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%
114.151801441794081794681796331798171796940.17
214.181795671795621795640.01
单位质量响应值RSD%判断
12699.2212663.190.21数据可信
供试品溶液-2763566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%
2min125586-2558614.26111.9856.1314.2611.9856.13
232881-3288118.32718.33
310379-103795.7855.79
47739-77394.3144.31
515608-156088.7008.70
636791-3679120.50720.51
5min173045-7304540.71442.605.5540.7142.605.55
281034-8103445.16745.17
370945-7094539.54339.54
474131-7413141.31941.32
579671-7967144.40744.41
679788-7978844.47244.47
10min1106025-10602559.09659.234.3959.1059.244.38
2107589-10758959.96859.97
398060-9806054.65754.66
4106701-10670159.47359.47
5112496-11249662.70362.70
6106769-10676959.51159.51
15min1123777-12377768.99167.811.5968.9967.811.59
2121239-12123967.57667.58
3118929-11892966.28966.29
4121827-12182767.90467.90
5123849-12384969.03169.03
6120330-12033067.07067.07
20min1130327-13032772.64273.090.6972.6473.090.70
2132042-13204273.59873.60
3131162-13116273.10773.11
4132385-13238573.78973.79
5130397-13039772.68172.68
6130434-13043472.70272.70
30min1143163-14316379.79778.532.8679.8078.532.86
2138805-13880577.36777.37
3133591-13359174.46174.46
4142412-14241279.37879.38
5144037-14403780.28480.28
6143342-14334279.89679.90
45min1151124-15112484.23484.481.2484.2384.481.24
2149447-14944783.29983.30
3149779-14977983.48483.48
4152523-15252385.01485.01
5154480-15448086.10486.10
6152033-15203384.74084.74
60min1157388-15738887.72587.311.1687.7387.311.16
2155652-15565286.75886.76
3154812-15481286.28986.29
4158088-15808888.11588.12
5159096-15909688.67788.68
6154818-15481886.29386.29
90min1161708-16170890.13389.401.2190.1389.401.21
2157731-15773187.91687.92
3160483-16048389.45089.45
4160420-16042089.41589.42
5163160-16316090.94290.94
6158879-15887988.55688.56
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1163540-16354091.15490.371.1291.1590.371.12
2162195-16219590.40590.40
3161983-16198390.28690.29
4159146-15914688.70588.71
5164403-16440391.63591.64
6161543-16154390.04190.04
极限1161845-16184590.21089.781.9490.2189.781.94
2159892-15989289.12189.12
3162704-16270490.68890.69
4163259-16325990.99891.00
5163445-16344591.10191.10
6155280-15528086.55086.55
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%
114.151806081796881802271800171799731801030.19
214.181808771811491810130.11
单位质量响应值RSD%判断
12728.1312765.370.21数据可信
供试品溶液-2763566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%
2min122018-2201812.2098.9554.6312.218.9554.66
231154-3115417.27517.28
38357-83574.6344.63
411688-116886.4816.48
59484-94845.2595.26
614138-141387.8407.84
5min183952-8395246.55343.385.8646.5543.385.86
274955-7495541.56441.56
378190-7819043.35843.36
472836-7283640.38940.39
575980-7598042.13242.13
683456-8345646.27846.28
10min1113181-11318162.76160.143.3962.7660.143.39
2106254-10625458.92058.92
3108161-10816159.97759.98
4103440-10344057.35957.36
5107498-10749859.60959.61
6112200-11220062.21762.22
15min1126750-12675070.28568.362.8270.2868.362.82
2124301-12430168.92768.93
3119927-11992766.50166.50
4125184-12518469.41769.42
5118060-11806065.46665.47
6125500-12550069.59269.59
20min1136477-13647775.67974.061.6375.6874.061.63
2132584-13258473.52073.52
3135202-13520274.97274.97
4130837-13083772.55172.55
5131795-13179573.08273.08
6134430-13443074.54474.54
30min1141502-14150278.46579.141.9078.4779.141.90
2145620-14562080.74980.75
3138303-13830376.69176.69
4141912-14191278.69278.69
5144453-14445380.10280.10
6144551-14455180.15680.16
45min1157205-15720587.17385.391.1387.1785.391.13
2154345-15434585.58785.59
3153461-15346185.09785.10
4153689-15368985.22385.22
5152107-15210784.34684.35
6153125-15312584.91084.91
60min1161084-16108489.32486.562.7989.3286.562.79
2156620-15662086.84886.85
3156973-15697387.04487.04
4148113-14811382.13182.13
5155624-15562486.29686.30
6158223-15822387.73787.74
90min1162305-16230590.00187.972.3790.0087.982.38
2160907-16090789.22689.23
3158892-15889288.10888.11
4158286-15828687.77287.77
5151559-15155984.04284.04
6159958-15995888.69988.70
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1165384-16538491.70889.242.8691.7189.242.86
2159819-15981988.62288.62
3162383-16238390.04490.04
4159988-15998888.71688.72
5152933-15293384.80484.80
6165113-16511391.55891.56
极限1162581-16258190.15490.001.2390.1590.001.23
2163782-16378290.82090.82
3162791-16279190.27090.27
4158881-15888188.10288.10
5161384-16138489.49089.49
6164457-16445791.19491.19
