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%
114.531856531854911853051860181858651856660.16
214.561859431869771864600.40
单位质量响应值RSD%判断
12778.1112806.320.16数据可信
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%
2min1136433-13643375.38568.559.3075.3968.559.30
2126297-12629769.78569.78
3115982-11598264.08564.09
4138722-13872276.65076.65
5114315-11431563.16463.16
6112584-11258462.20862.21
5min1168219-16821992.94991.311.7792.9591.301.77
2163452-16345290.31590.31
3163312-16331290.23790.24
4165477-16547791.43391.43
5161867-16186789.43989.44
6169144-16914493.46093.46
10min1173406-17340695.81594.021.5795.8194.021.57
2169553-16955393.68693.69
3167775-16777592.70392.70
4168510-16851093.10993.11
5168107-16810792.88792.89
6173640-17364095.94495.94
15min1174211-17421196.25994.791.4296.2694.791.42
2171176-17117694.58294.58
3168932-16893293.34293.34
4170424-17042494.16794.17
5169725-16972593.78193.78
6174840-17484096.60796.61
20min1174387-17438796.35795.201.1296.3695.201.12
2172117-17211795.10295.10
3170508-17050894.21394.21
4170721-17072194.33194.33
5171089-17108994.53494.53
6174926-17492696.65496.65
30min1175188-17518896.79995.571.3096.8095.571.30
2173131-17313195.66395.66
3171341-17134194.67494.67
4171002-17100294.48694.49
5171003-17100394.48794.49
6176116-17611697.31297.31
45min1175521-17552196.98395.531.2596.9895.531.25
2173057-17305795.62295.62
3171979-17197995.02695.03
4170627-17062794.27994.28
5170821-17082194.38694.39
6175372-17537296.90196.90
60min1176409-17640997.47495.731.2997.4795.731.29
2173182-17318295.69195.69
3171745-17174594.89794.90
4172011-17201195.04495.04
5170723-17072394.33294.33
6175431-17543196.93396.93
极限1176096-17609697.30196.001.1097.3096.001.09
2174521-17452196.43196.43
3172637-17263795.39095.39
4172178-17217895.13695.14
5171509-17150994.76694.77
6175523-17552396.98496.98
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%
114.531864691863781862371859691863621862830.11
214.561852271852331852300.01
单位质量响应值RSD%判断
12820.5812721.840.55数据可信
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%
2min1130752-13075272.36670.024.0872.3770.024.08
2126224-12622469.86069.86
3124488-12448868.89968.90
4132695-13269573.44273.44
5118015-11801565.31765.32
6126857-12685770.21070.21
5min1170221-17022194.21191.691.4894.2191.691.48
2163845-16384590.68290.68
3163860-16386090.69090.69
4164948-16494891.29291.29
5164621-16462191.11191.11
6166518-16651892.16192.16
10min1175209-17520996.97194.961.2396.9794.961.24
2169900-16990094.03394.03
3169176-16917693.63293.63
4172240-17224095.32895.33
5171393-17139394.85994.86
6171505-17150594.92194.92
15min1176613-17661397.74895.771.1397.7595.771.13
2171416-17141694.87294.87
3171371-17137194.84794.85
4172557-17255795.50495.50
5172676-17267695.56995.57
6173620-17362096.09296.09
20min1176947-17694797.93395.961.1597.9395.961.14
2171078-17107894.68594.69
3172155-17215595.28195.28
4173412-17341295.97795.98
5173253-17325395.88995.89
6173484-17348496.01796.02
30min1177975-17797598.50296.371.2198.5096.371.21
2171777-17177795.07295.07
3172808-17280895.64395.64
4173983-17398396.29396.29
5173973-17397396.28796.29
6174228-17422896.42896.43
45min1178444-17844498.76296.291.3598.7696.291.35
2171655-17165595.00495.00
3173092-17309295.80095.80
4173256-17325695.89095.89
5173131-17313195.82195.82
6174304-17430496.47196.47
60min1178014-17801498.52496.351.2698.5296.351.26
2171383-17138394.85494.85
3173617-17361796.09096.09
4173255-17325595.89095.89
5173942-17394296.27096.27
6174285-17428596.46096.46
极限1177826-17782698.42096.461.3598.4296.461.35
2171753-17175395.05995.06
3176237-17623797.54097.54
4172528-17252895.48895.49
5173032-17303295.76795.77
6174346-17434696.49496.49
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%
114.531877881873681872521866661874211872990.22
214.561900681903261901970.10
单位质量响应值RSD%判断
12890.5013062.980.94数据可信
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%
2min1122794-12279466.88765.454.0066.8965.454.00
2117891-11789164.21764.22
3120026-12002665.37965.38
4127333-12733369.36069.36
5112986-11298661.54561.54
6119868-11986865.29365.29
5min1169766-16976692.47391.351.0192.4791.351.01
2167116-16711691.03091.03
3167845-16784591.42791.43
4169481-16948192.31892.32
5165434-16543490.11490.11
6166559-16655990.72790.73
10min1176301-17630196.03395.340.8996.0395.340.89
2173281-17328194.38894.39
3175935-17593595.83495.83
4176956-17695696.39096.39
5173796-17379694.66994.67
6173907-17390794.72994.73
15min1177423-17742396.64495.891.0096.6495.890.99
2175281-17528195.47895.48
3177864-17786496.88596.88
4176756-17675696.28196.28
5175882-17588295.80595.80
6173057-17305794.26694.27
20min1177627-17762796.75596.321.0196.7696.321.01
2174785-17478595.20795.21
3178959-17895997.48197.48
4178488-17848897.22497.22
5176133-17613395.94295.94
6175024-17502495.33895.34
30min1178360-17836097.15596.351.4497.1596.351.44
2172976-17297694.22294.22
3178843-17884397.41897.42
4179221-17922197.62497.62
5177339-17733996.59996.60
6174598-17459895.10595.11
45min1180060-18006098.08196.901.4398.0896.901.43
2176637-17663796.21696.22
3180287-18028798.20498.20
4180025-18002598.06298.06
5175805-17580595.76395.76
6174558-17455895.08495.08
60min1178627-17862797.30096.601.2197.3096.601.21
2175319-17531995.49895.50
3179458-17945897.75397.75
4179699-17969997.88497.88
5175718-17571895.71695.72
6175198-17519895.43295.43
极限1177975-17797596.94596.571.1596.9496.571.16
2174851-17485195.24395.24
3179918-17991898.00398.00
4179133-17913397.57697.58
5176387-17638796.08096.08
6175494-17549495.59495.59
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