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%
117.58 1925791918951920501917731917691920130.18
217.621925321923451924380.07
单位质量响应值RSD%判断
10922.2410921.570.01数据可信
供试品溶液-24052001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%
5min1107840-10784099.745100.340.7299.75100.340.72
2108441-108441100.301100.30
3109926-109926101.675101.67
4107901-10790199.80299.80
5108677-108677100.519100.52
6108107-10810799.99299.99
10min1106882-10688298.859100.151.3699.97101.261.35
2108043-10804399.933101.05
3110982-110982102.651103.78
4107915-10791599.815100.92
5107212-10721299.164100.28
6108634-108634100.480101.59
15min1105820-10582097.87798.871.49100.08101.101.47
2108028-10802899.919102.14
3109567-109567101.343103.61
4106552-10655298.554100.77
5105554-10555497.63199.85
6105861-10586197.915100.14
20min1106142-10614298.17597.643.00101.47100.972.93
2103535-10353595.76399.10
3111517-111517103.146106.54
4103735-10373595.94899.26
5102947-10294795.22098.52
6105540-10554097.618100.93
30min1104465-10446596.62497.271.60101.01101.681.59
2104042-10404296.232100.63
3108510-108510100.365104.91
4104539-10453996.692101.07
5104325-10432596.494100.86
6105111-10511197.221101.62
45min1103461-10346195.69596.702.70101.15102.192.64
2103291-10329195.538101.01
3110289-110289102.010107.67
4103758-10375895.970101.42
5103161-10316195.417100.85
6103298-10329895.544101.02
60min1102475-10247594.78395.483.13101.30102.053.03
2102051-10205194.391100.92
3109687-109687101.454108.24
4101963-10196394.309100.83
5100766-10076693.20299.70
6102452-10245294.762101.30
90min1100991-10099193.41095.303.96100.99102.933.80
2103027-10302795.294102.87
3111040-111040102.705110.62
4101064-10106493.478101.05
599816-9981692.32499.85
6102268-10226894.591102.19
极限1100530-10053092.98494.534.66101.60103.224.44
298342-9834290.96099.60
3111684-111684103.301112.36
4101320-10132093.715102.32
5100923-10092393.347101.90
6100418-10041892.880101.53
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%
115.87 1922461923641926321927451923741924720.11
215.901926871930371928620.13
单位质量响应值RSD%判断
12128.0412129.690.01数据可信
供试品溶液-24052001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%
5min121956-2195618.57321.026.6418.5721.026.65
224056-2405620.34920.35
326305-2630522.25222.25
425176-2517621.29721.30
525265-2526521.37221.37
626336-2633622.27822.28
10min145741-4574138.69338.603.0038.9038.832.99
246136-4613639.02739.25
344944-4494438.01938.27
443464-4346436.76737.00
545887-4588738.81739.05
647596-4759640.26240.51
15min161439-6143951.97250.604.0752.6151.264.03
261984-6198452.43353.09
357477-5747748.62149.29
456248-5624847.58148.23
559940-5994050.70451.37
661834-6183452.30653.00
20min171478-7147860.46458.524.4661.6859.744.42
270553-7055359.68260.92
368660-6866058.08159.29
463523-6352353.73554.91
568838-6883858.23159.46
672016-7201660.91962.20
30min182770-8277070.01669.233.5171.9071.103.50
283291-8329170.45772.36
381071-8107168.57970.43
476920-7692065.06866.84
581503-8150368.94570.82
685473-8547372.30374.26
45min192422-9242278.18179.081.8080.8481.721.82
294050-9405079.55882.25
395373-9537380.67883.29
491186-9118677.13679.63
592626-9262678.35481.00
695235-9523580.56183.32
60min196899-9689981.96883.412.5385.5086.942.48
298941-9894183.69687.27
3100888-10088885.34388.86
497682-9768282.63185.98
595305-9530580.62084.14
6101914-10191486.21189.86
90min1101760-10176086.08088.593.4790.5293.043.36
2105336-10533689.10593.61
3109777-10977792.86297.32
4103935-10393587.92092.19
599977-9997784.57288.98
6107559-10755990.98695.60
极限1104496-10449688.39587.447.6093.7992.877.07
2103846-10384687.84593.34
3112061-11206194.794100.29
4106571-10657190.15095.40
5104635-10463588.51293.86
688563-8856374.91780.54
