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%
114.191793971797991793161794611792701794490.12
214.301795111794751794930.02
单位质量响应值RSD%判断
12646.1612551.960.53数据可信
供试品溶液-2011707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%
2min152827-5282729.65829.186.9929.6629.186.99
253072-5307229.79529.80
353029-5302929.77129.77
448341-4834127.13927.14
547332-4733226.57326.57
657269-5726932.15232.15
5min1103639-10363958.18561.084.2858.1861.084.29
2110107-11010761.81661.82
3111050-11105062.34562.35
4109962-10996261.73461.73
5102971-10297157.81057.81
6115095-11509564.61664.62
10min1125365-12536570.38274.323.2370.3874.323.23
2135618-13561876.13876.14
3131671-13167173.92273.92
4133015-13301574.67774.68
5130948-13094873.51673.52
6137695-13769577.30477.30
15min1132177-13217774.20678.983.4174.2178.983.41
2144334-14433481.03181.03
3139193-13919378.14578.15
4141240-14124079.29479.29
5141353-14135379.35879.36
6145794-14579481.85181.85
20min1138551-13855177.78579.451.3977.7879.451.39
2140917-14091779.11379.11
3144055-14405580.87580.87
4142491-14249179.99780.00
5140415-14041578.83178.83
6142703-14270380.11680.12
30min1145086-14508681.45482.991.2581.4582.991.25
2148966-14896683.63283.63
3147365-14736582.73382.73
4149609-14960983.99383.99
5146427-14642782.20782.21
6149512-14951283.93883.94
45min1147850-14785083.00585.552.7983.0185.552.79
2152897-15289785.83985.84
3151216-15121684.89584.90
4151187-15118784.87984.88
5150769-15076984.64484.64
6160377-16037790.03890.04
60min1150986-15098684.76685.641.0184.7785.641.01
2153083-15308385.94385.94
3150785-15078584.65384.65
4153229-15322986.02586.03
5152263-15226385.48385.48
6154862-15486286.94286.94
90min1147944-14794483.05886.082.1683.0686.082.16
2150829-15082984.67884.68
3153641-15364186.25786.26
4155629-15562987.37387.37
5156263-15626387.72987.73
6155667-15566787.39487.39
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1145000-14500081.40582.833.8381.4182.833.83
2147881-14788183.02383.02
3149061-14906183.68583.69
4137761-13776177.34177.34
5152980-15298085.88585.89
6152543-15254385.64085.64
极限1148250-14825083.23085.751.7683.2385.751.76
2152751-15275185.75785.76
3151880-15188085.26885.27
4152642-15264285.69685.70
5155889-15588987.51987.52
6155017-15501787.02987.03
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%
114.191807631808121805211806511809871807470.10
214.301804351801511802930.12
单位质量响应值RSD%判断
12737.6312607.900.73数据可信
供试品溶液-2011707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%
2min167407-6740737.62439.732.9637.6239.732.96
270175-7017539.16939.17
372195-7219540.29640.30
472190-7219040.29340.29
573285-7328540.90540.90
671803-7180340.07740.08
5min1117545-11754565.60965.621.9765.6165.621.97
2114029-11402963.64663.65
3120488-12048867.25167.25
4119678-11967866.79966.80
5117035-11703565.32465.32
6116660-11666065.11565.11
10min1130011-13001172.56775.213.5872.5775.213.58
2132899-13289974.17974.18
3141991-14199179.25379.25
4129991-12999172.55672.56
5138643-13864377.38577.38
6134912-13491275.30275.30
15min1146413-14641381.72281.482.6981.7281.482.69
2140956-14095678.67678.68
3148078-14807882.65182.65
4146581-14658181.81581.82
5151640-15164084.63984.64
6142168-14216879.35279.35
20min1151159-15115984.37184.490.8284.3784.490.82
2149903-14990383.67083.67
3153628-15362885.74985.75
4151307-15130784.45384.45
5151295-15129584.44684.45
6150909-15090984.23184.23
30min1152621-15262185.18785.741.6785.1985.741.67
2152805-15280585.28985.29
3156133-15613387.14787.15
4156414-15641487.30487.30
5149538-14953883.46683.47
6154184-15418486.05986.06
45min1153531-15353185.69587.861.9785.6987.861.97
2153647-15364785.75985.76
3158854-15885488.66688.67
4158879-15887988.68088.68
5161077-16107789.90689.91
6158424-15842488.42688.43
60min1155663-15566386.88587.921.5286.8887.921.52
2154755-15475586.37886.38
3158945-15894588.71688.72
4160653-16065389.67089.67
5159210-15921088.86488.86
6155881-15588187.00687.01
90min1157415-15741587.86288.532.1887.8688.532.18
2152776-15277685.27385.27
3161000-16100089.86389.86
4158063-15806388.22488.22
5162734-16273490.83190.83
6159674-15967489.12389.12
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1165992-16599292.65089.702.3492.6589.702.34
2155706-15570686.90986.91
3163297-16329791.14691.15
4161669-16166990.23790.24
5159979-15997989.29489.29
6157629-15762987.98287.98
极限1160401-16040189.52989.411.2589.5389.411.25
2157729-15772988.03888.04
3163006-16300690.98390.98
4161770-16177090.29390.29
5158429-15842988.42888.43
6159754-15975489.16889.17
