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)0
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%
111.009743497298972229712297175972500.13
211.019794197794978680.11
单位质量响应值RSD%判断
8840.918889.010.39数据可信
加速3月-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%
5min141585-4158542.12243.176.8442.1243.176.84
238919-3891939.42139.42
339789-3978940.30240.30
444678-4467845.25545.25
545767-4576746.35846.36
644967-4496745.54745.55
10min164839-6483965.67669.172.9666.1469.652.98
267924-6792468.80169.24
367454-6745468.32568.77
470266-7026671.17371.68
569367-6936770.26270.78
669905-6990570.80771.31
15min174342-7434275.30179.012.6076.5080.262.60
278218-7821879.22780.43
377300-7730078.29879.50
479296-7929680.31981.61
578845-7884579.86381.16
680024-8002481.05782.35
20min180206-8020681.24183.952.1883.2886.082.19
283222-8322284.29686.38
381983-8198383.04185.12
484317-8431785.40587.59
582306-8230683.36885.55
685272-8527286.37288.57
30min183148-8314884.22187.772.3487.1690.832.34
287612-8761288.74391.76
386159-8615987.27190.27
487704-8770488.83691.97
586236-8623687.34990.46
689061-8906190.21093.36
45min185966-8596687.07589.901.8790.9593.931.89
289371-8937190.52494.53
388594-8859489.73793.71
489172-8917290.32394.44
588367-8836789.50793.59
691046-9104692.22196.38
60min186050-8605087.16190.302.0392.0095.342.03
289813-8981390.97295.98
389343-8934390.49695.46
489727-8972790.88596.01
588490-8849089.63294.71
691486-9148692.66797.85
90min185318-8531886.41991.112.7892.2397.142.73
291577-9157792.75998.78
390114-9011491.27797.25
490793-9079391.96598.10
589464-8946490.61996.69
692400-9240093.59299.80
120min185814-8581486.92190.202.3893.6997.242.33
290126-9012691.28998.34
390535-9053591.70398.69
488796-8879689.94297.10
587507-8750788.63695.71
691507-9150792.68899.94
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191807-9180792.99292.680.84100.73100.730.83
291976-9197693.163101.23
390745-9074591.91699.92
491852-9185293.037101.19
590359-9035991.52599.59
692257-9225793.448101.73
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)0
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%
111.009673896937969709712797350970240.24
211.019809098286981880.15
单位质量响应值RSD%判断
8820.368918.070.78数据可信
加速3月-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%
5min146180-4618046.75538.4317.4246.7538.4317.42
241495-4149542.01142.01
332002-3200232.40032.40
429348-2934829.71329.71
535833-3583336.27936.28
642891-4289143.42543.42
10min170954-7095471.83765.017.2272.3665.447.28
264803-6480365.60966.08
359645-5964560.38760.75
461062-6106261.82262.15
560488-6048861.24161.64
668304-6830469.15469.64
15min180301-8030181.30076.914.2882.6278.064.35
275108-7510876.04377.24
373084-7308473.99375.02
474741-7474175.67176.69
572888-7288873.79574.88
679682-7968280.67381.92
20min184525-8452585.57782.743.2187.8084.753.28
281097-8109782.10684.15
378071-7807179.04280.90
481969-8196982.98984.85
579908-7990880.90282.81
684771-8477185.82687.97
30min187567-8756788.65787.272.2091.8390.202.24
283657-8365784.69887.65
384355-8435585.40588.14
487590-8759088.68091.46
585806-8580686.87489.68
688229-8822989.32792.43
45min189947-8994791.06689.782.7195.2293.672.71
285824-8582486.89290.79
385615-8561586.68090.36
489976-8997691.09694.86
589272-8927290.38394.15
691420-9142092.55796.65
60min189775-8977590.89290.322.7096.0695.212.67
286613-8661387.69192.55
386032-8603287.10291.75
491947-9194793.09197.87
589632-8963290.74795.52
691250-9125092.38597.51
90min188835-8883589.94091.072.4496.1296.962.40
288145-8814589.24295.08
387291-8729188.37793.99
491451-9145192.58998.40
591025-9102592.15897.94
692953-9295394.110100.26
120min187742-8774288.83488.312.4996.0195.212.50
285019-8501986.07792.90
384572-8457285.62492.22
488749-8874989.85396.69
587045-8704588.12894.93
690214-9021491.33698.53
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189636-8963690.75192.161.6398.92100.061.53
289669-8966990.78598.57
390015-9001591.13598.68
491952-9195293.096100.94
593234-9323494.394102.18
691687-9168792.828101.04
