氢溴酸伏硫西汀片项目信息
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%
114.171804771805241805371800391800641803280.15
214.061807671807451807560.01
单位质量响应值RSD%判断
12726.0412856.050.72数据可信
供试品溶液-2733947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%
2min11612-16120.8918.0261.180.898.0261.19
225738-2573814.22314.22
322042-2204212.18112.18
411243-112436.2136.21
59289-92895.1335.13
617157-171579.4819.48
5min1133518-13351873.78373.806.5073.7873.816.50
2134770-13477074.47574.48
3141393-14139378.13578.14
4118163-11816365.29865.30
5131478-13147872.65672.66
6142011-14201178.47778.48
10min1174802-17480296.59796.651.3196.6096.641.31
2173709-17370995.99395.99
3178486-17848698.63398.63
4173563-17356395.91295.91
5172239-17223995.18195.18
6176543-17654397.55997.56
15min1179523-17952399.20699.931.3699.2199.931.36
2179052-17905298.94698.95
3183676-183676101.501101.50
4182774-182774101.003101.00
5177516-17751698.09798.10
6182405-182405100.799100.80
20min1179952-17995299.443100.521.4799.44100.521.47
2180126-18012699.53999.54
3184756-184756102.098102.10
4184941-184941102.200102.20
5178721-17872198.76398.76
6182932-182932101.090101.09
30min1180360-18036099.669100.661.5699.67100.661.56
2180078-18007899.51399.51
3185664-185664102.600102.60
4185391-185391102.449102.45
5179021-17902198.92998.93
6182448-182448100.822100.82
45min1179174-17917499.013100.841.9699.01100.841.97
2180402-18040299.69299.69
3184757-184757102.098102.10
4188070-188070103.929103.93
5179098-17909898.97198.97
6183389-183389101.342101.34
60min1180210-18021099.586101.222.1999.59101.222.19
2180352-18035299.66499.66
3186565-186565103.098103.10
4189239-189239104.575104.58
5179293-17929399.07999.08
6183331-183331101.310101.31
极限1180260-18026099.613101.492.4999.61101.502.49
2180537-18053799.76699.77
3186572-186572103.101103.10
4191257-191257105.690105.69
5179541-17954199.21699.22
6183817-183817101.579101.58
氢溴酸伏硫西汀片项目信息
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%
114.171802171803711803711799721798671801600.13
214.061814431813781814100.03
单位质量响应值RSD%判断
12714.1812902.561.04数据可信
供试品溶液-2733947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%
2min126500-2650014.62511.6257.5714.6211.6257.55
242590-4259023.50423.50
320658-2065811.40111.40
410489-104895.7895.79
512573-125736.9396.94
613494-134947.4477.45
5min1142597-14259778.69673.8313.1778.7073.8313.16
2147414-14741481.35481.35
3141087-14108777.86377.86
498947-9894754.60754.61
5138171-13817176.25376.25
6134446-13444674.19874.20
10min1174452-17445296.27695.461.0396.2895.461.03
2170807-17080794.26494.26
3173275-17327595.62695.63
4171329-17132994.55394.55
5175401-17540196.80096.80
6172536-17253695.21995.22
15min1178459-17845998.48798.721.5698.4998.721.56
2175032-17503296.59696.60
3177793-17779398.12098.12
4181670-181670100.259100.26
5182536-182536100.737100.74
6177788-17778898.11798.12
20min1180798-18079899.77899.381.5899.7899.381.58
2175162-17516296.66896.67
3179057-17905798.81798.82
4182068-182068100.479100.48
5183322-183322101.171101.17
6180035-18003599.35799.36
30min1180976-18097699.87699.661.7599.8899.661.75
2176672-17667297.50197.50
3177159-17715997.77097.77
4184358-184358101.743101.74
5183404-183404101.216101.22
6180970-18097099.87399.87
45min1181235-181235100.01999.931.83100.0299.931.83
2176493-17649397.40297.40
3178050-17805098.26298.26
4185034-185034102.116102.12
5183948-183948101.517101.52
6181672-181672100.261100.26
60min1181256-181256100.031100.171.62100.03100.171.62
2177633-17763398.03298.03
3179161-17916198.87598.87
4185565-185565102.409102.41
5183907-183907101.494101.49
6181530-181530100.182100.18
极限1181492-181492100.161100.351.58100.16100.351.58
2178637-17863798.58698.59
3179218-17921898.90698.91
4185975-185975102.635102.64
5184364-184364101.746101.75
6181272-181272100.040100.04
氢溴酸伏硫西汀片项目信息
