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%
111.079791698038979239822698184980570.15
211.069782297741977820.06
单位质量响应值RSD%判断
8857.908841.050.14数据可信
影响因素30天-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%
5min141483-4148342.09234.7618.4642.0934.7618.45
227848-2784828.25728.26
330590-3059031.03931.04
441321-4132141.92741.93
528007-2800728.41828.42
636267-3626736.79936.80
10min169044-6904470.05764.0610.6470.5264.4410.67
253389-5338954.17254.49
366497-6649767.47367.82
466582-6658267.55968.02
555809-5580956.62856.94
667467-6746768.45768.87
15min179017-7901780.17675.647.0881.4276.747.14
268334-6833469.33770.25
371984-7198473.04074.13
477047-7704778.17779.39
569699-6969970.72271.67
681193-8119382.38483.55
20min184588-8458885.82981.764.5687.9783.704.65
275089-7508976.19177.88
378210-7821079.35781.26
481141-8114182.33184.42
579993-7999381.16782.90
684429-8442985.66887.75
30min188004-8800489.29588.032.4892.3990.882.56
283481-8348184.70687.24
384872-8487286.11788.91
486891-8689188.16691.17
588496-8849689.79492.43
688801-8880190.10493.14
45min188439-8843989.73690.081.5093.8293.911.47
288150-8815089.44392.92
387704-8770488.99192.74
487505-8750588.78992.77
590516-9051691.84495.47
690367-9036791.69395.73
60min188387-8838789.68490.682.0794.7695.512.09
288003-8800389.29493.76
387272-8727288.55293.29
489695-8969591.01195.98
590665-9066591.99596.65
692213-9221393.56698.62
90min188770-8877090.07289.721.7996.1595.561.86
286191-8619187.45692.92
386959-8695988.23593.95
488558-8855889.85795.83
589982-8998291.30296.98
690081-9008191.40397.50
120min188137-8813789.43089.161.7796.5195.991.65
288719-8871990.02196.45
385597-8559786.85393.55
486334-8633487.60194.58
589389-8938990.70097.39
689026-8902690.33297.44
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189976-8997691.29676.5548.3599.3784.3644.09
21016-10161.0318.46
390509-9050991.83799.50
488850-8885090.15498.10
591763-9176393.109100.80
690516-9051691.84499.96
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%
111.079826898340981329837497950982130.18
211.069813097813979720.23
单位质量响应值RSD%判断
8872.008858.230.11数据可信
影响因素30天-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%
5min132730-3273033.15232.8615.4633.1532.8615.46
241141-4114141.67141.67
330568-3056830.96230.96
433918-3391834.35534.35
526241-2624126.57926.58
630034-3003430.42130.42
10min155781-5578156.50061.168.5956.8761.538.62
268249-6824969.12869.59
360316-6031661.09361.44
462292-6229263.09463.48
553666-5366654.35754.65
662004-6200462.80363.14
15min170249-7024971.15474.555.1172.1575.595.18
278549-7854979.56180.79
373861-7386174.81275.84
476298-7629877.28178.36
568383-6838369.26470.16
674254-7425475.21076.25
20min177451-7745178.44981.912.7380.2483.792.81
283112-8311284.18386.30
382257-8225783.31785.17
482488-8248883.55185.49
579137-7913780.15681.83
680784-8078481.82583.70
30min183554-8355484.63087.943.2287.2990.723.23
288359-8835989.49792.55
385213-8521386.31189.09
491541-9154192.72095.59
586417-8641787.53090.09
685845-8584586.95189.73
45min188454-8845489.59390.211.8393.1993.971.66
287232-8723288.35692.40
390571-9057191.73895.48
489567-8956790.72194.62
591123-9112392.29795.83
687426-8742688.55292.30
60min188863-8886390.00891.082.0394.6095.841.89
287981-8798189.11494.14
391847-9184793.03097.79
491219-9121992.39497.30
591593-9159392.77397.33
688046-8804689.18093.91
90min185392-8539286.49289.482.4092.0995.252.26
286926-8692688.04694.06
390848-9084892.01897.81
488796-8879689.94095.87
590490-9049091.65697.24
687581-8758188.70994.43
120min186231-8623187.34288.812.7593.9095.582.53
284298-8429885.38492.38
391013-9101392.18599.00
488624-8862489.76696.70
589224-8922490.37396.98
686667-8666787.78394.49
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189389-8938990.54091.591.6398.0799.351.57
288983-8898390.12998.07
391142-9114292.316100.15
492735-9273593.930101.86
591052-9105292.22599.84
689262-8926290.41298.09
