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%
114.001820001819791820511820951821511820550.04
214.011820861819731820300.05
单位质量响应值RSD%判断
13003.9312992.860.07数据可信
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%
10min1125606-12560668.30267.991.3768.3067.991.37
2126377-12637768.72168.72
3123122-12312266.95166.95
2min1165288-16528889.88090.451.2989.8890.451.29
2168801-16880191.79191.79
3164923-16492389.68289.68
5min1171891-17189193.47193.280.3293.4793.280.32
2171816-17181693.43093.43
3170913-17091392.93992.94
15min1172549-17254993.82993.422.1493.8393.422.14
2175030-17503095.17895.18
3167800-16780091.24691.25
20min1173322-17332294.24994.270.8594.2594.270.84
2174838-17483895.07395.07
3171920-17192093.48793.49
30min1175895-17589595.64894.951.1395.6594.951.13
2175570-17557095.47195.47
3172349-17234993.72093.72
45min1174975-17497595.14894.891.1695.1594.891.16
2176232-17623295.83195.83
3172300-17230093.69393.69
60min1171834-17183493.44094.681.2293.4494.681.22
2176026-17602695.71995.72
3174471-17447194.87494.87
极限1176121-17612195.77194.672.1795.7794.662.17
2176402-17640295.92495.92
3169740-16974092.30192.30
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%
114.001824291823361826331825711824421824820.07
214.011831921830271831100.07
单位质量响应值RSD%判断
13034.4313069.950.20数据可信
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%
10min1128330-12833069.49670.623.3369.5070.623.33
2127504-12750469.04869.05
3135401-13540173.32573.32
2min1172202-17220293.25493.260.7193.2593.260.71
2171005-17100592.60692.61
3173444-17344493.92793.93
5min1175453-17545395.01595.040.2195.0195.040.21
2175176-17517694.86594.86
3175895-17589595.25495.25
15min1170710-17071092.44694.381.8392.4594.381.83
2176845-17684595.76995.77
3175286-17528694.92494.92
20min1176792-17679295.74095.230.8195.7495.230.81
2174233-17423394.35494.35
3176534-17653495.60095.60
30min1172248-17224893.27995.061.6693.2895.061.66
2177799-17779996.28596.29
3176541-17654195.60495.60
45min1175467-17546795.02296.321.2095.0296.321.21
2178554-17855496.69496.69
3179561-17956197.23997.24
60min1177379-17737996.05896.570.6396.0696.570.62
2178065-17806596.42996.43
3179546-17954697.23197.23
极限1174125-17412594.29695.210.8594.3095.220.85
2176934-17693495.81795.82
3176397-17639795.52695.53
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%
114.001827481825871826411825511825411826140.05
214.011829311830941830120.07
单位质量响应值RSD%判断
13043.8613062.960.11数据可信
供试品溶液-2757904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%
10min140260-4026021.80036.5459.9021.8036.5459.91
248260-4826026.13226.13
3113926-11392661.69061.69
2min1149412-14941280.90585.618.6380.9085.608.64
2151053-15105381.79381.79
3173813-17381394.11894.12
5min1173631-17363194.01995.112.4994.0295.102.49
2172643-17264393.48493.48
3180637-18063797.81397.81
15min1173224-17322493.79996.312.3493.8096.312.33
2179192-17919297.03097.03
3181191-18119198.11398.11
20min1175391-17539194.97296.672.0494.9796.672.04
2177691-17769196.21896.22
3182513-18251398.82998.83
30min1174046-17404694.24497.372.8794.2497.362.87
2181414-18141498.23498.23
3183983-18398399.62599.62
45min1177021-17702195.85597.501.9395.8597.491.94
2179287-17928797.08297.08
3183842-18384299.54899.55
60min1178143-17814396.46297.961.3396.4697.961.34
2182157-18215798.63698.64
3182447-18244798.79398.79
极限1177039-17703995.86598.122.0995.8698.122.09
2182168-18216898.64298.64
3184399-18439999.85099.85
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%
114.001828591832641831551829111828991830180.10
214.011847761846331847040.06
单位质量响应值RSD%判断
13072.7113183.730.60数据可信
供试品溶液-2757904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%
10min194509-9450950.88537.1740.7650.8837.1740.76
273766-7376639.71639.72
338841-3884120.91220.91
2min1164190-16419088.40287.971.4888.4087.971.48
2165285-16528588.99188.99
3160675-16067586.50986.51
5min1169323-16932391.16692.421.9791.1792.421.97
2175511-17551194.49794.50
3170113-17011391.59191.59
15min1172189-17218992.70992.743.6192.7192.743.62
2178502-17850296.10896.11
3166071-16607189.41589.41
20min1173096-17309693.19795.032.2593.2095.042.25
2180856-18085697.37597.38
3175572-17557294.53094.53
30min1171898-17189892.55293.743.7792.5593.743.77
2181487-18148797.71597.71
3168932-16893290.95590.95
45min1174052-17405293.71295.012.0993.7195.012.09
2180694-18069497.28897.29
3174661-17466194.04094.04
60min1173401-17340193.36195.292.1293.3695.292.12
2180870-18087097.38397.38
3176667-17666795.12095.12
极限1172017-17201792.61693.903.0892.6293.903.08
2180549-18054997.21097.21
3170654-17065491.88291.88
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