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115240801对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.6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%
111.169996299940999881004001001991000980.20
211.151004391001381002880.22
单位质量响应值RSD%判断
8969.358994.440.20数据可信
供试品溶液-25010801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%
5min151528-5152851.94257.035.0651.9457.025.06
259109-5910959.58459.58
358851-5885159.32459.32
456853-5685357.31057.31
555177-5517755.62055.62
657918-5791858.38358.38
10min161209-6120961.70065.213.4761.9965.533.47
265529-6552966.05566.39
366971-6697167.50967.84
466055-6605566.58566.90
562668-6266863.17163.48
665736-6573666.26466.59
15min166310-6631066.84270.083.5567.4770.763.55
269657-6965770.21670.91
371365-7136571.93872.64
471744-7174472.32073.01
566666-6666667.20167.86
671398-7139871.97172.66
20min168884-6888469.43772.642.6170.4473.702.62
272359-7235972.94074.03
372277-7227772.85773.96
474114-7411474.70975.80
571139-7113971.71072.74
673574-7357474.16575.26
30min173660-7366074.25177.643.7275.6479.113.70
276377-7637776.99078.48
376225-7622576.83778.35
481414-8141482.06883.57
575078-7507875.68177.11
679365-7936580.00281.51
45min180164-8016480.80882.473.3382.6184.383.30
279910-7991080.55282.47
382095-8209582.75484.69
487028-8702887.72789.69
579961-7996180.60382.46
681725-8172582.38184.33
60min181379-8137982.03283.964.2584.2886.324.20
281105-8110581.75684.12
383001-8300183.66786.06
489785-8978590.50692.95
580050-8005080.69382.99
684444-8444485.12287.53
极限193390-9339094.14096.034.4196.8598.864.35
291704-9170492.44095.26
393527-9352794.27897.14
4103103-103103103.931106.88
593024-9302493.77196.52
696847-9684797.625100.50
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115240801对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.6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%
111.16100244998921005331002981002161002370.23
211.1599893100092999920.15
单位质量响应值RSD%判断
8981.818967.890.11数据可信
供试品溶液-2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%
5min178337-7833779.02884.968.5979.0384.968.59
286892-8689287.65887.66
376272-7627276.94576.94
491371-9137192.17792.18
593189-9318994.01194.01
679234-7923479.93379.93
10min184437-8443785.18290.646.1085.6291.116.11
290024-9002490.81891.30
384358-8435885.10285.53
495907-9590796.75397.26
596823-9682397.67798.20
687543-8754388.31588.76
15min186117-8611786.87791.525.0987.7992.505.11
291201-9120192.00593.00
386760-8676087.52588.43
496585-9658597.43798.49
595841-9584196.68697.75
687802-8780288.57689.51
20min186737-8673787.50291.584.3688.9093.074.39
290924-9092491.72693.23
386891-8689187.65789.04
495669-9566996.51398.10
595273-9527396.11397.72
689204-8920489.99191.42
30min185666-8566686.42291.563.7788.3093.553.81
291930-9193092.74194.75
388493-8849389.27391.15
493759-9375994.58696.71
594794-9479495.63097.77
689910-8991090.70392.63
45min185749-8574986.50590.834.1788.8793.334.20
289780-8978090.57293.10
386647-8664787.41189.78
494401-9440195.23497.89
594542-9454295.37698.04
689071-8907189.85792.29
60min185860-8586086.61790.352.8289.4693.362.89
290027-9002790.82193.85
388454-8845489.23492.09
492218-9221893.03196.21
592418-9241893.23396.43
688394-8839489.17492.10
极限190479-9047991.27793.562.0994.6097.072.00
291416-9141692.22295.76
396112-9611296.960100.31
493252-9325294.07497.77
592366-9236693.18196.90
692847-9284793.66697.09
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115240801对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.6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%
111.1610045999839100398100379998331001820.32
211.159947099628995490.12
单位质量响应值RSD%判断
8976.888928.160.39数据可信
供试品溶液-4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%
5min171001-7100171.80677.7213.6271.8177.7213.62
289264-8926490.27690.28
370571-7057171.37171.37
465173-6517365.91265.91
574865-7486575.71475.71
690236-9023691.26091.26
10min181865-8186582.79489.027.9583.1989.457.98
294076-9407695.14395.64
385778-8577886.75187.15
478988-7898879.88480.25
590654-9065491.68292.10
696778-9677897.87698.38
15min187394-8739488.38592.845.4789.2493.765.51
298636-9863699.755100.78
390775-9077591.80592.68
485981-8598186.95687.77
591264-9126492.29993.23
696738-9673897.83598.89
20min191752-9175292.79395.123.0094.1496.563.06
298070-9807099.182100.77
395162-9516296.24197.63
491229-9122992.26493.56
591917-9191792.96094.40
696159-9615997.25098.84
30min194476-9447695.54896.281.4797.4198.251.52
296074-9607497.16499.30
397071-9707198.172100.10
494057-9405795.12496.93
593479-9347994.53996.50
696051-9605197.14099.28
45min191609-9160992.64895.151.4795.0497.661.53
295524-9552496.60799.28
394876-9487695.95298.42
493888-9388894.95397.29
593818-9381894.88297.37
694807-9480795.88298.56
60min191822-9182292.86495.422.3895.7798.462.41
298182-9818299.296102.51
395046-9504696.12499.13
494187-9418795.25598.12
592454-9245493.50396.51
694427-9442795.49898.70
极限192975-9297594.03094.261.3397.4697.831.33
295122-9512296.20199.96
393180-9318094.23797.77
493857-9385794.92298.31
591409-9140992.44695.98
692703-9270393.75497.49
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