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%
111.05997871001409984710000399667998890.19
211.119907199657993640.42
单位质量响应值RSD%判断
9039.738943.650.76数据可信
中间条件6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%
5min137859-3785937.80843.8811.9037.8143.8811.91
243983-4398343.92443.92
338646-3864638.59438.59
448160-4816048.09548.10
543738-4373843.67943.68
651279-5127951.21051.21
10min166383-6638366.29370.055.8766.7170.535.91
271197-7119771.10171.59
366148-6614866.05966.49
473078-7307872.97973.51
567676-6767667.58568.07
676364-7636476.26176.83
15min177685-7768577.58080.004.5278.7481.274.57
281999-8199981.88883.17
376203-7620376.10077.26
482798-8279882.68684.03
576994-7699476.89078.13
684997-8499784.88286.30
20min182097-8209781.98683.862.9484.0086.023.02
285326-8532685.21187.40
381483-8148381.37383.38
485973-8597385.85788.12
581818-8181881.70883.80
687159-8715987.04189.40
30min188162-8816288.04388.921.8090.9792.011.84
289780-8978089.65992.79
390004-9000489.88392.80
490126-9012690.00493.22
586150-8615086.03489.03
690044-9004489.92293.25
45min189431-8943189.31090.902.2393.2294.972.23
291496-9149691.37395.50
392776-9277692.65196.56
492717-9271792.59296.81
587724-8772487.60691.56
691990-9199091.86696.19
60min190262-9026290.14091.642.1395.0496.722.10
291020-9102090.89796.04
394167-9416794.04098.98
493615-9361593.48998.74
589179-8917989.05993.99
692321-9232192.19697.54
90min190626-9062690.50491.961.4296.4198.061.29
292212-9221292.08898.24
393871-9387193.74499.73
490609-9060990.48796.77
593055-9305592.92998.85
692131-9213192.00798.38
120min188669-8866988.54990.821.7395.4697.941.65
290089-9008989.96797.15
393389-9338993.263100.29
490718-9071890.59697.89
591289-9128991.16698.12
691477-9147791.35498.75
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193079-9307992.95393.510.83100.84101.640.89
294005-9400593.878102.06
394564-9456494.436102.50
493763-9376393.636101.93
592404-9240492.279100.24
694021-9402193.894102.30
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%
111.05100368997671001039967099700999220.31
211.119943399694995640.19
单位质量响应值RSD%判断
9042.718961.660.64数据可信
中间条件6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%
5min148054-4805447.93344.2011.4747.9344.2011.46
238285-3828538.18838.19
351093-5109350.96450.96
444033-4403343.92243.92
545631-4563145.51645.52
638754-3875438.65638.66
10min172894-7289472.71069.605.5573.2470.095.59
265926-6592665.76066.18
375501-7550175.31175.88
470441-7044170.26370.75
567730-6773067.55968.06
666172-6617266.00566.43
15min183237-8323783.02779.784.4684.3781.044.49
276087-7608775.89577.05
384291-8429184.07885.48
481776-8177681.57082.84
576608-7660876.41577.67
677882-7788277.68678.85
20min186316-8631686.09883.932.8088.3686.082.87
281510-8151081.30483.30
386943-8694386.72489.06
485197-8519784.98287.16
581691-8169181.48583.59
683177-8317782.96784.99
30min191062-9106290.83289.081.9194.0592.161.93
289979-8997989.75292.65
390229-9022990.00193.30
489634-8963489.40892.53
586194-8619485.97788.99
688717-8871788.49391.44
45min192644-9264492.41091.752.8796.6495.822.73
292650-9265092.41696.32
391272-9127291.04295.34
491680-9168091.44995.56
587733-8773387.51291.48
695890-9589095.64899.58
60min193535-9353593.29991.442.2298.5596.542.16
294142-9414293.90598.83
392318-9231892.08597.40
490780-9078090.55195.68
588781-8878188.55793.50
690495-9049590.26795.26
90min190483-9048390.25591.411.4296.5597.521.22
293930-9393093.69399.66
390875-9087590.64696.98
491444-9144491.21397.35
592310-9231092.07798.00
690803-9080390.57496.57
120min189855-8985589.62890.752.1996.9297.881.93
290573-9057390.34597.35
388524-8852488.30195.64
491435-9143591.20498.35
591048-9104890.81897.76
694461-9446194.223101.23
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194394-9439494.15693.431.10102.45101.561.04
293640-9364093.404101.42
392732-9273292.498100.82
493866-9386693.629101.79
592303-9230392.070100.02
695059-9505994.819102.87
