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%
114.531860131862351861051859571856171859850.13
214.561875351879711877530.17
单位质量响应值RSD%判断
12800.0712895.120.53数据可信
供试品溶液-24050601批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min157059-5705931.39229.6410.0231.3929.6410.03
259793-5979332.89632.90
349747-4974727.36927.37
458573-5857332.22532.23
551657-5165728.42028.42
646375-4637525.51425.51
5min1108285-10828559.57559.411.0859.5859.411.08
2108593-10859359.74559.74
3105958-10595858.29558.29
4108179-10817959.51759.52
5107537-10753759.16459.16
6109368-10936860.17160.17
10min1126318-12631869.49670.381.5769.5070.381.57
2126318-12631869.49669.50
3126599-12659969.65169.65
4128635-12863570.77170.77
5128186-12818670.52470.52
6131461-13146172.32672.33
15min1132275-13227572.77473.911.8872.7773.901.88
2134864-13486474.19874.20
3131004-13100472.07472.07
4135748-13574874.68474.68
5134056-13405673.75473.75
6138061-13806175.95775.96
20min1136428-13642875.05975.791.8875.0675.791.88
2138641-13864176.27676.28
3137426-13742675.60875.61
4136963-13696375.35375.35
5134721-13472174.11974.12
6142331-14233178.30678.31
30min1140505-14050577.30277.493.2877.3077.493.28
2133397-13339773.39173.39
3139469-13946976.73276.73
4142997-14299778.67378.67
5141270-14127077.72277.72
6147492-14749281.14681.15
45min1143354-14335478.86980.112.2678.8780.112.25
2145760-14576080.19380.19
3146040-14604080.34780.35
4145928-14592880.28580.29
5141426-14142677.80877.81
6151162-15116283.16583.16
60min1145773-14577380.20081.311.7680.2081.311.76
2147469-14746981.13381.13
3149136-14913682.05082.05
4143996-14399679.22279.22
5149251-14925182.11382.11
6151098-15109883.13083.13
90min1146644-14664480.67982.891.7280.6882.891.72
2149968-14996882.50882.51
3150783-15078382.95682.96
4150269-15026982.67382.67
5151669-15166983.44483.44
6154619-15461985.06785.07
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1145927-14592780.28582.991.7980.2882.991.79
2150140-15014082.60382.60
3151723-15172383.47383.47
4151639-15163983.42783.43
5151784-15178483.50783.51
6153900-15390084.67184.67
极限1144823-14482379.67782.822.1079.6882.822.09
2149913-14991382.47882.48
3152046-15204683.65183.65
4150597-15059782.85482.85
5151780-15178083.50583.50
6154098-15409884.78084.78
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%
114.531864121869871872061870541872771869870.19
214.561882511886431884470.15
单位质量响应值RSD%判断
12869.0312942.790.41数据可信
供试品溶液-24050602批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min157684-5768431.59230.396.2331.5930.396.23
256889-5688931.15731.16
352550-5255028.78128.78
455538-5553830.41730.42
550437-5043727.62327.62
659818-5981832.76132.76
5min1105730-10573057.90658.653.8957.9158.653.89
2110605-11060560.57660.58
3104175-10417557.05557.05
4111567-11156761.10361.10
5100931-10093155.27855.28
6109534-10953459.99059.99
10min1125248-12524868.59668.692.9668.6068.692.97
2130296-13029671.36171.36
3118998-11899865.17365.17
4126107-12610769.06669.07
5124748-12474868.32268.32
6127131-12713169.62769.63
15min1137329-13732975.21272.862.7875.2172.862.78
2130732-13073271.59971.60
3128478-12847870.36570.36
4137698-13769875.41575.41
5132113-13211372.35672.36
6131906-13190672.24272.24
20min1141034-14103477.24275.792.7677.2475.792.75
2140751-14075177.08777.09
3131371-13137171.94971.95
4140831-14083177.13077.13
5136660-13666074.84674.85
6139673-13967376.49676.50
