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%
114.741881281879601879831878741879531879800.05
214.701879551879491879520.01
单位质量响应值RSD%判断
12753.0512785.850.19数据可信
中间条件3月-供试品溶液-24050601批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1158829-15882987.91785.411.6187.9285.411.61
2153805-15380585.13685.14
3153551-15355184.99585.00
4154560-15456085.55485.55
5153721-15372185.08985.09
6151335-15133583.76883.77
5min1179756-17975699.50097.672.8999.5097.672.89
2167504-16750492.71892.72
3180815-180815100.087100.09
4174155-17415596.40096.40
5176219-17621997.54397.54
6180272-18027299.78699.79
10min1182752-182752101.15999.602.94101.1699.602.94
2169495-16949593.82193.82
3183112-183112101.358101.36
4181649-181649100.548100.55
5179603-17960399.41699.42
6183017-183017101.305101.31
15min1182700-182700101.13099.682.46101.1399.682.47
2172261-17226195.35295.35
3184320-184320102.027102.03
4182774-182774101.171101.17
5177921-17792198.48598.48
6180547-18054799.93899.94
20min1184088-184088101.89899.582.95101.9099.582.95
2170151-17015194.18494.18
3182593-182593101.071101.07
4181441-181441100.433100.43
5177613-17761398.31498.31
6183525-183525101.587101.59
30min1184078-184078101.893100.343.04101.89100.343.04
2170455-17045594.35294.35
3185556-185556102.711102.71
4183936-183936101.814101.81
5182012-182012100.749100.75
6181614-181614100.529100.53
45min1184530-184530102.143100.472.57102.14100.472.57
2172403-17240395.43095.43
3184960-184960102.381102.38
4182620-182620101.086101.09
5181247-181247100.326100.33
6183279-183279101.450101.45
60min1183839-183839101.760100.832.37101.76100.832.37
2173940-17394096.28196.28
3186065-186065102.993102.99
4182866-182866101.222101.22
5181530-181530100.482100.48
6184700-184700102.237102.24
极限1184261-184261101.994101.171.78101.99101.171.78
2176960-17696097.95397.95
3186368-186368103.160103.16
4183651-183651101.656101.66
5181443-181443100.434100.43
6183925-183925101.808101.81
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%
114.741880141880631881671881031880761880850.03
214.701909341908701909020.03
单位质量响应值RSD%判断
12760.1812986.531.25数据可信
中间条件3月-供试品溶液-24050602批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1148328-14832881.44778.333.2781.4578.333.27
2140503-14050377.15177.15
3143896-14389679.01479.01
4145581-14558179.93979.94
5142774-14277478.39878.40
6134823-13482374.03274.03
5min1168132-16813292.32292.440.7592.3292.440.75
2167849-16784992.16792.17
3170319-17031993.52393.52
4169097-16909792.85292.85
5166612-16661291.48791.49
6168092-16809292.30092.30
10min1172892-17289294.93693.162.4494.9493.162.45
2170839-17083993.80893.81
3171741-17174194.30494.30
4171722-17172294.29394.29
5161596-16159688.73388.73
6169196-16919692.90692.91
15min1171624-17162494.23994.610.7394.2494.610.73
2170508-17050893.62793.63
3173979-17397995.53395.53
4173414-17341495.22295.22
5172200-17220094.55694.56
6172094-17209494.49894.50
20min1174063-17406395.57994.921.1095.5894.921.10
2170689-17068993.72693.73
3173233-17323395.12395.12
4175576-17557696.40996.41
5172821-17282194.89794.90
6170763-17076393.76793.77
30min1173680-17368095.36894.801.1795.3794.801.17
2170726-17072693.74693.75
3174355-17435595.73995.74
4175193-17519396.19996.20
5170455-17045593.59893.60
6171446-17144694.14294.14
45min1174434-17443495.78295.370.4795.7895.370.47
2172419-17241994.67694.68
3174291-17429195.70495.70
4174179-17417995.64295.64
5173769-17376995.41795.42
6172969-17296994.97894.98
60min1174350-17435095.73695.600.8395.7495.590.83
2171468-17146894.15494.15
3175749-17574996.50496.50
4174765-17476595.96495.96
5173937-17393795.51095.51
6174292-17429295.70495.70
极限1174036-17403695.56495.311.2895.5695.311.29
2173440-17344095.23795.24
3174957-17495796.07096.07
4176042-17604296.66596.67
5169521-16952193.08593.08
6173456-17345695.24595.25
