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%
111.049793197879979259791297854979000.04
211.049740297464974330.05
单位质量响应值RSD%判断
8867.758825.450.34数据可信
供试品溶液-2025051521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%
5min124875-2487525.24827.2210.8825.2527.2210.88
226091-2609126.48326.48
329208-2920829.64629.65
431518-3151831.99131.99
524052-2405224.41324.41
625155-2515525.53225.53
10min145386-4538646.06746.875.3946.3547.175.42
243239-4323943.88844.18
349082-4908249.81950.15
449381-4938150.12250.48
544788-4478845.46045.73
645166-4516645.84446.13
15min156344-5634457.18956.112.9357.9856.942.97
252976-5297653.77154.55
356514-5651457.36258.24
456998-5699857.85358.77
553817-5381754.62555.40
655060-5506055.88656.68
20min161116-6111662.03361.962.6563.4663.412.68
258638-5863859.51860.90
363171-6317164.11965.64
462339-6233963.27464.83
560948-6094861.86363.25
660047-6004760.94862.36
30min170922-7092271.98669.312.6074.1071.442.59
265882-6588266.87168.91
368057-6805769.07871.31
469495-6949570.53872.80
567069-6706968.07570.15
668263-6826369.28771.38
45min176760-7676077.91275.502.3380.8378.402.23
272825-7282573.91876.70
373272-7327274.37177.37
473047-7304774.14377.19
574081-7408175.19378.02
676314-7631477.45980.32
60min176610-7661077.76077.421.4781.5481.171.45
274180-7418075.29378.90
376773-7677377.92581.75
476021-7602177.16281.03
577409-7740978.57182.23
676681-7668177.83281.55
90min183826-8382685.08482.201.9889.7386.811.94
279463-7946380.65585.10
381748-8174882.97587.67
480492-8049281.70086.42
579823-7982381.02185.56
680571-8057181.78086.37
120min186135-8613587.42884.112.2293.0289.622.16
280493-8049381.70187.04
382944-8294484.18989.80
482257-8225783.49189.12
582645-8264583.88589.32
682709-8270983.95089.45
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188834-8883490.16784.853.1796.7391.303.03
281488-8148882.71188.96
383019-8301984.26590.81
483305-8330584.55591.11
582249-8224983.48389.85
682678-8267883.91990.35
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%
111.049815397945981289811097773980220.17
211.049734897246972970.08
单位质量响应值RSD%判断
8878.808813.130.53数据可信
供试品溶液-2025051621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%
5min129457-2945729.90130.1016.4429.9030.1016.44
232347-3234732.83532.84
334105-3410534.62034.62
420571-2057120.88120.88
528860-2886029.29529.30
632568-3256833.05933.06
10min147340-4734048.05448.547.8448.3948.877.90
249992-4999250.74651.11
350707-5070751.47251.86
440844-4084441.46041.69
547354-4735448.06848.39
650649-5064951.41351.78
15min141151-4115141.77254.9612.4042.6455.8312.27
257914-5791458.78859.72
358516-5851659.39960.36
452870-5287053.66854.36
555978-5597856.82357.68
658406-5840659.28760.23
20min162558-6255863.50262.632.7064.8364.112.79
262093-6209363.03064.61
363327-6332764.28265.90
458521-5852159.40460.69
561580-6158062.50964.00
662118-6211863.05564.65
30min168316-6831669.34769.511.9471.3871.691.89
267943-6794368.96871.25
368834-6883469.87272.20
469337-6933770.38372.33
566297-6629767.29769.48
670153-7015371.21173.51
45min173017-7301774.11974.930.7176.9277.880.71
273798-7379874.91177.96
373815-7381574.92978.04
474546-7454675.67178.40
573584-7358474.69477.63
674148-7414875.26778.36
60min176771-7677177.92978.330.7381.5682.120.84
276682-7668277.83981.72
377756-7775678.92982.87
476613-7661377.76981.34
577329-7732978.49682.26
677859-7785979.03482.96
90min180204-8020481.41481.670.8285.9186.320.79
281327-8132782.55487.30
380520-8052081.73586.55
481026-8102682.24886.68
579511-7951180.71185.35
680148-8014881.35786.16
120min181732-8173282.96583.471.0888.3789.041.03
283279-8327984.53590.20
382083-8208383.32189.05
483203-8320384.45889.81
580963-8096382.18487.72
682120-8212083.35989.07
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183485-8348584.74484.111.2291.0790.601.07
282477-8247783.72190.32
382742-8274283.99090.64
484248-8424885.51991.81
581243-8124382.46988.91
682963-8296384.21590.85
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%
111.049729597362974699744597291973720.09
211.049787698077979760.15
单位质量响应值RSD%判断
8819.938874.640.44数据可信
供试品溶液-2025051622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%
5min128545-2854528.97127.5214.3628.9727.5214.36
228026-2802628.44428.44
329722-2972230.16630.17
424562-2456224.92924.93
531236-3123631.70231.70
620592-2059220.89920.90
10min147617-4761748.32846.845.6148.6547.145.67
247956-4795648.67248.99
347436-4743648.14448.48
444051-4405144.70944.99
548005-4800548.72249.07
641837-4183742.46242.69
15min155892-5589256.72755.794.3457.5956.624.40
256375-5637557.21758.07
356170-5617057.00957.88
452917-5291753.70754.48
557289-5728958.14459.04
651161-5116151.92552.63
20min160205-6020561.10461.482.7362.5962.922.81
261919-6191962.84464.34
361906-6190662.83064.33
460096-6009660.99362.36
561667-6166762.58864.13
657661-5766158.52259.80
30min167057-6705768.05868.801.7170.2370.931.78
268990-6899070.02072.21
367742-6774268.75370.96
467229-6722968.23370.28
569334-6933470.36972.60
666389-6638967.38069.31
45min173779-7377974.88174.431.0877.8077.321.18
274280-7428075.38978.36
373081-7308174.17277.14
473138-7313874.23077.04
573703-7370374.80377.82
672006-7200673.08175.76
60min174679-7467975.79477.621.2879.5581.341.19
277459-7745978.61682.42
376338-7633877.47881.27
476863-7686378.01181.64
576481-7648177.62381.47
677072-7707278.22381.71
90min178695-7869579.87081.351.0484.4785.930.97
280662-8066281.86686.55
379718-7971880.90885.56
481014-8101482.22486.72
580417-8041781.61886.33
680390-8039081.59085.95
120min181995-8199583.21982.780.8888.7188.260.95
281968-8196883.19288.78
381352-8135282.56788.12
481651-8165182.87088.28
582158-8215883.38589.00
680228-8022881.42686.69
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182419-8241983.65083.801.0390.0690.200.91
283727-8372784.97791.49
381506-8150682.72389.19
482894-8289484.13290.46
581734-8173482.95489.50
683108-8310884.34990.52
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