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%
117.161909921910541911941913351910571911260.08
217.031905681904971905320.03
单位质量响应值RSD%判断
11137.8811188.020.32数据可信
供试品溶液-24061402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%
5min1109073-10907398.708100.041.4498.71100.041.44
2110474-11047499.97699.98
3111899-111899101.265101.27
4112300-112300101.628101.63
5108311-10831198.01898.02
6111227-111227100.657100.66
10min1109800-10980099.36699.741.52100.46100.851.52
2109303-10930398.916100.03
3111570-111570100.967102.09
4112327-112327101.652102.78
5107653-10765397.42398.51
6110597-110597100.087101.21
15min1108766-10876698.43099.161.51100.63101.381.50
2109500-10950099.094101.30
3111348-111348100.767103.01
4110963-110963100.418102.68
5106822-10682296.67198.84
6110040-11004099.583101.81
20min1106194-10619496.10297.481.6099.40100.801.60
2107891-10789197.638100.95
3110025-11002599.569102.94
4108999-10899998.641102.02
5105381-10538195.36798.61
6107807-10780797.562100.90
30min1104134-10413494.23896.591.7998.60101.001.77
2106975-10697596.809101.20
3109042-10904298.680103.15
4108113-10811397.839102.31
5104807-10480794.84799.15
6107355-10735597.153101.57
45min1103964-10396494.08495.141.6099.49100.611.59
2104802-10480294.843100.31
3106937-10693796.775102.34
4107198-10719897.011102.57
5102908-10290893.12998.49
6104944-10494494.971100.47
60min1104527-10452794.59495.102.06101.05101.632.02
2104363-10436394.445100.97
3106170-10617096.081102.73
4108273-10827397.984104.62
5101770-10177092.09998.49
6105387-10538795.372101.93
90min1102971-10297193.18693.581.63100.69101.171.62
2102816-10281693.045100.62
3105176-10517695.181102.89
4104987-10498795.010102.73
5100624-10062491.06298.48
6103890-10389094.017101.63
极限1102102-10210292.39992.991.71100.94101.621.69
2102769-10276993.003101.61
3104113-10411394.219102.99
4105133-10513395.142103.92
5100046-10004690.53998.97
6102394-10239492.663101.32
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 1974741972281973581972411972601973120.06
216.071968441967211967820.05
单位质量响应值RSD%判断
12308.9212245.300.37数据可信
供试品溶液-24061402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%
5min119749-1974916.50417.744.5016.5017.744.51
221481-2148117.95217.95
321893-2189318.29618.30
422484-2248418.79018.79
520977-2097717.53117.53
620759-2075917.34817.35
10min130003-3000325.07426.824.4525.2627.024.44
231446-3144626.28026.48
333111-3311127.67127.87
434076-3407628.47828.69
532392-3239227.07027.27
631522-3152226.34326.54
15min135860-3586029.96832.104.4830.4332.604.48
237505-3750531.34331.83
339503-3950333.01333.52
440857-4085734.14434.67
538766-3876632.39732.89
638001-3800131.75832.24
20min138954-3895432.55435.064.3333.3535.924.33
241122-4112234.36635.21
343257-4325736.15037.03
444110-4411036.86337.77
542590-4259035.59336.45
641714-4171434.86135.70
30min144431-4443137.13139.353.7138.2940.603.72
245805-4580538.28039.50
348021-4802140.13141.41
449269-4926941.17442.49
548009-4800940.12141.37
647013-4701339.28940.51
45min149722-4972241.55342.732.9543.1244.412.98
249426-4942641.30642.95
351664-5166443.17644.90
453609-5360944.80146.57
551099-5109942.70444.40
651260-5126042.83844.50
60min153910-5391045.05345.251.6547.0847.411.68
252949-5294944.25046.36
354104-5410445.21547.42
455319-5531946.23048.50
553581-5358144.77846.95
655040-5504045.99748.14
90min160074-6007450.20448.881.6552.7451.541.52
257998-5799848.46951.07
357664-5766448.19050.90
459112-5911249.40052.18
557582-5758248.12250.79
658543-5854348.92551.57
极限181722-8172268.29667.741.2471.3870.941.22
280914-8091467.62070.76
381150-8115067.81871.06
482461-8246168.91372.25
579561-7956166.49069.69
680508-8050867.28170.47
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%
