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%
114.111834221828201835251825791828261830340.23
214.131832911830131831520.11
单位质量响应值RSD%判断
12971.9312961.920.06数据可信
供试品溶液-2816279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%
2min151452-5145228.06628.8526.8528.0728.8526.85
264419-6441935.13935.14
364216-6421635.02935.03
464424-6442435.14235.14
530583-3058316.68216.68
642224-4222423.03223.03
5min174472-7447240.62339.2710.1440.6239.2710.14
277025-7702542.01642.02
371105-7110538.78638.79
473411-7341140.04440.04
557970-5797031.62231.62
677932-7793242.51042.51
10min1113601-11360161.96758.917.5961.9758.917.59
2115367-11536762.93162.93
3109024-10902459.47159.47
4113003-11300361.64161.64
593848-9384851.19251.19
6103157-10315756.27056.27
15min1133519-13351972.83269.705.2372.8369.705.23
2132113-13211372.06572.07
3128121-12812169.88869.89
4128921-12892170.32470.32
5114812-11481262.62862.63
6129178-12917870.46470.46
20min1143041-14304178.02675.734.6178.0375.724.61
2147620-14762080.52480.52
3139701-13970176.20476.20
4138169-13816975.36975.37
5128990-12899070.36270.36
6135414-13541473.86673.87
30min1154649-15464984.35882.453.0184.3682.453.01
2157633-15763385.98685.99
3151078-15107882.41082.41
4148396-14839680.94780.95
5144770-14477078.96978.97
6150368-15036882.02382.02
45min1159047-15904786.75786.863.6586.7686.863.65
2170269-17026992.87992.88
3155409-15540984.77384.77
4156794-15679485.52885.53
5154195-15419584.11184.11
6159656-15965687.08987.09
60min1155398-15539884.76788.303.6084.7788.303.60
2172813-17281394.26694.27
3161057-16105787.85487.85
4159433-15943386.96886.97
5161851-16185188.28788.29
6160682-16068287.64987.65
90min1166487-16648790.81688.612.3190.8288.602.31
2158407-15840786.40886.41
3163988-16398889.45289.45
4157153-15715385.72485.72
5164393-16439389.67389.67
6164185-16418589.56089.56
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1167877-16787791.57491.183.1291.5791.183.12
2177087-17708796.59896.60
3166098-16609890.60390.60
4162619-16261988.70688.71
5163648-16364889.26789.27
6165599-16559990.33190.33
极限1169166-16916692.27790.683.9492.2890.683.94
2177805-17780596.98996.99
3162393-16239388.58288.58
4162928-16292888.87488.87
5159506-15950687.00887.01
6165636-16563690.35190.35
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%
114.111832491837391832401830801832471833110.14
214.131827561821031824300.26
单位质量响应值RSD%判断
12991.5712910.830.45数据可信
供试品溶液-2816279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%
2min125757-2575714.06718.2924.4114.0718.2924.39
237508-3750820.48520.48
344044-4404424.05524.05
433390-3339018.23618.24
537953-3795320.72820.73
622238-2223812.14512.15
5min159756-5975632.63634.6615.3832.6434.6615.38
271210-7121038.89138.89
371629-7162939.12039.12
464133-6413335.02635.03
568302-6830237.30337.30
645799-4579925.01325.01
10min198970-9897054.05257.914.9054.0557.914.90
2109754-10975459.94259.94
3109832-10983259.98559.98
499842-9984254.52954.53
5109866-10986660.00360.00
6107962-10796258.96358.96
15min1117817-11781764.34668.163.7864.3568.163.78
2125773-12577368.69168.69
3130949-13094971.51871.52
4121382-12138266.29366.29
5128256-12825670.04770.05
6124668-12466868.08768.09
20min1129896-12989670.94373.432.7270.9473.432.72
2140045-14004576.48576.49
3135269-13526973.87773.88
4132118-13211872.15672.16
5132653-13265372.44872.45
6136701-13670174.65974.66
30min1142946-14294678.07081.253.8678.0781.253.86
2152729-15272983.41383.41
3157630-15763086.09086.09
4144129-14412978.71678.72
5150026-15002681.93781.94
6145158-14515879.27879.28
45min1151391-15139182.68285.331.9782.6885.331.97
2155532-15553284.94484.94
3158503-15850386.56686.57
4160403-16040387.60487.60
5156320-15632085.37485.37
6155340-15534084.83984.84
60min1154349-15434984.29887.943.5284.3087.943.52
2157738-15773886.14986.15
3170429-17042993.08093.08
4163189-16318989.12689.13
5162485-16248588.74188.74
6157890-15789086.23286.23
90min1158764-15876486.70989.233.3886.7189.233.38
2163664-16366489.38589.38
3174133-17413395.10395.10
4161198-16119888.03888.04
5162061-16206188.51088.51
6160489-16048987.65187.65
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1163968-16396889.55189.402.1689.5589.402.16
2165771-16577190.53690.54
3167199-16719991.31691.32
4166240-16624090.79290.79
5160815-16081587.82987.83
6158149-15814986.37386.37
极限1162446-16244688.72090.162.1588.7290.162.15
2163076-16307689.06489.06
3170398-17039893.06393.06
4167508-16750891.48491.48
5166087-16608790.70890.71
6161013-16101387.93787.94
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%
