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171336-202301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(%)99.9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%
114.181823581823431822961821651822361822800.05
214.231822591822771822680.01
单位质量响应值RSD%判断
12854.7212808.710.26数据可信
供试品溶液-2025102321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%
2min198064-9806454.05662.1714.3954.0662.1714.39
2100820-10082055.57555.58
3124641-12464168.70668.71
4130938-13093872.17772.18
5126618-12661869.79669.80
695598-9559852.69752.70
5min1174226-17422696.03996.830.7496.0496.830.74
2174945-17494596.43596.44
3177587-17758797.89197.89
4175564-17556496.77696.78
5174803-17480396.35796.36
6176808-17680897.46297.46
10min1181154-18115499.858100.020.7399.86100.020.73
2182691-182691100.705100.70
3182389-182389100.538100.54
4182422-182422100.557100.56
5180855-18085599.69399.69
6179227-17922798.79598.80
15min1180587-18058799.545100.200.6599.55100.210.65
2181664-181664100.139100.14
3182832-182832100.783100.78
4182135-182135100.398100.40
5180304-18030499.38999.39
6183183-183183100.976100.98
20min1179917-17991799.17699.990.7899.1899.980.78
2180892-18089299.71399.71
3180945-18094599.74399.74
4183841-183841101.339101.34
5180601-18060199.55399.55
6182128-182128100.395100.39
30min1180224-18022499.345100.290.9799.35100.290.97
2181751-181751100.187100.19
3181363-18136399.97399.97
4182403-182403100.546100.55
5180702-18070299.60999.61
6185148-185148102.059102.06
45min1180412-18041299.449100.511.3899.45100.511.38
2182027-182027100.339100.34
3181592-181592100.099100.10
4182887-182887100.813100.81
5180111-18011199.28399.28
6187020-187020103.091103.09
60min1179857-17985799.143100.411.3099.14100.411.30
2180688-18068899.60199.60
3181293-18129399.93499.93
4183322-183322101.053101.05
5181454-181454100.023100.02
6186348-186348102.721102.72
极限1180034-18003499.240100.090.8399.24100.090.83
2180552-18055299.52699.53
3181229-18122999.89999.90
4182884-182884100.811100.81
5180883-18088399.70899.71
6183891-183891101.366101.37
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171336-202301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(%)99.9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%
114.181819691820721820501825871821541821660.14
214.231826911822201824560.19
单位质量响应值RSD%判断
12846.6912821.930.14数据可信
供试品溶液-2025102321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%
2min1128022-12802270.55568.084.6370.5668.084.63
2125855-12585569.36169.36
3124638-12463868.69068.69
4127520-12752070.27970.28
5122505-12250567.51567.51
6112604-11260462.05862.06
5min1176051-17605197.02596.171.0297.0396.171.02
2173082-17308295.38995.39
3176250-17625097.13597.13
4176012-17601297.00497.00
5173136-17313695.41895.42
6172462-17246295.04795.05
10min1179484-17948498.917100.181.1498.92100.181.14
2180485-18048599.46999.47
3184901-184901101.902101.90
4183487-183487101.123101.12
5181862-181862100.228100.23
6180475-18047599.46399.46
15min1182843-182843100.768100.860.94100.77100.860.95
2183881-183881101.340101.34
3185650-185650102.315102.32
4183244-183244100.989100.99
5181789-181789100.187100.19
6180671-18067199.57199.57
20min1182272-182272100.454100.591.35100.45100.591.35
2181625-181625100.097100.10
3186126-186126102.578102.58
4184171-184171101.500101.50
5182011-182011100.310100.31
6178886-17888698.58798.59
30min1182581-182581100.624100.970.70100.62100.970.70
2184597-184597101.735101.73
3184964-184964101.937101.94
4182963-182963100.834100.83
5182015-182015100.312100.31
6182145-182145100.384100.38
45min1182602-182602100.635100.710.55100.64100.710.55
2182866-182866100.781100.78
3183974-183974101.392101.39
4183591-183591101.180101.18
5182087-182087100.352100.35
6181265-18126599.89999.90
60min1182912-182912100.806101.110.87100.81101.110.87
2184287-184287101.564101.56
3185917-185917102.462102.46
4183828-183828101.311101.31
5181349-18134999.94599.94
6182508-182508100.584100.58
极限1181081-18108199.797100.401.2199.80100.401.20
2182096-182096100.357100.36
3185119-185119102.023102.02
4183627-183627101.200101.20
5178720-17872098.49698.50
6182381-182381100.514100.51
