玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109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(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.069857698741986189861798516986140.09
2 11.049870998581986450.10
单位质量响应值RSD%判断
8916.278935.240.16数据可信
供试品溶液-2025051521批-pH6.8(内含0.07%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141274-4127441.52238.499.5841.5238.499.57
232723-3272332.91932.92
334562-3456234.76934.77
441040-4104041.28641.29
540043-4004340.28340.28
639904-3990440.14340.14
10min167586-6758667.99266.014.4368.4566.444.46
260941-6094161.30761.67
363058-6305863.43663.82
467732-6773268.13868.60
567618-6761868.02468.47
666763-6676367.16467.61
15min177063-7706377.52576.942.3278.7478.102.38
273713-7371374.15575.20
374835-7483575.28476.38
477681-7768178.14779.36
577553-7755378.01879.22
678038-7803878.50679.70
20min182028-8202882.52081.492.0884.6083.512.13
277879-7787978.34680.22
380580-8058081.06382.99
481051-8105181.53783.62
582259-8225982.75384.82
682249-8224982.74284.81
30min184678-8467885.18686.612.2888.1889.542.27
283297-8329783.79786.54
387108-8710887.63190.46
486140-8614086.65789.65
586383-8638386.90189.89
688977-8897789.51192.49
45min187276-8727687.80088.092.8991.7491.972.87
283300-8330083.80087.47
388462-8846288.99392.79
486722-8672287.24291.20
588792-8879289.32593.28
690814-9081491.35995.34
60min186144-8614486.66188.222.2091.5893.082.18
285347-8534785.85990.46
388798-8879889.33194.12
486754-8675487.27592.20
588650-8865089.18294.13
690458-9045891.00195.99
90min185746-8574686.26087.892.4492.1493.732.42
284453-8445384.96090.52
388047-8804788.57594.36
487150-8715087.67393.56
588255-8825588.78594.72
690555-9055591.09897.10
120min185596-8559686.11088.072.7092.9594.892.67
284387-8438784.89391.39
387972-8797288.50095.27
487524-8752488.04994.92
588714-8871489.24696.17
691087-9108791.63498.65
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187571-8757188.09690.311.8295.8998.101.78
289218-8921889.75397.20
390592-9059291.13698.89
488478-8847889.00996.85
590826-9082691.37199.29
691919-9191992.471100.51
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109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(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.069894999076990459888099082990060.09
2 11.049833998357983480.02
单位质量响应值RSD%判断
8951.728908.330.35数据可信
供试品溶液-2025051621批-pH6.8(内含0.07%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134964-3496435.15734.0517.6435.1634.0517.63
238823-3882339.03739.04
324691-2469124.82724.83
439673-3967339.89239.89
536436-3643636.63736.64
628583-2858328.74128.74
10min163466-6346663.81761.788.8664.2162.158.91
264776-6477665.13465.57
353827-5382754.12454.40
466890-6689067.25967.70
564292-6429264.64765.05
655363-5536355.66955.99
15min176567-7656776.99074.165.3678.0975.235.44
273791-7379174.19975.36
368749-6874969.12970.01
478747-7874779.18280.37
575176-7517675.59176.72
669501-6950169.88570.82
20min181775-8177582.22780.234.1884.1882.124.28
280741-8074181.18783.17
375911-7591176.33077.98
484324-8432484.79086.86
580063-8006380.50582.47
675915-7591576.33478.05
30min185902-8590286.37784.803.1989.2587.583.28
283910-8391084.37387.26
382205-8220582.65985.15
488967-8896789.45892.47
583141-8314183.60086.46
681879-8187982.33184.89
45min188459-8845988.94888.653.1992.7892.383.28
287345-8734587.82791.65
384859-8485985.32888.74
492984-9298493.49897.50
589068-8906889.56093.35
686272-8627286.74990.23
60min188241-8824188.72888.223.3993.5592.933.46
288725-8872589.21594.01
385360-8536085.83290.19
492971-9297193.48598.53
585964-8596486.43991.22
685170-8517085.64090.08
90min188098-8809888.58588.913.5494.3994.603.59
289202-8920289.69595.48
386120-8612086.59691.91
494315-9431594.836100.92
586644-8664487.12392.87
686175-8617586.65192.04
120min187034-8703487.51587.443.3994.3094.123.44
287228-8722887.71094.50
385414-8541485.88692.16
492542-9254293.053100.19
585027-8502785.49792.21
684510-8451084.97791.33
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187684-8768488.16890.964.4895.9398.604.34
288802-8880289.29397.05
388819-8881989.31096.54
498297-9829798.840107.01
587885-8788588.37096.03
691262-9126291.76699.07
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109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(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.069863498739988789851298940987410.18
2 11.049844598631985380.14
单位质量响应值RSD%判断
8927.768925.540.02数据可信
供试品溶液-2025051622批-pH6.8(内含0.07%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135325-3532535.53332.619.0035.5332.619.00
228010-2801028.17528.18
332084-3208432.27332.27
435148-3514835.35535.36
533790-3379033.98933.99
630134-3013430.31230.31
10min161630-6163061.99359.594.8962.3959.954.90
254969-5496955.29355.61
360037-6003760.39160.75
459153-5915359.50259.89
562697-6269763.06763.44
656944-5694457.28057.62
15min174634-7463475.07472.032.9976.1673.053.03
268620-6862069.02569.95
371293-7129371.71372.74
472192-7219272.61873.67
572912-7291273.34274.42
669984-6998470.39771.37
20min179723-7972380.19378.152.4582.1179.982.49
275815-7581576.26277.96
377499-7749977.95679.78
478369-7836978.83180.69
579586-7958680.05581.95
675186-7518675.62977.38
30min185932-8593286.43983.442.0689.2586.132.09
282418-8241882.90485.45
381694-8169482.17684.87
482993-8299383.48286.22
583557-8355784.05086.83
681091-8109181.56984.17
45min186474-8647486.98485.651.4090.7589.271.41
285801-8580186.30789.77
383763-8376384.25787.86
485696-8569686.20189.87
585551-8555186.05689.77
683585-8358584.07887.58
60min185673-8567386.17885.150.8790.9189.720.95
283476-8347683.96888.39
384951-8495185.45289.99
484897-8489785.39890.02
584610-8461085.10989.78
684314-8431484.81189.25
90min186741-8674187.25385.681.5592.9591.201.52
286402-8640286.91292.27
385015-8501585.51691.01
485105-8510585.60791.18
584727-8472785.22790.85
683060-8306083.55088.93
120min185082-8508285.58484.821.1892.2591.291.14
285032-8503285.53491.85
384197-8419784.69491.14
485339-8533985.84292.36
582972-8297283.46190.03
683330-8333083.82190.13
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188115-8811588.63589.911.7896.2597.321.57
288853-8885389.37796.65
391702-9170292.24399.63
489363-8936389.89097.37
587510-8751088.02695.52
690728-9072891.26398.50
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