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%
111.009701597650975449766597154974060.31
211.019794998254981020.22
单位质量响应值RSD%判断
8855.098910.260.44数据可信
加速3月-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%
5min133045-3304533.40527.8212.7033.4027.8112.70
228188-2818828.49528.49
322942-2294223.19223.19
428740-2874029.05329.05
524759-2475925.02925.03
627425-2742527.72427.72
10min152754-5275453.32854.434.9553.7054.744.96
256786-5678657.40457.72
349556-4955650.09650.35
455642-5564256.24856.57
552787-5278753.36253.64
655546-5554656.15156.46
15min168233-6823368.97670.583.5969.9471.493.58
272717-7271773.50974.46
365835-6583566.55267.37
469718-6971870.47771.42
571792-7179272.57473.44
670630-7063071.39972.33
20min176167-7616776.99678.812.0278.7380.512.04
279315-7931580.17981.95
375761-7576176.58678.14
479114-7911479.97581.71
578794-7879479.65281.33
678604-7860479.46081.19
30min184455-8445585.37487.591.7187.9690.171.61
286732-8673287.67690.34
388257-8825789.21891.62
486494-8649487.43690.06
588242-8824289.20391.77
685708-8570886.64189.25
45min189733-8973390.71091.702.1494.2495.242.05
289210-8921090.18193.82
390684-9068491.67195.07
490736-9073691.72495.31
594447-9444795.47599.03
689445-8944590.41993.99
60min191078-9107892.07091.872.3096.6196.442.12
288947-8894789.91594.55
394139-9413995.16499.58
488271-8827189.23293.84
591396-9139692.39197.01
691453-9145392.44997.02
90min187944-8794488.90191.721.6494.4797.301.56
290483-9048391.46897.11
390874-9087491.86397.34
492218-9221893.22298.82
591549-9154992.54698.19
691302-9130292.29697.90
120min187431-8743188.38390.393.5194.9497.003.26
288409-8840989.37296.03
392377-9237793.38399.88
485220-8522086.14892.79
593621-9362194.640101.31
689421-8942190.39597.02
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188143-8814389.10390.801.5696.6498.411.50
289898-8989890.87798.52
389928-8992890.90798.44
488682-8868289.64897.24
592173-9217393.177100.90
690116-9011691.09798.73
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%
111.009743897671977929783797545976570.18
211.019729997767975330.34
单位质量响应值RSD%判断
8877.918858.580.16数据可信
加速3月-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%
5min131292-3129231.68430.7815.8231.6830.7815.82
223665-2366523.96123.96
329158-2915829.52329.52
429293-2929329.66029.66
530413-3041330.79430.79
638559-3855939.04239.04
10min157926-5792658.65158.676.4659.0059.016.51
253112-5311253.77754.04
356528-5652857.23657.56
455635-5563556.33256.66
561063-6106361.82862.17
663382-6338264.17664.61
15min173491-7349174.41173.024.6775.4274.024.72
268994-6899469.85870.72
368053-6805368.90569.87
471481-7148172.37673.33
573450-7345074.37075.40
677247-7724778.21479.36
20min181410-8141082.43080.673.4084.2682.483.45
278250-7825079.23080.87
375990-7599076.94278.67
477718-7771878.69180.45
582357-8235783.38885.24
682313-8231383.34485.36
30min185280-8528086.34887.522.4589.0990.222.48
286653-8665387.73890.26
383599-8359984.64687.23
487085-8708588.17690.81
586064-8606487.14289.92
689946-8994691.07294.01
45min187858-8785888.95889.371.2892.6693.041.28
288740-8874089.85193.35
387539-8753988.63592.16
487014-8701488.10491.72
590214-9021491.34495.09
688216-8821689.32193.27
60min186571-8657187.65589.401.8992.3594.071.80
291161-9116192.30396.80
386844-8684487.93292.44
487918-8791889.01993.61
588338-8833889.44494.21
688947-8894790.06195.01
90min188090-8809089.19389.450.8794.8695.110.87
289238-8923890.35695.87
387096-8709688.18793.67
488359-8835989.46695.05
589051-8905190.16695.93
688217-8821789.32295.27
120min185374-8537486.44387.301.3593.1093.961.28
287914-8791489.01595.54
384813-8481385.87592.34
486166-8616687.24593.82
587217-8721788.30995.07
685849-8584986.92493.86
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187867-8786788.96789.451.0796.5997.071.06
287898-8789888.99996.51
387949-8794989.05096.47
488024-8802489.12696.67
590250-9025091.38099.12
688047-8804789.15097.05