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%
111.079801398188982489794897826980450.18
211.069881398493986530.23
单位质量响应值RSD%判断
8856.828919.800.51数据可信
影响因素30天-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%
5min123639-2363923.88130.0629.1323.8830.0629.13
224266-2426624.51524.51
332095-3209532.42432.42
426903-2690327.17927.18
525303-2530325.56225.56
646324-4632446.79946.80
10min152658-5265853.19859.7511.6953.4660.0911.79
253295-5329553.84154.11
360880-6088061.50461.86
460127-6012760.74361.05
556470-5647057.04957.33
671453-7145372.18572.71
15min167389-6738968.08074.968.1368.9475.968.24
267706-6770668.40069.27
377432-7743278.22679.27
475265-7526576.03677.01
574190-7419074.95075.87
683244-8324484.09785.42
20min177976-7797678.77583.884.8980.3985.715.05
279159-7915979.97081.60
385524-8552486.40188.31
483646-8364684.50386.33
582906-8290683.75685.51
688942-8894289.85492.11
30min185419-8541986.29589.182.5388.7891.942.74
287053-8705387.94590.46
387886-8788688.78791.66
489502-8950290.41993.18
587840-8784088.74091.42
691922-9192292.86496.12
45min186785-8678587.67591.102.3391.1294.862.50
289514-8951490.43193.93
391898-9189892.84096.70
491688-9168892.62896.39
589099-8909990.01293.68
692098-9209893.04297.33
60min190033-9003390.95691.861.5195.3896.621.72
289848-8984890.76995.27
392546-9254693.49598.39
491267-9126792.20297.00
589408-8940890.32494.99
692443-9244393.39198.71
90min189181-8918190.09591.491.6395.5397.271.87
289714-8971490.63496.14
390797-9079791.72897.66
491090-9109092.02497.84
589432-8943290.34996.02
693132-9313294.087100.44
120min190087-9008791.01090.831.2697.4497.631.32
288802-8880289.71296.23
388505-8850589.41296.36
491508-9150892.44699.29
589884-8988490.80597.48
690672-9067291.60199.00
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192003-9200392.94677.0448.37100.3984.8543.57
289967-8996790.88998.40
390006-9000690.92998.87
491578-9157892.517100.39
592984-9298493.937101.62
61012-10121.0229.44
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%
111.079837597896980629814897862980690.22
211.069900098968989840.03
单位质量响应值RSD%判断
8858.998949.730.73数据可信
影响因素30天-供试品溶液-B0012N01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%
5min117843-1784317.99423.7019.8417.9923.7019.85
220891-2089121.06721.07
322541-2254122.73122.73
429982-2998230.23530.24
528274-2827428.51328.51
621472-2147221.65321.65
10min155903-5590356.37563.317.3856.5763.577.42
263194-6319463.72863.96
364115-6411564.65664.91
469923-6992370.51370.85
563336-6333663.87164.19
660205-6020560.71360.95
15min175709-7570976.34881.524.2877.1782.484.31
281488-8148882.17683.12
383135-8313583.83784.81
484876-8487685.59386.71
577712-7771278.36879.39
682084-8208482.77783.69
20min184998-8499885.71688.191.6087.3990.061.66
288300-8830089.04590.90
388984-8898489.73591.64
487682-8768288.42290.49
586832-8683287.56589.46
687933-8793388.67590.51
30min189731-8973190.48991.501.4493.1294.361.52
289452-8945290.20793.05
391449-9144992.22195.12
492998-9299893.78396.84
590405-9040591.16894.04
690390-9039091.15393.97
45min189578-8957890.33491.601.2593.9795.471.24
289910-8991090.66994.52
391817-9181792.59296.52
490013-9001390.77394.87
592225-9222593.00496.89
691462-9146292.23496.07
60min188217-8821788.96291.591.5293.6096.481.56
291993-9199392.77097.62
391766-9176692.54197.49
491249-9124992.01997.12
590524-9052491.28896.20
691197-9119791.96796.82
90min187491-8749188.23091.581.9793.8597.491.95
291985-9198592.76298.65
391263-9126392.03398.01
490249-9024991.01197.14
591507-9150792.28098.21
692399-9239993.17999.06
120min190231-9023190.99375.5548.2297.6082.4844.12
289307-8930790.06196.98
31213-12131.2238.23
487808-8780888.54995.69
589988-8998890.74897.70
690975-9097591.74398.66
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11050-10501.05915.55228.668.6723.31152.97
21049-10491.0588.97
31005-10051.0138.03
41019-10191.0289.15
587385-8738588.12396.09
61005-10051.0138.95
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