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%
114.871876261876161878351876081876491876670.06
214.861875581875831875700.01
单位质量响应值RSD%判断
12620.5112622.480.02数据可信
中间条件3月-供试品溶液-24050601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%
2min1129111-12911172.30464.468.9472.3064.468.95
2109611-10961161.38461.38
3117620-11762065.86965.87
498523-9852355.17555.17
5119672-11967267.01867.02
6116059-11605964.99565.00
5min1163691-16369191.67090.791.3391.6790.781.33
2161325-16132590.34590.34
3165691-16569192.79092.79
4161191-16119190.27090.27
5160869-16086990.09090.09
6159905-15990589.55089.55
10min1171119-17111995.83095.261.3795.8395.261.37
2169067-16906794.68194.68
3173529-17352997.17997.18
4171134-17113495.83895.84
5168930-16893094.60494.60
6166815-16681593.41993.42
15min1172318-17231896.50196.341.2596.5096.341.25
2171429-17142996.00396.00
3175447-17544798.25398.25
4173157-17315796.97196.97
5170341-17034195.39495.39
6169460-16946094.90194.90
20min1173637-17363797.24097.041.3297.2497.041.32
2172384-17238496.53896.54
3176963-17696399.10299.10
4174531-17453197.74097.74
5171303-17130395.93395.93
6170810-17081095.65795.66
30min1174286-17428697.60397.241.4397.6097.241.43
2173343-17334397.07597.08
3177418-17741899.35799.36
4174700-17470097.83597.84
5171745-17174596.18096.18
6170304-17030495.37395.37
45min1174273-17427397.59697.471.4297.6097.481.42
2173754-17375497.30597.31
3177787-17778799.56499.56
4175607-17560798.34398.34
5171934-17193496.28696.29
6170976-17097695.75095.75
60min1174675-17467597.82197.571.5197.8297.571.51
2174104-17410497.50197.50
3178185-17818599.78799.79
4175638-17563898.36098.36
5171730-17173096.17296.17
6171019-17101995.77495.77
极限1174766-17476697.87297.521.4697.8797.521.46
2174000-17400097.44397.44
3178320-17832099.86299.86
4174722-17472297.84797.85
5171751-17175196.18496.18
6171282-17128295.92195.92
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%
114.871876801876581876391877401877421876920.03
214.861877241877991877620.03
单位质量响应值RSD%判断
12622.1912635.400.08数据可信
中间条件3月-供试品溶液-24050602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%
2min1129962-12996272.73967.237.1472.7467.227.14
2105485-10548559.03959.04
3115886-11588664.86164.86
4125216-12521670.08370.08
5123585-12358569.17069.17
6120537-12053767.46467.46
5min1165726-16572692.75692.761.0392.7692.761.03
2166262-16626293.05693.06
3167542-16754293.77293.77
4163699-16369991.62191.62
5163743-16374391.64691.65
6167413-16741393.70093.70
10min1173087-17308796.87697.040.9596.8897.040.95
2174610-17461097.72897.73
3175068-17506897.98597.98
4171633-17163396.06296.06
5171246-17124695.84595.85
6174596-17459697.72097.72
15min1174642-17464297.74698.011.0397.7598.011.03
2176208-17620898.62398.62
3177403-17740399.29199.29
4173860-17386097.30897.31
5172484-17248496.53896.54
6176062-17606298.54198.54
20min1174391-17439197.60698.121.0197.6198.121.00
2176361-17636198.70898.71
3177583-17758399.39299.39
4174141-17414197.46697.47
5172930-17293096.78896.79
6176433-17643398.74998.75
30min1175366-17536698.15198.611.1598.1598.611.15
2177442-17744299.31399.31
3178829-178829100.090100.09
4174536-17453697.68797.69
5173552-17355297.13697.14
6177416-17741699.29999.30
45min1175681-17568198.32898.741.0798.3398.741.07
2177434-17743499.30999.31
3178863-178863100.109100.11
4175340-17534098.13798.14
5173627-17362797.17897.18
6177537-17753799.36699.37
60min1175801-17580198.39598.671.0498.3998.661.05
2177406-17740699.29399.29
3178451-17845199.87899.88
4175388-17538898.16498.16
5173335-17333597.01597.01
6177323-17732399.24799.25
极限1175165-17516598.03998.641.1498.0498.641.14
2176655-17665598.87398.87
3179314-179314100.361100.36
4175643-17564398.30698.31
5173435-17343597.07197.07
6177223-17722399.19199.19
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%
114.871878091878881878331877701877121878020.04
214.861874441874331874380.01
单位质量响应值RSD%判断
12629.5912613.590.09数据可信
中间条件3月-供试品溶液-24050603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%
2min1108668-10866860.85659.585.9160.8659.585.91
2107330-10733060.10660.11
3111489-11148962.43562.44
495090-9509053.25253.25
5111942-11194262.68962.69
6103836-10383658.15058.15
5min1167604-16760493.86192.791.0993.8692.791.09
2164811-16481192.29692.30
3167424-16742493.76093.76
4164000-16400091.84291.84
5166805-16680593.41393.41
6163543-16354391.58691.59
10min1177053-17705399.15298.381.0199.1598.381.01
2173685-17368597.26697.27
3176165-17616598.65598.65
4176526-17652698.85798.86
5177395-17739599.34499.34
6173251-17325197.02397.02
15min1178421-17842199.91899.171.0799.9299.171.07
2174894-17489497.94397.94
3177162-17716299.21399.21
4178237-17823799.81599.82
5179076-179076100.285100.29
6174683-17468397.82597.82
