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%
111.159936499275993200.07
211.029925499015991340.18
单位质量响应值RSD%判断
8907.628995.830.70数据可信
加速6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%
5min136053-3605336.16547.8437.4236.1647.8337.42
238670-3867038.79038.79
328925-2892529.01529.01
442682-4268242.81542.81
572288-7228872.51272.51
667505-6750567.71567.71
10min155879-5587956.05270.8315.8656.4571.3615.93
257703-5770357.88258.31
371816-7181672.03972.36
478203-7820378.44678.92
581791-8179182.04582.85
678297-7829778.54079.29
15min171010-7101071.23079.767.5772.2681.087.73
273372-7337273.60074.67
383715-8371583.97585.10
479669-7966979.91681.26
584909-8490985.17386.89
684406-8440684.66886.29
20min178540-7854078.78485.035.7280.6087.245.93
279452-7945279.69981.59
386825-8682587.09589.15
485081-8508185.34587.58
587954-8795488.22790.89
690766-9076691.04893.61
30min186677-8667786.94689.161.8389.6492.322.16
287033-8703387.30390.08
389474-8947489.75292.78
489723-8972390.00293.19
590587-9058790.86894.51
689835-8983590.11493.69
45min188077-8807788.35089.582.3792.0193.722.38
289037-8903789.31393.06
392600-9260092.88896.91
486301-8630186.56990.75
589861-8986190.14094.79
689967-8996790.24694.83
60min189981-8998190.26090.131.1894.9095.271.07
289777-8977790.05694.80
391824-9182492.10997.16
488862-8886289.13894.28
589614-8961489.89295.55
689061-8906189.33894.92
90min189415-8941589.69389.651.6195.3395.791.48
290692-9069290.97496.71
390586-9058690.86796.94
486947-8694787.21793.35
590054-9005490.33496.99
688549-8854988.82495.40
120min189026-8902689.30290.341.4995.9497.471.75
288644-8864488.91995.67
389069-8906989.34696.43
490903-9090391.18598.29
590714-9071490.99698.65
692007-9200792.29399.85
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192060-9206092.34645.73109.5799.9853.8792.37
289312-8931289.58997.33
392154-9215492.440100.52
4-0.0008.12
5-0.0008.67
6-0.0008.59
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%
111.1599214992349973999400100057995290.37
211.029967199765997180.07
单位质量响应值RSD%判断
8926.379048.820.97数据可信
加速6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%
5min141386-4138641.35030.7622.4741.3530.7622.47
223713-2371323.69223.69
324997-2499724.97524.98
434015-3401533.98533.99
534318-3431834.28834.29
626284-2628426.26126.26
10min169908-6990869.84760.0310.1470.3160.3710.21
253894-5389453.84754.11
353834-5383453.78754.06
462346-6234662.29162.67
562040-6204061.98662.37
658469-5846958.41858.71
15min182119-8211982.04775.815.4283.2876.825.51
274386-7438674.32175.18
369405-6940569.34470.22
476697-7669776.63077.70
576729-7672976.66277.73
675945-7594575.87876.82
20min182864-8286482.79180.692.8084.9482.542.92
279547-7954779.47781.16
376813-7681376.74678.39
482141-8214182.06983.99
581011-8101180.94082.86
682218-8221882.14683.93
30min188973-8897388.89588.050.9091.9690.801.05
288360-8836088.28390.85
386720-8672086.64489.14
488502-8850288.42491.26
587779-8777987.70290.52
688449-8844988.37191.07
45min191651-9165191.57191.830.6195.6395.560.47
292706-9270692.62596.18
392465-9246592.38495.85
491339-9133991.25995.07
591887-9188791.80695.60
691444-9144491.36495.04
60min193562-9356293.48091.911.7898.5596.661.71
294461-9446194.37898.96
391633-9163391.55396.04
490626-9062690.54795.38
590519-9051990.44095.26
691167-9116791.08795.78
90min191273-9127391.19391.822.0197.3097.581.84
295415-9541595.331100.96
390982-9098290.90296.41
490075-9007589.99695.83
591682-9168291.60297.42
691960-9196091.87997.59
120min191275-9127591.19590.321.4398.3297.101.30
291357-9135791.27797.97
392006-9200691.92598.44
489239-8923989.16196.00
589337-8933789.25996.10
689153-8915389.07595.80
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190188-9018890.10991.451.1098.2599.240.87
293123-9312393.041100.74
392018-9201891.93799.47
490886-9088690.80698.63
591375-9137591.29599.12
691587-9158791.50799.22
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%
111.159940199441994279920299244993430.12
211.029917898937990580.18
单位质量响应值RSD%判断
8909.698988.930.63数据可信
-供试品溶液-B0012N01批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110693-1069310.72918.1549.5210.7318.1549.51
212225-1222512.26612.27
37992-79928.0198.02
425979-2597926.06726.07
529575-2957529.67529.67
622070-2207022.14422.14
10min140677-4067740.81454.8223.6340.9355.0223.71
248837-4883749.00249.14
341278-4127841.41741.51
459793-5979359.99560.28
570716-7071670.95471.28
666503-6650366.72766.97
15min168003-6800368.23276.999.2868.8077.809.48
276360-7636076.61777.30
368656-6865668.88769.44
479769-7976980.03880.99
584887-8488785.17386.29
682710-8271082.98983.98
20min181500-8150081.77586.224.2983.1187.894.52
288015-8801588.31289.84
381304-8130481.57882.89
486294-8629486.58588.43
589588-8958889.89091.95
688888-8888889.18891.10
30min189700-8970090.00291.821.4092.2494.441.57
292748-9274893.06195.57
391369-9136991.67793.90
491626-9162691.93594.74
593052-9305293.36696.43
690548-9054890.85393.75
45min188901-8890189.20192.832.0992.4496.482.20
294515-9451594.83498.38
393047-9304793.36196.60
492742-9274293.05596.88
593565-9356593.88097.98
692367-9236792.67896.59
60min192205-9220592.51692.982.0796.7597.662.01
296352-9635296.677101.28
391363-9136391.67195.95
492463-9246392.77597.64
592635-9263592.94798.09
690988-9098891.29596.23
90min191273-9127391.58191.272.1396.8496.981.99
293295-9329593.60999.28
390511-9051190.81696.11
491465-9146591.77397.67
591737-9173792.04698.22
687491-8749187.78693.74
120min191804-9180492.11390.331.9798.3997.051.70
289472-8947289.77496.49
390816-9081691.12297.43
490742-9074291.04897.96
590557-9055790.86298.06
686752-8675287.04493.97
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184840-8484085.12688.732.1092.4396.462.19
289741-8974190.04497.76
388793-8879389.09296.41
488407-8840788.70596.63
589887-8988790.19098.40
688909-8890989.20997.11
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