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%
117.58 1929621927081927431924841924601926710.11
217.621914801915261915030.02
单位质量响应值RSD%判断
10959.6710868.500.60数据可信
供试品溶液-24052002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%
5min1106136-10613698.24199.851.2498.2499.851.24
2108131-108131100.088100.09
3108567-108567100.491100.49
4109887-109887101.713101.71
5106768-10676898.82698.83
6107771-10777199.75599.75
10min1106720-10672098.78299.710.9899.87100.820.98
2108059-108059100.021101.13
3108785-108785100.693101.81
4108492-108492100.422101.55
5106135-10613598.24099.34
6108166-108166100.120101.23
15min1105515-10551597.66698.840.9199.86101.050.91
2107010-10701099.050101.27
3108027-10802799.992102.23
4107622-10762299.617101.86
5105959-10595998.077100.27
6106537-10653798.612100.83
20min1101387-10138793.84597.722.0497.12101.042.00
2105793-10579397.924101.25
3106580-10658098.652102.00
4107425-10742599.434102.79
5106587-10658798.659101.94
6105693-10569397.831101.15
30min1102759-10275995.11596.531.0999.43100.931.09
2104540-10454096.764101.18
3105098-10509897.280101.72
4105705-10570597.842102.30
5103157-10315795.48499.86
6104459-10445996.689101.09
45min1101869-10186994.29295.311.2799.67100.781.25
2103909-10390996.180101.67
3103166-10316695.492101.02
4104553-10455396.776102.32
5101025-10102593.51098.95
6103265-10326595.584101.06
60min199968-9996892.53294.141.5598.95100.681.51
2101037-10103793.521100.08
3103748-10374896.031102.62
4103174-10317495.499102.12
5100174-10017492.72399.20
6102153-10215394.554101.09
90min199591-9959192.18392.921.0599.63100.501.00
2100744-10074493.250100.85
3101331-10133193.794101.45
499255-9925591.87299.55
599603-9960392.19499.70
6101794-10179494.222101.81
极限199229-9922991.84892.361.13100.32100.971.11
2100240-10024092.784101.41
3100175-10017592.724101.42
4101515-10151593.964102.67
598220-9822090.91499.44
699310-9931091.923100.56
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%
115.87 1927681925971927241926401926721926800.04
215.901921181920941921060.01
单位质量响应值RSD%判断
12141.1512082.140.35数据可信
供试品溶液-24052002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%
5min122703-2270319.23219.714.9919.2319.715.00
224986-2498621.16621.17
324128-2412820.43920.44
423547-2354719.94719.95
521992-2199218.63018.63
622264-2226418.86018.86
10min142111-4211135.67335.643.7035.8935.863.70
244030-4403037.29937.53
343782-4378237.08937.32
441116-4111634.83035.05
540123-4012333.98934.20
641278-4127834.96835.18
15min154903-5490346.51046.872.9447.1247.492.95
258022-5802249.15249.80
356248-5624847.64948.29
454650-5465046.29546.90
553260-5326045.11845.70
654910-5491046.51647.11
20min162438-6243852.89355.173.2454.0256.303.23
267568-6756857.23858.43
367324-6732457.03258.20
465759-6575955.70656.83
563396-6339653.70454.79
664251-6425154.42955.54
30min176056-7605664.42965.622.5966.1467.372.60
279692-7969267.50969.34
379661-7966167.48369.29
478287-7828766.31968.06
575888-7588864.28765.97
675198-7519863.70265.42
45min188155-8815574.67874.063.1377.1176.543.07
290489-9048976.65579.24
389069-8906975.45278.00
482578-8257869.95472.43
586438-8643873.22475.62
687822-8782274.39676.82
60min193588-9358879.28179.840.8882.5483.140.92
294829-9482980.33283.77
394870-9487080.36783.76
495088-9508880.55183.81
593004-9300478.78682.00
694127-9412779.73782.99
90min199845-9984584.58185.050.9388.7289.230.97
2101670-10167086.12790.45
3101104-10110485.64889.93
499019-9901983.88188.03
5100274-10027484.94489.03
6100461-10046185.10389.24
极限1102107-10210786.49786.191.2391.5891.331.22
2103385-10338587.58092.86
3101518-10151885.99891.23
4102743-10274387.03692.12
5100609-10060985.22890.26
6100133-10013384.82589.91