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%
114.151799651804501802631804011802111802580.11
214.181804721802881803800.08
单位质量响应值RSD%判断
12739.0812720.730.11数据可信
供试品溶液-2757904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%
2min112560-125606.9746.2250.336.976.2250.38
22168-21681.2041.20
311192-111926.2146.21
419086-1908610.59710.60
513667-136677.5897.59
68525-85254.7334.73
5min171666-7166639.79241.025.3939.7941.025.39
273049-7304940.56040.56
369933-6993338.83038.83
480835-8083544.88444.88
571686-7168639.80439.80
676049-7604942.22642.23
10min1108124-10812460.03659.023.1960.0459.023.19
2107670-10767059.78459.78
3104012-10401257.75357.75
4107346-10734659.60459.60
5100607-10060755.86255.86
6109972-10997261.06261.06
15min1126944-12694470.48668.462.7470.4968.462.73
2124514-12451469.13669.14
3120982-12098267.17567.18
4125429-12542969.64469.64
5117707-11770765.35765.36
6124187-12418768.95568.95
20min1139878-13987877.66773.962.6477.6773.962.64
2133898-13389874.34774.35
3131001-13100172.73872.74
4132469-13246973.55373.55
5130230-13023072.31072.31
6131737-13173773.14773.15
30min1150199-15019983.39880.582.0883.4080.582.08
2144455-14445580.20880.21
3142321-14232179.02479.02
4146223-14622381.19081.19
5142000-14200078.84578.85
6145578-14557880.83280.83
45min1163101-16310190.56286.072.9590.5686.062.95
2153014-15301484.96184.96
3150426-15042683.52483.52
4156812-15681287.07087.07
5151825-15182584.30184.30
6154852-15485285.98185.98
60min1166972-16697292.71187.663.6492.7187.663.64
2159692-15969288.66988.67
3150741-15074183.69983.70
4160480-16048089.10689.11
5154277-15427785.66285.66
6155090-15509086.11486.11
90min1170319-17031994.56989.493.1794.5789.493.17
2158272-15827287.88087.88
3156428-15642886.85686.86
4163175-16317590.60390.60
5157806-15780687.62287.62
6161014-16101489.40389.40
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1170737-17073794.80291.012.6394.8091.012.63
2163594-16359490.83590.84
3158055-15805587.76087.76
4166306-16630692.34192.34
5161556-16155689.70489.70
6163216-16321690.62690.63
极限1172259-17225995.64790.863.0395.6590.863.03
2161062-16106289.42989.43
3158140-15814087.80787.81
4165556-16555691.92591.92
5160872-16087289.32489.32
6163906-16390691.00991.01
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%
114.151807671807971806821804191805281806390.09
214.181824361819871822120.18
单位质量响应值RSD%判断
12766.0112849.930.47数据可信
供试品溶液-2757904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%
2min127234-2723415.03012.2512.5215.0312.2512.51
222279-2227912.29512.30
318841-1884110.39810.40
422209-2220912.25612.26
520930-2093011.55111.55
621651-2165111.94911.95
5min152289-5228928.85725.3623.5628.8625.3623.56
231109-3110917.16817.17
338164-3816421.06221.06
443595-4359524.05924.06
548795-4879526.92926.93
661802-6180234.10734.11
10min186962-8696247.99242.6017.2547.9942.6017.25
266868-6686836.90236.90
370769-7076939.05539.06
461590-6159033.99033.99
580024-8002444.16344.16
696985-9698553.52353.52
15min1112984-11298462.35355.6013.0162.3555.6013.01
295980-9598052.96952.97
397964-9796454.06354.06
480745-8074544.56144.56
599425-9942554.87054.87
6117365-11736564.77064.77
20min1128375-12837570.84663.5911.7870.8563.6011.78
2120409-12040966.45066.45
3118949-11894965.64465.64
490614-9061450.00750.01
5109524-10952460.44360.44
6123537-12353768.17668.18
30min1149656-14965682.59173.9413.2982.5973.9413.29
2144226-14422679.59479.59
3136899-13689975.55175.55
4102842-10284256.75556.76
5123897-12389768.37568.38
6146379-14637980.78280.78
45min1162119-16211989.46981.578.3189.4781.578.31
2154531-15453185.28185.28
3149177-14917782.32682.33
4130426-13042671.97871.98
5135607-13560774.83774.84
6154976-15497685.52785.53
60min1168271-16827192.86485.875.6592.8685.875.65
2162516-16251689.68889.69
3156068-15606886.12986.13
4143946-14394679.44079.44
5149713-14971382.62282.62
6153078-15307884.47984.48
90min1173670-17367095.84388.955.1095.8488.955.10
2166107-16610791.67091.67
3158142-15814287.27487.27
4157389-15738986.85886.86
5149677-14967782.60282.60
6162129-16212989.47489.47
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1174549-17454996.32890.853.6596.3390.853.65
2167271-16727192.31292.31
3162054-16205489.43389.43
4161750-16175089.26589.27
5156900-15690086.58886.59
6165231-16523191.18691.19
极限1174996-17499696.57590.703.3496.5890.713.34
2165183-16518391.16091.16
3161182-16118288.95288.95
4162078-16207889.44689.45
5160162-16016288.38988.39
6162553-16255389.70889.71
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