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%
114.191801491801961802771799971796621800560.14
214.301834121839071836600.20
单位质量响应值RSD%判断
12688.9412843.360.86数据可信
供试品溶液-2011707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%
2min11106-11060.6133.0887.840.613.0887.84
24360-43602.4162.42
34522-45222.5062.51
413847-138477.6727.67
58464-84644.6904.69
61089-10890.6030.60
5min149342-4934227.33936.8321.0627.3436.8321.06
268115-6811537.74137.74
371656-7165639.70339.70
486946-8694648.17548.18
571044-7104439.36439.36
651755-5175528.67628.68
10min192023-9202350.98858.5410.3850.9958.5410.38
2109992-10999260.94460.94
3112085-11208562.10462.10
4115180-11518063.81963.82
5113301-11330162.77862.78
691300-9130050.58850.59
15min1101419-10141956.19463.5910.6856.1963.5910.68
2115571-11557164.03664.04
3128429-12842971.16071.16
4114281-11428163.32163.32
5128325-12832571.10271.10
6100591-10059155.73655.74
20min1122949-12294968.12471.545.0268.1271.545.02
2127274-12727470.52070.52
3135947-13594775.32675.33
4136921-13692175.86575.87
5130159-13015972.11972.12
6121409-12140967.27067.27
30min1110342-11034261.13869.7510.1261.1469.7410.13
2121032-12103267.06267.06
3128339-12833971.11071.11
4141652-14165278.48778.49
5138970-13897077.00177.00
6114918-11491863.67463.67
45min1132278-13227873.29378.806.6773.2978.806.67
2146819-14681981.35081.35
3153922-15392285.28585.29
4136524-13652475.64575.65
5150801-15080183.55683.56
6132962-13296273.67273.67
60min1144007-14400779.79285.205.1379.7985.205.13
2162208-16220889.87689.88
3157128-15712887.06287.06
4158575-15857587.86387.86
5156905-15690586.93886.94
6143775-14377579.66379.66
90min1150913-15091383.61882.535.1483.6282.535.14
2153882-15388285.26385.26
3139402-13940277.24077.24
4157388-15738887.20687.21
5139518-13951877.30477.30
6152556-15255684.52884.53
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1148058-14805882.03684.836.3582.0484.836.35
2164091-16409190.92090.92
3157994-15799487.54187.54
4138289-13828976.62376.62
5161158-16115889.29589.29
6148985-14898582.55082.55
极限1137657-13765776.27382.906.7476.2782.906.74
2161292-16129289.36989.37
3158262-15826287.69087.69
4147633-14763381.80181.80
5154475-15447585.59285.59
6138384-13838476.67676.68
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%
114.191813661814281816751814791815441814980.07
214.301809621810351809980.03
单位质量响应值RSD%判断
12790.5612657.200.75数据可信
供试品溶液-2011707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%
2min123689-2368913.1699.8830.1213.179.8830.12
224986-2498613.89013.89
313943-139437.7517.75
413198-131987.3377.34
513242-132427.3617.36
617562-175629.7639.76
5min190336-9033650.21941.8816.1650.2241.8816.16
287207-8720748.48048.48
367761-6776137.66937.67
462669-6266934.83934.84
563824-6382435.48135.48
680241-8024144.60744.61
10min1118078-11807865.64259.2110.5165.6459.2110.51
2122623-12262368.16868.17
3104508-10450858.09858.10
496241-9624153.50253.50
597383-9738354.13754.14
6100225-10022555.71755.72
15min1132631-13263173.73266.859.5373.7366.859.53
2131309-13130972.99773.00
3101503-10150356.42756.43
4118727-11872766.00266.00
5121978-12197867.81067.81
6115347-11534764.12364.12
20min1132019-13201973.39271.343.6273.3971.343.62
2133054-13305473.96773.97
3123901-12390168.87968.88
4129667-12966772.08472.08
5129892-12989272.20972.21
6121417-12141767.49867.50
30min1142761-14276179.36376.415.4179.3676.415.41
2138100-13810076.77276.77
3145951-14595181.13781.14
4127829-12782971.06271.06
5129076-12907671.75571.76
6140963-14096378.36478.36
45min1135643-13564375.40672.259.9075.4172.269.89
2136016-13601675.61475.61
3140213-14021377.94777.95
4114597-11459763.70663.71
5112639-11263962.61862.62
6140732-14073278.23578.24
60min1131807-13180773.27480.686.9673.2780.686.96
2133601-13360174.27174.27
3146206-14620681.27881.28
4153492-15349285.32985.33
5154922-15492286.12486.12
6150796-15079683.83083.83
90min1156832-15683287.18587.932.2587.1987.932.25
2159459-15945988.64688.65
3162961-16296190.59390.59
4159560-15956088.70288.70
5157939-15793987.80187.80
6152295-15229584.66384.66
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1162795-16279590.50088.062.5790.5088.062.57
2162748-16274890.47490.47
3158488-15848888.10688.11
4155908-15590886.67286.67
5158281-15828187.99187.99
6152240-15224084.63384.63
极限1151715-15171584.34185.312.8884.3485.312.88
2155881-15588186.65786.66
3149289-14928982.99282.99
4158658-15865888.20188.20
5157240-15724087.41287.41
6147984-14798482.26782.27
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