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%
117.58 1926281923911920451921341920651922530.14
217.621924721926581925650.07
单位质量响应值RSD%判断
10935.8910928.770.05数据可信
供试品溶液-24052001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%
5min1110382-110382101.999100.250.95102.00100.250.95
2107825-10782599.63699.64
3107874-10787499.68199.68
4107619-10761999.44699.45
5108741-108741100.483100.48
6108498-108498100.258100.26
10min1111312-111312102.858100.581.25103.99101.691.24
2107286-10728699.138100.25
3108254-108254100.033101.14
4108758-108758100.498101.60
5108400-108400100.168101.28
6109050-109050100.768101.88
15min1109609-109609101.28599.041.55103.56101.281.53
2107170-10717099.031101.24
3107098-10709898.964101.18
4107065-10706598.934101.16
5104450-10445096.51898.75
6107710-10771099.530101.76
20min1108556-108556100.31298.281.41103.71101.611.40
2104054-10405496.15299.46
3105666-10566697.641100.96
4106832-10683298.719102.04
5106119-10611998.060101.36
6106920-10692098.800102.14
30min1106930-10693098.80997.541.02103.33101.961.02
2104954-10495496.983101.36
3105498-10549897.486101.89
4105755-10575597.723102.14
5103865-10386595.977100.37
6106320-10632098.246102.68
45min1104493-10449396.55796.140.27102.17101.640.31
2103802-10380295.919101.37
3104071-10407196.167101.65
4104220-10422096.305101.81
5103801-10380195.918101.38
6103853-10385395.966101.49
60min1104079-10407996.17595.270.91102.86101.850.89
2101460-10146093.755100.28
3102914-10291495.098101.65
4103913-10391396.021102.59
5103192-10319295.355101.88
6103066-10306695.239101.83
90min1102851-10285195.04094.580.64102.80102.210.62
2102028-10202894.279101.84
3102135-10213594.378101.99
4101318-10131893.623101.26
5102721-10272194.920102.50
6103043-10304395.217102.87
极限1100579-10057992.94192.580.52101.75101.260.51
299563-9956392.002100.61
399958-9995892.367101.03
499690-9969092.119100.80
5100628-10062892.986101.62
6100718-10071893.069101.78
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%
115.87 1925441924881923941924931925371924910.04
215.901930181932221931200.08
单位质量响应值RSD%判断
12129.2412145.910.10数据可信
供试品溶液-24052001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%
5min140140-4014033.93132.342.6733.9332.342.67
237282-3728231.51531.51
337658-3765831.83331.83
437725-3772531.88931.89
538283-3828332.36132.36
638460-3846032.51132.51
10min168655-6865558.03555.682.2558.4156.042.25
264578-6457854.58854.94
364884-6488454.84755.20
465143-6514355.06655.42
566058-6605855.83956.20
665876-6587655.68656.05
15min184408-8440871.35169.431.7372.3770.411.73
281699-8169969.06170.02
381341-8134168.75869.72
481246-8124668.67869.64
580782-8078268.28669.27
683335-8333570.44471.42
20min194159-9415979.59377.781.8381.4179.531.83
289521-8952175.67377.40
391188-9118877.08278.81
491813-9181377.61079.34
591802-9180277.60179.34
693621-9362179.13980.90
30min1103580-10358087.55786.211.3290.2688.821.33
2100867-10086785.26487.83
3101559-10155985.84988.43
4101793-10179386.04788.64
5100458-10045884.91887.52
6103630-10363087.59990.24
45min1108567-10856791.77391.010.6295.4494.580.65
2107026-10702690.47093.98
3107623-10762390.97594.51
4107669-10766991.01494.56
5106888-10688890.35393.90
6108241-10824191.49795.11
60min1111820-11182094.52292.961.3299.2197.551.31
2107545-10754590.90995.43
3109684-10968492.71797.27
4110808-11080893.66798.23
5109545-10954592.59997.15
6110451-11045193.36598.00
90min1112748-11274895.30794.380.63101.0599.990.67
2110982-11098293.81499.34
3111117-11111793.92899.51
4111088-11108893.90499.50
5111892-11189294.583100.16
6112047-11204794.714100.38
极限1110717-11071793.59093.040.76100.3999.710.77
2108682-10868291.87098.44
3109618-10961892.66199.28
4110061-11006193.03699.68
5110425-11042593.34399.97
