托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号TAAF210008对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.719806298055980179797697937980090.06
216.699888298938989100.05
单位质量响应值RSD%判断
5865.295926.300.74数据可信
供试品溶液-24030101批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min145032-4503246.05845.807.2246.0645.807.23
243334-4333444.32244.32
339587-3958740.48940.49
445604-4560446.64346.64
545695-4569546.73646.74
649430-4943050.55750.56
10min164231-6423165.69566.676.1065.9566.936.11
262901-6290164.33564.58
359717-5971761.07861.30
464789-6478966.26666.52
568957-6895770.52970.79
670537-7053772.14572.43
15min173680-7368075.35975.464.3375.9876.084.35
270777-7077772.39072.99
369474-6947471.05771.62
474502-7450276.20076.83
576628-7662878.37479.03
677608-7760879.37780.06
20min176878-7687878.63079.143.9079.6780.183.92
274696-7469676.39877.40
373892-7389275.57676.54
477085-7708578.84279.89
579958-7995881.78082.87
681753-8175383.61684.74
30min181884-8188483.75084.354.2785.2385.834.28
278314-7831480.09981.53
378680-7868080.47381.85
483548-8354885.45286.94
585467-8546787.41588.96
686926-8692688.90790.49
45min186823-8682388.80289.142.4790.7491.092.51
284768-8476886.70088.58
384721-8472186.65288.48
487563-8756389.55991.52
589484-8948491.52393.55
689536-8953691.57793.66
60min190341-9034192.40091.442.9794.8393.883.00
285900-8590087.85890.21
386648-8664888.62390.93
489413-8941391.45193.91
592438-9243894.54597.08
691668-9166893.75796.35
90min190209-9020992.26594.393.0895.2197.343.09
291721-9172193.81196.66
388886-8888690.91293.71
491506-9150693.59196.56
595545-9554597.722100.78
695858-9585898.043101.15
120min189601-8960191.64391.663.8395.1095.143.81
283983-8398385.89789.26
388243-8824390.25493.56
489682-8968291.72695.21
592365-9236594.47098.07
693817-9381795.95599.61
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限193745-9374595.88192.952.8199.8596.942.81
287023-8702389.00692.85
388746-8874690.76994.57
490895-9089592.96696.96
592418-9241894.52498.65
692462-9246294.56998.76
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号TAAF210008对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.719790097903978149780797883978610.05
216.699845998514984860.04
单位质量响应值RSD%判断
5856.435900.900.54数据可信
供试品溶液-24030101批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min134711-3471135.60535.540.7835.6135.540.78
234608-3460835.49935.50
334567-3456735.45735.46
434643-3464335.53535.54
535085-3508535.98935.99
634248-3424835.13035.13
10min155997-5599757.43959.112.6857.6459.312.67
258373-5837359.87760.07
356750-5675058.21258.41
456090-5609057.53557.73
559520-5952061.05361.25
659021-5902160.54160.74
15min165672-6567267.36469.171.8567.8869.691.84
268396-6839670.15870.69
368991-6899170.76871.29
466380-6638068.09068.61
567820-6782069.56770.11
667313-6731369.04769.58
20min172884-7288474.76174.221.3475.6575.131.33
272811-7281174.68675.61
373342-7334275.23176.14
470733-7073372.55573.45
572714-7271474.58775.51
671672-7167273.51874.43
30min179718-7971881.77179.241.8983.0880.561.86
276175-7617578.13779.47
378284-7828480.30081.63
476558-7655878.53079.83
575962-7596277.91979.26
676810-7681078.78880.11
45min183731-8373185.88886.452.2487.6588.212.21
285225-8522587.42089.19
386711-8671188.94490.72
481468-8146883.56685.30
585440-8544087.64189.41
683080-8308085.22086.98
60min187080-8708089.32388.710.7191.5690.960.71
287010-8701089.25191.51
387024-8702489.26691.54
485924-8592488.13790.34
586022-8602288.23890.50
685834-8583488.04590.28
90min186470-8647088.69789.271.6691.4392.001.63
285647-8564787.85390.60
389179-8917991.47694.24
485624-8562487.82990.52
588259-8825990.53293.28
686980-8698089.22091.94
120min189475-8947591.78092.842.1495.0196.072.09
293228-9322895.62998.87
391274-9127493.62596.90
489219-8921991.51794.69
591843-9184394.20997.46
688010-8801090.27793.50
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限189558-8955891.86592.182.9695.6095.932.89
288273-8827390.54794.32
393766-9376696.18199.98
486263-8626388.48592.17
591941-9194194.30998.09
689376-8937691.67895.40
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