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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
111.159735297171975009742797380973660.13
211.199749497334974140.12
单位质量响应值RSD%判断
8732.388705.450.22数据可信
供试品溶液-B0069N01批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111071-1107111.49710.1425.8211.5010.1425.82
210158-1015810.54810.55
311470-1147011.91111.91
44709-47094.8904.89
510774-1077411.18811.19
610422-1042210.82310.82
10min131225-3122532.42532.437.4832.5532.547.52
228796-2879629.90330.02
331751-3175132.97133.10
428259-2825929.34529.40
533263-3326334.54134.67
634079-3407935.38935.51
15min145135-4513546.87046.583.4247.3647.053.35
244239-4423945.93946.39
344803-4480346.52547.02
446147-4614747.92148.30
542255-4225543.87944.39
646547-4654748.33648.85
20min153317-5331755.36655.701.2456.3856.701.27
252610-5261054.63255.59
353830-5383055.89956.91
453444-5344455.49856.41
554380-5438056.47057.47
654276-5427656.36257.41
30min163680-6368066.12865.340.9867.7566.951.01
261895-6189564.27465.84
363230-6323065.66067.30
462609-6260965.01566.54
563193-6319365.62267.24
662912-6291265.33067.01
45min168059-6805970.67571.781.4673.0374.111.41
270352-7035273.05675.34
368575-6857571.21173.58
469139-6913971.79674.05
568277-6827770.90173.25
670319-7031973.02275.42
60min172083-7208374.85376.932.1878.0080.072.07
276014-7601478.93682.03
375252-7525278.14481.30
473637-7363776.46779.52
575080-7508077.96681.11
672448-7244875.23378.45
90min179669-7966982.73182.720.6186.7186.710.53
280147-8014783.22787.20
379691-7969182.75486.78
480158-8015883.23987.14
579380-7938082.43186.44
678895-7889581.92785.98
120min181231-8123184.35385.662.7189.2590.572.58
283000-8300086.19091.08
379382-7938282.43387.38
482172-8217285.33090.15
583072-8307286.26591.19
686097-8609789.40694.37
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184234-8423487.47188.411.3693.3094.271.34
285352-8535288.63294.48
384954-8495488.21994.08
483521-8352186.73192.50
586264-8626489.58095.46
686514-8651489.83995.79
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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
111.159717197059972599717497599972520.22
211.199681497319970660.37
单位质量响应值RSD%判断
8722.158674.350.39数据可信
供试品溶液-B0069N01批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110888-1088811.33311.632.1011.3311.632.11
211424-1142411.89111.89
311298-1129811.76011.76
411414-1141411.88111.88
510964-1096411.41311.41
611059-1105911.51111.51
10min138102-3810239.66140.373.0439.7940.503.03
239470-3947041.08541.22
340111-4011141.75241.88
436942-3694238.45338.59
538444-3844440.01740.14
639639-3963941.26041.39
15min154430-5443056.65757.051.9157.2257.631.89
255865-5586558.15058.74
353760-5376055.95956.55
455585-5558557.85958.42
553515-5351555.70456.28
655713-5571357.99258.58
20min164018-6401866.63765.151.8067.8366.361.77
261839-6183964.36965.60
361316-6131663.82465.04
463148-6314865.73166.93
561660-6166064.18265.37
663561-6356166.16167.39
30min170624-7062473.51373.932.7575.4575.872.67
271959-7195974.90376.85
371074-7107473.98175.91
473498-7349876.50578.44
571406-7140674.32776.23
667602-6760270.36772.33
45min177450-7745080.61881.592.1283.3784.352.07
281733-8173385.07687.86
377578-7757880.75183.50
477814-7781480.99783.78
578175-7817581.37384.10
677573-7757380.74683.49
60min180030-8003083.30484.591.4686.9588.261.43
282794-8279486.18189.91
381324-8132484.65188.30
482191-8219185.55389.24
581500-8150084.83488.47
679774-7977483.03786.68
90min187287-8728790.85888.652.2395.4393.252.15
287783-8778391.37496.06
383791-8379187.21991.80
484336-8433687.78692.42
584512-8451287.96992.55
683271-8327186.67791.24
120min182092-8209285.45089.373.1491.0394.962.95
284421-8442187.87493.57
385552-8555289.05294.61
488950-8895092.58998.20
588984-8898492.62498.18
685169-8516988.65394.18
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186406-8640689.94191.792.8196.4798.372.61
287591-8759191.17497.85
386321-8632189.85296.40
488472-8847292.09198.73
587324-8732490.89697.48
692959-9295996.762103.28
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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
111.159814898351983049844498475983440.14
211.199768297924978030.18
单位质量响应值RSD%判断
8820.098740.210.65数据可信
供试品溶液-B0069N01批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119846-1984620.46518.419.1520.4718.419.15
218553-1855319.13219.13
316174-1617416.67916.68
418098-1809818.66318.66
515611-1561116.09816.10
618830-1883019.41819.42
10min143319-4331944.67144.266.4544.9044.476.45
245333-4533346.74846.96
341130-4113042.41442.60
445258-4525846.67146.88
538244-3824439.43839.62
644252-4425245.63345.85
15min157466-5746659.26059.033.9359.9859.733.96
260024-6002461.89762.63
356184-5618457.93858.59
458349-5834960.17060.90
553437-5343755.10555.72
658028-5802859.83960.56
20min164773-6477366.79566.663.7068.1868.023.72
267258-6725869.35770.78
363834-6383465.82667.13
463966-6396665.96267.36
560876-6087662.77664.01
667162-6716269.25870.65
30min171717-7171773.95573.352.2976.0875.442.35
273215-7321575.50077.69
370091-7009172.27974.31
470730-7073072.93875.06
568698-6869870.84272.77
672301-7230174.55876.71
45min177821-7782180.25079.232.4683.2082.142.50
280000-8000082.49785.53
375141-7514177.48680.32
476608-7660878.99981.94
574865-7486577.20279.92
676574-7657478.96481.95
60min180830-8083083.35382.181.9287.1985.971.98
281700-8170084.25088.20
378311-7831180.75584.45
478906-7890681.36985.18
577927-7792780.35983.93
680490-8049083.00286.87
90min185139-8513987.79685.212.6992.5689.922.67
284477-8447787.11492.00
383731-8373186.34490.94
481312-8131283.85088.57
579235-7923581.70886.17
681913-8191384.47089.25
120min188400-8840091.15988.171.9596.9093.821.85
284333-8433386.96592.82
384291-8429186.92292.47
484020-8402086.64292.29
586059-8605988.74594.12
685891-8589188.57294.30
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191953-9195394.82389.803.05101.5896.432.84
284524-8452487.16293.98
386322-8632289.01695.53
485900-8590088.58195.20
588096-8809690.84697.20
685688-8568888.36295.07
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