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%
114.171800381800521801271799371800431800390.04
214.061799331798731799030.03
单位质量响应值RSD%判断
12705.6512795.380.50数据可信
供试品溶液-2757904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%
2min124654-2465413.66718.2228.2413.6718.2228.24
249335-4933527.34927.35
334126-3412618.91818.92
433229-3322918.42118.42
532521-3252118.02818.03
623363-2336312.95112.95
5min1147017-14701781.50078.684.6881.5078.684.68
2148242-14824282.17982.18
3144955-14495580.35780.36
4140841-14084178.07678.08
5140563-14056377.92277.92
6130009-13000972.07272.07
10min1176099-17609997.62296.171.5297.6296.171.52
2174514-17451496.74396.74
3173065-17306595.94095.94
4174134-17413496.53396.53
5174571-17457196.77596.77
6168504-16850493.41293.41
15min1180541-180541100.08498.801.02100.0898.791.03
2178861-17886199.15399.15
3177364-17736498.32398.32
4179882-17988299.71999.72
5176501-17650197.84597.84
6176156-17615697.65497.65
20min1182103-182103100.950100.001.28100.95100.001.28
2179762-17976299.65399.65
3177999-17799998.67598.68
4180354-18035499.98199.98
5183940-183940101.969101.97
6178164-17816498.76798.77
30min1183259-183259101.591101.101.22101.59101.101.22
2181664-181664100.707100.71
3179791-17979199.66999.67
4183126-183126101.517101.52
5185897-185897103.054103.05
6180466-180466100.043100.04
45min1183980-183980101.991101.021.21101.99101.021.20
2182201-182201101.005101.00
3179840-17984099.69699.70
4180745-180745100.197100.20
5185611-185611102.895102.89
6180996-180996100.337100.34
60min1182897-182897101.390101.201.04101.39101.201.04
2182415-182415101.123101.12
3179752-17975299.64799.65
4183290-183290101.608101.61
5185424-185424102.791102.79
6181522-181522100.628100.63
极限1183126-183126101.517100.931.78101.52100.931.78
2181928-181928100.853100.85
3179410-17941099.45799.46
4183390-183390101.664101.66
5186845-186845103.579103.58
6177678-17767898.49798.50
氢溴酸伏硫西汀片项目信息
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%
114.171805841806351807121808431807841807120.06
214.061800481801061800770.03
单位质量响应值RSD%判断
12753.1412807.750.31数据可信
供试品溶液-2757904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%
2min125418-2541814.05817.2146.9814.0617.2047.00
215016-150168.3058.30
349284-4928427.25727.26
449398-4939827.32027.32
525226-2522613.95113.95
622320-2232012.34412.34
5min1135476-13547674.92678.423.5974.9378.423.59
2137903-13790376.26876.27
3147470-14747081.55981.56
4147949-14794981.82481.82
5139768-13976877.29977.30
6142210-14221078.65078.65
10min1174330-17433096.41496.051.4196.4196.051.41
2171061-17106194.60694.61
3172364-17236495.32795.33
4171655-17165594.93594.93
5177535-17753598.18798.19
6175069-17506996.82396.82
15min1178741-17874198.85498.701.9698.8598.701.95
2176755-17675597.75597.76
3178889-17888998.93698.94
4175687-17568797.16597.16
5184976-184976102.302102.30
6175765-17576597.20897.21
20min1180584-18058499.87399.891.8599.8799.901.85
2177705-17770598.28198.28
3179721-17972199.39699.40
4177158-17715897.97897.98
5186197-186197102.977102.98
6182368-182368100.860100.86
30min1181563-181563100.414100.202.06100.41100.202.06
2177603-17760398.22498.22
3180280-18028099.70599.70
4177249-17724998.02998.03
5187199-187199103.531103.53
6183152-183152101.293101.29
45min1181163-181163100.193100.302.25100.19100.302.25
2178201-17820198.55598.56
3180489-18048999.82099.82
4176785-17678597.77297.77
5188275-188275104.127104.13
6183198-183198101.319101.32
60min1180773-18077399.977100.202.1399.98100.202.13
2178002-17800298.44598.44
3180489-18048999.82099.82
4176986-17698697.88397.88
5187644-187644103.778103.78
6183128-183128101.280101.28
极限1181386-181386100.317100.312.09100.32100.312.09
2178193-17819398.55198.55
3180125-18012599.61999.62
4177631-17763198.24098.24
5187955-187955103.950103.95
6182981-182981101.199101.20
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