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%
111.009763697204973109719397241973170.19
211.019824898164982060.07
单位质量响应值RSD%判断
8847.008919.710.58数据可信
加速3月-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%
5min123075-2307523.32531.4617.5723.3231.4617.58
238509-3850938.92638.93
328750-2875029.06129.06
435908-3590836.29636.30
529973-2997330.29730.30
630547-3054730.87730.88
10min148537-4853749.06259.8010.0349.3260.1510.06
264285-6428564.98065.41
356312-5631256.92157.24
463522-6352264.20964.61
562073-6207362.74463.08
660224-6022460.87561.22
15min161908-6190862.57874.518.6063.3875.538.65
278856-7885679.70980.86
371283-7128372.05473.01
477721-7772178.56279.68
576355-7635577.18178.21
676177-7617777.00178.02
20min173577-7357774.37381.624.7775.8783.464.87
281661-8166182.54484.58
379508-7950880.36882.12
482253-8225383.14385.13
583675-8367584.58086.47
683815-8381584.72286.60
30min182350-8235083.24187.432.9785.5790.183.08
288425-8842589.38292.34
386066-8606686.99789.65
484993-8499385.91288.83
589244-8924490.20993.04
687883-8788388.83491.65
45min187456-8745688.40290.901.7891.6594.621.91
290774-9077491.75695.71
390023-9002390.99794.61
488591-8859189.54993.42
591399-9139992.38896.22
691314-9131492.30296.11
60min187620-8762088.56890.892.5592.8095.622.54
289222-8922290.18795.16
391212-9121292.19996.83
487840-8784088.79093.65
593720-9372094.73499.59
689875-8987590.84795.68
90min187932-8793288.88390.341.1194.1096.081.24
289904-8990490.87796.85
390438-9043891.41697.07
489392-8939290.35996.21
590105-9010591.08096.99
688438-8843889.39595.23
120min188586-8858689.54489.811.5995.7596.551.55
289844-8984490.81697.80
389714-8971490.68497.35
487289-8728988.23395.09
590510-9051091.48998.41
687140-8714088.08394.91
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189556-8955690.52592.001.0397.7299.741.16
290896-9089691.87999.87
390977-9097791.96199.64
491888-9188892.882100.72
590614-9061491.59499.54
692148-9214893.145100.96
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%
111.009799797734976659747097839977410.21
211.019902697984985050.75
单位质量响应值RSD%判断
8885.558946.870.49数据可信
中间条件3月-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%
5min134474-3447434.71835.3618.2334.7235.3618.23
227779-2777927.97627.98
347040-4704047.37347.37
434444-3444434.68834.69
532357-3235732.58632.59
634551-3455134.79634.80
10min161433-6143361.86862.887.1362.2563.287.18
261245-6124561.67961.99
370583-7058371.08371.61
463711-6371164.16364.55
559997-5999760.42260.78
657684-5768458.09358.48
15min171742-7174272.25175.286.8073.3276.386.80
275930-7593076.46877.46
381334-8133481.91183.23
476369-7636976.91078.01
576696-7669677.24078.27
666454-6645466.92567.96
20min180496-8049681.06781.494.2382.9483.424.24
283697-8369784.29086.14
383462-8346284.05486.28
480740-8074081.31283.27
582620-8262083.20685.10
674505-7450575.03376.81
30min185594-8559486.20186.653.6088.9889.483.60
290271-9027190.91193.69
387340-8734087.95991.12
486358-8635886.97089.83
585906-8590686.51589.33
680747-8074781.31983.93
45min189808-8980890.44589.302.7694.1893.092.82
290307-9030790.94794.74
390499-9049991.14095.28
489476-8947690.11093.93
587854-8785488.47792.25
684061-8406184.65788.17
60min190019-9001990.65790.072.4095.4094.862.48
291349-9134991.99796.80
390981-9098191.62696.78
489763-8976390.39995.22
589111-8911189.74394.50
685393-8539385.99890.45
90min187785-8778588.40788.852.5894.1594.642.61
290999-9099991.64497.47
389693-8969390.32996.50
486885-8688587.50193.33
589348-8934889.98195.74
684659-8465985.25990.67
120min185734-8573486.34287.212.6293.0793.992.71
287989-8798988.61395.46
389533-8953390.16897.34
487442-8744288.06294.86
585927-8592786.53693.29
682960-8296083.54889.90
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189956-8995690.59490.710.5198.2898.450.50
290242-9024290.88298.71
389391-8939190.02598.20
490726-9072691.36999.15
590285-9028590.92598.64
689820-8982090.45797.74
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%
