氢溴酸伏硫西汀片项目信息
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%
114.161817021815891815911815811816241816170.03
214.071817581814371815980.13
单位质量响应值RSD%判断
12826.0612906.750.45数据可信
供试品溶液-2024051221批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1124470-12447068.37968.933.7968.3868.933.79
2119186-11918665.47665.48
3126538-12653869.51569.52
4133663-13366373.43073.43
5123426-12342667.80667.81
6125567-12556768.98268.98
5min1175325-17532596.31795.900.6796.3295.900.67
2172831-17283194.94794.95
3175236-17523696.26896.27
4175829-17582996.59496.59
5173519-17351995.32595.32
6174703-17470395.97595.98
10min1180134-18013498.95998.960.3998.9698.960.39
2179321-17932198.51298.51
3180633-18063399.23399.23
4181225-18122599.55899.56
5179717-17971798.73098.73
6179815-17981598.78498.78
15min1180384-18038499.09699.020.5099.1099.020.50
2178701-17870198.17298.17
3180721-18072199.28299.28
4181374-18137499.64099.64
5179902-17990298.83298.83
6180332-18033299.06899.07
20min1179889-17988998.82498.890.7598.8298.890.75
2179403-17940398.55798.56
3180671-18067199.25499.25
4182054-182054100.014100.01
5178018-17801897.79797.80
6179988-17998898.87998.88
30min1180053-18005398.91599.120.3798.9199.110.37
2179449-17944998.58398.58
3181156-18115699.52099.52
4181086-18108699.48299.48
5180179-18017998.98498.98
6180591-18059199.21099.21
45min1180692-18069299.26698.950.7799.2798.950.78
2177611-17761197.57397.57
3181038-18103899.45699.46
4180404-18040499.10799.11
5179522-17952298.62398.62
6181423-18142399.66799.67
60min1180264-18026499.03098.960.4999.0398.960.49
2178964-17896498.31698.32
3180554-18055499.19099.19
4181219-18121999.55599.56
5179206-17920698.44998.45
6180569-18056999.19899.20
极限1179590-17959098.66098.830.5698.6698.830.56
2178391-17839198.00198.00
3180727-18072799.28599.28
4181050-18105099.46299.46
5179286-17928698.49398.49
6180367-18036799.08799.09
氢溴酸伏硫西汀片项目信息
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%
114.161820671820781820991819931820441820560.03
214.071820861821321821090.02
单位质量响应值RSD%判断
12857.0612943.070.48数据可信
供试品溶液-2024051221批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1119876-11987665.68466.992.1165.6866.992.11
2121292-12129266.46066.46
3126748-12674869.44969.45
4121876-12187666.78066.78
5123615-12361567.73267.73
6120154-12015465.83665.84
5min1170738-17073893.55394.771.1793.5594.771.17
2171817-17181794.14494.14
3175977-17597796.42396.42
4172610-17261094.57894.58
5174813-17481395.78595.79
6171768-17176894.11794.12
10min1176468-17646896.69297.370.9596.6997.360.95
2178108-17810897.59197.59
3180023-18002398.64098.64
4175980-17598096.42596.42
5179245-17924598.21498.21
6176380-17638096.64496.64
15min1176982-17698296.97497.891.0396.9797.891.03
2178536-17853697.82597.83
3181358-18135899.37299.37
4178772-17877297.95597.95
5179881-17988198.56298.56
6176415-17641596.66396.66
20min1176714-17671496.82797.620.8196.8397.620.81
2177663-17766397.34797.35
3180595-18059598.95498.95
4177498-17749897.25797.26
5179136-17913698.15498.15
6177331-17733197.16597.17
30min1176650-17665096.79297.630.8796.7997.630.87
2178148-17814897.61397.61
3180559-18055998.93498.93
4176908-17690896.93396.93
5179458-17945898.33198.33
6177342-17734297.17197.17
45min1176458-17645896.68797.470.7996.6997.470.79
2177964-17796497.51297.51
3179522-17952298.36698.37
4176585-17658596.75696.76
5179597-17959798.40798.41
6177167-17716797.07597.08
60min1175254-17525496.02797.421.1396.0397.421.13
2177530-17753097.27497.27
3181195-18119599.28299.28
4177901-17790197.47797.48
5178344-17834497.72097.72
6176561-17656196.74396.74
极限1176858-17685896.90697.930.9496.9197.930.93
2178099-17809997.58697.59
3181358-18135899.37299.37
4178285-17828597.68897.69
5180065-18006598.66398.66
6177697-17769797.36697.37
氢溴酸伏硫西汀片项目信息
