贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.892975372975252975202975432974682975190.01
29.862972822972532972680.01
单位质量响应值RSD%判断
30082.8130148.880.16数据可信
供试品溶液-24060301批-pH4.5(内含0.45%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15508-55083.6484.8416.903.654.8416.91
26809-68094.5094.51
36738-67384.4624.46
47987-79875.2895.29
57764-77645.1425.14
69084-90846.0166.02
10min123976-2397615.87817.625.6615.8817.635.67
226067-2606717.26317.27
327171-2717117.99418.00
428477-2847718.85918.87
526964-2696417.85717.87
627003-2700317.88317.89
15min139144-3914425.92329.178.1025.9629.218.10
240840-4084027.04627.08
343777-4377728.99129.03
448449-4844932.08532.13
546996-4699631.12331.16
645107-4510729.87229.91
20min153034-5303435.12137.624.5735.2037.704.57
255118-5511836.50236.58
356084-5608437.14137.23
459939-5993939.69439.79
559207-5920739.20939.30
657443-5744338.04138.13
30min169860-6986046.26447.592.1046.4047.742.11
270850-7085046.92047.06
371108-7110847.09147.24
472410-7241047.95348.11
573165-7316548.45348.61
673803-7380348.87649.03
45min183991-8399155.62257.352.4655.8357.582.47
284634-8463456.04856.27
386637-8663757.37557.60
486583-8658357.33957.58
588058-8805858.31658.55
689727-8972759.42159.66
60min196450-9645063.87363.811.0264.1864.141.01
295636-9563663.33463.65
396276-9627663.75864.08
495183-9518363.03463.37
596574-9657463.95664.29
698029-9802964.91965.25
极限1104895-10489569.46670.352.0869.8870.792.07
2108836-10883672.07672.50
3104128-10412868.95869.39
4104117-10411768.95169.39
5106608-10660870.60071.04
6108835-10883572.07572.52
贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.892983862984492984762984192986602984780.04
29.862977382979102978240.05
单位质量响应值RSD%判断
30179.7830205.270.06数据可信
供试品溶液-24030401批-pH4.5(内含0.45%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119361-1936112.78913.6010.3112.7913.6110.30
217617-1761711.63711.64
322398-2239814.79514.80
421840-2184014.42714.43
523000-2300015.19315.19
619359-1935912.78812.79
10min147824-4782431.59131.422.5331.6131.442.53
245758-4575830.22630.25
347961-4796131.68131.71
447907-4790731.64531.67
549256-4925632.53732.56
646686-4668630.83930.86
15min160190-6019039.75938.822.0439.8338.892.04
256888-5688837.57837.65
357815-5781538.19038.27
459258-5925839.14439.22
559401-5940139.23839.32
659031-5903138.99439.07
20min168953-6895345.54844.403.2845.6944.543.28
263913-6391342.21842.35
365492-6549243.26143.40
469757-6975746.07946.22
568109-6810944.99045.14
667070-6707044.30444.44
30min180550-8055053.20851.123.5453.4251.343.53
272882-7288248.14348.35
376443-7644350.49550.71
479880-7988052.76652.98
577152-7715250.96451.18
677467-7746751.17251.38
45min194882-9488262.67559.545.8162.9859.845.80
280433-8043353.13153.41
390263-9026359.62459.92
494216-9421662.23562.54
589201-8920158.92359.23
691834-9183460.66260.96
60min1103050-10305068.07165.565.0968.4865.965.08
289581-8958159.17459.55
399810-9981065.93166.33
4103481-10348168.35668.77
599268-9926865.57365.98
6100273-10027366.23666.63
极限1115869-11586976.53972.503.2377.0673.003.22
2106160-10616070.12570.60
3106594-10659470.41270.92
4108799-10879971.86872.39
5110179-11017972.78073.29
6110903-11090373.25873.77
贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.892982232982662981122982362981522981980.03
29.862974952974912974930.01
单位质量响应值RSD%判断
30151.4730171.700.05数据可信
供试品溶液-24042201批-pH4.5(内含0.45%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117183-1718311.36210.019.0511.3610.029.05
213345-133458.8248.82
316026-1602610.59710.60
414077-140779.3089.31
515301-1530110.11810.12
614936-149369.8769.88
10min144755-4475529.59426.147.1929.6126.167.18
238154-3815425.22925.24
339969-3996926.42926.45
439868-3986826.36226.38
537551-3755124.83024.85
636908-3690824.40524.42
15min153665-5366535.48534.562.5735.5534.622.58
251632-5163234.14134.20
353996-5399635.70435.77
452418-5241834.66134.72
551240-5124033.88233.94
650663-5066333.50033.56
20min162867-6286741.57041.212.9641.7041.322.96
260372-6037239.92040.03
364807-6480742.85342.97
463783-6378342.17642.29
561838-6183840.89041.00
660246-6024639.83739.95
30min174468-7446849.24148.291.7249.4448.481.73
273204-7320448.40548.59
373925-7392548.88249.07
473581-7358148.65548.84
571716-7171647.42147.60
671320-7132047.16047.34
45min184234-8423455.69956.081.5055.9856.341.50
286294-8629457.06157.32
385421-8542156.48456.76
483681-8368155.33355.60
585987-8598756.85857.12
683223-8322355.03055.29
60min189613-8961359.25660.963.8659.6361.323.83
296075-9607563.52863.88
394085-9408562.21362.58
495781-9578163.33463.69
589774-8977459.36259.72
687834-8783458.07958.43
极限199516-9951665.80467.261.8566.2767.721.84
2103429-10342968.39168.85
3103027-10302768.12568.60
4103732-10373268.59269.06
5100489-10048966.44766.90
6100136-10013666.21466.66
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