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%
114.871809121809751810061809681809191809560.03
214.861812711814481813600.07
单位质量响应值RSD%判断
12169.2012204.580.21数据可信
中间条件3月-供试品溶液-24050601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%
2min142178-4217824.46325.935.2524.4625.935.27
244790-4479025.97825.98
345840-4584026.58726.59
445596-4559626.44526.45
541817-4181724.25324.25
647976-4797627.82627.83
5min188822-8882251.51655.485.1051.5255.485.10
2101854-10185459.07459.07
394877-9487755.02855.03
4100675-10067558.39158.39
593035-9303553.95953.96
694642-9464254.89154.89
10min1103589-10358960.08165.564.4960.0865.564.49
2117044-11704467.88467.88
3113896-11389666.05966.06
4117771-11777168.30668.31
5112994-11299465.53565.54
6112888-11288865.47465.47
15min1118110-11811068.50371.053.4868.5071.053.49
2127670-12767074.04774.05
3120508-12050869.89369.89
4127858-12785874.15674.16
5119130-11913069.09469.09
6121710-12171070.59170.59
20min1123806-12380671.80673.773.8371.8173.773.83
2132316-13231676.74276.74
3124060-12406071.95471.95
4133832-13383277.62177.62
5127142-12714273.74173.74
6122021-12202170.77170.77
30min1129970-12997075.38177.313.4175.3877.323.41
2137875-13787579.96679.97
3128594-12859474.58374.58
4139877-13987781.12781.13
5132413-13241376.79876.80
6131096-13109676.03476.03
45min1134175-13417577.82080.143.0377.8280.143.03
2143037-14303782.96082.96
3134117-13411777.78777.79
4143532-14353283.24783.25
5136675-13667579.27079.27
6137480-13748079.73779.74
60min1136458-13645879.14481.583.2579.1481.583.26
2148167-14816785.93585.94
3136186-13618678.98778.99
4143552-14355283.25983.26
5139313-13931380.80080.80
6140255-14025581.34781.35
90min1139902-13990281.14284.252.5581.1484.252.55
2146683-14668385.07585.07
3143390-14339083.16583.16
4151023-15102387.59287.59
5145907-14590784.62584.62
6144683-14468383.91583.91
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1142713-14271382.77285.173.6182.7785.173.61
2152069-15206988.19988.20
3145478-14547884.37684.38
4153348-15334888.94088.94
5139702-13970281.02681.03
6147777-14777785.70985.71
极限1142741-14274182.78885.742.9082.7985.742.90
2152453-15245388.42188.42
3145621-14562184.45984.46
4153610-15361089.09289.09
5145469-14546984.37184.37
6147093-14709385.31385.31
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%
114.871818301819451819721817141818451818610.06
214.861809791808881809340.04
单位质量响应值RSD%判断
12230.0612175.910.32数据可信
中间条件3月-供试品溶液-24050602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%
2min142588-4258824.66823.876.1324.6723.876.13
241025-4102523.76323.76
336831-3683121.33421.33
443804-4380425.37225.37
542903-4290324.85124.85
640140-4014023.25023.25
5min199810-9981057.81354.767.4557.8154.767.45
299761-9976157.78457.78
381724-8172447.33747.34
498698-9869857.16957.17
595807-9580755.49455.49
691449-9144952.97052.97
10min1118790-11879068.80665.785.7568.8165.785.75
2118554-11855468.67068.67
3107553-10755362.29862.30
4118063-11806368.38568.39
5114953-11495366.58466.58
6103466-10346659.93059.93
15min1128380-12838074.36171.893.5774.3671.893.57
2128722-12872274.55974.56
3116917-11691767.72167.72
4125383-12538372.62572.63
5123228-12322871.37771.38
6122063-12206370.70270.70
20min1133097-13309777.09374.873.3277.0974.873.32
2135139-13513978.27678.28
3123429-12342971.49371.49
4129474-12947474.99574.99
5127047-12704773.58973.59
6127409-12740973.79973.80
30min1136855-13685579.27078.244.1879.2778.244.18
2141665-14166582.05682.06
3126203-12620373.10073.10
4139181-13918180.61780.62
5135562-13556278.52178.52
6131008-13100875.88375.88
45min1143897-14389783.34981.852.8783.3581.852.87
2143531-14353183.13783.14
3133794-13379477.49777.50
4144912-14491283.93783.94
5140403-14040381.32581.33
6141278-14127881.83281.83
60min1148734-14873486.15183.823.1986.1583.823.18
2147871-14787185.65185.65
3137523-13752379.65779.66
4147977-14797785.71285.71
5145523-14552384.29184.29
6140612-14061281.44681.45
90min1147281-14728185.30985.312.5585.3185.322.55
2150716-15071687.29987.30
3140410-14041081.32981.33
4148870-14887086.23086.23
5150064-15006486.92186.92
6146400-14640084.79984.80
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1154840-15484089.68886.483.3689.6986.483.36
2153328-15332888.81288.81
3141335-14133581.86581.87
4151853-15185387.95787.96
5147101-14710185.20585.20
6147367-14736785.35985.36
极限1152183-15218388.14987.082.3688.1587.082.36
2154310-15431089.38189.38
3144949-14494983.95883.96
4152320-15232088.22888.23
5151092-15109287.51787.52
6147192-14719285.25885.26
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%
