辅酶Q10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2306201对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)10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%
111.001081321080401076591076961076841078420.21
211.081086811081001083900.38
单位质量响应值RSD%判断
9803.829782.490.16数据可信
供试品溶液-1批-SHUI(内含5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137588-3758834.37140.8511.2034.3740.8511.20
240474-4047437.01037.01
348606-4860644.44644.45
450095-5009545.80845.81
547917-4791743.81643.82
643351-4335139.64139.64
10min154567-5456749.89771.3014.8850.0971.5314.86
280782-8078273.86874.07
381806-8180674.80575.05
483631-8363176.47376.73
581434-8143474.46474.71
685616-8561678.28978.51
15min160689-6068955.49576.4115.0055.9677.0314.96
294640-9464086.54087.16
378497-7849771.77972.44
486695-8669579.27579.95
588228-8822880.67781.33
692619-9261984.69285.35
30min184862-8486277.59986.377.4778.3887.417.47
293615-9361585.60386.70
3103181-10318194.35095.41
488540-8854080.96282.08
5101052-10105292.40393.51
695447-9544787.27888.40
45min197480-9748089.13789.335.7990.3490.865.70
297992-9799289.60591.18
387469-8746979.98381.57
4102957-10295794.14595.72
597317-9731788.98890.61
6102905-10290594.09895.71
60min197816-9781689.44487.488.0591.1589.507.87
2101171-10117192.51294.58
389429-8942981.77583.81
484549-8454977.31379.41
595425-9542587.25889.37
6105619-10561996.58098.71
90min191080-9108083.28586.844.9985.4889.354.94
2102525-10252593.75096.33
390103-9010382.39284.88
497519-9751989.17391.69
592186-9218684.29686.89
696387-9638788.13890.81
120min181484-8148474.51085.577.7777.1788.567.67
291002-9100283.21486.32
390724-9072482.95985.90
498885-9888590.42293.44
599748-9974891.21194.28
699610-9961091.08594.24
极限1100005-10000591.44690.731.6094.5294.201.43
299270-9927090.77494.34
3101742-10174293.03496.44
499054-9905490.57694.10
597178-9717888.86192.43
698090-9809089.69593.36
辅酶Q10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2306201对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)10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%
111.001089961095061093491090531091981092200.20
211.081088261086181087220.14
单位质量响应值RSD%判断
9929.099812.450.84数据可信
供试品溶液-2批-SHUI(内含5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128708-2870826.04527.7514.8126.0527.7514.81
234877-3487731.64231.64
323038-2303820.90120.90
433347-3334730.25430.25
529205-2920526.49626.50
634340-3434031.15531.16
10min179019-7901971.69069.163.6271.8469.313.60
275619-7561968.60668.78
377021-7702169.87869.99
478985-7898571.66071.83
574948-7494867.99768.14
671759-7175965.10465.28
15min175786-7578668.75773.035.4569.3073.575.41
286225-8622578.22878.79
376770-7677069.65070.15
477355-7735570.18170.75
583256-8325675.53476.06
683592-8359275.83976.37
30min191785-9178583.27283.909.7184.2084.849.60
298702-9870289.54890.54
397905-9790588.82589.72
491328-9132882.85883.81
575637-7563768.62269.57
699491-9949190.26491.22
45min178677-7867771.38077.9011.7672.7779.3111.61
290471-9047182.08083.57
374627-7462767.70669.09
496792-9679287.81589.23
577634-7763470.43471.76
696965-9696587.97289.43
60min198408-9840889.28190.302.3591.0792.142.23
296176-9617687.25689.20
3100740-10074091.39793.16
499555-9955590.32292.23
5103156-10315693.58995.31
699147-9914789.95291.90
90min199099-9909989.90890.314.2492.1992.664.19
2102815-10281593.27995.71
3102735-10273593.20795.48
4101322-10132291.92594.33
591497-9149783.01185.25
699811-9981190.55493.00
120min199734-9973490.48491.781.1693.2694.621.12
2101122-10112291.74394.69
3101992-10199292.53395.32
4102606-10260693.09096.01
5101662-10166292.23394.93
699856-9985690.59593.54
极限1101278-10127891.88591.502.1295.1794.861.96
2101587-10158792.16595.62
3102391-10239192.89596.20
499639-9963990.39893.83
5103049-10304993.49296.70
697210-9721088.19491.65
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