6110928-11092893.768100.49
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%
117.58 1921021920251918241919291921111919980.07
217.621924001922721923360.05
单位质量响应值RSD%判断
10921.3910915.780.04数据可信
供试品溶液-24052002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%
5min1103610-10361095.86297.401.9795.8697.401.97
2106009-10600998.08198.08
3103183-10318395.46795.47
4104604-10460496.78296.78
5105341-10534197.46397.46
6108917-108917100.772100.77
10min1103569-10356995.82497.131.5296.8998.211.52
2105623-10562397.72498.81
3103070-10307095.36296.42
4104374-10437496.56997.64
5105982-10598298.05799.14
6107262-10726299.241100.36
15min1102324-10232494.67295.901.5296.8098.061.52
2104344-10434496.54198.72
3101532-10153293.93996.06
4103270-10327095.54797.70
5104669-10466996.84299.01
6105750-10575097.842100.06
20min1100439-10043992.92894.361.9796.1197.581.95
2102959-10295995.26098.51
3100508-10050892.99296.16
499706-9970692.25095.46
5104055-10405596.27499.52
6104236-10423696.44199.75
30min198848-9884891.45692.640.9295.6796.920.90
2101579-10157993.98398.29
399937-9993792.46496.66
4100663-10066393.13597.37
599791-9979192.32896.65
699970-9997092.49496.88
45min197922-9792290.59992.691.9095.8397.991.86
2102321-10232194.669100.02
398483-9848391.11896.34
499464-9946492.02697.30
5100510-10051092.99498.34
6102360-10236094.705100.11
60min197125-9712589.86291.852.0796.1098.182.02
2101005-10100593.45299.85
397424-9742490.13896.38
498307-9830790.95597.25
599530-9953092.08798.46
6102261-10226194.614101.07
90min196773-9677389.53690.891.8996.7798.251.86
299233-9923391.81299.25
396740-9674089.50696.74
496770-9677089.53396.84
598598-9859891.22598.63
6101320-10132093.743101.26
极限195491-9549188.35090.242.2296.5898.612.15
297643-9764390.34198.80
395733-9573388.57496.81
496042-9604288.86097.16
5100032-10003292.551100.97
6100273-10027392.774101.33
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%
115.87 1921121920881923801922141923641922320.08
215.901926591923811925200.11
单位质量响应值RSD%判断
12112.9212108.180.03数据可信
供试品溶液-24052002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%
5min133325-3332528.23328.172.5928.2328.162.59
233891-3389128.71228.71
333611-3361128.47528.48
432389-3238927.44027.44
532036-3203627.14127.14
634222-3422228.99328.99
10min159366-5936650.29548.472.1150.6148.792.11
257494-5749448.70949.03
357106-5710648.38048.70
456696-5669648.03348.34
555740-5574047.22347.52
656891-5689148.19848.52
15min173133-7313361.95861.031.2062.8361.881.20
272685-7268561.57862.44
370789-7078959.97260.83
471980-7198060.98161.82
571339-7133960.43861.26
672287-7228761.24162.10
20min180693-8069368.36368.301.5069.9269.831.48
281851-8185169.34470.89
378980-7898066.91168.43
479381-7938167.25168.77
581018-8101868.63870.14
681778-8177869.28270.82
30min189511-8951175.83375.951.3878.1578.241.35
291358-9135877.39879.71
389307-8930775.66077.92
490786-9078676.91379.18
587982-8798274.53876.80
688973-8897375.37877.69
45min195525-9552580.92882.761.8484.0985.891.79
299848-9984884.59187.77
396089-9608981.40684.51
497580-9758082.66985.79
597395-9739582.51385.60
699691-9969184.45887.60
60min198644-9864483.57185.652.1987.6389.702.12
2102926-10292687.19891.31
399105-9910583.96187.97
4100519-10051985.15989.20
5101039-10103985.60089.61
6104358-10435888.41292.50
90min1101788-10178886.23487.882.0291.2392.881.96
2104975-10497588.93494.02
3102146-10214686.53891.48
4102300-10230086.66891.65
5103991-10399188.10193.06
6107181-10718190.80395.87
极限1101693-10169386.15487.912.0692.1093.891.99
2104497-10449788.52994.60
3101723-10172386.17992.08
4102628-10262886.94692.89
5105021-10502188.97394.91
6107057-10705790.69896.77
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