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%
116.141834191832211837191834291834241834420.10
216.011829621829671829640.01
单位质量响应值RSD%判断
11365.6811428.110.39数据可信
供试品溶液-24052301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%
5min1107694-10769495.45995.661.5795.4695.661.57
2108214-10821495.92095.92
3107454-10745495.24795.25
4108560-10856096.22796.23
5105211-10521193.25993.26
6110413-11041397.87097.87
10min1106649-10664994.53395.110.9395.5996.180.93
2108908-10890896.53697.60
3106997-10699794.84295.90
4107347-10734795.15296.22
5106069-10606994.01995.06
6107852-10785295.60096.69
15min1107129-10712994.95994.021.2097.0796.141.19
2106330-10633094.25096.39
3106088-10608894.03696.15
4106553-10655394.44896.57
5103587-10358791.81993.90
6106706-10670694.58496.73
20min1105759-10575993.74493.031.0796.9196.201.07
2105836-10583693.81397.00
3105024-10502493.09396.25
4105193-10519393.24396.42
5102779-10277991.10394.20
6105148-10514893.20396.40
30min1102697-10269791.03091.782.0095.2495.981.94
2103618-10361891.84796.07
3102151-10215190.54694.74
4107118-10711894.94999.16
5101282-10128289.77693.89
6104379-10437992.52196.76
45min1101406-10140689.88690.941.4495.1096.161.39
2104665-10466592.77598.02
3103464-10346491.71096.91
4101652-10165290.10495.37
5100949-10094989.48194.59
6103443-10344391.69196.96
60min1102534-10253490.88690.301.3297.1096.531.30
2103276-10327691.54397.82
3101580-10158090.04096.26
4102383-10238390.75297.02
599387-9938788.09694.20
6102095-10209590.49796.78
90min1101122-10112289.63489.530.9896.8696.760.98
2101947-10194790.36597.66
3101379-10137989.86297.08
4100726-10072689.28396.56
599180-9918087.91395.00
6101652-10165290.10497.39
极限1107251-10725195.06789.253.34103.2997.483.09
299955-9995588.60096.90
399394-9939488.10296.32
499942-9994288.58896.86
597476-9747686.40294.46
6100103-10010388.73197.02
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%
116.781933631932861934351931861929201932380.11
216.841920301924851922580.17
单位质量响应值RSD%判断
11515.9711416.750.62数据可信
供试品溶液-24052301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%
5min13289-32892.94310.2648.942.9410.2648.95
215114-1511413.52413.52
315311-1531113.70013.70
417523-1752315.68015.68
511177-1117710.00110.00
66393-63935.7215.72
10min131887-3188728.53326.425.2228.5726.535.15
229235-2923526.16026.31
328013-2801325.06625.22
430439-3043927.23727.41
529769-2976926.63826.75
627793-2779324.86924.93
15min142683-4268338.19333.267.9038.5433.677.75
236907-3690733.02533.47
334585-3458530.94731.38
437213-3721333.29833.78
536848-3684832.97233.38
634768-3476831.11131.45
20min148316-4831643.23437.577.8944.0138.357.75
241999-4199937.58138.39
339200-3920035.07635.85
440856-4085636.55837.41
541954-4195437.54138.31
639603-3960335.43736.12
30min153582-5358247.94642.716.7249.2043.906.64
247047-4704742.09843.32
344753-4475340.04541.21
447913-4791342.87344.13
548095-4809543.03644.23
644969-4496940.23941.32
45min157257-5725751.23446.616.6753.0248.286.55
253246-5324647.64549.34
351091-5109145.71747.33
447743-4774342.72144.45
554054-5405448.36850.04
649161-4916143.99045.52
60min160369-6036954.01948.927.0156.3851.106.89
256040-5604050.14552.37
353433-5343347.81249.93
450212-5021244.93047.13
556856-5685650.87553.08
651096-5109645.72147.74
90min162567-6256755.98551.237.2858.9453.967.13
258949-5894952.74855.53
357942-5794251.84754.50
451934-5193446.47149.17
559548-5954853.28456.06
652599-5259947.06649.59
极限177074-7707468.96666.932.8172.5570.232.91
275381-7538167.45270.82
374673-7467366.81870.04
472386-7238664.77267.99
576955-7695568.86072.22
672337-7233764.72867.77
