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 11.119710297342974019723297331972820.13
2 11.129799698200980980.15
单位质量响应值RSD%判断
8756.268821.760.53数据可信
供试品溶液-2025090921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%
5min135161-3516135.92336.792.3835.9236.792.38
235145-3514535.90635.91
337067-3706737.87037.87
435827-3582736.60336.60
535838-3583836.61436.61
637020-3702037.82237.82
10min141790-4179042.69543.180.7142.8943.380.71
242180-4218043.09443.29
342132-4213243.04543.26
442618-4261843.54143.74
542494-4249443.41543.62
642366-4236643.28443.49
15min144207-4420745.16545.331.4945.6045.771.48
244197-4419745.15545.59
344009-4400944.96245.41
443489-4348944.43144.88
545081-4508146.05846.50
645206-4520646.18546.64
20min146169-4616947.16946.960.7247.8647.660.71
245580-4558046.56747.26
346307-4630747.31048.01
445863-4586346.85747.55
545600-4560046.58847.29
646263-4626347.26547.97
30min147352-4735248.37848.450.6449.3349.410.63
247098-4709848.11849.07
347360-4736048.38649.35
447177-4717748.19949.15
547868-4786848.90549.86
647698-4769848.73149.70
45min148521-4852149.57249.461.6950.7950.681.66
248406-4840649.45550.67
347805-4780548.84150.07
447300-4730048.32549.54
549677-4967750.75351.98
648743-4874349.79951.04
60min148064-4806449.10549.270.7950.6050.770.76
247685-4768548.71850.21
348540-4854049.59251.09
448754-4875449.81051.30
548178-4817849.22250.73
648111-4811149.15350.67
90min149890-4989050.97149.831.2652.7451.601.21
248588-4858849.64151.40
348304-4830449.35151.13
448762-4876249.81851.58
548188-4818849.23251.02
648901-4890149.96051.75
120min148019-4801949.05949.861.1651.1151.911.11
249343-4934350.41252.45
348722-4872249.77851.83
449052-4905250.11552.16
548280-4828049.32651.39
649379-4937950.44952.52
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149878-4987850.95950.311.1953.2852.641.14
249546-4954650.61952.94
348970-4897050.03152.36
449184-4918450.25052.57
548242-4824249.28751.62
649615-4961550.69053.04
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 11.119752597791977149773797390976310.18
2 11.129795298402981770.33
单位质量响应值RSD%判断
8787.678828.870.34数据可信
供试品溶液-2025090921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%
5min135735-3573536.42935.721.1736.4335.721.18
234952-3495235.63135.63
334533-3453335.20435.20
435084-3508435.76535.77
534766-3476635.44135.44
635161-3516135.84435.84
10min140985-4098541.78142.091.3441.9842.291.34
241858-4185842.67142.87
340981-4098141.77741.97
441684-4168442.49442.69
540480-4048041.26641.46
641737-4173742.54842.75
15min144831-4483145.70244.671.2746.1445.101.27
243651-4365144.49944.93
343195-4319544.03444.46
443926-4392644.77945.21
543756-4375644.60645.03
643531-4353144.37644.81
20min145479-4547946.36246.011.5147.0546.691.51
246207-4620747.10447.79
344575-4457545.44146.11
445383-4538346.26446.95
544731-4473145.60046.27
644419-4441945.28245.96
30min147222-4722248.13947.760.9249.0948.700.91
247330-4733048.24949.19
347130-4713048.04548.97
446390-4639047.29148.23
546674-4667447.58148.51
646366-4636647.26748.20
45min147490-4749048.41248.300.9149.6349.510.91
248198-4819849.13450.35
347048-4704847.96249.15
447220-4722048.13749.34
547283-4728348.20149.39
647069-4706947.98349.18
60min148404-4840449.34448.681.0150.8350.151.01
247876-4787648.80650.29
347287-4728748.20549.66
448199-4819949.13550.61
547416-4741648.33749.80
647323-4732348.24249.70
90min148111-4811149.04549.480.9250.8051.220.87
248537-4853749.48051.24
349175-4917550.13051.86
448042-4804248.97550.72
548922-4892249.87251.60
648451-4845149.39251.12
120min148560-4856049.50349.841.4951.5351.861.44
250287-5028751.26453.29
348748-4874849.69551.70
448999-4899949.95151.97
548294-4829449.23251.24
648463-4846349.40451.41
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148655-4865549.60048.980.9651.9051.270.93
248272-4827249.21051.53
347980-4798048.91251.19
447270-4727048.18850.48
547937-4793748.86851.15
648168-4816849.10451.38
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 11.119778297654979119769397986978050.15
2 11.129802698240981330.16
单位质量响应值RSD%判断
8803.338824.910.18数据可信
供试品溶液-2025090921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%
5min132901-3290133.51833.791.2133.5233.801.21
233394-3339434.02034.02
333386-3338634.01234.01
433508-3350834.13634.14
533363-3336333.98833.99
632478-3247833.08733.09
10min138490-3849039.21138.930.7839.4039.120.77
238168-3816838.88339.07
338508-3850839.23039.42
437882-3788238.59238.78
537858-3785838.56838.76
638394-3839439.11439.30
15min139579-3957940.32140.560.7940.7240.960.79
239814-3981440.56040.97
340344-4034441.10041.51
439991-3999140.74141.14
539512-3951240.25340.66
639627-3962740.37040.77
20min141738-4173842.52042.071.3143.1542.701.30
241517-4151742.29542.93
341826-4182642.61043.25
441121-4112141.89242.52
540359-4035941.11541.74
641212-4121241.98442.61
30min142492-4249243.28843.151.5944.1544.011.56
242750-4275043.55144.42
342810-4281043.61244.48
442515-4251543.31244.17
542569-4256943.36744.22
641014-4101441.78342.64
45min143450-4345044.26443.961.4245.3745.061.39
242970-4297043.77544.88
343150-4315043.95945.07
443195-4319544.00545.11
543993-4399344.81845.91
642134-4213442.92444.01
60min143687-4368744.50644.291.0245.8645.641.01
243542-4354244.35845.71
343845-4384544.66746.03
443340-4334044.15245.50
543802-4380244.62345.97
642659-4265943.45944.79
90min143200-4320044.01045.011.4745.6146.601.42
243957-4395744.78146.38
344289-4428945.11946.73
444342-4434245.17346.77
545200-4520046.04747.64
644095-4409544.92146.49
120min144524-4452445.35844.900.6147.2046.740.57
243849-4384944.67146.52
343816-4381644.63746.49
443976-4397644.80046.64
544073-4407344.89946.75
644219-4421945.04846.87
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144352-4435245.18344.790.9947.2846.880.96
244026-4402644.85146.94
343954-4395444.77846.88
443521-4352144.33746.43
544521-4452145.35547.45
643445-4344544.25946.33
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