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%
111.079863098715987239858498743986790.07
211.069837798410983940.03
单位质量响应值RSD%判断
8914.098896.380.15数据可信
影响因素30天-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%
5min142950-4295043.30738.9119.1743.3138.9119.17
244269-4426944.63744.64
340941-4094141.28241.28
425497-2549725.70925.71
534198-3419834.48234.48
643681-4368144.04444.04
10min169827-6982770.40866.249.3570.8966.689.41
270698-7069871.28671.78
367980-6798068.54569.00
453815-5381554.26354.55
565720-6572066.26766.65
666136-6613666.68667.18
15min177825-7782578.47277.647.0779.7478.817.12
280705-8070581.37682.66
383946-8394684.64485.86
467989-6798968.55569.44
576545-7654577.18278.30
674989-7498975.61376.84
20min183663-8366384.35982.423.8686.4984.443.98
284710-8471085.41587.61
383936-8393684.63486.79
476487-7648777.12378.77
582007-8200782.68984.67
679608-7960880.27082.34
30min188838-8883889.57787.533.3192.6590.483.43
289117-8911789.85893.00
389267-8926790.00993.11
482365-8236583.05085.56
586863-8686387.58690.48
684389-8438985.09188.05
45min190103-9010390.85289.832.5394.9293.752.66
291986-9198692.75196.89
390369-9036991.12195.22
486202-8620286.91990.35
589226-8922689.96893.84
686676-8667687.39791.30
60min191695-9169592.45890.252.3597.5495.172.50
291167-9116791.92597.10
389812-8981290.55995.67
486157-8615786.87491.27
590305-9030591.05695.92
687902-8790288.63393.51
90min189774-8977490.52187.992.7896.6393.922.78
284999-8499985.70691.90
389953-8995390.70196.82
484820-8482085.52690.89
588550-8855089.28795.17
685513-8551386.22492.09
120min188940-8894089.68089.052.7896.7995.942.87
291289-9128992.04899.19
389441-8944190.18597.31
484827-8482785.53391.84
589515-8951590.26097.13
685861-8586186.57593.40
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188278-8827889.01291.781.9397.1299.671.89
292522-9252293.292101.46
391416-9141692.176100.31
489701-8970190.44797.71
592923-9292393.696101.57
691317-9131792.07799.86
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%
111.079881698755986929873598792987580.05
211.069847598359984170.09
单位质量响应值RSD%判断
8921.238898.460.19数据可信
影响因素30天-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%
5min141820-4182042.14642.833.8942.1542.843.88
240054-4005440.36640.37
342425-4242542.75642.76
442802-4280243.13643.14
545143-4514345.49545.49
642770-4277043.10343.10
10min165648-6564866.16067.482.5366.6367.962.54
265975-6597566.48966.94
364910-6491065.41665.89
467660-6766068.18868.67
569151-6915169.69070.20
668424-6842468.95769.44
15min174995-7499575.58077.692.6376.7878.922.63
276017-7601776.61077.80
375065-7506575.65076.85
478796-7879679.41080.65
579784-7978480.40681.69
677882-7788278.48979.73
20min179588-7958880.20982.762.3982.2584.852.37
283550-8355084.20186.24
379747-7974780.36982.41
484007-8400784.66286.78
583293-8329383.94286.12
682556-8255683.20085.32
30min183943-8394384.59787.392.3987.5390.402.36
289285-8928589.98192.96
384734-8473485.39588.33
487648-8764888.33191.39
588219-8821988.90792.01
686448-8644887.12290.16
45min193080-9308093.80690.702.9397.6894.682.79
292786-9278693.50997.48
386381-8638187.05590.94
490524-9052491.23095.27
588815-8881589.50793.60
688410-8841089.09993.11
60min186315-8631586.98889.712.8491.9094.702.75
293082-9308293.80898.82
386441-8644187.11591.97
490016-9001690.71895.77
588662-8866289.35394.44
689605-8960590.30495.30
90min185119-8511985.78390.013.3891.6796.003.27
293162-9316293.88899.94
386538-8653887.21393.03
491566-9156692.28098.34
589761-8976190.46196.54
689743-8974390.44396.45
120min186280-8628086.95389.433.1193.7996.423.01
293339-9333994.067101.17
385581-8558186.24893.04
489460-8946090.15897.25
588534-8853489.22496.31
689226-8922689.92296.93
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191491-9149192.20491.531.74100.0199.511.69
293525-9352594.254102.40
388831-8883189.52497.27
490257-9025790.96199.05
590219-9021990.92299.00
690608-9060891.31499.32
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%
111.079874198739986609859398548986560.09
211.069928599333993090.04
单位质量响应值RSD%判断
8912.018979.110.54数据可信
影响因素30天-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%
5min141157-4115741.31345.585.7341.3145.585.73
247382-4738247.56147.56
343376-4337643.54043.54
446960-4696047.13847.14
545923-4592346.09746.10
647646-4764647.82647.83
10min166902-6690267.15570.053.1867.6170.553.20
272504-7250472.77873.31
368889-6888969.15069.63
470959-7095971.22871.75
567895-6789568.15268.66
671558-7155871.82972.36
15min177378-7737877.67180.322.1578.8881.602.17
281707-8170782.01683.35
379961-7996180.26481.52
480452-8045280.75782.07
578789-7878979.08780.36
681808-8180882.11883.45
20min180277-8027780.58183.992.5482.6586.172.54
285175-8517585.49787.75
383667-8366783.98486.13
486085-8608586.41188.62
582266-8226682.57784.73
684582-8458284.90287.14
30min187775-8777588.10788.281.3791.0791.391.38
288377-8837788.71291.91
388231-8823188.56591.64
489391-8939189.72992.90
585748-8574886.07389.14
688141-8814188.47591.66
45min186153-8615386.47989.652.0990.4293.742.09
291145-9114591.49095.67
390096-9009690.43794.50
490770-9077091.11495.28
588212-8821288.54692.57
689472-8947289.81193.98
60min186063-8606386.38989.902.4091.2994.992.39
290975-9097591.31996.52
389925-8992590.26595.33
492026-9202692.37497.56
588138-8813888.47293.48
690237-9023790.57995.74
90min189010-8901089.34790.171.1195.2196.251.16
291168-9116891.51397.73
388777-8877789.11395.18
490808-9080891.15297.36
589210-8921089.54895.54
689986-8998690.32796.50
120min184287-8428784.60688.442.3491.4695.532.27
289774-8977490.11497.35
390012-9001290.35397.41
488231-8823188.56595.79
588336-8833688.67095.65
688023-8802388.35695.53
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189702-8970290.04290.750.7397.8498.820.75
289767-8976790.10798.34
390066-9006690.40798.47
491286-9128691.63299.84
590827-9082791.17199.14
690820-9082091.16499.32
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