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 11.069841998375985609853098158984080.17
2 11.049824898428983380.13
单位质量响应值RSD%判断
8897.658907.430.08数据可信
供试品溶液-2025051221批-pH6.8(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133151-3315133.43737.9819.3733.4437.9819.37
232797-3279733.08033.08
345527-4552745.92045.92
429186-2918629.43829.44
547036-4703647.44247.44
638244-3824438.57438.57
10min161730-6173062.26265.5311.9562.6365.9511.99
260813-6081361.33761.70
372146-7214672.76873.28
453173-5317353.63153.96
573265-7326573.89774.42
668681-6868169.27369.70
15min177141-7714177.80678.166.6478.8779.316.75
273907-7390774.54475.59
381357-8135782.05983.38
469449-6944970.04870.97
583378-8337884.09785.45
679699-7969980.38681.58
20min180754-8075481.45083.624.0983.3885.644.25
281496-8149682.19984.08
386573-8657387.31989.55
478373-7837379.04980.75
586978-8697887.72890.01
683237-8323783.95586.05
30min187799-8779988.55689.831.5991.3992.781.59
287322-8732288.07590.87
390716-9071691.49894.70
490674-9067491.45694.04
588838-8883889.60492.86
689048-8904889.81692.84
45min188783-8878389.54990.361.6793.3794.311.44
289052-8905289.82093.59
389637-8963790.41094.63
492509-9250993.30796.90
588361-8836189.12393.38
689187-8918789.95693.98
60min187759-8775988.51690.162.7393.3395.112.53
287813-8781388.57093.34
391183-9118391.96997.19
493551-9355194.35898.99
588203-8820388.96494.21
687817-8781788.57493.60
90min186701-8670187.44989.363.0093.2495.312.78
286695-8669587.44393.19
389966-8996690.74296.99
493410-9341094.21599.90
587069-8706987.82094.05
687752-8775288.50994.51
120min186959-8695987.70989.703.3894.4896.643.10
287062-8706287.81394.54
389454-8945490.22597.48
494772-9477295.589102.32
587837-8783788.59495.80
687487-8748788.24195.23
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191436-9143692.22492.644.6799.97100.594.25
288989-8898989.75697.46
390247-9024791.02599.28
4100304-100304101.169108.96
591268-9126892.055100.25
688866-8886689.63297.60
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 11.069847598490985449824498451984410.12
2 11.049850298183983420.23
单位质量响应值RSD%判断
8900.638907.790.06数据可信
供试品溶液-2025051321批-pH6.8(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128308-2830828.54733.3212.0728.5533.3212.07
235479-3547935.77835.78
339492-3949239.82539.83
430932-3093231.19331.19
530811-3081131.07131.07
633223-3322333.50333.50
10min155427-5542755.89460.045.6656.2160.415.67
257762-5776258.24958.65
363838-6383864.37664.82
462329-6232962.85563.20
556756-5675657.23557.58
661133-6113361.64962.02
15min170884-7088471.48274.703.4172.4275.743.45
272916-7291673.53174.58
377055-7705577.70578.86
475256-7525675.89176.94
571919-7191972.52573.51
676406-7640677.05078.11
20min179508-7950880.17880.861.9581.9182.731.98
279737-7973780.40982.27
380350-8035081.02883.05
480889-8088981.57183.46
577968-7796878.62680.41
682645-8264583.34285.26
30min184132-8413284.84186.161.2387.4688.931.26
285546-8554686.26789.02
384934-8493485.65088.57
485695-8569586.41889.21
585095-8509585.81388.47
687262-8726287.99890.84
45min188269-8826989.01389.161.3192.5892.881.26
289131-8913189.88393.60
386931-8693187.66491.54
490099-9009990.85994.61
587391-8739188.12891.74
688669-8866989.41793.23
60min188214-8821488.95889.010.8793.5193.720.85
288772-8877289.52194.23
387746-8774688.48693.33
489555-8955590.31095.07
587596-8759688.33592.93
687715-8771588.45593.27
90min185346-8534686.06687.431.6891.6193.131.68
288535-8853589.28294.99
387402-8740288.13993.97
486624-8662487.35593.12
584675-8467585.38990.96
687593-8759388.33294.13
120min184871-8487185.58786.880.8092.0993.550.85
286738-8673887.46994.17
386715-8671587.44694.26
486150-8615086.87793.61
586120-8612086.84693.37
686298-8629887.02693.80
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190017-9001790.77689.761.1998.2397.401.12
287905-8790588.64696.32
390376-9037691.13898.92
489315-8931590.06897.77
588008-8800888.75096.24
688441-8844189.18796.93
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 11.069888498800989429862499014988530.16
2 11.049848598848986660.27
单位质量响应值RSD%判断
8937.888937.140.01数据可信
供试品溶液-2025051421批-pH6.8(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131036-3103631.18132.1930.9031.1832.2030.90
231710-3171031.85831.86
326545-2654526.66926.67
417268-1726817.34917.35
541017-4101741.20941.21
644689-4468944.89844.90
10min158976-5897659.25259.3217.3559.6059.6817.43
258851-5885159.12659.48
354230-5423054.48454.78
442629-4262942.82843.02
569215-6921569.53970.00
670362-7036270.69171.19
15min173812-7381274.15773.7810.4675.1674.8010.62
273924-7392474.27075.28
369504-6950469.82970.73
460910-6091061.19561.86
581192-8119281.57282.80
681304-8130481.68482.97
20min179113-7911379.48379.886.1181.3181.726.35
278900-7890079.26981.11
377598-7759877.96179.64
471892-7189272.22873.58
584841-8484185.23887.37
684722-8472285.11887.31
30min186290-8629086.69386.911.6989.4189.642.02
286743-8674387.14989.87
386436-8643686.84089.38
483969-8396984.36286.51
588385-8838588.79891.88
687224-8722487.63290.77
45min186286-8628686.68988.981.5290.3692.671.60
288111-8811188.52392.21
389760-8976090.18093.69
488442-8844288.85691.94
589994-8999490.41594.49
688811-8881189.22693.34
60min187053-8705387.46089.911.7592.1094.591.74
290568-9056890.99195.66
391615-9161592.04396.55
488740-8874089.15593.23
589629-8962990.04895.12
689340-8934089.75894.86
90min187081-8708187.48889.501.7693.1095.181.76
290220-9022090.64296.32
391373-9137391.80097.33
487822-8782288.23393.30
589111-8911189.52895.60
688912-8891289.32895.43
120min185350-8535085.74987.702.0192.3394.371.93
287864-8786488.27594.96
390291-9029190.71397.27
486291-8629186.69492.74
587673-8767388.08395.15
686270-8627086.67393.77
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187603-8760388.01391.302.0495.5598.941.91
292753-9275393.187100.85
392406-9240692.838100.40
491217-9121791.64498.65
590203-9020390.62598.67
691056-9105691.48299.54
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