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)10
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%
111.089969599620995349942599818996180.16
211.169936398963991630.29
单位质量响应值RSD%判断
8990.798885.570.84数据可信
供试品溶液-N0001N04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%
5min123488-2348823.59720.9029.2023.6020.9029.19
222461-2246122.56522.57
315737-1573715.81015.81
411085-1108511.13611.14
526060-2606026.18126.18
625969-2596926.08926.09
10min163523-6352363.81759.3814.5864.0859.6114.64
262354-6235462.64362.89
351469-5146951.70851.88
445508-4550845.71945.84
567575-6757567.88868.18
664207-6420764.50564.79
15min180880-8088081.25581.536.0482.2382.436.16
284308-8430884.69985.65
377751-7775178.11178.86
473617-7361773.95874.59
587309-8730987.71488.76
683077-8307783.46284.47
20min185005-8500585.39988.914.2187.2790.714.31
291601-9160192.02693.91
386274-8627486.67488.29
484654-8465485.04686.50
593560-9356093.99496.01
689923-8992390.34092.27
30min192077-9207792.50493.901.2895.3396.681.39
294059-9405994.49597.41
393562-9356293.99696.58
492709-9270993.13995.54
595448-9544895.89098.95
692936-9293693.36796.30
45min189290-8929089.70492.852.0193.5596.681.85
293473-9347393.90697.87
393109-9310993.54197.17
494374-9437494.81198.24
593088-9308893.51997.65
691217-9121791.64095.61
60min186798-8679887.20092.072.7392.0596.922.64
293964-9396494.40099.40
391793-9179392.21896.88
492398-9239892.82697.31
592887-9288793.31898.49
692003-9200392.42997.42
90min185851-8585186.24989.501.8292.0795.391.78
289768-8976890.18496.24
389521-8952189.93695.63
489824-8982490.24095.76
590243-9024390.66196.87
689317-8931789.73195.75
120min183857-8385784.24688.752.6391.0295.632.45
289088-8908889.50196.56
389290-8929089.70496.39
490488-9048890.90797.43
589204-8920489.61796.83
688127-8812788.53595.55
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185153-8515385.54888.972.1193.2696.841.96
288074-8807488.48296.53
390330-9033090.74998.43
489720-8972090.13697.67
589573-8957389.98898.20
688535-8853588.94596.95
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)10
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%
111.0899797998859984510003399822998760.10
211.161002111002301002200.02
单位质量响应值RSD%判断
9014.088980.290.27数据可信
供试品溶液-N0001N04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%
5min116703-1670316.67021.4025.3016.6721.4025.29
216739-1673916.70616.71
323784-2378423.73723.74
426016-2601625.96425.96
528747-2874728.69028.69
616675-1667516.64216.64
10min146674-4667446.58154.1512.2446.7754.3912.27
245197-4519745.10745.29
356735-5673556.62256.89
461215-6121561.09461.38
558158-5815858.04358.36
657596-5759657.48257.67
15min167642-6764267.50875.528.9468.2176.368.97
267204-6720467.07167.76
380770-8077080.61081.50
479925-7992579.76680.73
575871-7587175.72076.68
682639-8263982.47583.30
20min181336-8133681.17586.075.4382.6387.745.51
280041-8004179.88281.31
389581-8958189.40391.19
487838-8783887.66489.52
586647-8664786.47588.28
691982-9198291.79993.54
30min189809-8980989.63192.652.8091.9995.282.90
290997-9099790.81693.14
395527-9552795.33798.12
492759-9275992.57595.40
591554-9155491.37294.14
696348-9634896.15798.92
45min192549-9254992.36593.131.0895.7296.791.22
292639-9263992.45595.78
393244-9324493.05996.90
494249-9424994.06297.92
592375-9237592.19295.97
694816-9481694.62898.46
60min192429-9242992.24692.902.1696.6297.602.22
291120-9112090.93995.30
393757-9375793.57198.45
495928-9592895.738100.64
590794-9079490.61495.42
694485-9448594.29899.18
90min189648-8964889.47090.611.5994.8796.341.72
289521-8952189.34394.71
392488-9248892.30498.22
491205-9120591.02496.99
589459-8945989.28295.09
692420-9242092.23798.16
120min188295-8829588.12090.232.0894.5296.962.10
290565-9056590.38596.74
391532-9153291.35098.29
490762-9076290.58297.56
588234-8823488.05994.86
693048-9304892.86399.82
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188464-8846488.28890.292.5395.6698.032.58
288430-8843088.25595.62
391458-9145891.27799.23
490763-9076390.58398.57
589296-8929689.11996.90
694394-9439494.207102.19
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