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%
116.141832331835261828071831671831471831760.14
216.011821181821481821330.02
单位质量响应值RSD%判断
11349.1911376.200.17数据可信
供试品溶液-24052301批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1107107-10710795.22494.890.8695.2294.890.86
2105519-10551993.81293.81
3106316-10631694.52194.52
4107721-10772195.77095.77
5106047-10604794.28294.28
6107703-10770395.75495.75
10min1107073-10707395.19495.391.0996.2596.441.09
2106582-10658294.75895.80
3106530-10653094.71195.76
4108009-10800996.02697.09
5106243-10624394.45695.50
6109308-10930897.18198.25
15min1106710-10671094.87194.081.5496.9996.191.52
2104682-10468293.06895.16
3105325-10532593.64095.74
4106434-10643494.62696.76
5103594-10359492.10194.20
6108158-10815896.15998.30
20min1102660-10266091.27192.831.9194.4495.991.87
2102959-10295991.53694.67
3102803-10280391.39894.54
4105151-10515193.48596.67
5105197-10519793.52696.65
6107696-10769695.74898.96
30min1103244-10324491.79092.332.6095.9796.522.54
2101419-10141990.16794.31
3101992-10199290.67794.84
4104751-10475193.13097.35
5102868-10286891.45695.62
6108826-10882696.753101.03
45min1102002-10200290.68691.841.6095.8997.061.58
2102627-10262791.24196.39
3102955-10295591.53396.70
4103197-10319791.74897.00
5102498-10249891.12796.30
6106555-10655594.733100.08
60min1102322-10232290.97090.222.0397.1896.461.97
2100774-10077489.59495.76
398068-9806887.18893.37
4101924-10192490.61696.89
5101473-10147390.21596.40
6104315-10431592.74299.15
90min1100014-10001488.91889.271.5796.1496.501.56
299427-9942788.39695.55
398431-9843187.51194.66
4101176-10117689.95197.23
5100391-10039189.25396.44
6102995-10299591.56899.00
极限199733-9973388.66888.751.4896.8896.981.47
298119-9811987.23395.37
398742-9874287.78795.91
4100356-10035689.22297.50
599655-9965588.59996.78
6102353-10235390.99899.45
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%
116.781921951920991918421919331922371920610.09
216.841901211902841902020.07
单位质量响应值RSD%判断
11445.8311294.660.95数据可信
供试品溶液-24052301批-叶酸-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18963-89638.0887.5613.938.097.5613.93
26806-68066.1426.14
310188-101889.1949.19
47880-78807.1117.11
58673-86737.8267.83
67757-77577.0007.00
10min114260-1426012.86813.187.2712.9613.267.28
214691-1469113.25713.33
316367-1636714.77014.87
413363-1336312.05912.14
515107-1510713.63213.72
613825-1382512.47612.55
15min117691-1769115.96416.407.6716.2016.647.66
218235-1823516.45516.67
320355-2035518.36818.63
416594-1659414.97415.19
519149-1914917.28017.52
617053-1705315.38915.60
20min120449-2044918.45319.228.2218.8619.638.21
221248-2124819.17419.57
323932-2393221.59622.07
419452-1945217.55317.93
522797-2279720.57221.00
619893-1989317.95118.34
30min125066-2506622.61923.668.1923.2324.298.18
226240-2624023.67924.29
329498-2949826.61927.33
423246-2324620.97721.55
527580-2758024.88825.55
625713-2571323.20323.79
45min130158-3015827.21427.785.3528.0828.665.28
232301-3230129.14830.02
330056-3005627.12228.13
428806-2880625.99426.80
533225-3322529.98230.92
630136-3013627.19528.04
60min135244-3524431.80432.308.1532.9733.508.08
235589-3558932.11533.31
340531-4053136.57537.88
432446-3244629.27930.38
537516-3751633.85435.12
633440-3344030.17631.32
90min146757-4675742.19338.7710.1743.7240.3210.00
241389-4138937.34938.90
348995-4899544.21345.93
437809-3780934.11935.54
543720-4372039.45341.10
639092-3909235.27636.76
极限151901-5190146.83543.887.2648.8345.877.23
247484-4748442.84944.82
353454-5345448.23750.44
444678-4467840.31742.12
548985-4898544.20446.29
645271-4527140.85242.73
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%