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)0
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%
111.009787798194982079799197991980520.15
211.019853798715986260.13
单位质量响应值RSD%判断
8913.828957.860.35数据可信
加速3月-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%
5min139550-3955039.74343.465.5039.7443.465.50
244254-4425444.47044.47
345616-4561645.83845.84
441699-4169941.90241.90
542800-4280043.00843.01
645559-4555945.78145.78
10min165690-6569066.01068.672.0866.4569.152.10
268991-6899169.32769.82
369718-6971870.05870.57
468115-6811568.44768.91
569173-6917369.51069.99
668332-6833268.66569.17
15min178727-7872779.11079.421.5680.2980.661.53
278914-7891479.29880.56
378876-7887679.26080.55
479822-7982280.21181.44
580767-8076781.16082.41
677077-7707777.45278.72
20min184106-8410684.51684.031.2386.5786.151.19
283580-8358083.98786.13
382952-8295283.35685.52
484097-8409784.50786.62
584946-8494685.36087.51
682027-8202782.42684.56
30min187972-8797288.40087.851.0291.3990.910.96
286379-8637986.80089.88
386754-8675487.17690.27
488850-8885089.28392.34
587306-8730687.73190.83
687258-8725887.68390.73
45min188273-8827388.70389.301.0892.6893.341.06
289126-8912689.56093.60
387708-8770888.13592.20
489701-8970190.13894.19
590171-9017190.61094.69
688201-8820188.63192.65
60min189409-8940989.84490.411.3294.8195.441.27
290133-9013390.57295.61
389640-8964090.07795.12
491977-9197792.42597.47
590248-9024890.68895.77
688416-8841688.84793.85
90min190105-9010590.54489.950.9696.5095.980.91
288872-8887289.30595.35
388893-8889389.32695.37
490782-9078291.22497.30
589793-8979390.23096.32
688620-8862089.05295.05
120min187878-8787888.30688.851.4495.2795.891.38
287857-8785788.28595.32
387367-8736787.79294.83
490785-9078591.22798.32
588943-8894389.37696.47
687714-8771488.14195.12
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191050-9105091.49391.710.4699.4499.730.47
290610-9061091.05199.07
391498-9149891.94499.95
491462-9146291.907100.01
591813-9181392.260100.35
691160-9116091.60499.57
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)0
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%
111.009811198099983339799398185981440.13
211.019902498718988710.22
单位质量响应值RSD%判断
8922.188980.110.46数据可信
中间条件3月-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%
5min126917-2691727.00238.6516.8827.0038.6516.89
245553-4555345.69745.70
339258-3925839.38239.38
439285-3928539.40939.41
543340-4334043.47743.48
636809-3680936.92536.93
10min156570-5657056.74963.496.2557.0563.926.31
266577-6657766.78767.29
365393-6539365.59966.04
464977-6497765.18265.62
565830-6583066.03866.52
660404-6040460.59561.00
15min170554-7055470.77774.903.7771.7176.033.85
275641-7564175.88077.13
376916-7691677.15978.33
475700-7570075.93977.10
577373-7737377.61778.83
671794-7179472.02173.10
20min177128-7712877.37180.763.0879.0982.733.16
280543-8054380.79782.89
382089-8208982.34884.37
481783-8178382.04184.05
583490-8349083.75385.83
678024-7802478.27080.15
30min185709-8570985.97986.202.2488.5689.072.28
287199-8719987.47490.46
386487-8648786.76089.70
486522-8652286.79589.71
587451-8745187.72790.74
682218-8221882.47785.23
45min188359-8835988.63888.302.4492.1792.122.45
288740-8874089.02092.98
388781-8878189.06192.96
487941-8794188.21992.10
590350-9035090.63594.62
683983-8398384.24887.92
60min189527-8952789.81088.692.5894.3393.492.56
289161-8916189.44294.39
388285-8828588.56493.46
488267-8826788.54693.41
590978-9097891.26596.26
684231-8423184.49789.10
90min189153-8915389.43488.502.0194.9594.282.02
289672-8967289.95595.90
388416-8841688.69594.57
487752-8775288.02993.87
589420-8942089.70295.71
684898-8489885.16690.71
120min188827-8882789.10789.261.1595.6296.041.14
288686-8868688.96695.91
387897-8789788.17495.04
490835-9083591.12297.95
589283-8928389.56596.57
688376-8837688.65595.15
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188618-8861888.89890.211.2396.4097.971.22
289484-8948489.76697.70
391265-9126591.55399.39
488853-8885389.13396.97
590892-9089291.17999.18
690443-9044390.72898.20
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