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171336-202301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(%)99.9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%
114.181831421831311831641832831827711830980.11
214.231823381823341823360.01
单位质量响应值RSD%判断
12912.4112813.490.55数据可信
供试品溶液-2025102421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%
2min1125315-12531568.91166.724.8768.9166.724.87
2120858-12085866.46066.46
3118266-11826665.03465.03
4130721-13072171.88371.88
5113953-11395362.66362.66
6118836-11883665.34865.35
5min1177103-17710397.38995.201.7697.3995.201.76
2173791-17379195.56795.57
3168766-16876692.80492.80
4171014-17101494.04094.04
5172482-17248294.84894.85
6175537-17553796.52896.53
10min1183214-183214100.74999.411.41100.7599.411.41
2182213-182213100.199100.20
3177034-17703497.35197.35
4179379-17937998.64098.64
5179472-17947298.69198.69
6183363-183363100.831100.83
15min1184525-184525101.47099.811.43101.4799.801.43
2182400-182400100.302100.30
3178102-17810297.93897.94
4179989-17998998.97698.98
5179815-17981598.88098.88
6184152-184152101.265101.26
20min1185086-185086101.779100.211.46101.78100.211.46
2183122-183122100.699100.70
3178445-17844598.12798.13
4181195-18119599.63999.64
5180508-18050899.26199.26
6185024-185024101.745101.74
30min1184624-184624101.525100.071.44101.52100.071.44
2182668-182668100.449100.45
3178783-17878398.31398.31
4180241-18024199.11499.11
5180316-18031699.15699.16
6185225-185225101.855101.86
45min1184503-184503101.45899.961.41101.4699.961.41
2181609-18160999.86799.87
3178750-17875098.29498.29
4180129-18012999.05399.05
5180534-18053499.27599.28
6185197-185197101.840101.84
60min1184686-184686101.559100.071.35101.56100.081.35
2181316-18131699.70599.71
3179448-17944898.67898.68
4180630-18063099.32899.33
5180440-18044099.22499.22
6185393-185393101.947101.95
极限1184917-184917101.686100.231.38101.69100.231.38
2182518-182518100.366100.37
3179076-17907698.47498.47
4181049-18104999.55999.56
5180614-18061499.31999.32
6185422-185422101.963101.96
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171336-202301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(%)99.9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%
114.181821031821621821951820561821151821260.03
214.231830051831711830880.07
单位质量响应值RSD%判断
12843.8612866.340.13数据可信
供试品溶液-2025102421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%
2min1125002-12500268.77970.271.5268.7870.281.52
2126075-12607569.37069.37
3128204-12820470.54170.54
4130498-13049871.80471.80
5128541-12854170.72770.73
6127996-12799670.42770.43
5min1174465-17446595.99596.470.9696.0096.470.96
2174221-17422195.86195.86
3177837-17783797.85197.85
4173318-17331895.36495.36
5175429-17542996.52696.53
6176653-17665397.19997.20
10min1182014-182014100.149100.231.29100.15100.231.29
2181838-181838100.052100.05
3185163-185163101.882101.88
4178244-17824498.07598.07
5181907-181907100.090100.09
6183803-183803101.133101.13
15min1183640-183640101.044100.991.29101.04101.001.29
2184137-184137101.317101.32
3186376-186376102.549102.55
4179251-17925198.62998.63
5184581-184581101.561101.56
6183322-183322100.869100.87
20min1183215-183215100.810101.001.30100.81101.001.30
2183778-183778101.120101.12
3186202-186202102.453102.45
4179174-17917498.58698.59
5184444-184444101.486101.49
6184535-184535101.536101.54
30min1183711-183711101.083100.911.25101.08100.901.25
2184172-184172101.336101.34
3186164-186164102.432102.43
4179185-17918598.59298.59
5183349-183349100.884100.88
6183765-183765101.112101.11
45min1182123-182123100.209100.711.69100.21100.711.70
2183568-183568101.004101.00
3187504-187504103.170103.17
4177933-17793397.90497.90
5183300-183300100.857100.86
6183815-183815101.140101.14
60min1181117-18111799.655100.251.3199.66100.251.31
2182620-182620100.482100.48
3185659-185659102.155102.15
4178404-17840498.16398.16
5182383-182383100.352100.35
6182971-182971100.676100.68
极限1180813-18081399.488100.311.7099.49100.311.70
2182939-182939100.658100.66
3186899-186899102.837102.84
4177459-17745997.64397.64
5182971-182971100.676100.68
6182754-182754100.556100.56
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