玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制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)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.119987510007799458100298100206999830.34
211.1299887100023999550.10
单位质量响应值RSD%判断
8999.378988.760.09数据可信
影响因素30天-供试品溶液-2025090921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%
5min153720-5372053.63250.005.2553.6350.005.25
247771-4777147.69347.69
349102-4910249.02149.02
448127-4812748.04848.05
548673-4867348.59348.59
653113-5311353.02653.03
10min171407-7140771.29067.895.2371.5968.175.23
267296-6729667.18667.45
366461-6646166.35266.62
465441-6544165.33465.60
564162-6416264.05764.33
673243-7324373.12373.42
15min180549-8054980.41779.434.2281.1180.094.22
278877-7887778.74879.39
378859-7885978.73079.37
477516-7751677.38978.02
575937-7593775.81276.44
685645-8564585.50486.21
20min186276-8627686.13484.073.2687.2885.173.27
284141-8414184.00385.08
384990-8499084.85185.93
482399-8239982.26483.32
579931-7993179.80080.85
687529-8752987.38588.56
30min189548-8954889.40188.062.7391.0289.622.75
288171-8817188.02689.57
388533-8853388.38889.94
486564-8656486.42287.94
584717-8471784.57886.07
691688-9168891.53893.20
45min189968-8996889.82090.151.5691.9492.211.58
289611-8961189.46491.50
392046-9204691.89593.94
488621-8862188.47690.47
589552-8955289.40591.37
691999-9199991.84894.02
60min190468-9046890.32090.311.0892.9392.861.13
290034-9003489.88692.41
390758-9075890.60993.16
489329-8932989.18291.67
589966-8996689.81892.28
692175-9217592.02494.70
极限191266-9126691.11691.453.1194.2394.503.04
288087-8808787.94290.97
396087-9608795.92998.98
491802-9180291.65194.64
589265-8926589.11892.07
693097-9309792.94496.14
玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制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)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.1199368993381000269947099085994570.35
211.12998921007801003360.63
单位质量响应值RSD%判断
8952.039023.020.56数据可信
影响因素30天-供试品溶液-2025090921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%
5min154621-5462154.57259.0710.3854.5759.0610.38
257327-5732757.27557.28
358827-5882758.77458.77
471199-7119971.13571.13
555027-5502754.97854.98
657711-5771157.65957.66
10min173966-7396673.89976.537.2974.2076.867.30
273886-7388673.82074.14
378187-7818778.11778.44
487281-8728187.20387.60
573774-7377473.70874.01
672513-7251372.44872.77
15min188115-8811588.03686.962.0288.7587.722.06
285740-8574085.66386.39
386310-8631086.23286.99
490134-9013490.05390.93
586308-8630886.23086.95
685649-8564985.57286.29
20min192443-9244392.36090.771.6293.5692.011.60
291953-9195391.87093.07
389300-8930089.22090.46
491043-9104390.96192.34
591555-9155591.47392.67
688836-8883688.75689.95
30min193577-9357793.49393.361.0395.2195.101.05
293334-9333493.25094.96
393251-9325193.16794.90
494336-9433694.25196.14
594392-9439294.30796.01
691766-9176691.68393.37
45min194175-9417594.09095.122.3696.3397.382.29
298923-9892398.834101.07
392550-9255092.46794.72
494337-9433794.25296.66
594573-9457394.48896.71
696658-9665896.57198.77
60min194082-9408293.99794.401.5096.7697.191.43
295081-9508194.99597.78
393939-9393993.85596.62
493397-9339793.31396.25
593355-9335593.27196.02
697084-9708496.99799.73
极限194456-9445694.37193.640.9497.6596.950.86
293671-9367193.58796.90
393868-9386893.78497.07
492387-9238792.30495.75
594811-9481194.72697.99
693148-9314893.06496.34
玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制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)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.1199336100143997189922499507995860.37
211.121000861001921001390.08
单位质量响应值RSD%判断
8963.649005.310.33数据可信
影响因素30天-供试品溶液-2025090921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%
5min152546-5254652.51654.763.2252.5254.763.22
255922-5592255.89055.89
356403-5640356.37156.37
452538-5253852.50852.51
555547-5554755.51555.52
655770-5577055.73855.74
10min171859-7185971.81872.683.5872.1172.993.57
274036-7403673.99474.30
375419-7541975.37675.69
469403-6940369.36369.66
570259-7025970.21970.53
675376-7537675.33375.64
15min179777-7977779.73283.063.8980.4283.763.88
285838-8583885.78986.51
387700-8770087.65088.38
479587-7958779.54280.22
582654-8265482.60783.31
683061-8306183.01483.74
20min186925-8692586.87587.772.4688.0188.942.46
289260-8926089.20990.41
388135-8813588.08589.30
485131-8513185.08286.20
586370-8637086.32187.48
691121-9112191.06992.26
30min191139-9113991.08792.102.2192.7093.762.20
292210-9221092.15793.85
391379-9137991.32793.04
489726-8972689.67591.27
592725-9272592.67294.31
695736-9573695.68197.38
45min189668-8966889.61791.541.2791.7493.711.27
292772-9277292.71994.92
390826-9082690.77492.99
491791-9179191.73993.83
591981-9198191.92994.08
692527-9252792.47494.70
60min189721-8972189.67091.712.1992.2994.392.15
290638-9063890.58693.31
390400-9040090.34893.07
491833-9183391.78194.38
592837-9283792.78495.45
695171-9517195.11797.86
极限189119-8911989.06891.001.4792.1994.181.48
291383-9138391.33194.56
390811-9081190.75993.98
490586-9058690.53493.64
591156-9115691.10494.28
693246-9324693.19396.46
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