氢溴酸伏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%
114.151797761797561797041797331799941797930.07
214.181806701804191805440.10
单位质量响应值RSD%判断
12706.2212732.300.15数据可信
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%
2min1131252-13125272.93965.2519.7272.9465.2519.72
271579-7157939.77739.78
3125532-12553269.76069.76
4133945-13394574.43574.44
5117885-11788565.51065.51
6124269-12426969.05869.06
5min1167760-16776093.22791.694.4293.2391.694.42
2170191-17019194.57894.58
3162919-16291990.53690.54
4172266-17226695.73195.73
5164959-16495991.67091.67
6151820-15182084.36984.37
10min1169366-16936694.11993.174.5694.1293.174.56
2172813-17281396.03596.03
3163335-16333590.76890.77
4175472-17547297.51297.51
5170498-17049894.74894.75
6154434-15443485.82185.82
15min1168793-16879393.80193.903.8493.8093.903.84
2174928-17492897.21097.21
3166110-16611092.31092.31
4175223-17522397.37497.37
5170908-17090894.97694.98
6157863-15786387.72787.73
20min1169429-16942994.15494.014.0194.1594.014.01
2175400-17540097.47297.47
3164929-16492991.65391.65
4175458-17545897.50497.50
5171880-17188095.51695.52
6157955-15795587.77887.78
30min1172643-17264395.94093.954.8895.9493.954.88
2174711-17471197.08997.09
3162298-16229890.19190.19
4176307-17630797.97697.98
5172834-17283496.04696.05
6155548-15554886.44086.44
45min1173177-17317796.23794.303.7996.2494.303.79
2174100-17410096.75096.75
3167152-16715292.88992.89
4172414-17241495.81395.81
5173650-17365096.50096.50
6157637-15763787.60187.60
60min1173571-17357196.45695.124.3596.4695.124.35
2176300-17630097.97297.97
3167831-16783193.26693.27
4177064-17706498.39798.40
5174739-17473997.10597.10
6157528-15752887.54187.54
极限1172913-17291396.09094.904.1596.0994.904.15
2176709-17670998.20098.20
3166661-16666192.61692.62
4176354-17635498.00298.00
5173589-17358996.46696.47
6158354-15835488.00088.00
氢溴酸伏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%
114.151801261801621799741799951800701800650.05
214.181808501808201808350.02
单位质量响应值RSD%判断
12725.4412752.820.16数据可信
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%
2min1106163-10616358.90473.3010.6158.9073.3010.61
2126083-12608369.95769.96
3142916-14291679.29779.30
4141101-14110178.28978.29
5137751-13775176.43176.43
6138621-13862176.91376.91
5min1166373-16637392.31294.092.1692.3194.092.16
2170003-17000394.32694.33
3169346-16934693.96193.96
4175392-17539297.31697.32
5171191-17119194.98594.98
6165129-16512991.62191.62
10min1172144-17214495.51495.911.2895.5195.911.28
2173379-17337996.19996.20
3171597-17159795.21095.21
4174892-17489297.03897.04
5175508-17550897.38097.38
6169602-16960294.10394.10
15min1172979-17297995.97795.791.4795.9895.791.47
2170090-17009094.37494.37
3171475-17147595.14295.14
4171772-17177295.30795.31
5177440-17744098.45298.45
6172115-17211595.49895.50
20min1173347-17334796.18197.021.2996.1897.021.29
2176934-17693498.17198.17
3173714-17371496.38596.38
4174893-17489397.03997.04
5178063-17806398.79898.80
6172174-17217495.53095.53
30min1170566-17056694.63897.001.7894.6497.001.78
2174673-17467396.91796.92
3173054-17305496.01996.02
4177928-17792898.72398.72
5178865-17886599.24399.24
6173880-17388096.47796.48
45min1172269-17226995.58397.131.3095.5897.141.30
2174644-17464496.90196.90
3174598-17459896.87596.88
4175636-17563697.45197.45
5179109-17910999.37899.38
6174133-17413396.61796.62
60min1173940-17394096.51097.071.2596.5197.071.25
2174230-17423096.67196.67
3172223-17222395.55795.56
4176738-17673898.06398.06
5178278-17827898.91798.92
6174280-17428096.69996.70
极限1173173-17317396.08596.531.2896.0896.531.28
2172809-17280995.88395.88
3170864-17086494.80394.80
4176249-17624997.79197.79
5176768-17676898.07998.08
6174042-17404296.56796.57
氢溴酸伏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%
114.151801651801211801241797691798621800080.10
214.181803921803321803620.03
单位质量响应值RSD%判断
12721.4112719.460.02数据可信
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%
2min1132821-13282173.80470.589.5373.8070.589.52
2128744-12874471.53871.54
3123717-12371768.74568.74
4130104-13010472.29472.29
5141340-14134078.53778.54
6105361-10536158.54558.55
5min1172217-17221795.69494.001.7795.6994.001.77
2171924-17192495.53295.53
3164758-16475891.55091.55
4169975-16997594.44994.45
5169665-16966594.27694.28
6166443-16644392.48692.49
10min1171451-17145195.26995.241.7595.2795.241.75
2174641-17464197.04197.04
3170837-17083794.92894.93
4166289-16628992.40092.40
5174167-17416796.77896.78
6171048-17104895.04595.04
15min1175723-17572397.64396.191.1197.6496.191.10
2174771-17477197.11497.11
3172295-17229595.73895.74
4170735-17073594.87194.87
5173510-17351096.41396.41
6171670-17167095.39095.39
20min1173725-17372596.53296.550.9096.5396.550.90
2175053-17505397.27097.27
3172243-17224395.70995.71
4171556-17155695.32795.33
5175386-17538697.45597.46
6174591-17459197.01497.01
30min1175823-17582397.69896.411.5197.7096.411.51
2176226-17622697.92297.92
3170149-17014994.54594.55
4171356-17135695.21695.22
5175365-17536597.44497.44
6172103-17210395.63195.63
45min1173711-17371196.52596.730.7996.5296.730.79
2176298-17629897.96297.96
3173793-17379396.57096.57
4172078-17207895.61795.62
5174535-17453596.98296.98
6174091-17409196.73696.74
60min1176853-17685398.27096.551.1098.2796.551.10
2173738-17373896.54096.54
3170915-17091594.97194.97
4173090-17309096.18096.18
5174096-17409696.73996.74
6173818-17381896.58496.58
极限1177242-17724298.48796.881.5198.4996.881.51
2174311-17431196.85896.86
3172131-17213195.64795.65
4170474-17047494.72694.73
5176560-17656098.10898.11
6175369-17536997.44697.45
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