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%
114.161817661819101817691817541817351817870.04
214.071822471818341820400.17
单位质量响应值RSD%判断
12838.0612938.170.55数据可信
供试品溶液-2763566批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min136489-3648920.01217.3940.0620.0117.3940.06
219932-1993210.93210.93
328429-2842915.59215.59
451862-5186228.44328.44
517298-172989.4879.49
636237-3623719.87419.87
5min1150817-15081782.71479.563.7282.7179.563.72
2140700-14070077.16677.17
3146250-14625080.20980.21
4150927-15092782.77582.77
5144214-14421479.09379.09
6137532-13753275.42875.43
10min1176264-17626496.67096.011.0696.6796.011.06
2173804-17380495.32195.32
3177508-17750897.35397.35
4174905-17490595.92595.93
5175597-17559796.30596.30
6172261-17226194.47594.47
15min1179605-17960598.50398.450.9098.5098.450.90
2179073-17907398.21198.21
3182248-18224899.95299.95
4178791-17879198.05698.06
5179949-17994998.69198.69
6177407-17740797.29797.30
20min1180611-18061199.05498.840.8599.0598.840.85
2180199-18019998.82998.83
3183041-183041100.387100.39
4179326-17932698.35098.35
5178997-17899798.16998.17
6179119-17911998.23698.24
30min1180761-18076199.13799.120.6099.1499.120.60
2180592-18059299.04499.04
3182682-182682100.190100.19
4180144-18014498.79898.80
5180755-18075599.13399.13
6179477-17947798.43398.43
45min1180694-18069499.10099.200.9499.1099.200.94
2180463-18046398.97398.97
3184086-184086100.960100.96
4179735-17973598.57498.57
5180928-18092899.22899.23
6179324-17932498.34998.35
60min1180852-18085299.18799.240.7999.1999.240.79
2179884-17988498.65698.66
3183510-183510100.644100.64
4180100-18010098.77498.77
5181552-18155299.57199.57
6179804-17980498.61298.61
极限1180902-18090299.21499.290.7899.2199.290.78
2180566-18056699.03099.03
3183282-183282100.519100.52
4180398-18039898.93898.94
5181913-18191399.76999.77
6179180-17918098.27098.27
氢溴酸伏硫西汀片项目信息
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%
114.161821131821401823011822841823071822290.06
214.071820451820141820300.02
单位质量响应值RSD%判断
12869.2812937.460.38数据可信
供试品溶液-2763566批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min122536-2253612.34519.0742.0312.3419.0642.05
226929-2692914.75114.75
324537-2453713.44113.44
459649-5964932.67532.68
529868-2986816.36116.36
645306-4530624.81824.82
5min1139386-13938676.35476.0510.8276.3576.0610.82
2147654-14765480.88380.88
3110005-11000560.25960.26
4151240-15124082.84782.85
5146771-14677180.39980.40
6137983-13798375.58575.59
10min1176811-17681196.85592.685.9296.8592.685.91
2171388-17138893.88493.88
3149192-14919281.72681.73
4173817-17381795.21595.21
5172276-17227694.37194.37
6171699-17169994.05594.05
15min1182315-18231599.87096.973.3999.8796.973.39
2178083-17808397.55297.55
3165396-16539690.60290.60
4178065-17806597.54297.54
5180753-18075399.01499.01
6177500-17750097.23297.23
20min1182427-18242799.93197.662.8999.9397.662.89
2179630-17963098.39998.40
3168180-16818092.12792.13
4179184-17918498.15598.15
5181528-18152899.43999.44
6178704-17870497.89297.89
30min1184890-184890101.28198.183.17101.2898.183.17
2180762-18076299.01999.02
3168245-16824592.16392.16
4180239-18023998.73398.73
5181221-18122199.27199.27
6180012-18001298.60898.61
45min1184558-184558101.09998.412.61101.1098.412.61
2180427-18042798.83698.84
3170763-17076393.54293.54
4180253-18025398.74098.74
5181956-18195699.67399.67
6179949-17994998.57498.57
60min1185135-185135101.41597.443.12101.4197.443.12
2180014-18001498.61098.61
3169813-16981393.02293.02
4173934-17393495.27995.28
5181674-18167499.51999.52
6176756-17675696.82596.82
极限1184650-184650101.14998.522.36101.1598.522.36
2180805-18080599.04399.04
3171983-17198394.21094.21
4180515-18051598.88498.88
5181733-18173399.55199.55
6179471-17947198.31298.31
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