20min1179005-179005100.24599.421.12100.2599.421.12
2175222-17522298.12798.13
3178034-17803499.70299.70
4178527-17852799.97899.98
5179515-179515100.531100.53
6174879-17487997.93597.93
30min1179870-179870100.73099.761.28100.7399.761.28
2176155-17615598.64998.65
3178724-178724100.088100.09
4178876-178876100.173100.17
5180579-180579101.127101.13
6174665-17466597.81597.81
45min1179512-179512100.52999.781.18100.5399.781.18
2176043-17604398.58798.59
3178618-178618100.029100.03
4178460-17846099.94099.94
5180966-180966101.343101.34
6175437-17543798.24798.25
60min1179653-179653100.60899.731.14100.6199.731.15
2175861-17586198.48598.48
3178000-17800099.68299.68
4178921-178921100.198100.20
5180525-180525101.097101.10
6175528-17552898.29898.30
极限1178748-178748100.10199.601.34100.1099.601.34
2175634-17563498.35798.36
3177931-17793199.64499.64
4179192-179192100.350100.35
5180997-180997101.361101.36
6174576-17457697.76597.76
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%
114.871880791881251879351877901879801879820.07
214.861892781893861893320.05
单位质量响应值RSD%判断
12641.6912741.050.56数据可信
中间条件3月-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%
2min1114663-11466363.86162.2510.4663.8662.2510.45
291295-9129550.84650.85
3105335-10533558.66658.67
4123246-12324668.64168.64
5119284-11928466.43466.43
6116803-11680365.05365.05
5min1169101-16910194.18094.350.9494.1894.350.94
2168033-16803393.58593.58
3168455-16845593.82093.82
4168924-16892494.08194.08
5169427-16942794.36194.36
6172483-17248396.06396.06
10min1178385-17838599.35099.041.0099.3599.041.00
2176445-17644598.27098.27
3176999-17699998.57898.58
4176380-17638098.23498.23
5177711-17771198.97598.97
6181074-181074100.848100.85
15min1178680-17868099.51599.350.7599.5199.350.75
2177577-17757798.90098.90
3177733-17773398.98798.99
4177211-17721198.69698.70
5178183-17818399.23899.24
6180894-180894100.748100.75
20min1178827-17882799.59698.561.9699.6098.561.96
2171067-17106795.27595.27
3177822-17782299.03799.04
4175180-17518097.56597.57
5177843-17784399.04899.05
6181054-181054100.837100.84
30min1179119-17911999.75999.450.6899.7699.450.69
2177872-17787299.06599.06
3177668-17766898.95198.95
4177458-17745898.83498.83
5178581-17858199.45999.46
6180695-180695100.637100.64
45min1179107-17910799.75299.390.9299.7599.390.92
2177337-17733798.76798.77
3177214-17721498.69898.70
4177493-17749398.85398.85
5178143-17814399.21699.22
6181447-181447101.056101.06
60min1179149-17914999.77699.380.7199.7899.380.71
2178190-17819099.24299.24
3177461-17746198.83698.84
4176900-17690098.52398.52
5178472-17847299.39999.40
6180457-180457100.504100.50
极限1179762-179762100.11799.610.88100.1299.610.88
2178325-17832599.31799.32
3177790-17779099.01999.02
4177419-17741998.81298.81
5178205-17820599.25099.25
6181573-181573101.126101.13
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%
114.871881491880011881051880691880881880820.03
214.861873571874291873930.03
单位质量响应值RSD%判断
12648.4212610.570.22数据可信
中间条件3月-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%
2min122182-2218212.41416.3423.8112.4116.3423.82
237416-3741620.94020.94
324576-2457613.75413.75
422757-2275712.73612.74
531498-3149817.62817.63
636714-3671420.54820.55
5min1104443-10444358.45359.959.0558.4559.959.05
2117437-11743765.72565.73
3103684-10368458.02858.03
490962-9096250.90850.91
5110653-11065361.92961.93
6115516-11551664.65064.65
10min1150060-15006083.98382.936.2283.9882.936.22
2156123-15612387.37787.38
3142735-14273579.88479.88
4132098-13209873.93173.93
5154725-15472586.59486.59
6153325-15332585.81185.81
15min1162604-16260491.00489.744.2991.0089.744.29
2164603-16460392.12292.12
3156881-15688187.80187.80
4148222-14822282.95582.95
5167357-16735793.66493.66
6162384-16238490.88190.88
20min1167541-16754193.76793.263.1493.7793.263.14
2169653-16965394.94994.95
3163120-16312091.29291.29
4157860-15786088.34988.35
5171823-17182396.16396.16
6169831-16983195.04895.05
30min1169818-16981895.04195.092.2095.0495.102.20
2172621-17262196.61096.61
3167173-16717393.56193.56
4164005-16400591.78891.79
5173838-17383897.29197.29
6172023-17202396.27596.28
45min1171082-17108295.74995.921.9095.7595.921.90
2173583-17358397.14897.15
3169261-16926194.72994.73
4166140-16614092.98392.98
5174585-17458597.70997.71
6173704-17370497.21697.22
60min1171585-17158596.03096.361.3996.0396.361.39
2174471-17447197.64597.65
3170785-17078595.58295.58
4168450-16845094.27594.28
5174604-17460497.72097.72
6173195-17319596.93196.93
极限1174771-17477197.81399.391.2197.8199.391.21
2177227-17722799.18899.19
3178741-178741100.035100.04
4177659-17765999.42999.43
5176142-17614298.58098.58
6180960-180960101.277101.28
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