116.141845391843171837191845361841881842600.19
216.011825571821711823640.15
单位质量响应值RSD%判断
11416.3611390.630.16数据可信
供试品溶液-24052301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%
5min1105827-10582793.75094.141.3193.7594.141.31
2106751-10675194.56894.57
3104293-10429392.39192.39
4107227-10722794.99094.99
5105369-10536993.34493.34
6108169-10816995.82495.82
10min1105719-10571993.65494.231.1194.7095.281.11
2106737-10673794.55695.61
3105957-10595793.86594.89
4105382-10538293.35594.41
5105821-10582193.74494.78
6108596-10859696.20397.27
15min1105481-10548193.44393.451.8895.5395.541.86
2106698-10669894.52196.62
3103861-10386192.00894.08
4105309-10530993.29195.38
5103022-10302291.26593.34
6108547-10854796.15998.29
20min1101963-10196390.32791.401.5893.4594.531.56
2104449-10444992.52995.68
3101127-10112789.58692.68
4103089-10308991.32494.45
5102853-10285391.11594.21
6105569-10556993.52196.72
30min1101029-10102989.49990.321.7193.6294.471.69
2102026-10202690.38294.56
399173-9917387.85591.94
4103178-10317891.40395.55
5102162-10216290.50394.61
6104185-10418592.29596.54
45min1100057-10005788.63889.341.1893.7694.501.18
2102018-10201890.37595.56
399666-9966688.29293.36
4101296-10129689.73694.90
599754-9975488.37093.48
6102323-10232390.64695.91
60min1100658-10065889.17189.511.6395.2795.661.60
2100725-10072589.23095.42
398703-9870387.43993.48
4101739-10173990.12896.28
5100737-10073789.24195.33
6103709-10370991.87398.15
90min199616-9961688.24788.241.4395.3495.381.42
299386-9938688.04495.22
397801-9780186.64093.66
4100257-10025788.81595.97
598654-9865487.39594.48
6101942-10194290.30897.60
极限198237-9823787.02687.451.4095.1095.571.39
298314-9831487.09495.25
397276-9727686.17594.15
498953-9895387.66095.81
598209-9820987.00195.06
6101304-10130489.74398.04
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%
116.781915261916431914921920671913181916090.15
216.841882991883991883490.04
单位质量响应值RSD%判断
11418.8911184.621.47数据可信
供试品溶液-24052301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%
5min127833-2783325.27026.162.7225.2726.162.72
229165-2916526.48026.48
329037-2903726.36326.36
427828-2782825.26625.27
529635-2963526.90626.91
629348-2934826.64626.65
10min136443-3644333.08733.982.7933.3734.272.78
237247-3724733.81734.11
336786-3678633.39933.69
436654-3665433.27933.56
538421-3842134.88335.18
638985-3898535.39535.69
15min140157-4015736.45937.203.6437.1137.873.61
240837-4083737.07737.75
341010-4101037.23437.90
439086-3908635.48736.14
541148-4114837.35938.05
643589-4358939.57540.26
20min141596-4159637.76638.503.9538.8239.583.92
242244-4224438.35439.44
342263-4226338.37139.45
440098-4009836.40637.45
543078-4307839.11140.21
645150-4515040.99342.12
30min144144-4414440.07940.564.2041.5542.074.15
243643-4364339.62441.13
344340-4434040.25741.76
442567-4256738.64740.10
545354-4535441.17842.71
648020-4802043.59845.18
45min146556-4655642.26942.524.3744.1944.484.31
246096-4609641.85243.80
347105-4710542.76844.72
444299-4429940.22042.10
546395-4639542.12344.12
650523-5052345.87147.94
60min148760-4876044.27044.535.5546.6646.965.43
247245-4724542.89545.31
348661-4866144.18046.61
446493-4649342.21244.54
548850-4885044.35246.81
654236-5423649.24251.82
90min150980-5098046.28646.566.2749.1749.496.10
249387-4938744.83947.73
351846-5184647.07249.99
448255-4825543.81246.61
549923-4992345.32648.28
657327-5732752.04855.17
极限187231-8723179.19979.081.1182.5982.521.22
286232-8623278.29281.68
386677-8667778.69682.14
486524-8652478.55781.84
587002-8700278.99182.45
688927-8892780.73984.44
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