左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.35 1877571880991881201878431880141879670.09
217.35 1878791876131877460.11
单位质量响应值RSD%判断
10833.8310821.100.09数据可信
供试品溶液-24051601批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1111537-111537104.065103.621.02104.06103.621.01
2109339-109339102.014102.01
3110885-110885103.456103.46
4110785-110785103.363103.36
5112791-112791105.235105.23
6111025-111025103.587103.59
10min1112527-112527104.988104.021.53106.14105.171.52
2108541-108541101.269102.40
3110349-110349102.956104.11
4112500-112500104.963106.11
5112817-112817105.259106.43
6112204-112204104.687105.84
15min1111043-111043103.604102.370.91105.93104.680.92
2108171-108171100.924103.18
3109796-109796102.440104.73
4109070-109070101.763104.08
5110306-110306102.916105.25
6109938-109938102.573104.89
20min1107965-107965100.732101.111.65104.21104.551.63
2106153-10615399.041102.42
3106742-10674299.591103.02
4109358-109358102.032105.48
5110988-110988103.552107.03
6108995-108995101.693105.15
30min1106984-10698499.817100.231.75104.41104.801.71
2104628-10462897.618102.10
3108138-108138100.893105.43
4107278-107278100.091104.67
5110413-110413103.016107.65
6107127-10712799.950104.53
45min1105829-10582998.73999.181.53104.44104.861.50
2103806-10380696.852102.42
3106455-10645599.323104.98
4108042-108042100.804106.49
5108066-108066100.826106.60
6105591-10559198.517104.21
60min1105177-10517798.13197.071.33104.93103.861.31
2102263-10226395.412102.05
3103773-10377396.821103.58
4104559-10455997.554104.37
5105759-10575998.674105.57
6102719-10271995.837102.63
90min1104586-10458697.57996.441.73105.47104.311.69
2100559-10055993.822101.52
3102988-10298896.088103.93
4103323-10332396.401104.30
5105838-10583898.747106.74
6102920-10292096.025103.88
极限1102707-10270795.82695.440.97104.80104.370.99
2101110-10111094.336103.08
3102242-10224295.392104.30
4102056-10205695.219104.19
5103979-10397997.013106.10
6101635-10163594.826103.75
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.03 1956911956861964921960501956171959070.19
216.03 1969551956431962990.48
单位质量响应值RSD%判断
12221.2712245.730.15数据可信
供试品溶液-24051601批-叶酸-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137332-3733231.31031.181.3231.3131.181.32
237711-3771131.62831.63
337190-3719031.19131.19
436758-3675830.82830.83
537603-3760331.53731.54
636447-3644730.56730.57
10min164357-6435753.97553.290.9454.3253.640.93
263033-6303352.86553.22
363801-6380153.50953.86
463466-6346653.22853.57
563864-6386453.56253.91
662731-6273152.61152.95
15min178927-7892766.19565.950.6767.1466.890.67
278836-7883666.11867.06
379112-7911266.35067.29
478054-7805465.46266.40
579001-7900166.25767.20
677907-7790765.33966.26
20min187245-8724573.17173.631.3174.8575.301.29
286909-8690972.88974.56
387331-8733173.24374.92
488312-8831274.06675.73
589898-8989875.39677.08
687052-8705273.00974.66
30min197060-9706081.40282.131.5683.9084.621.53
297009-9700981.36083.84
397208-9720881.52784.02
498021-9802182.20884.69
5100949-10094984.66487.18
697329-9732981.62884.09
45min1104343-10434387.51187.821.5890.9191.221.54
2103842-10384287.09090.48
3102720-10272086.14989.55
4106306-10630689.15792.55
5107102-10710289.82493.28
6103978-10397887.20490.57
60min1107548-10754890.19989.301.8294.5793.681.77
2105820-10582088.74993.10
3103828-10382887.07991.43
4107971-10797190.55394.94
5108798-10879891.24795.71
6104918-10491887.99392.33
90min1109093-10909391.49490.692.0696.8796.062.00
2106653-10665389.44894.79
3105385-10538588.38493.71
4109152-10915291.54496.94
5111557-11155793.56199.03
6106980-10698089.72295.04
极限1108172-10817290.72290.521.4397.1196.901.41
2107006-10700689.74496.08
3106109-10610988.99295.30
4108874-10887491.31197.72
5110352-11035292.55099.06
6107054-10705489.78496.10