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%
111.059916499330991499918999170992000.08
211.119862598902987640.20
单位质量响应值RSD%判断
8977.388889.650.70数据可信
中间条件6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%
5min142688-4268842.90844.4813.5242.9144.4813.52
250975-5097551.23851.24
344967-4496745.19945.20
433937-3393734.11234.11
549162-4916249.41549.42
643801-4380144.02744.03
10min168226-6822668.57770.305.1769.0570.805.22
275102-7510275.48976.06
371975-7197572.34672.85
464464-6446464.79665.17
570799-7079971.16471.71
669092-6909269.44869.94
15min181000-8100081.41781.103.6382.6682.383.66
285157-8515785.59687.00
377377-7737777.77579.08
477766-7776678.16679.27
582430-8243082.85484.19
680381-8038180.79582.06
20min183010-8301083.43785.213.7185.5887.383.73
287207-8720787.65690.02
388828-8882889.28591.46
479927-7992780.33982.31
585215-8521585.65487.91
684437-8443784.87287.03
30min188910-8891089.36891.072.3192.4494.192.33
293270-9327093.75097.08
393249-9324993.72996.89
489526-8952689.98792.85
589751-8975190.21393.43
688907-8890789.36592.47
45min190484-9048490.95094.282.5395.0198.422.46
296647-9664797.145101.52
394545-9454595.03299.24
495663-9566396.156100.02
591572-9157292.04496.26
693861-9386194.34498.44
60min190968-9096891.43694.532.2896.5199.722.18
295703-9570396.196101.65
394583-9458395.070100.33
496504-9650497.001101.93
591999-9199992.47397.71
694533-9453395.020100.16
90min190310-9031090.77594.372.7996.86100.602.63
294783-9478395.271101.79
393545-9354594.027100.34
496007-9600796.501102.51
591561-9156192.03398.30
697121-9712197.621103.82
120min189485-8948589.94693.752.7597.04101.032.61
294614-9461495.101102.68
393720-9372094.203101.56
495597-9559796.089103.17
590770-9077091.23798.52
695433-9543395.924103.21
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193365-9336593.84695.221.29101.94103.541.22
295092-9509295.582104.22
394826-9482695.314103.72
496504-9650497.001105.15
593342-9334293.823102.12
695263-9526395.754104.10
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%
111.059908499177990639894499083990700.09
211.119947999294993860.14
单位质量响应值RSD%判断
8965.618945.630.16数据可信
中间条件6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%
5min143613-4361343.72844.4013.6943.7344.4013.70
250943-5094351.07851.08
349705-4970549.83649.84
434011-3401134.10134.10
542420-4242042.53242.53
645008-4500845.12745.13
10min169429-6942969.61370.825.4370.1071.325.48
275157-7515775.35675.92
373498-7349873.69274.25
464892-6489265.06465.44
568158-6815868.33868.81
672684-7268472.87673.38
15min180466-8046680.67980.973.4381.9482.253.46
284302-8430284.52585.93
382181-8218182.39883.77
477943-7794378.14979.25
582457-8245782.67583.91
677182-7718277.38678.70
20min184542-8454284.76685.213.6186.9287.393.63
287268-8726887.49989.84
385496-8549685.72288.01
480300-8030080.51282.48
583258-8325883.47885.63
689036-8903689.27291.44
30min191407-9140791.64991.321.9094.7594.441.94
293179-9317993.42596.74
389840-8984090.07893.32
489691-8969189.92892.79
589303-8930389.53992.62
693030-9303093.27696.44
45min194305-9430594.55494.102.5898.6798.242.49
296632-9663296.888101.24
391651-9165191.89396.13
495749-9574996.00299.87
590322-9032290.56194.63
694436-9443694.68698.89
60min194463-9446394.71394.192.4099.8899.372.28
295741-9574195.994101.43
391855-9185592.09897.36
496466-9646696.721101.65
590648-9064890.88895.97
694452-9445294.70299.95
90min195602-9560295.85593.043.24102.0799.273.05
293201-9320193.44899.94
391884-9188492.12798.41
495666-9566695.919101.92
587502-8750287.73393.82
692895-9289593.14199.44
120min195176-9517695.42893.562.55102.71100.832.41
293701-9370193.949101.48
391143-9114391.38498.69
489690-8969089.92797.00
595589-9558995.842102.91
694601-9460194.851102.19
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196285-9628596.54094.641.76104.88102.941.75
295950-9595096.204104.78
393290-9329093.537101.86
493458-9345893.705101.78
592169-9216992.413100.54
695173-9517395.425103.82