114.111832921829341830801829841827691830120.11
214.131846761838811842780.31
单位质量响应值RSD%判断
12970.3813041.610.39数据可信
供试品溶液-2025102321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%
2min182431-8243144.83047.2610.3644.8347.2610.36
294637-9463751.46851.47
398190-9819053.40053.40
487208-8720847.42847.43
572865-7286539.62739.63
686053-8605346.80046.80
5min195262-9526251.80852.381.7651.8152.381.76
296601-9660152.53652.54
398897-9889753.78553.78
494173-9417351.21651.22
597455-9745553.00153.00
695542-9554251.96051.96
10min1126046-12604668.55069.035.5968.5569.035.59
2125913-12591368.47768.48
3129498-12949870.42770.43
4114276-11427662.14962.15
5130632-13063271.04471.04
6135238-13523873.54973.55
15min1134929-13492973.38175.721.8173.3875.721.81
2138203-13820375.16175.16
3142505-14250577.50177.50
4139886-13988676.07776.08
5139736-13973675.99576.00
6140087-14008776.18676.19
20min1138089-13808975.09979.953.2475.1079.953.24
2145554-14555479.15979.16
3149011-14901181.03981.04
4149796-14979681.46681.47
5148313-14831380.66080.66
6151272-15127282.26982.27
30min1145216-14521678.97582.832.3978.9882.832.39
2151764-15176482.53682.54
3154741-15474184.15584.16
4153648-15364883.56183.56
5153903-15390383.70083.70
6154571-15457184.06384.06
45min1151476-15147682.38084.282.1382.3884.282.13
2150620-15062081.91481.91
3155361-15536184.49384.49
4155890-15589084.78084.78
5158614-15861486.26286.26
6157914-15791485.88185.88
60min1154679-15467984.12285.552.3384.1285.542.32
2151838-15183882.57782.58
3158692-15869286.30486.30
4157172-15717285.47885.48
5159145-15914586.55186.55
6162256-16225688.24288.24
90min1158093-15809385.97886.371.3885.9886.371.38
2156668-15666885.20385.20
3158471-15847186.18486.18
4159346-15934686.66086.66
5157476-15747685.64385.64
6162858-16285888.57088.57
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1150676-15067681.94585.423.0881.9485.423.08
2159582-15958286.78886.79
3160541-16054187.31087.31
4153743-15374383.61383.61
5154465-15446584.00584.01
6163344-16334488.83488.83
极限1158758-15875886.34086.600.5286.3486.600.52
2159288-15928886.62886.63
3159567-15956786.78086.78
4157862-15786285.85385.85
5160012-16001287.02287.02
6159946-15994686.98686.99
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%
114.111832661833401831101832411830401831990.07
214.131834821833691834260.05
单位质量响应值RSD%判断
12983.6312981.320.02数据可信
供试品溶液-2025102321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%
2min150707-5070727.62728.728.4327.6328.728.43
255756-5575630.37730.38
351493-5149328.05528.05
446277-4627725.21325.21
559220-5922032.26532.26
652842-5284228.79028.79
5min193717-9371751.06053.583.0951.0653.583.09
298954-9895453.91353.91
3101812-10181255.47055.47
495946-9594652.27452.27
5100863-10086354.95354.95
698734-9873453.79353.79
10min1127658-12765869.55271.402.4569.5571.402.45
2133535-13353572.75472.75
3128068-12806869.77569.78
4132016-13201671.92671.93
5135619-13561973.88973.89
6129364-12936470.48170.48
15min1144036-14403678.47578.111.5378.4778.111.53
2145188-14518879.10379.10
3139971-13997176.26076.26
4144629-14462978.79878.80
5145065-14506579.03679.04
6141313-14131376.99176.99
20min1147745-14774580.49681.221.8180.5081.221.81
2152495-15249583.08483.08
3148254-14825480.77380.77
4148092-14809280.68580.68
5152190-15219082.91782.92
6145713-14571379.38979.39
30min1154011-15401183.91083.732.1283.9183.732.12
2156127-15612785.06285.06
3149644-14964481.53081.53
4156746-15674685.40085.40
5155895-15589584.93684.94
6149672-14967281.54681.55
45min1159806-15980687.06785.342.3087.0785.342.30
2160102-16010287.22887.23
3156761-15676185.40885.41
4156468-15646885.24885.25
5156539-15653985.28785.29
6150119-15011981.78981.79
60min1160602-16060287.50187.321.2187.5087.321.21
2160447-16044787.41687.42
3159342-15934286.81486.81
4157106-15710685.59685.60
5162841-16284188.72088.72
6161299-16129987.88087.88
90min1153667-15366783.72287.192.2483.7287.182.24
2163034-16303488.82688.83
3162838-16283888.71988.72
4158221-15822186.20386.20
5161778-16177888.14188.14
6160603-16060387.50187.50
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1156803-15680385.43186.971.3285.4386.971.32
2160243-16024387.30587.30
3162343-16234388.44988.45
4161100-16110087.77287.77
5159715-15971587.01787.02
6157617-15761785.87485.87
极限1161665-16166588.08087.502.5588.0887.502.55
2152802-15280283.25183.25
3161699-16169988.09888.10
4159937-15993787.13887.14
5163872-16387289.28289.28
6163603-16360389.13689.14
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