比索洛尔左氨氯地平片项目信息
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%
110.318813588239882068813088121881660.07
210.408856388568885660.01
单位质量响应值RSD%判断
8551.508515.960.30数据可信
加速6月-供试品溶液-G01RY4批-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%
5min174446-7444678.35774.1011.1578.3674.1011.15
272752-7275276.57476.57
368011-6801171.58471.58
482591-8259186.93086.93
562700-6270065.99465.99
661905-6190565.15765.16
10min181207-8120785.47383.497.1085.6083.617.11
279552-7955283.73183.86
376299-7629980.30780.43
489349-8934994.04394.19
573423-7342377.28077.39
676092-7609280.08980.20
15min183313-8331387.69086.755.6487.9687.015.65
282180-8218086.49786.76
379535-7953583.71383.97
490733-9073395.50095.80
577017-7701781.06381.30
681729-8172986.02386.26
20min184261-8426188.68888.674.7089.1189.084.71
284022-8402288.43688.85
381743-8174386.03786.43
491442-9144296.24696.71
579753-7975383.94384.32
684262-8426288.68989.07
30min185213-8521389.69090.423.7490.2690.973.75
285741-8574190.24590.80
383851-8385188.25688.79
491666-9166696.48297.10
582315-8231586.63987.15
686659-8665991.21191.74
45min185844-8584490.35491.423.0891.0792.123.09
285638-8563890.13790.85
385431-8543189.91990.60
491606-9160696.41897.20
584315-8431588.74489.40
688286-8828692.92493.61
极限186126-8612690.65092.192.7491.5293.052.74
285952-8595290.46791.33
386118-8611890.64291.48
491657-9165796.47297.41
586265-8626590.79791.60
689411-8941194.10894.95
比索洛尔左氨氯地平片项目信息
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%
110.318844188512884388846588104883920.19
210.408868388588886360.08
单位质量响应值RSD%判断
8573.428522.690.42数据可信
长期6月-供试品溶液-G01RY4批-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%
5min173809-7380977.55773.7611.8977.5673.7611.88
279856-7985683.91183.91
373244-7324476.96376.96
474503-7450378.28678.29
560519-6051963.59263.59
659248-5924862.25662.26
10min182154-8215486.32583.538.3886.4583.668.39
287555-8755592.00192.14
380790-8079084.89285.02
482939-8293987.15087.28
574692-7469278.48478.59
668853-6885372.34972.45
15min185228-8522889.55587.246.4989.8387.506.50
289230-8923093.76194.05
383040-8304087.25687.53
485842-8584290.20190.48
581290-8129085.41785.65
673499-7349977.23177.46
20min186909-8690991.32289.385.7591.7489.785.76
290585-9058595.18495.63
384566-8456688.86089.27
487754-8775492.21092.64
584269-8426988.54888.93
676275-7627580.14880.50
30min188307-8830792.79191.635.2693.3792.195.27
292125-9212596.80397.41
385700-8570090.05190.61
489815-8981594.37594.96
588385-8838592.87393.40
678889-7888982.89583.38
45min189067-8906793.58992.994.9594.3293.704.96
292898-9289897.61598.38
386004-8600490.37191.08
491035-9103595.65796.39
591016-9101695.63796.32
680946-8094685.05685.68
极限188945-8894593.46194.094.6394.3594.954.63
293497-9349798.24499.18
386085-8608590.45691.32
491191-9119195.82196.72
593946-9394698.71699.56
683580-8358087.82488.59
比索洛尔左氨氯地平片项目信息
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%
110.318895989060890798907689043890430.06
210.408902489155890900.11
单位质量响应值RSD%判断
8636.578566.350.58数据可信
中间条件6月-供试品溶液-G01RY4批-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%
5min177792-7779281.23578.364.3681.2478.374.36
271827-7182775.00675.01
371074-7107474.22074.22
477806-7780681.25081.25
573572-7357276.82876.83
678186-7818681.64681.65
10min184894-8489488.65186.794.7688.7986.924.75
279831-7983183.36483.49
380279-8027983.83283.96
488415-8841592.32892.46
578926-7892682.41982.55
686341-8634190.16290.30
15min187046-8704690.89989.604.3591.1889.884.35
282294-8229485.93686.20
384469-8446988.20888.47
491195-9119595.23195.52
581502-8150285.10985.37
688324-8832492.23392.52
20min188042-8804291.93991.194.1492.3791.624.13
283425-8342587.11787.52
387989-8798991.88392.29
492742-9274296.84797.29
583110-8311086.78887.20
688659-8865992.58393.02
30min189436-8943693.39493.064.0893.9893.644.07
285133-8513388.90189.45
391597-9159795.65196.21
494068-9406898.23198.84
584776-8477688.52889.08
689714-8971493.68594.28
45min189979-8997993.96193.673.8194.7094.403.80
286560-8656090.39191.09
392646-9264696.74697.47
494114-9411498.27999.05
585215-8521588.98789.69
689704-8970493.67494.42
极限190147-9014794.13794.143.8095.0495.033.79
287109-8710990.96491.82
394215-9421598.38599.27
493977-9397798.13699.07
585944-8594489.74890.60
689525-8952593.48794.39
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