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.35 1884101883411882831874971879191880900.21
217.35 1878471882381880420.15
单位质量响应值RSD%判断
10840.9210838.160.02数据可信
供试品溶液-24051602批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1107579-107579100.26099.691.33100.2699.691.33
2106706-10670699.44699.45
3104317-10431797.22097.22
4107342-107342100.039100.04
5107362-107362100.058100.06
6108502-108502101.120101.12
10min1108022-108022100.67399.810.90101.79100.920.90
2106427-10642799.186100.29
3105769-10576998.57399.65
4107525-107525100.210101.32
5106681-10668199.423100.53
6108163-108163100.804101.93
15min1105575-10557598.39298.361.13100.62100.581.12
2106937-10693799.662101.87
3103759-10375996.70098.88
4104882-10488297.74699.97
5105370-10537098.201100.42
6106742-10674299.480101.72
20min1104383-10438397.28197.511.60100.61100.821.57
2103920-10392096.850100.16
3102436-10243695.46798.72
4106169-10616998.946102.26
5103855-10385596.789100.10
6106986-10698699.707103.06
30min1102027-10202795.08696.081.9399.49100.481.88
2103212-10321296.190100.58
3100590-10059093.74698.06
4105591-10559198.407102.82
5101917-10191794.98399.37
6105246-10524698.086102.54
45min1100934-10093494.06795.191.5999.53100.651.56
2100919-10091994.05399.51
3100432-10043293.59998.95
4102927-10292795.924101.43
5103079-10307996.066101.50
6104551-10455197.438102.98
60min1101635-10163594.72094.411.96101.23100.921.91
2101075-10107594.198100.70
397677-9767791.03297.42
4103427-10342796.390102.96
5101328-10132894.434100.94
6102651-10265195.667102.30
90min1101134-10113494.25393.501.24101.81101.061.23
2100045-10004593.238100.79
397987-9798791.32098.72
4101390-10139094.492102.13
5100479-10047993.643101.20
6100902-10090294.037101.73
极限199419-9941992.65593.011.10101.26101.611.10
299886-9988693.090101.68
397849-9784991.19299.61
4100306-10030693.482102.17
5100318-10031893.493102.09
6100997-10099794.126102.86
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.03 1964471959001963221957331956791960160.18
216.03 1955681952571954120.12
单位质量响应值RSD%判断
12228.0712190.390.22数据可信
供试品溶液-24051602批-叶酸-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135552-3555229.87629.550.9429.8829.550.95
235325-3532529.68529.69
334843-3484329.28029.28
435490-3549029.82429.82
534856-3485629.29129.29
634916-3491629.34229.34
10min160337-6033750.70450.280.9651.0450.610.95
259874-5987450.31550.64
360518-6051850.85651.18
459944-5994450.37450.71
559096-5909649.66149.99
659245-5924549.78750.11
15min173860-7386062.06862.561.1062.9663.451.09
275372-7537263.33964.23
375474-7547463.42564.31
474354-7435462.48363.37
573463-7346361.73562.61
674181-7418162.33863.22
20min182924-8292469.68570.230.8271.2771.810.81
283449-8344970.12671.72
384342-8434270.87772.47
484503-8450371.01272.60
583116-8311669.84771.41
683105-8310569.83771.41
30min191169-9116976.61478.381.6378.9780.741.59
292751-9275177.94380.32
393769-9376978.79981.18
495643-9564380.37482.75
592488-9248877.72280.06
693809-9380978.83281.18
45min197139-9713981.63183.711.5184.8486.941.46
298690-9869082.93486.17
3101311-10131185.13788.39
499642-9964283.73487.00
5100475-10047584.43487.64
6100422-10042284.39087.61
60min1100445-10044584.40985.351.1288.5389.521.09
2100981-10098184.85989.02
3101111-10111184.96989.17
4103645-10364587.09891.30
5101244-10124485.08089.22
6101983-10198385.70189.86
90min1102577-10257786.20186.210.6791.2691.320.65
2101745-10174585.50190.60
3103831-10383187.25492.40
4102465-10246586.10691.27
5102630-10263086.24591.33
6102302-10230285.96991.08
极限1101533-10153385.32385.900.6191.3491.970.57
2102445-10244586.09092.14
3101960-10196085.68291.80
4101940-10194085.66591.79
5102104-10210485.80391.85
6103317-10331786.82292.89
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.35 1876231879641872961871791876701875460.17
