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%
1 10.719715897546969749713897221972070.22
2 10.849742397610975160.14
单位质量响应值RSD%判断
9076.288995.940.63数据可信
供试品溶液-25040101批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136317-3631736.08937.352.1936.0937.362.19
237254-3725437.02137.02
337320-3732037.08637.09
438293-3829338.05338.05
537752-3775237.51537.52
638607-3860738.36538.37
10min142693-4269342.42542.311.9042.6342.521.89
243151-4315142.88143.09
342295-4229542.03042.24
441596-4159641.33541.55
541956-4195641.69341.90
643790-4379043.51643.73
15min143964-4396443.68843.954.9144.1244.394.87
246000-4600045.71246.16
344788-4478844.50744.95
444914-4491444.63245.07
540044-4004439.79340.23
645653-4565345.36745.82
20min144489-4448944.21043.883.8444.8944.563.77
243871-4387143.59644.29
341154-4115440.89641.58
444263-4426343.98644.67
546314-4631446.02446.68
644848-4484844.56745.27
30min146682-4668246.38946.234.8247.3147.164.75
248208-4820847.90648.85
344304-4430444.02644.94
448630-4863048.32549.26
543270-4327042.99943.92
648028-4802847.72748.68
45min149078-4907848.77048.811.2449.9550.001.20
249490-4949049.18050.39
349212-4921248.90450.06
447942-4794247.64248.84
549558-4955849.24750.40
649437-4943749.12750.35
60min150551-5055150.23449.142.4751.6950.602.42
250001-5000149.68851.17
350150-5015049.83651.27
448249-4824947.94749.41
547576-4757647.27848.71
650151-5015149.83751.33
90min149020-4902048.71350.312.2850.4552.042.22
251051-5105150.73152.49
349347-4934749.03850.74
451844-5184451.51953.25
551237-5123750.91652.61
651243-5124350.92252.69
120min151844-5184451.51950.722.6253.5252.732.51
251439-5143951.11753.15
352073-5207351.74753.73
448406-4840648.10350.12
551181-5118150.86052.84
651307-5130750.98553.04
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149684-4968449.37350.175.6451.6652.465.42
251703-5170351.37953.70
345082-4508244.79947.07
451770-5177051.44653.73
551760-5176051.43653.69
652916-5291652.58454.92
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%
1 10.719750397613975519750097658975650.08
2 10.849714097308972240.13
单位质量响应值RSD%判断
9109.718969.001.11数据可信
供试品溶液-25040101批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134572-3457234.34436.293.8434.3436.293.85
238430-3843038.17738.18
337272-3727237.02737.03
437345-3734537.09937.10
535801-3580135.56535.57
635735-3573535.50035.50
10min136935-3693536.69238.995.7636.8839.195.74
240249-4024939.98440.20
339116-3911638.85839.06
438979-3897938.72238.93
543069-4306942.78542.98
637129-3712936.88537.08
15min145175-4517544.87845.631.6245.2746.041.63
246555-4655546.24846.68
345021-4502144.72545.15
446072-4607245.76946.19
546907-4690746.59847.03
645838-4583845.53645.94
20min142654-4265442.37345.524.2543.0246.204.21
247322-4732247.01047.70
345877-4587745.57546.25
444447-4444744.15444.83
546979-4697946.67047.36
647668-4766847.35448.01
30min144868-4486844.57346.366.6645.4547.286.53
249736-4973649.40950.36
344775-4477544.48045.40
449184-4918448.86049.78
542262-4226241.98442.94
649173-4917348.84949.77
45min150122-5012249.79248.761.6750.9249.941.61
248894-4889448.57249.80
347733-4773347.41948.59
449610-4961049.28350.48
548836-4883648.51449.70
649304-4930448.97950.17
60min149946-4994649.61749.280.8451.0250.740.80
249648-4964849.32150.82
349861-4986149.53350.97
449929-4992949.60051.07
548880-4888048.55850.01
649399-4939949.07450.54
90min150088-5008849.75850.201.0651.4451.921.03
250667-5066750.33352.10
351421-5142151.08252.79
450359-5035950.02751.77
549936-4993649.60751.33
650709-5070950.37552.11
120min150989-5098950.65350.360.9352.6152.370.89
251056-5105650.72052.77
350491-5049150.15952.15
451153-5115350.81652.84
550558-5055850.22552.23
649920-4992049.59151.61
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149488-4948849.16250.641.8451.4052.921.78
250480-5048050.14852.48
350966-5096650.63052.90
451535-5153551.19653.50
551155-5115550.81853.10
652229-5222951.88554.17
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%
1 10.719728697770973289758697635975210.22
2 10.849791598048979820.10
单位质量响应值RSD%判断
9105.609038.930.52数据可信
供试品溶液-25040101批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136091-3609135.72235.350.9935.7235.350.98
235888-3588835.52135.52
335964-3596435.59635.60
435248-3524834.88734.89
535792-3579235.42635.43
635317-3531734.95634.96
10min141089-4108940.66840.660.6440.8740.850.64
240966-4096640.54740.74
341235-4123540.81341.01
441406-4140640.98241.18
541122-4112240.70140.90
640640-4064040.22440.42
15min142080-4208041.64942.581.6542.0743.001.63
243739-4373943.29143.71
343976-4397643.52643.95
442760-4276042.32242.74
542743-4274342.30642.73
642808-4280842.37042.79
20min143715-4371543.26843.781.3143.9244.441.30
244837-4483744.37845.04
344570-4457044.11444.78
444755-4475544.29744.95
544075-4407543.62444.28
643442-4344242.99743.65
30min144693-4469344.23645.422.0445.1346.322.01
245300-4530044.83645.75
347159-4715946.67647.59
446673-4667346.19547.10
545356-4535644.89245.79
646131-4613145.65946.55
45min143960-4396043.51044.701.5144.6545.851.49
246047-4604745.57646.73
345050-4505044.58945.76
445350-4535044.88646.05
545364-4536444.90046.05
645178-4517844.71645.86
60min145096-4509644.63444.911.2046.0246.311.15
245264-4526444.80146.21
345131-4513144.66946.09
445308-4530844.84446.25
544995-4499544.53545.93
646453-4645345.97847.37
90min145107-4510744.64545.621.2146.2847.281.19
246439-4643945.96447.62
346701-4670146.22347.89
446224-4622445.75147.41
545866-4586645.39747.04
646238-4623845.76547.41
120min144717-4471744.25946.072.2946.1447.982.21
247413-4741346.92848.84
345884-4588445.41447.34
446888-4688846.40848.32
546900-4690046.42048.32
647483-4748346.99748.90
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144182-4418243.73046.132.9145.8648.302.81
248179-4817947.68649.86
346760-4676046.28148.46
447475-4747546.98949.16
546512-4651246.03648.19
646550-4655046.07448.24
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