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%
110.078469385158848368479685225849420.28
210.088602686045860360.02
单位质量响应值RSD%判断
8435.158535.320.84数据可信
加速3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%
5min173586-7358677.89781.7310.8777.9081.7310.87
282124-8212486.93586.93
379776-7977684.44984.45
486183-8618391.23291.23
562273-6227365.92165.92
679322-7932283.96983.97
10min180970-8097085.71387.897.7785.8488.027.77
286395-8639591.45691.60
385106-8510690.09290.23
490443-9044395.74195.89
571521-7152175.71175.82
683703-8370388.60688.75
15min182894-8289487.75090.206.0788.0290.486.08
288047-8804793.20593.50
387468-8746892.59292.88
491434-9143496.79097.10
576482-7648280.96281.20
684923-8492389.89890.19
20min183551-8355188.44691.255.0288.8691.695.04
288744-8874493.94394.40
388139-8813993.30293.75
491665-9166597.03597.51
579398-7939884.04984.42
685726-8572690.74891.19
30min183955-8395588.87392.064.3889.4492.644.39
289018-8901894.23394.84
388921-8892194.13094.73
492028-9202897.41998.05
581569-8156986.34786.86
686277-8627791.33191.92
45min184016-8401688.93892.494.0589.6593.234.06
289078-8907894.29695.06
389536-8953694.78195.54
492176-9217697.57698.37
582940-8294087.79988.45
686506-8650691.57492.31
极限183679-8367988.58192.543.9189.4493.433.93
289230-8923094.45795.38
389502-8950294.74595.66
491895-9189597.27898.24
583406-8340688.29289.09
686777-8677791.86192.75
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%
110.078537884903850308502385159850990.22
210.088461984718846680.09
单位质量响应值RSD%判断
8450.748399.600.43数据可信
长期3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%
5min169787-6978774.40073.267.8674.4073.267.86
265004-6500469.30169.30
378736-7873683.94083.94
464584-6458468.85368.85
565084-6508469.38669.39
669129-6912973.69873.70
10min183161-8316188.65885.874.2888.7885.994.28
276590-7659081.65381.77
386053-8605391.74191.88
479394-7939484.64284.76
579582-7958284.84284.96
678496-7849683.68583.81
15min187476-8747693.25890.423.3693.5390.693.36
281958-8195887.37587.63
387893-8789393.70394.00
485753-8575391.42191.68
584875-8487590.48590.74
680946-8094686.29786.56
20min186799-8679992.53692.273.0692.9692.693.06
284536-8453690.12490.52
388731-8873194.59695.05
488994-8899494.87795.28
587962-8796293.77694.18
682288-8228887.72788.13
30min187561-8756193.34994.173.3193.9394.743.30
286917-8691792.66293.21
389452-8945295.36595.97
492253-9225398.35198.92
589987-8998795.93596.50
683800-8380089.33989.89
45min188313-8831394.15195.453.4494.8996.183.43
289035-8903594.92095.62
389976-8997695.92396.69
493988-93988100.201100.93
591141-9114197.16597.89
684739-8473990.34091.04
极限188363-8836394.20496.053.7595.1096.943.73
291583-9158397.63798.50
389769-8976995.70396.63
494608-94608100.862101.76
591553-9155397.60598.49
684694-8469490.29291.14
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%
110.078460984491844528450084689845480.12
210.088571685652856840.06
单位质量响应值RSD%判断
8396.038500.400.88数据可信
中间条件3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%
5min179060-7906084.05880.504.5684.0680.504.56
274349-7434979.05079.05
380884-8088485.99886.00
473959-7395978.63578.63
572037-7203776.59176.59
673985-7398578.66378.66
10min189387-8938795.03890.684.4395.1890.814.43
281252-8125286.38986.52
389831-8983195.51095.65
484637-8463789.98890.12
581147-8114786.27786.41
685459-8545990.86290.99
15min192974-9297498.85293.944.1399.1594.224.13
284432-8443289.77090.05
392065-9206597.88698.19
487269-8726992.78793.07
584546-8454689.89190.16
688811-8881194.42694.71
20min194918-94918100.91995.653.95101.3896.103.95
285774-8577491.19791.62
392940-9294098.81699.28
488721-8872194.33094.77
586799-8679992.28792.71
690648-9064896.37996.82
30min195138-95138101.15396.903.30101.7897.503.31
287627-8762793.16793.74
393899-9389999.836100.47
489823-8982395.50296.09
588501-8850194.09694.67
691864-9186497.67298.27
45min195875-95875101.93797.682.98102.7498.452.99
289217-8921794.85895.59
394170-94170100.124100.92
490218-9021895.92296.67
589402-8940295.05495.79
692372-9237298.21298.98
极限196636-96636102.74698.272.78103.7299.192.79
290378-9037896.09296.98
394123-94123100.074101.04
490365-9036596.07896.99
590464-9046496.18497.07
692567-9256798.41999.35
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