217.35 1882391874451878420.30
单位质量响应值RSD%判断
10809.5710826.630.12数据可信
供试品溶液-24051601批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1115466-115466107.824104.052.75107.82104.052.74
2111045-111045103.695103.70
3107351-107351100.246100.25
4111416-111416104.042104.04
5114240-114240106.679106.68
6109049-109049101.831101.83
10min1115263-115263107.634104.082.41108.83105.242.41
2111226-111226103.864105.02
3107894-107894100.753101.87
4111086-111086103.734104.89
5113685-113685106.161107.35
6109588-109588102.335103.47
15min1113686-113686106.161103.022.46108.56105.332.46
2112346-112346104.910107.22
3106624-10662499.567101.80
4110247-110247102.950105.26
5111272-111272103.907106.27
6107730-107730100.600102.87
20min1111007-111007103.660101.562.44107.23105.022.44
2111098-111098103.745107.22
3104687-10468797.758101.10
4108350-108350101.179104.63
5110703-110703103.376106.90
6106735-10673599.671103.06
30min1108442-108442101.265100.102.17105.99104.682.17
2109448-109448102.204106.83
3103934-10393497.055101.48
4106320-10632099.283103.86
5109592-109592102.338107.01
6105422-10542298.444102.94
45min1108739-108739101.54299.212.06107.39104.912.07
2107502-107502100.387106.15
3102667-10266795.872101.38
4106117-10611799.093104.77
5107491-107491100.377106.18
6104932-10493297.987103.57
60min1109569-109569102.31798.872.40109.30105.672.37
2104371-10437197.463104.34
3103801-10380196.931103.50
4104883-10488397.941104.72
5108624-108624101.435108.35
6104011-10401197.127103.80
90min1106905-10690599.82997.922.10107.94105.822.11
2105603-10560398.613106.57
3101738-10173895.004102.65
4104309-10430997.405105.27
5107436-107436100.325108.37
6103189-10318996.359104.11
极限1105457-10545798.47796.862.21107.70105.842.20
2103474-10347496.625105.68
3100654-10065493.992102.69
4103403-10340396.559105.51
5107110-107110100.021109.18
6102253-10225395.485104.31
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.03 1964561961091959451953271955321958740.24
216.03 1965101965881965490.03
单位质量响应值RSD%判断
12219.2112261.320.25数据可信
供试品溶液-24051601批-叶酸-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149835-4983541.77338.385.4341.7738.385.43
247158-4715839.52939.53
343825-4382536.73536.73
445429-4542938.07938.08
545588-4558838.21338.21
642870-4287035.93435.93
10min182528-8252869.17765.324.0469.6465.744.04
280462-8046267.44567.88
375324-7532463.13863.55
477661-7766165.09765.52
577496-7749664.95965.38
674087-7408762.10162.50
15min197616-9761681.82479.863.6283.0681.013.62
299524-9952483.42384.61
392254-9225477.32978.44
495413-9541379.97781.12
596549-9654980.92982.08
690275-9027575.67076.76
20min1105191-10519188.17386.443.2690.3288.483.27
2106528-10652889.29491.41
399624-9962483.50785.48
4103585-10358586.82788.86
5105476-10547688.41290.46
698367-9836782.45384.38
30min1110747-11074792.83091.842.8495.9594.842.86
2113155-11315594.84997.96
3106475-10647589.24992.15
4109488-10948891.77594.77
5112153-11215394.00997.04
6105358-10535888.31391.16
45min1115351-11535196.68994.392.70100.8498.412.72
2114813-11481396.238100.40
3109329-10932991.64295.53
4112432-11243294.24398.26
5115157-11515796.527100.60
6108565-10856591.00194.83
60min1118121-11812199.01195.363.13104.24100.433.10
2112603-11260394.38699.62
3111649-11164993.58698.49
4112536-11253694.33099.40
5118120-11812099.010104.16
6109535-10953591.81496.65
90min1116349-11634997.52695.282.85103.85101.402.86
2115231-11523196.589102.87
3110332-11033292.48298.43
4113469-11346995.112101.23
5117261-11726198.290104.54
6109343-10934391.65397.51
极限1115049-11504996.43694.422.84103.85101.612.83
2112577-11257794.364101.72
3109449-10944991.74298.72
4112701-11270194.468101.64
5117190-11719098.231105.57
6108877-10887791.26398.14
