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%
111.179801897603977049761797451976790.22
211.219732697020971730.23
单位质量响应值RSD%判断
8744.768668.420.62数据可信
供试品溶液-25031801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%
5min135331-3533136.43836.563.2236.4436.563.22
234641-3464135.72735.73
336815-3681537.96937.97
433714-3371434.77134.77
535836-3583636.95936.96
636354-3635437.49337.49
10min140735-4073542.01241.670.7742.2141.870.76
240348-4034841.61341.81
340785-4078542.06342.27
440145-4014541.40341.60
540389-4038941.65541.86
640013-4001341.26741.48
15min143954-4395445.33243.712.1645.7744.142.13
242296-4229643.62244.05
342366-4236643.69444.14
442635-4263543.97144.39
541775-4177543.08443.52
641266-4126642.55943.00
20min142763-4276344.10343.572.7044.7944.252.66
242642-4264243.97844.65
342666-4266644.00344.69
443012-4301244.36045.03
542448-4244843.77844.45
639954-3995441.20641.88
30min143180-4318044.53345.431.9945.4746.351.94
244964-4496446.37347.29
344173-4417345.55746.49
444620-4462046.01846.93
542778-4277844.11945.04
644579-4457945.97646.88
45min144479-4447945.87346.251.6347.0547.421.59
245316-4531646.73647.91
344716-4471646.11747.30
445435-4543546.85948.03
545488-4548846.91448.08
643613-4361344.98046.14
60min143960-4396045.33846.242.8546.7747.672.76
243102-4310244.45345.89
345137-4513746.55247.99
446660-4666048.12249.55
545725-4572547.15848.58
644423-4442345.81547.22
90min144458-4445845.85146.731.7547.5448.421.70
246128-4612847.57449.25
344884-4488446.29147.99
446146-4614647.59249.29
545749-4574947.18348.87
644496-4449645.89147.55
120min146413-4641347.86847.960.9349.8149.900.89
245780-4578047.21549.16
346374-4637447.82749.78
446705-4670548.16950.13
546654-4665448.11650.07
647065-4706548.54050.46
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147522-4752249.01148.781.4451.2250.991.39
247243-4724348.72450.93
346693-4669348.15650.38
448544-4854450.06552.29
546842-4684248.31050.53
646942-4694248.41350.60
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%
111.179722997330970439730997589973000.21
211.219854498804986740.19
单位质量响应值RSD%判断
8710.838802.320.74数据可信
供试品溶液-25031801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%
5min135154-3515436.04936.672.1236.0536.672.12
236344-3634437.26937.27
335311-3531136.21036.21
435317-3531736.21636.22
537034-3703437.97737.98
635388-3538836.28936.29
10min141423-4142342.47841.591.7542.6841.791.74
240638-4063841.67341.88
341012-4101242.05642.26
440471-4047141.50241.70
540459-4045941.48941.70
639326-3932640.32740.53
15min143909-4390945.02744.751.4845.4645.181.47
244394-4439445.52445.96
344072-4407245.19445.63
443712-4371244.82545.26
542985-4298544.08044.52
642738-4273843.82644.25
20min146001-4600147.17245.612.2447.8646.292.22
245231-4523146.38347.07
343221-4322144.32245.01
443914-4391445.03245.71
544431-4443145.56246.25
644072-4407245.19445.86
30min147462-4746248.67147.272.5049.6248.212.47
246358-4635847.53848.49
346530-4653047.71548.65
446046-4604647.21848.15
546193-4619347.36948.31
643984-4398445.10446.02
45min149069-4906950.31848.853.3651.5450.053.27
245081-4508146.22947.44
348163-4816349.38950.59
448320-4832049.55050.74
546282-4628247.46048.66
648902-4890250.14751.32
60min150026-5002651.30050.071.5452.8051.541.52
248792-4879250.03451.50
348275-4827549.50450.98
448882-4888250.12751.60
549113-4911350.36451.83
647846-4784649.06450.51
90min149645-4964550.90950.801.9152.6952.541.84
249867-4986751.13752.88
347818-4781849.03650.78
449424-4942450.68252.43
550675-5067551.96553.71
649783-4978351.05152.77
120min151347-5134752.65451.541.3354.7253.571.31
250136-5013651.41353.44
349518-4951850.77952.80
449878-4987851.14853.18
550732-5073252.02454.06
649937-4993751.20953.21
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150530-5053051.81751.770.9854.1854.090.95
251189-5118952.49254.81
349939-4993951.21153.51
450939-5093952.23654.55
550139-5013951.41653.74
650190-5019051.46853.76
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%
111.179783897937977299806297588978310.19
211.219765597742976980.07
单位质量响应值RSD%判断
8758.378715.250.35数据可信
供试品溶液-25031801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%
5min136769-3676937.79038.921.9237.7938.921.92
237750-3775038.79838.80
338138-3813839.19739.20
437654-3765438.69938.70
538997-3899740.08040.08
637925-3792538.97838.98
10min142826-4282644.01543.470.8744.2243.690.86
241747-4174742.90643.12
342062-4206243.23043.45
442397-4239743.57443.79
542458-4245843.63743.86
642308-4230843.48343.70
15min145537-4553746.80145.951.5947.2646.401.57
245104-4510446.35646.81
345344-4534446.60347.06
444333-4433345.56446.02
543949-4394945.16945.63
643976-4397645.19745.65
20min147068-4706848.37547.781.2749.0948.501.25
246895-4689548.19748.91
346612-4661247.90648.62
445396-4539646.65647.37
546563-4656347.85648.57
646424-4642447.71348.42
30min147500-4750048.81949.341.1849.8050.311.16
247690-4769049.01449.99
348782-4878250.13651.12
448477-4847749.82350.79
548180-4818049.51850.50
647385-4738548.70049.67
45min149127-4912750.49150.701.5451.7551.951.51
250587-5058751.99153.24
349855-4985551.23952.50
448654-4865450.00551.25
549072-4907250.43451.69
648664-4866450.01551.26
60min151139-5113952.55951.991.0254.0953.520.99
250199-5019951.59353.13
350370-5037051.76853.31
449932-4993251.31852.84
550643-5064352.04953.59
651209-5120952.63154.15
90min149654-4965451.03252.542.1052.8654.362.03
250513-5051351.91553.74
352009-5200953.45355.29
450445-5044551.84553.65
551674-5167453.10954.93
652407-5240753.86255.68
120min150533-5053351.93652.401.0254.0554.511.00
250450-5045051.85153.97
351360-5136052.78654.92
450603-5060352.00854.10
551696-5169653.13155.25
651242-5124252.66554.78
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150850-5085052.26252.791.3254.6655.191.28
250671-5067152.07854.48
351723-5172353.15955.58
451332-5133252.75755.14
552518-5251853.97656.39
651084-5108452.50254.91
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