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%
114.151822411821741823091822831819771821970.08
214.161834941835921835430.04
单位质量响应值RSD%判断
12876.1112962.080.48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%
2min1128281-12828170.18669.163.4470.1969.163.44
2129956-12995671.10271.10
3126721-12672169.33269.33
4127276-12727669.63669.64
5117831-11783164.46864.47
6128334-12833470.21570.21
5min1161754-16175488.49990.141.2588.5090.141.24
2166673-16667391.19191.19
3163830-16383089.63589.64
4167387-16738791.58191.58
5164730-16473090.12890.13
6164115-16411589.79189.79
10min1165153-16515390.35991.831.8090.3691.831.79
2172911-17291194.60494.60
3165898-16589890.76790.77
4169949-16994992.98392.98
5167258-16725891.51191.51
6165930-16593090.78490.78
15min1165030-16503090.29291.882.2790.2991.882.26
2174119-17411995.26595.26
3167067-16706791.40691.41
4170148-17014893.09293.09
5167795-16779591.80591.80
6163492-16349289.45089.45
20min1165084-16508490.32192.412.0190.3292.412.01
2174693-17469395.57995.58
3168455-16845592.16692.17
4170478-17047893.27393.27
5168231-16823192.04392.04
6166446-16644691.06791.07
30min1166187-16618790.92592.611.9290.9292.611.92
2174998-17499895.74695.75
3168285-16828592.07392.07
4170779-17077993.43793.44
5168684-16868492.29192.29
6166715-16671591.21491.21
45min1165974-16597490.80892.952.2790.8192.952.27
2176372-17637296.49796.50
3167848-16784891.83491.83
4172260-17226094.24894.25
5169585-16958592.78492.78
6167297-16729791.53291.53
60min1166357-16635791.01892.721.7891.0292.721.78
2174729-17472995.59895.60
3167737-16773791.77391.77
4170818-17081893.45993.46
5169421-16942192.69492.69
6167714-16771491.76091.76
极限1165868-16586890.75093.242.5090.7593.242.50
2176257-17625796.43496.43
3168070-16807091.95591.96
4175075-17507595.78895.79
5169678-16967892.83592.83
6167566-16756691.67991.68
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%
114.151833621831151829791829081829491830630.11
214.161824571824901824740.02
单位质量响应值RSD%判断
12937.3112886.580.28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%
2min1123077-12307767.37562.398.1967.3862.398.19
2115130-11513063.02563.02
3121023-12102366.25166.25
4117271-11727164.19764.20
597450-9745053.34653.35
6109860-10986060.14060.14
5min1165174-16517490.42091.471.4290.4291.471.41
2171538-17153893.90493.90
3166797-16679791.30891.31
4165490-16549090.59390.59
5165936-16593690.83790.84
6167665-16766591.78491.78
10min1170954-17095493.58495.101.5593.5895.101.55
2178226-17822697.56597.56
3172003-17200394.15894.16
4172070-17207094.19594.19
5175254-17525495.93895.94
6173788-17378895.13595.14
15min1172833-17283394.61396.061.5394.6196.061.54
2180091-18009198.58698.59
3174078-17407895.29495.29
4173592-17359295.02895.03
5176950-17695096.86696.87
6175361-17536195.99796.00
20min1173279-17327994.85796.281.5694.8696.281.56
2180651-18065198.89298.89
3174611-17461195.58695.59
4173682-17368295.07795.08
5177033-17703396.91296.91
6176026-17602696.36196.36
30min1173128-17312894.77496.371.6194.7796.371.61
2181033-18103399.10299.10
3174873-17487395.72995.73
4174137-17413795.32795.33
5177269-17726997.04197.04
6175806-17580696.24096.24
45min1172994-17299494.70196.341.5594.7096.341.55
2180564-18056498.84598.84
3175146-17514695.87995.88
4174005-17400595.25495.25
5177508-17750897.17297.17
6175670-17567096.16696.17
60min1173798-17379895.14196.241.5495.1496.241.54
2180822-18082298.98698.99
3174974-17497495.78595.78
4173262-17326294.84894.85
5176266-17626696.49296.49
6175688-17568896.17696.18
极限1172274-17227494.30796.161.6794.3196.161.67
2180828-18082898.98998.99
3174999-17499995.79895.80
4173796-17379695.14095.14
5176506-17650696.62396.62
6175586-17558696.12096.12
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%
114.151824581825431824571823731823381824340.05
214.161828281826481827380.07
单位质量响应值RSD%判断
12892.8612905.230.07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%
2min1111034-11103460.84363.366.2860.8463.366.28
2123569-12356967.71267.71
3107114-10711458.69558.70
4123457-12345767.65167.65
5118866-11886665.13565.13
6109736-10973660.13260.13
5min1168011-16801192.06591.871.1192.0691.871.10
2170181-17018193.25493.25
3167156-16715691.59691.60
4166957-16695791.48791.49
5164767-16476790.28790.29
6168847-16884792.52392.52
10min1175046-17504695.92096.211.0895.9296.211.08
2178179-17817997.63697.64
3176382-17638296.65296.65
4175173-17517395.98995.99
5172470-17247094.50894.51
6176200-17620096.55296.55
15min1175580-17558096.21296.931.0596.2196.931.05
2179248-17924898.22298.22
3178359-17835997.73597.74
4176468-17646896.69996.70
5174246-17424695.48195.48
6177461-17746197.24397.24
20min1176765-17676596.86297.100.9296.8697.100.92
2179219-17921998.20698.21
3178603-17860397.86997.87
4176444-17644496.68696.69
5174690-17469095.72595.72
6177443-17744397.23397.23
30min1177269-17726997.13897.370.9897.1497.370.98
2179681-17968198.45998.46
3179095-17909598.13898.14
4176910-17691096.94196.94
5174868-17486895.82295.82
6178358-17835897.73597.73
45min1177324-17732497.16897.441.0797.1797.441.07
2179942-17994298.60298.60
3179342-17934298.27498.27
4176654-17665496.80196.80
5174887-17488795.83395.83
6178727-17872797.93797.94
60min1177207-17720797.10497.341.1497.1097.341.14
2179671-17967198.45498.45
3179004-17900498.08898.09
4177014-17701496.99897.00
5174113-17411395.40895.41
6178770-17877097.96097.96
极限1175927-17592796.40297.051.0296.4097.041.02
2179431-17943198.32298.32
3178260-17826097.68197.68
4176160-17616096.53096.53
5174662-17466295.70995.71
6178163-17816397.62897.63
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