坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.977667676212772337699676573767380.52
215.947727977499773890.21
单位质量响应值RSD%判断
4805.134855.020.74数据可信
供试品溶液-2025022821批-含0.35%吐温20的磷酸盐缓冲液(pH6.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119552-1955222.72524.397.4922.7224.387.49
221724-2172425.24925.25
322985-2298526.71526.71
419291-1929122.42222.42
522348-2234825.97525.97
619985-1998523.22823.23
10min151498-5149859.85560.774.1959.8960.814.19
251567-5156759.93559.98
355415-5541564.40864.45
450067-5006758.19258.23
554563-5456363.41763.46
650586-5058658.79558.83
15min171607-7160783.22782.962.7183.3683.102.71
268640-6864079.77979.92
373629-7362985.57785.73
470227-7022781.62381.76
573441-7344185.35985.51
670728-7072882.20682.34
20min179109-7910991.94791.581.3792.2291.861.38
277166-7716689.68889.96
380309-8030993.34293.64
478525-7852591.26891.54
579418-7941892.30692.60
678236-7823690.93291.21
30min182527-8252795.91995.720.6996.3596.150.70
281403-8140394.61395.04
383079-8307996.56197.01
482405-8240595.77896.20
582620-8262096.02896.47
682091-8209195.41395.84
45min183395-8339596.92896.740.5097.5297.330.50
283169-8316996.66697.25
383804-8380497.40498.01
482902-8290296.35596.94
582657-8265796.07196.68
683473-8347397.01997.60
60min183390-8339096.92296.710.4897.6797.470.49
282547-8254795.94396.69
383755-8375597.34798.12
483063-8306396.54297.29
583269-8326996.78297.55
683238-8323896.74697.49
极限183658-8365897.23496.780.5098.1597.690.50
283105-8310596.59197.49
383883-8388397.49698.43
482941-8294196.40197.30
582857-8285796.30397.23
683147-8314796.64097.55
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.977735677319768817677176773770200.39
215.947698276864769230.11
单位质量响应值RSD%判断
4822.794825.780.05数据可信
供试品溶液-2025030121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118007-1800720.95422.598.9320.9522.598.94
217405-1740520.25320.25
322316-2231625.96825.97
419871-1987123.12323.12
519027-1902722.14122.14
619872-1987223.12423.12
10min146380-4638053.97054.078.7254.0054.118.72
239378-3937845.82245.86
350923-5092359.25659.30
445476-4547652.91852.96
546898-4689854.57354.61
649741-4974157.88157.92
15min169337-6933780.68478.876.2880.8179.006.28
259544-5954469.28869.40
368198-6819879.35879.50
467756-6775678.84478.97
570571-7057182.11982.25
671277-7127782.94183.08
20min178228-7822891.02990.492.6691.2990.752.67
273924-7392486.02186.25
377945-7794590.70090.97
477449-7744990.12390.38
579767-7976792.82093.09
679264-7926492.23592.51
30min181544-8154494.88895.981.4895.3096.381.49
281188-8118894.47494.84
383848-8384897.56997.99
481413-8141394.73695.14
583533-8353397.20397.62
683354-8335496.99497.42
45min182167-8216795.61396.421.3496.1897.001.35
282001-8200195.42095.95
384698-8469898.55899.15
481923-8192395.32995.90
583658-8365897.34897.93
682742-8274296.28296.87
60min182186-8218695.63596.711.1296.3697.441.13
282617-8261796.13796.82
383994-8399497.73998.49
482529-8252996.03496.76
584525-8452598.35799.10
682824-8282496.37897.13
极限182195-8219595.64697.291.6196.5398.181.61
283433-8343397.08697.93
384653-8465398.50699.42
482323-8232395.79596.68
585663-8566399.681100.59
683365-8336597.00797.92
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.977719977539772777757477471774120.22
215.947721377168771900.05
单位质量响应值RSD%判断
4847.344842.530.08数据可信
供试品溶液-2025030221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121047-2104724.38718.5323.9324.3918.5323.93
219674-1967422.79622.80
315273-1527317.69717.70
416009-1600918.54918.55
512799-1279914.83014.83
611157-1115712.92712.93
10min152477-5247760.80449.1317.4460.8449.1617.45
251364-5136459.51559.55
337046-3704642.92542.95
438331-3833144.41444.44
537355-3735543.28343.31
637838-3783843.84243.86
15min169107-6910780.07373.309.5380.2273.429.53
270759-7075981.98782.12
355783-5578364.63564.74
457773-5777366.94167.05
561500-6150071.25971.36
664664-6466474.92575.02
20min176780-7678088.96487.173.6389.2487.403.65
278223-7822390.63690.91
371375-7137582.70182.91
472307-7230783.78184.00
576375-7637588.49588.71
676306-7630688.41588.63
30min180898-8089893.73595.191.4994.1695.571.48
282990-8299096.15996.58
382000-8200095.01295.36
480648-8064893.44693.80
583779-8377997.07397.44
682591-8259195.69796.06
45min182327-8232795.39196.491.0495.9797.031.04
284271-8427197.64398.23
383871-8387197.18097.68
482133-8213395.16695.68
583642-8364296.91597.44
683421-8342196.65997.18
60min182693-8269395.81596.611.1896.5597.311.16
283482-8348296.72997.48
383780-8378097.07597.74
481819-8181994.80295.47
584542-8454297.95798.64
683954-8395497.27697.96
极限183296-8329696.51497.181.0297.4198.041.02
284720-8472098.16499.07
384765-8476598.21699.04
482551-8255195.65196.48
584017-8401797.34998.20
683854-8385497.16098.01
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