30min1145718-14571879.80778.552.6779.8178.552.67
2145537-14553779.70879.71
3136571-13657174.79774.80
4146999-14699980.50980.51
5141658-14165877.58377.58
6144077-14407778.90878.91
45min1148835-14883581.51480.123.0081.5180.123.00
2149426-14942681.83881.84
3138213-13821375.69775.70
4149748-14974882.01482.01
5144716-14471679.25879.26
6146807-14680780.40380.40
60min1152365-15236583.44781.412.7183.4581.412.71
2150983-15098382.69182.69
3141432-14143277.46077.46
4151354-15135482.89482.89
5147148-14714880.59080.59
6148613-14861381.39381.39
90min1155151-15515184.97383.362.2984.9783.362.29
2153864-15386484.26884.27
3145873-14587379.89279.89
4154913-15491384.84384.84
5150992-15099282.69582.70
6152463-15246383.50183.50
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1156019-15601985.44983.283.0285.4583.283.02
2151167-15116782.79182.79
3143650-14365078.67478.67
4156146-15614685.51885.52
5152460-15246083.49983.50
6152892-15289283.73683.74
极限1157681-15768186.35983.752.4986.3683.752.49
2154927-15492784.85184.85
3148409-14840981.28181.28
4155700-15570085.27485.27
5148878-14887881.53881.54
6151872-15187283.17783.18
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%
114.531870801873871871321868531868591870620.12
214.561856721858261857490.06
单位质量响应值RSD%判断
12874.1912757.490.65数据可信
供试品溶液-24050603批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min146406-4640625.59527.9910.6225.5927.9910.63
249233-4923327.15427.15
360425-6042533.32733.33
447299-4729926.08726.09
553587-5358729.55529.56
647522-4752226.21026.21
5min198928-9892854.56254.652.7254.5654.652.71
299199-9919954.71254.71
399450-9945054.85054.85
4102535-10253556.55256.55
594294-9429452.00752.01
6100106-10010655.21255.21
10min1121897-12189767.23166.481.6267.2366.481.62
2118933-11893365.59665.60
3117657-11765764.89264.89
4122605-12260567.62167.62
5120213-12021366.30266.30
6121874-12187467.21867.22
15min1130601-13060172.03170.832.6472.0370.832.63
2122669-12266967.65667.66
3127514-12751470.32970.33
4128068-12806870.63470.63
5129080-12908071.19271.19
6132645-13264573.15973.16
20min1134810-13481074.35373.771.6174.3573.771.61
2130774-13077472.12772.13
3133152-13315273.43873.44
4134656-13465674.26874.27
5132276-13227672.95572.96
6136873-13687375.49175.49
30min1139749-13974977.07776.752.0677.0876.752.06
2136433-13643375.24875.25
3138632-13863276.46176.46
4139882-13988277.15077.15
5136205-13620575.12275.12
6144021-14402179.43379.43
45min1144552-14455279.72679.001.7879.7379.001.78
2140312-14031277.38777.39
3141518-14151878.05278.05
4143453-14345379.12079.12
5142087-14208778.36678.37
6147454-14745481.32681.33
60min1147411-14741181.30380.342.3181.3080.342.31
2143753-14375379.28579.29
3146369-14636980.72880.73
4145157-14515780.05980.06
5140711-14071177.60777.61
6150614-15061483.06983.07
90min1145789-14578980.40881.881.0780.4181.881.07
2147308-14730881.24681.25
3149582-14958282.50082.50
4148874-14887482.11082.11
5149612-14961282.51782.52
6149619-14961982.52082.52
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1151588-15158883.60683.101.5683.6183.101.56
2146875-14687581.00781.01
3148850-14885082.09682.10
4151720-15172083.67983.68
5153311-15331184.55784.56
6151660-15166083.64683.65
极限1147569-14756981.39082.981.9781.3982.981.96
2149989-14998982.72482.72
3153502-15350284.66284.66
4152649-15264984.19284.19
5146403-14640380.74780.75
6152572-15257284.14984.15
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