氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.151839351840341836751836211834501837430.13
214.161831531834151832840.11
单位质量响应值RSD%判断
12985.3712943.790.23数据可信
供试品溶液-24050601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%
2min157606-5760631.40731.367.0231.4131.367.02
250842-5084227.71927.72
355742-5574230.39130.39
462847-6284734.26434.26
558406-5840631.84331.84
659629-5962932.51032.51
5min1111837-11183760.97360.541.9560.9760.541.95
2107946-10794658.85258.85
3113629-11362961.95061.95
4110638-11063860.32060.32
5109331-10933159.60759.61
6112857-11285761.53061.53
10min1129482-12948270.59471.091.4470.5971.091.44
2128461-12846170.03770.04
3133528-13352872.79972.80
4130125-13012570.94470.94
5129165-12916570.42170.42
6131645-13164571.77371.77
15min1138612-13861275.57174.962.4375.5774.962.44
2135248-13524873.73773.74
3141965-14196577.39977.40
4137224-13722474.81474.81
5132434-13243472.20372.20
6139453-13945376.03076.03
20min1143784-14378478.39177.432.1478.3977.432.14
2140355-14035576.52176.52
3146155-14615579.68479.68
4140347-14034776.51776.52
5137833-13783375.14675.15
6143678-14367878.33378.33
30min1148572-14857281.00180.231.3081.0080.231.30
2144292-14429278.66878.67
3149068-14906881.27281.27
4148383-14838380.89880.90
5145447-14544779.29879.30
6147203-14720380.25580.26
45min1151540-15154082.62081.901.5682.6281.901.56
2146741-14674180.00380.00
3152894-15289483.35883.36
4151073-15107382.36582.36
5148006-14800680.69380.69
6151090-15109082.37482.37
60min1153399-15339983.63382.542.0983.6382.542.08
2149177-14917781.33181.33
3155235-15523584.63484.63
4147529-14752980.43380.43
5149162-14916281.32381.32
6153842-15384283.87583.87
90min1155606-15560684.83683.841.8384.8483.841.84
2151362-15136282.52282.52
3156539-15653985.34585.34
4154728-15472884.35884.36
5149311-14931181.40481.40
6155151-15515184.58884.59
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1155018-15501884.51683.622.9284.5283.622.92
2149956-14995681.75681.76
3157699-15769985.97785.98
4155542-15554284.80184.80
5145961-14596179.57879.58
6156021-15602185.06385.06
极限1156227-15622785.17582.923.3385.1782.923.32
2152084-15208482.91682.92
3157219-15721985.71685.72
4148782-14878281.11681.12
5143856-14385678.43078.43
6154401-15440184.17984.18
氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.151836231837231838281835931838341837200.07
214.161849311848801849060.02
单位质量响应值RSD%判断
12983.7513058.330.41数据可信
供试品溶液-24050602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%
2min142522-4252223.08324.8716.5423.0824.8716.55
247425-4742525.74425.74
358130-5813031.55531.56
448482-4848226.31826.32
535522-3552219.28319.28
642845-4284523.25823.26
5min1100223-10022354.40555.463.6754.4055.463.66
2104912-10491256.95056.95
3106964-10696458.06458.06
4104251-10425156.59156.59
597359-9735952.85052.85
699305-9930553.90753.91
10min1124247-12424767.44667.052.1467.4567.062.14
2125849-12584968.31668.32
3125718-12571868.24568.24
4124414-12441467.53767.54
5121941-12194166.19466.19
6118983-11898364.58964.59
15min1134797-13479773.17372.461.7773.1772.461.77
2133915-13391572.69472.69
3135645-13564573.63373.63
4135182-13518273.38273.38
5131883-13188371.59171.59
6129514-12951470.30570.31
20min1136962-13696274.34874.481.9274.3574.481.92
2138478-13847875.17175.17
3139460-13946075.70475.70
4140071-14007176.03676.04
5134548-13454873.03873.04
6133674-13367472.56372.56
30min1143150-14315077.70776.911.3477.7176.911.34