111.009680196683968489662196750967410.10
211.019663196689966600.05
单位质量响应值RSD%判断
8794.648779.290.13数据可信
中间条件3月-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%
5min135648-3564836.42829.8816.8636.4329.8816.86
226995-2699527.58627.59
325678-2567826.24026.24
435486-3548636.26336.26
526307-2630726.88326.88
625351-2535125.90625.91
10min159497-5949760.79958.328.2461.2058.658.25
254703-5470355.90056.21
360406-6040661.72862.02
463404-6340464.79265.19
551828-5182852.96253.26
652587-5258753.73854.03
15min173260-7326074.86472.526.3575.9473.506.39
269035-6903570.54671.47
373711-7371175.32576.30
477204-7720478.89480.02
565252-6525266.68067.57
667325-6732568.79969.68
20min177380-7738079.07479.552.8880.9981.332.97
277413-7741379.10880.82
379604-7960481.34683.16
481120-8112082.89684.90
574718-7471876.35477.98
676814-7681478.49580.14
30min182390-8239084.19387.051.9686.9889.721.87
285037-8503786.89889.49
387598-8759889.51592.23
485112-8511286.97589.90
585312-8531287.17989.66
685652-8565287.52790.05
45min185969-8596987.85190.541.6891.5894.181.53
289341-8934191.29794.85
387877-8787789.80193.51
488876-8887690.82194.71
590073-9007392.04595.49
689495-8949591.45494.95
60min186721-8672188.61990.881.5393.3295.531.38
289661-8966191.62496.19
387912-8791289.83694.55
489174-8917491.12696.02
590012-9001291.98296.45
690145-9014592.11896.63
90min185550-8555087.42390.132.4493.1195.782.22
288517-8851790.45596.04
387037-8703788.94294.65
487497-8749789.41295.32
588642-8864290.58296.07
691935-9193593.94799.48
120min183325-8332585.14989.002.5091.8195.662.35
286757-8675788.65695.25
386251-8625188.13994.84
489124-8912491.07597.98
588221-8822190.15296.65
688899-8889990.84597.42
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189909-8990991.87791.841.1599.4899.491.07
289519-8951991.47999.06
388894-8889490.84098.52
489825-8982591.79199.71
589271-8927191.22598.72
691844-9184493.854101.44
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%
111.009712196953970399713696998970490.09
211.019743697628975320.14
单位质量响应值RSD%判断
8822.648858.490.29数据可信
中间条件3月-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%
5min144122-4412244.81531.9426.2744.8131.9426.26
222177-2217722.52522.53
330304-3030430.78030.78
423524-2352423.89323.89
531611-3161132.10732.11
636964-3696437.54437.54
10min170477-7047771.58359.6512.9972.0860.0113.06
250089-5008950.87551.13
355297-5529756.16556.51
452723-5272353.55153.82
559657-5965760.59360.95
664152-6415265.15965.58
15min179840-7984081.09373.357.7982.3974.377.92
265544-6554466.57367.39
369831-6983170.92771.89
468208-6820869.27970.14
571869-7186972.99774.03
678018-7801879.24380.38
20min184094-8409485.41480.404.7187.6182.234.89
274162-7416275.32676.88
377050-7705078.25980.01
477100-7710078.31079.94
580135-8013581.39383.23
682383-8238383.67685.70
30min183417-8341784.72687.172.1987.8789.892.14
284591-8459185.91988.31
384615-8461585.94388.57
486776-8677688.13890.64
587269-8726988.63991.38
688247-8824789.63292.58
45min185877-8587787.22590.852.5091.3194.542.16
291229-9122992.66196.01
388459-8845989.84893.43
492135-9213593.58197.06
590115-9011591.53095.26
688844-8884490.23994.19
60min187069-8706988.43691.682.3193.4996.382.04
290080-9008091.49495.87
393510-9351094.97899.55
490437-9043791.85796.38
590852-9085292.27897.03
689632-8963291.03995.99
90min185561-8556186.90489.811.8792.9495.541.61
288699-8869990.09195.48
388168-8816889.55295.18
490143-9014391.55897.10
589893-8989391.30497.08
688089-8808989.47295.43
120min184465-8446585.79187.711.7492.7994.431.48
286174-8617487.52793.92
386904-8690488.26894.90
488957-8895790.35396.91
585794-8579487.14193.93
685833-8583387.18094.14
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187302-8730288.67290.941.6696.6398.641.48
290537-9053791.95899.32
388136-8813689.51997.13
489945-8994591.35798.92
590253-9025391.67099.43
691057-9105792.486100.41
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