114.871808441809251809511808131808541808770.04
214.861813111814991814050.08
单位质量响应值RSD%判断
12163.8912207.600.26数据可信
中间条件3月-供试品溶液-24050603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%
2min152004-5200430.16530.595.7430.1630.595.74
252874-5287430.66930.67
356192-5619232.59432.59
449650-4965028.79928.80
556286-5628632.64832.65
649393-4939328.65028.65
5min197350-9735056.46755.842.3456.4755.842.34
299112-9911257.48957.49
396093-9609355.73855.74
493370-9337054.15954.16
597759-9775956.70556.70
693933-9393354.48554.49
10min1118421-11842168.69068.102.0568.6968.102.05
2119905-11990569.55069.55
3117488-11748868.14868.15
4114216-11421666.25066.25
5119568-11956869.35569.35
6114807-11480766.59366.59
15min1129645-12964575.20073.662.8775.2073.662.88
2131672-13167276.37676.38
3122593-12259371.11071.11
4123313-12331371.52771.53
5128835-12883574.73074.73
6125906-12590673.03173.03
20min1133140-13314077.22778.092.2277.2378.092.22
2138073-13807380.08980.09
3136555-13655579.20879.21
4129684-12968475.22375.22
5136013-13601378.89478.89
6134260-13426077.87777.88
30min1142965-14296582.92682.302.1582.9382.302.15
2144213-14421383.65083.65
3143024-14302482.96082.96
4136036-13603678.90778.91
5143879-14387983.45683.46
6141229-14122981.91981.92
45min1150537-15053787.31886.062.7787.3286.062.76
2152364-15236488.37888.38
3149997-14999787.00587.01
4141051-14105181.81681.82
5149992-14999287.00287.00
6146282-14628284.85084.85
60min1154035-15403589.34787.363.0989.3587.363.09
2156209-15620990.60890.61
3151866-15186688.08988.09
4143068-14306882.98682.99
5150344-15034487.20687.21
6148128-14812885.92185.92
90min1154049-15404989.35588.732.9389.3688.732.94
2148817-14881786.32186.32
3158091-15809191.70091.70
4146686-14668685.08585.08
5156983-15698391.05791.06
6153236-15323688.88488.88
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1158965-15896592.20791.122.4192.2191.122.41
2159217-15921792.35392.35
3160338-16033893.00393.00
4149874-14987486.93486.93
5157536-15753691.37891.38
6156606-15660690.83990.84
极限1158073-15807391.69091.281.5791.6991.281.57
2158220-15822091.77591.77
3159708-15970892.63892.64
4152744-15274488.59888.60
5158710-15871092.05992.06
6156697-15669790.89190.89
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%
114.871819531820411818881817971816431818640.09
214.861827711828891828300.05
单位质量响应值RSD%判断
12230.2612303.500.43数据可信
中间条件3月-供试品溶液-2024051221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%
2min166188-6618838.13836.794.5138.1436.794.52
264400-6440037.10837.11
366327-6632738.21838.22
462760-6276036.16336.16
564762-6476237.31737.32
658603-5860333.76833.77
5min1101467-10146758.46758.033.5658.4758.033.56
2102965-10296559.33059.33
3105504-10550460.79360.79
4101237-10123758.33458.33
596209-9620955.43755.44
696857-9685755.81055.81
10min1110832-11083263.86364.472.9463.8664.472.94
2114142-11414265.77065.77
3115776-11577666.71266.71
4110377-11037763.60163.60
5113541-11354165.42465.42
6106647-10664761.45161.45
15min1116183-11618366.94667.082.2666.9567.082.26
2119704-11970468.97568.97
3119373-11937368.78468.78
4115607-11560766.61466.61
5114379-11437965.90765.91
6113238-11323865.24965.25
20min1120282-12028269.30869.643.1869.3169.643.18
2122524-12252470.60070.60
3124684-12468471.84471.84
4119495-11949568.85468.85
5123973-12397371.43571.43
6114214-11421465.81265.81
30min1124576-12457671.78273.442.1371.7873.442.13
2129758-12975874.76874.77
3131253-13125375.63075.63
4125831-12583172.50572.51
5128186-12818673.86273.86
6125134-12513472.10472.10
45min1130623-13062375.26775.922.6975.2775.922.69
2134301-13430177.38677.39
3135892-13589278.30378.30
4127388-12738873.40373.40
5134112-13411277.27777.28
6128171-12817173.85473.85
60min1131986-13198676.05278.203.6076.0578.203.59
2139258-13925880.24280.24
3142415-14241582.06182.06
4132468-13246876.33076.33
5138019-13801979.52879.53
6130103-13010374.96774.97
90min1142508-14250882.11581.632.8482.1181.632.84
2143327-14332782.58782.59
3147981-14798185.26885.27
4138016-13801679.52779.53
5141398-14139881.47581.48
6136787-13678778.81878.82
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1143192-14319282.50983.522.4882.5183.522.48
2145286-14528683.71683.72
3151662-15166287.38987.39
4141808-14180881.71281.71
5145299-14529983.72383.72
6142445-14244582.07982.08
极限1146191-14619184.23783.124.0984.2483.124.10
2145828-14582884.02884.03
3152945-15294588.12988.13
4140924-14092481.20281.20
5144389-14438983.19983.20
6135247-13524777.93177.93
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