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%
111.159914699364992509927599408992890.11
211.029925499015991340.18
单位质量响应值RSD%判断
8904.848995.830.72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%
5min136053-3605336.17136.2121.2336.1736.2121.23
244847-4484744.99344.99
338670-3867038.79638.80
425353-2535325.43625.44
528925-2892529.01929.02
642682-4268242.82142.82
10min165863-6586366.07865.3910.7066.4865.7910.76
272288-7228872.52473.02
367505-6750567.72568.16
455879-5587956.06156.34
557703-5770357.89158.21
671816-7181672.05072.53
15min178203-7820378.45877.986.2379.5979.116.34
281791-8179182.05883.36
378297-7829778.55279.74
471010-7101071.24272.15
573372-7337273.61174.58
683715-8371583.98885.26
20min179669-7966979.92982.574.2581.9484.564.38
284909-8490985.18687.40
384406-8440684.68186.74
478540-7854078.79680.49
579452-7945279.71181.49
686825-8682587.10889.32
30min185081-8508185.35988.122.3388.2591.032.41
287954-8795488.24191.40
390766-9076691.06294.06
486677-8667786.96089.53
587033-8703387.31789.99
689474-8947489.76692.94
45min189723-8972390.01690.271.7193.8694.161.90
290587-9058790.88395.03
389835-8983590.12894.14
488077-8807788.36491.90
589037-8903789.32792.97
692600-9260092.90297.08
60min186301-8630186.58389.912.0191.4394.812.02
289861-8986190.15495.31
389967-8996790.26095.27
489981-8998190.27594.80
589777-8977790.07094.70
691824-9182492.12497.33
90min188862-8886289.15290.000.8694.9695.890.89
289614-8961489.90696.06
389061-8906189.35295.36
489415-8941589.70795.23
590692-9069290.98896.62
690586-9058690.88297.11
120min186947-8694787.23189.001.1594.0395.901.21
290054-9005490.34897.50
388549-8854988.83895.84
489026-8902689.31695.84
588644-8864488.93395.58
689069-8906989.36096.60
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190903-9090391.20091.491.2398.9799.371.25
290714-9071491.01099.17
392007-9200792.307100.30
492060-9206092.36099.87
589312-8931289.60397.24
692154-9215492.455100.69
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
加速6月-供试品溶液-B0012N01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%
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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