46
3199755-19975592.99993.53
4205001-20500195.44196.00
5204059-20405995.00295.60
6197632-19763292.01092.55
45min1200796-20079693.48394.921.4594.1595.621.46
2203605-20360594.79195.48
3203698-20369894.83495.52
4208904-20890497.25897.98
5205089-20508995.48296.24
6201200-20120093.67194.36
极限1206107-20610795.95696.521.0996.7897.381.10
2207583-20758396.64397.49
3207324-20732496.52397.36
4211169-21116998.31399.19
5207419-20741996.56797.48
6204324-20432495.12695.97
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