富马酸比索洛尔片项目信息
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100711-202203对照品来源中检院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)5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%
110.128270182775824558266482465826120.18
210.158156381774816680.19
单位质量响应值RSD%判断
8163.248046.111.03数据可信
供试品溶液-G01T78批-5mg-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min168306-6830675.70461.6926.7875.7061.6826.78
267106-6710674.37474.37
361977-6197768.69068.69
463000-6300069.82369.82
534227-3422737.93437.93
639341-3934143.60243.60
10min176004-7600484.23674.3918.1584.3674.4918.16
275719-7571983.92084.04
374200-7420082.23682.35
473736-7373681.72281.84
549426-4942654.77954.84
653639-5363959.44859.52
15min180245-8024588.93681.3013.7489.2081.5313.77
280317-8031789.01689.28
380534-8053489.25689.51
478236-7823686.71086.96
559590-5959066.04466.20
661226-6122667.85768.03
20min182599-8259991.54584.9611.8991.9685.3211.91
283209-8320992.22192.63
383844-8384492.92593.33
480273-8027388.96789.36
565030-6503072.07372.34
664972-6497272.00972.29
30min185507-8550794.76889.709.0595.3490.219.09
286960-8696096.37896.94
387187-8718796.63097.19
482472-8247291.40491.95
571457-7145779.19679.58
672030-7203079.83180.24
45min187461-8746196.93493.146.8797.6693.806.92
289354-8935499.03299.76
389044-8904498.68899.40
484440-8444093.58594.28
576220-7622084.47584.99
677722-7772286.14086.68
极限190866-90866100.70799.882.13101.59100.692.17
293093-93093103.176104.07
390720-90720100.546101.43
487674-8767497.17098.02
588521-8852198.10898.77
689841-8984199.571100.25
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检院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)5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%
110.128340183457835448357383320834590.13
210.158271182821827660.10
单位质量响应值RSD%判断
8246.948154.290.80数据可信
供试品溶液-G01T78批-5mg-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min164955-6495571.14665.1719.7271.1565.1719.72
271888-7188878.74078.74
337258-3725840.80940.81
462521-6252168.48068.48
560005-6000565.72565.72
660370-6037066.12466.12
10min175025-7502582.17676.9313.4982.2977.0413.50
280875-8087588.58488.72
352859-5285957.89757.97
473301-7330180.28880.40
569136-6913675.72675.84
670238-7023876.93377.04
15min180480-8048088.15183.2510.3788.4183.4910.39
284713-8471392.78893.07
361828-6182867.72167.89
479251-7925186.80587.05
574316-7431681.40081.64
675436-7543682.62682.86
20min183419-8341991.37087.098.1691.7787.468.18
286669-8666994.93095.36
368170-6817074.66874.95
482664-8266490.54390.94
577424-7742484.80485.18
678711-7871186.21486.59
30min186558-8655894.80991.705.7595.3692.225.79
289124-8912497.61998.21
375730-7573082.94983.35
486694-8669494.95895.50
581515-8151589.28589.80
682693-8269390.57591.10
45min188528-8852896.96695.013.9897.6895.684.03
290688-9068899.332100.09
381564-8156489.33989.88
489575-8957598.11398.82
584909-8490993.00293.66
685175-8517593.29493.96
极限190312-9031298.92099.562.1399.79100.402.14
292833-92833101.682102.60
390658-9065899.29999.99
493335-93335102.232103.10
590205-9020598.80399.62
688051-8805196.44497.27
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