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%
111.059824197886982919820898066981380.17
211.119856698176983710.29
单位质量响应值RSD%判断
8881.278854.280.22数据可信
中间条件6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%
5min144092-4409244.64740.5416.3144.6540.5416.31
243298-4329843.84343.84
335456-3545635.90235.90
428718-2871829.07929.08
544290-4429044.84744.85
644356-4435644.91444.91
10min169894-6989470.77367.1510.4471.2767.6010.48
270701-7070171.59072.08
360967-6096761.73462.13
454593-5459355.28055.60
570729-7072971.61972.12
670984-7098471.87772.38
15min180446-8044681.45878.876.9782.7480.077.06
280493-8049381.50682.79
373779-7377974.70775.79
468818-6881869.68470.62
583007-8300784.05185.35
680825-8082581.84283.14
20min184987-8498786.05684.184.2588.2486.264.39
285175-8517586.24688.43
380893-8089381.91183.83
476904-7690477.87179.58
585005-8500586.07488.30
685865-8586586.94589.15
30min188985-8898590.10488.102.5593.2591.102.56
284068-8406885.12688.27
387879-8787988.98491.81
485251-8525186.32388.90
589728-8972890.85794.04
686108-8610887.19190.36
45min189615-8961590.74289.991.4594.8993.981.46
288437-8843789.54993.64
388389-8838989.50193.31
488852-8885289.97093.51
590865-9086592.00896.20
687063-8706388.15892.30
60min188091-8809189.19990.841.9494.3595.831.94
289713-8971390.84295.93
388650-8865089.76594.57
489440-8944090.56595.10
593035-9303594.20599.42
689349-8934990.47395.59
90min188067-8806789.17590.462.0395.3296.462.13
289611-8961190.73896.83
388691-8869189.80795.61
486965-8696588.05993.60
591877-9187793.03399.30
690811-9081191.95398.08
120min190568-9056891.70790.491.0698.8497.491.18
289350-8935090.47497.58
387989-8798989.09695.90
488774-8877489.89196.41
589286-8928690.40997.71
690214-9021491.34998.50
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195861-9586197.06792.113.23105.22100.122.96
288406-8840689.51897.63
392071-9207193.229101.02
490287-9028791.42398.94
587730-8773088.83497.13
691466-9146692.617100.78
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%
111.059757098178978969797898463980170.34
211.119935799500994280.11
单位质量响应值RSD%判断
8870.328949.410.63数据可信
中间条件6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%
5min128602-2860228.82540.5615.9328.8340.5615.93
244435-4443544.78244.78
343079-4307943.41643.42
444430-4443044.77744.78
544109-4410944.45444.45
636803-3680337.09137.09
10min154944-5494455.37366.7110.1655.6967.1610.19
270472-7047271.02371.52
370625-7062571.17771.66
470721-7072171.27471.77
569597-6959770.14170.63
660793-6079361.26861.68
15min169102-6910269.64278.446.8670.5879.636.94
281363-8136381.99983.29
380616-8061681.24682.52
482433-8243383.07784.37
580068-8006880.69481.97
673386-7338673.95975.05
20min176705-7670577.30483.754.2179.0185.814.34
285616-8561686.28588.48
384958-8495885.62287.80
484935-8493585.59987.81
585050-8505085.71487.88
681334-8133481.96983.88
30min183795-8379584.45087.942.2087.0290.942.40
288519-8851989.21192.37
387974-8797488.66191.79
488602-8860289.29492.46
588443-8844389.13492.26
686224-8622486.89889.72
45min189190-8919089.88790.580.8593.3994.551.02
290137-9013790.84194.99
389164-8916489.86193.97
490510-9051091.21795.37
590942-9094291.65395.77
689319-8931990.01793.81
60min190079-9007990.78391.501.4295.2996.481.42
291629-9162992.34597.50
390712-9071291.42196.53
492259-9225992.98098.15
588663-8866389.35694.49
691387-9138792.10196.89
90min190607-9060791.31590.981.0096.8396.970.99
289879-8987990.58196.76
390173-9017390.87897.00
491891-9189192.60998.81
589360-8936090.05896.18
689733-8973390.43496.25
120min188399-8839989.09090.451.5395.6297.451.47
288932-8893289.62796.82
389444-8944490.14397.28
490860-9086091.57098.80
588899-8889989.59496.72
691946-9194692.66499.48
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191579-9157992.29492.532.3499.81100.542.06
289538-8953890.23898.42
391261-9126191.974100.11
491565-9156592.280100.53
591051-9105191.76299.88
695907-9590796.656104.51
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