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.35 1872051870341877301873391875241873660.15
217.35 1872711881831877270.35
单位质量响应值RSD%判断
10799.1910820.000.14数据可信
供试品溶液-24051602批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1109062-109062101.924101.281.39101.92101.281.39
2110127-110127102.919102.92
3108182-108182101.101101.10
4107151-107151100.138100.14
5109548-109548102.378102.38
6106164-10616499.21599.22
10min1108382-108382101.288102.031.12102.42103.161.11
2109528-109528102.359103.50
3108572-108572101.466102.59
4109121-109121101.979103.09
5111415-111415104.123105.26
6108060-108060100.987102.09
15min1106738-10673899.752100.621.41102.01102.881.40
2109472-109472102.307104.59
3107641-107641100.596102.85
4108454-108454101.355103.60
5108474-108474101.374103.67
6105200-10520098.314100.54
20min1104780-10478097.92299.791.69101.29103.161.66
2107388-107388100.359103.78
3108784-108784101.664105.03
4106204-10620499.253102.62
5108691-108691101.577105.00
6104818-10481897.957101.27
30min1105137-10513798.25699.260.88102.71103.750.89
2106965-10696599.964104.50
3106350-10635099.389103.89
4105675-10567598.758103.23
5107586-107586100.544105.09
6105569-10556998.659103.06
45min1104636-10463697.78797.641.26103.33103.221.24
2104881-10488198.016103.66
3104217-10421797.396103.00
4102922-10292296.186101.76
5106708-10670899.724105.39
6103479-10347996.706102.21
60min1103965-10396597.16097.380.73103.79104.050.73
2104387-10438797.555104.29
3104428-10442897.593104.28
4103017-10301796.274102.92
5105332-10533298.438105.21
6104042-10404297.232103.81
90min1101189-10118994.56696.291.93102.28104.041.85
2105995-10599599.057106.87
3102939-10293996.201103.97
4102307-10230795.611103.32
5104738-10473897.883105.75
6101031-10103194.418102.07
极限1100991-10099194.38195.181.69103.14104.001.63
2103633-10363396.850105.77
3102422-10242295.718104.56
499932-9993293.391102.16
5103871-10387197.072106.03
6100222-10022293.662102.37
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.03 1948951951631953191950661951381951160.08
216.03 1959141954061956600.19
单位质量响应值RSD%判断
12171.9312205.860.20数据可信
供试品溶液-24051602批-叶酸-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145976-4597638.70038.963.1238.7038.963.11
247935-4793540.34940.35
345846-4584638.59138.59
447821-4782140.25340.25
546060-4606038.77138.77
644062-4406237.08937.09
10min176825-7682564.66865.302.0865.1065.742.09
279312-7931266.76167.21
377187-7718764.97265.40
478743-7874366.28266.73
578496-7849666.07466.50
674922-7492263.06663.48
15min191225-9122576.78978.471.9077.9479.631.90
295597-9559780.46981.66
393715-9371578.88580.04
493593-9359378.78279.97
594160-9416079.25980.42
691043-9104376.63677.75
20min196565-9656581.28484.512.5483.2986.542.51
2101436-10143685.38487.47
3103285-10328586.94088.97
4100650-10065084.72286.78
5102253-10225386.07288.12
698202-9820282.66284.63
30min1102475-10247586.25889.011.9889.1691.981.97
2107282-10728290.30593.34
3107344-10734490.35793.35
4106309-10630989.48692.49
5107209-10720990.24393.25
6103839-10383987.40790.29
45min1104275-10427587.77490.051.8391.6494.011.82
2108021-10802190.92794.96
3107646-10764690.61194.61
4106982-10698290.05294.05
5109682-10968292.32596.33
6105287-10528788.62592.48
60min1104526-10452687.98590.321.4092.8295.281.40
2107560-10756090.53995.59
3108271-10827191.13796.14
4107518-10751890.50395.50
5108837-10883791.61496.64
6107083-10708390.13794.98
90min1102191-10219186.01989.642.2691.8495.612.22
2108669-10866991.47297.52
3107554-10755490.53496.55
4107152-10715290.19596.20
5108104-10810490.99797.05
6105299-10529988.63694.48
极限1102372-10237286.17289.011.9492.9495.961.92
2107542-10754290.52497.59
3106904-10690489.98797.01
4104726-10472688.15395.16
5107665-10766590.62797.69
6105224-10522488.57295.40
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