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%
114.741880671881061880641879751875711879570.12
214.701884461886021885240.06
单位质量响应值RSD%判断
12751.4912824.760.41数据可信
中间条件3月-供试品溶液-24050603批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1143013-14301379.04777.772.9379.0577.772.93
2141887-14188778.42578.42
3147189-14718981.35581.36
4138454-13845476.52776.53
5137375-13737575.93175.93
6136271-13627175.32075.32
5min1171958-17195895.04694.461.0295.0594.461.02
2169167-16916793.50393.50
3173505-17350595.90195.90
4168951-16895193.38393.38
5170553-17055394.26994.27
6171209-17120994.63294.63
10min1176462-17646297.53596.640.8797.5496.640.87
2172926-17292695.58195.58
3176313-17631397.45397.45
4173689-17368996.00296.00
5175775-17577597.15597.16
6173939-17393996.14096.14
15min1173944-17394496.14396.731.3096.1496.721.29
2173633-17363395.97195.97
3178229-17822998.51298.51
4171958-17195895.04695.05
5176533-17653397.57497.57
6175694-17569497.11197.11
20min1177444-17744498.07897.191.1098.0897.191.10
2173657-17365795.98595.98
3175818-17581897.17997.18
4173381-17338195.83295.83
5177798-17779898.27398.27
6176970-17697097.81697.82
30min1178093-17809398.43796.952.2798.4496.952.27
2168220-16822092.97992.98
3177821-17782198.28698.29
4173382-17338295.83395.83
5178392-17839298.60298.60
6176533-17653397.57497.57
45min1177979-17797998.37397.710.7298.3797.710.72
2175607-17560797.06297.06
3177571-17757198.14898.15
4174824-17482496.63096.63
5177126-17712697.90297.90
6177547-17754798.13598.13
60min1177019-17701997.84397.201.1597.8497.201.15
2175464-17546496.98396.98
3176611-17661197.61797.62
4174426-17442696.41096.41
5178648-17864898.74398.74
6172953-17295395.59595.60
极限1178698-17869898.77197.891.3298.7797.891.32
2173894-17389496.11696.12
3178361-17836198.58598.58
4174351-17435196.36896.37
5179081-17908198.98398.98
6178239-17823998.51798.52
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%
114.741877771877881876851876821876141877090.04
214.701877811877821877820.01
单位质量响应值RSD%判断
12734.6712774.290.22数据可信
中间条件3月-供试品溶液-2024051221批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1143682-14368279.62675.856.0179.6375.866.01
2140650-14065077.94577.95
3146747-14674781.32481.32
4134058-13405874.29274.29
5130928-13092872.55872.56
6125190-12519069.37869.38
5min1169588-16958893.98294.320.9993.9894.320.99
2167804-16780492.99492.99
3172451-17245195.56995.57
4171524-17152495.05595.06
5170529-17052994.50494.50
6169250-16925093.79593.80
10min1169297-16929793.82196.111.4793.8296.121.47
2173113-17311395.93695.94
3175363-17536397.18397.18
4175911-17591197.48697.49
5175089-17508997.03197.03
6171835-17183595.22895.23
15min1172545-17254595.62196.641.1595.6296.641.15
2174242-17424296.56196.56
3176708-17670897.92897.93
4175478-17547897.24697.25
5175771-17577197.40997.41
6171573-17157395.08295.08
20min1171991-17199195.31496.711.0495.3196.721.04
2174900-17490096.92696.93
3176352-17635297.73197.73
4175624-17562497.32797.33
5175679-17567997.35897.36
6172567-17256795.63395.63
30min1171802-17180295.20996.881.2695.2196.881.26
2173559-17355996.18396.18
3176703-17670397.92597.93
4176327-17632797.71797.72
5177144-17714498.17098.17
6173352-17335296.06896.07
45min1173875-17387596.35897.530.9696.3697.530.96
2175832-17583297.44397.44
3177038-17703898.11198.11
4177805-17780598.53698.54
5177293-17729398.25298.25
6174109-17410996.48896.49
60min1173943-17394396.39697.701.0496.4097.701.04
2175987-17598797.52997.53
3178124-17812498.71398.71
4177606-17760698.42698.43
5177751-17775198.50698.51
6174340-17434096.61696.62
极限1174155-17415596.51397.161.2996.5197.161.29
2175089-17508997.03197.03
3178077-17807798.68798.69
4176347-17634797.72897.73
5176669-17666997.90697.91
6171632-17163295.11595.12
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