2141788-14178876.96876.97
3142841-14284177.54077.54
4143070-14307077.66477.66
5140991-14099176.53576.54
6138225-13822575.03475.03
45min1136992-13699274.36577.982.6574.3677.982.66
2146321-14632179.42979.43
3147360-14736079.99379.99
4145217-14521778.82978.83
5144448-14444878.41278.41
6141626-14162676.88076.88
60min1152978-15297883.04279.852.6583.0479.852.65
2144929-14492978.67378.67
3146185-14618579.35579.35
4149127-14912780.95280.95
5147860-14786080.26480.26
6141534-14153476.83076.83
90min1155581-15558184.45580.143.3584.4680.143.35
2146839-14683979.71079.71
3147694-14769480.17480.17
4150359-15035981.62181.62
5142144-14214477.16177.16
6143132-14313277.69877.70
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1154832-15483284.04979.645.9184.0579.645.91
2150992-15099281.96481.96
3150022-15002281.43881.44
4130216-13021670.68670.69
5149069-14906980.92080.92
6145146-14514678.79178.79
极限1157284-15728485.38080.505.0185.3880.505.01
2148966-14896680.86480.86
3149522-14952281.16681.17
4135337-13533773.46673.47
5152661-15266182.87082.87
6145950-14595079.22779.23
氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.151862701858911857961859181860171859780.10
214.161858291856541857420.07
单位质量响应值RSD%判断
13143.3213117.370.14数据可信
供试品溶液-24050603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%
2min152479-5247928.25027.474.4828.2527.474.48
248524-4852426.12126.12
352075-5207528.03328.03
448746-4874626.24126.24
550086-5008626.96226.96
654267-5426729.21329.21
5min199478-9947853.55153.672.7153.5553.672.71
2100021-10002153.84353.84
3101430-10143054.60154.60
496379-9637951.88251.88
597192-9719252.32052.32
6103699-10369955.82355.82
10min1122300-12230065.83665.972.8165.8465.972.81
2117530-11753063.26863.27
3123355-12335566.40466.40
4122624-12262466.01066.01
5121299-12129965.29765.30
6128179-12817969.00169.00
15min1133477-13347771.85372.052.7271.8572.052.72
2135109-13510972.73172.73
3135317-13531772.84372.84
4135479-13547972.93072.93
5126762-12676268.23868.24
6136889-13688973.68973.69
20min1138423-13842374.51575.051.6874.5275.051.69
2142001-14200176.44176.44
3140581-14058175.67775.68
4140028-14002875.37975.38
5135244-13524472.80472.80
6140188-14018875.46575.47
30min1148832-14883280.11980.421.6680.1280.421.66
2151232-15123281.41181.41
3148548-14854879.96679.97
4147304-14730479.29679.30
5146992-14699279.12879.13
6153394-15339482.57482.57
45min1152997-15299782.36182.222.6182.3682.222.61
2155906-15590683.92783.93
3150904-15090481.23481.23
4152175-15217581.91881.92
5146523-14652378.87678.88
6157896-15789684.99885.00
60min1155124-15512483.50682.602.6083.5182.602.60
2153103-15310382.41882.42
3154129-15412982.97082.97
4149773-14977380.62580.63
5148767-14876780.08480.08
6159790-15979086.01786.02
90min1156610-15661084.30683.183.2884.3183.183.28
2158722-15872285.44385.44
3151736-15173681.68281.68
4150928-15092881.24781.25
5148038-14803879.69179.69
6161113-16111386.73086.73
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1157777-15777784.93483.192.7984.9383.192.79
2158420-15842085.28085.28
3153941-15394182.86982.87
4153602-15360282.68682.69
5146716-14671678.98078.98
6156750-15675084.38184.38
极限1156138-15613884.05283.962.8084.0583.962.80
2160716-16071686.51686.52
3156002-15600283.97883.98
4153201-15320182.47082.47
5149305-14930580.37380.37
6160476-16047686.38786.39
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