117.161899651902391905351904411904881903340.13
217.031911241910161910700.04
单位质量响应值RSD%判断
11091.7211219.610.82数据可信
供试品溶液-24061402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%
5min1107428-10742897.285100.522.5797.29100.522.57
2108794-10879498.52298.52
3109450-10945099.11699.12
4113623-113623102.895102.90
5112238-112238101.641101.64
6114494-114494103.684103.68
10min1107448-10744897.303100.372.3898.38101.492.38
2110084-11008499.690100.79
3108454-10845498.21499.32
4113705-113705102.970104.11
5111617-111617101.079102.21
6113699-113699102.964104.12
15min1107681-10768197.51499.491.6499.68101.731.65
2109226-10922698.913101.12
3108185-10818597.971100.16
4111208-111208100.708103.00
5110653-110653100.206102.46
6112240-112240101.643103.94
20min1105332-10533295.38797.591.8598.63100.931.86
2106842-10684296.755100.06
3106338-10633896.29899.58
4109863-10986399.490102.90
5107905-10790597.717101.08
6110336-11033699.919103.34
30min1103563-10356393.78596.572.2298.09100.992.22
2105516-10551695.55499.93
3104866-10486694.96599.32
4108810-10881098.537103.05
5107513-10751397.362101.81
6109567-10956799.222103.76
45min1102284-10228492.62795.582.4997.97101.072.47
2103893-10389394.08499.52
3103865-10386594.05999.46
4107165-10716597.047102.65
5106742-10674296.664102.20
6109318-10931898.997104.63
60min1103055-10305593.32594.602.0799.70101.162.07
2103178-10317893.43699.92
3101965-10196592.33898.79
4107108-10710896.995103.68
5104503-10450394.636101.24
6107001-10700196.899103.64
90min199832-9983290.40693.782.8897.82101.392.82
2101655-10165592.05799.58
3101263-10126391.70299.18
4105755-10575595.770103.53
5106121-10612196.102103.76
6106751-10675196.672104.49
极限1101120-10112091.57393.191.9699.99101.841.99
2101344-10134491.776100.32
3100971-10097191.43899.93
4104628-10462894.750103.58
5103739-10373993.944102.67
6105608-10560895.637104.53
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 1964191966811966111967811963611965710.09
216.071964901967301966100.09
单位质量响应值RSD%判断
12262.6912234.600.17数据可信
供试品溶液-24061402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%
5min135352-3535229.61229.806.7629.6129.806.76
233593-3359328.13928.14
333214-3321427.82227.82
434607-3460728.98828.99
539563-3956333.14033.14
637156-3715631.12431.12
10min150920-5092042.65342.506.7142.9842.836.71
248558-4855840.67440.99
346723-4672339.13739.45
449163-4916341.18141.50
556235-5623547.10547.47
652821-5282144.24544.59
15min158682-5868249.15548.316.9849.9649.126.97
255028-5502846.09446.86
353570-5357044.87345.62
454822-5482245.92146.70
564300-6430053.86154.75
659650-5965049.96650.80
20min161833-6183351.79450.886.3653.1452.226.37
258452-5845248.96250.24
356595-5659547.40648.65
458054-5805448.62949.92
567130-6713056.23157.72
662422-6242252.28753.68
30min166221-6622155.47054.515.6257.3956.415.65
261894-6189451.84553.67
363003-6300352.77454.54
461904-6190451.85453.68
571409-7140959.81561.93
666012-6601255.29557.27
45min180326-8032667.28561.2211.1869.8363.7410.76
264592-6459254.10556.50
384466-8446670.75273.11
465344-6534454.73557.14
574785-7478562.64365.42
669032-6903257.82460.41
60min190777-9077776.03967.0011.0279.3370.2010.55
268201-6820157.12860.13
387261-8726173.09476.24
484312-8431270.62373.64
576268-7626863.88567.36
673116-7311661.24564.48
90min194532-9453279.18470.1610.2683.3274.109.86
271744-7174460.09663.73
389180-8918074.70178.66
488988-8898874.54078.34
580933-8093367.79371.98
677165-7716564.63768.55
极限1101362-10136284.90586.182.3089.9290.892.28
299196-9919683.09187.39
3103732-10373286.89191.67
4106153-10615388.91893.55
5103294-10329486.52491.46
6103532-10353286.72391.35
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