沙库巴曲缬沙坦钠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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.471006211005961006041006521006261006200.03
215.299921199182991960.03
单位质量响应值RSD%判断
6504.206487.640.19数据可信
供试品溶液-25092301批-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%
5min137655-3765537.57740.5015.3337.5840.5015.33
243575-4357543.48543.49
340553-4055340.46940.47
430725-3072530.66230.66
541573-4157341.48741.49
649394-4939449.29249.29
10min188031-8803187.84986.302.3687.9186.372.37
286113-8611385.93586.01
384693-8469384.51884.59
484270-8427084.09684.15
586105-8610585.92786.00
689647-8964789.46289.54
15min190218-9021890.03288.411.7590.2488.621.75
289201-8920189.01789.23
387019-8701986.84087.05
488309-8830988.12788.32
586627-8662786.44886.66
690188-9018890.00290.23
20min190574-9057490.38787.783.0590.7588.143.04
283937-8393783.76484.13
386710-8671086.53186.88
488278-8827888.09688.43
587072-8707286.89287.25
691189-9118991.00191.38
30min191272-9127291.08489.032.3591.5989.542.35
289297-8929789.11389.62
387314-8731487.13487.63
489893-8989389.70890.19
586192-8619286.01486.52
691337-9133791.14991.68
45min192268-9226892.07889.212.8892.7489.872.87
289480-8948089.29589.95
386415-8641586.23786.88
489945-8994589.75990.39
586365-8636586.18786.83
691918-9191891.72892.41
60min191915-9191591.72589.632.4392.5490.432.43
289230-8923089.04689.85
388007-8800787.82588.61
490100-9010089.91490.70
587020-8702086.84187.63
692600-9260092.40993.25
极限197321-9732197.12094.011.9998.0994.961.99
292105-9210591.91592.86
393466-9346693.27394.21
493765-9376593.57294.51
593126-9312692.93493.87
695419-9541995.22296.21
沙库巴曲缬沙坦钠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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.471005071006291007861006511006431006430.10
215.291016631014221015420.17
单位质量响应值RSD%判断
6505.696641.071.46数据可信
供试品溶液-25092302批-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%
5min152493-5249351.77348.9819.5251.7748.9819.52
265845-6584564.94264.94
345125-4512544.50644.51
443674-4367443.07543.07
538089-3808937.56637.57
652716-5271651.99351.99
10min187094-8709485.89986.741.9385.9986.821.94
289977-8997788.74388.85
389773-8977388.54188.62
486587-8658785.39985.47
585912-8591284.73384.80
688332-8833287.12087.21
15min188699-8869987.48288.181.3387.7188.411.33
290567-9056789.32489.58
391101-9110189.85190.07
489276-8927688.05188.27
588039-8803986.83187.04
688785-8878587.56787.80
20min186910-8691085.71887.342.1586.0987.712.14
289089-8908987.86788.27
391303-9130390.05090.42
489900-8990088.66789.03
587815-8781586.61086.96
686287-8628785.10385.48
30min187995-8799586.78886.783.6787.3187.303.64
282120-8212080.99381.54
391494-9149490.23990.76
489653-8965388.42388.93
587264-8726486.06786.56
689398-8939888.17288.69
45min188489-8848987.27588.661.4087.9489.321.39
290792-9079289.54690.23
391650-9165090.39391.06
490218-9021888.98089.64
588554-8855487.33987.98
689664-8966488.43489.10
60min185829-8582984.65187.872.0285.4688.682.02
290540-9054089.29890.13
390048-9004888.81389.64
489747-8974788.51689.32
588193-8819386.98387.76
690222-9022288.98489.80
极限192208-9220890.94392.010.8391.8992.970.83
293375-9337592.09493.08
393972-9397292.68393.65
493371-9337192.09093.04
592613-9261391.34292.27
694211-9421192.91893.88
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