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%
111.189859399148989379907098881989260.22
211.239916599282992240.09
单位质量响应值RSD%判断
8848.488835.620.11数据可信
供试品溶液-2025062721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%
5min134731-3473135.27036.182.4035.2736.182.40
234679-3467935.21735.22
336509-3650937.07637.08
436593-3659337.16137.16
535954-3595436.51236.51
635295-3529535.84335.84
10min141336-4133641.97842.021.3742.1742.221.37
241080-4108041.71841.91
342475-4247543.13443.34
441348-4134841.99042.20
540906-4090641.54141.74
641109-4110941.74741.95
15min143004-4300443.67244.431.2744.1044.861.27
243917-4391744.59945.03
344397-4439745.08645.53
443689-4368944.36744.81
544256-4425644.94345.38
643226-4322643.89744.33
20min145682-4568246.39145.830.8547.0646.520.82
244700-4470045.39446.07
345186-4518645.88746.58
444747-4474745.44246.13
545073-4507345.77346.46
645408-4540846.11346.79
30min147021-4702147.75147.260.7848.6848.190.77
246130-4613046.84647.77
346250-4625046.96847.92
446835-4683547.56248.50
546684-4668447.40948.35
646287-4628747.00647.94
45min148101-4810148.84848.461.3050.0449.661.25
248114-4811448.86150.05
346779-4677947.50548.72
447653-4765348.39349.60
548426-4842649.17850.38
647263-4726347.99749.19
60min148436-4843649.18848.921.0150.6550.390.98
247336-4733648.07149.53
347967-4796748.71250.19
448396-4839649.14750.62
548170-4817048.91850.39
648722-4872249.47850.94
90min149836-4983650.61050.320.9952.3552.060.95
249967-4996750.74352.47
349588-4958850.35852.10
449049-4904949.81051.56
549997-4999750.77352.52
648862-4886249.62051.35
120min148140-4814048.88750.211.8850.9152.231.80
249362-4936250.12852.14
350273-5027351.05353.08
449277-4927750.04252.06
548923-4892349.68251.71
650707-5070751.49453.50
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149054-4905449.81549.371.2152.1151.661.16
248444-4844449.19651.48
348481-4848149.23451.54
447654-4765448.39450.69
548693-4869349.44951.75
649363-4936350.12952.42
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%
111.189929199616996899971499650995920.18
211.2310027199237997540.74
单位质量响应值RSD%判断
8908.058882.810.21数据可信
供试品溶液-2025062821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%
5min134951-3495135.28135.122.3035.2835.122.29
233562-3356233.87833.88
335084-3508435.41535.41
435995-3599536.33436.33
534707-3470735.03435.03
634467-3446734.79234.79
10min140826-4082641.21141.631.1141.4141.821.10
241861-4186142.25642.44
340802-4080241.18741.38
441687-4168742.08042.28
540939-4093941.32541.52
641303-4130341.69241.89
15min143490-4349043.90043.860.9744.3344.280.96
244025-4402544.44044.86
342936-4293643.34143.77
443072-4307243.47843.91
543340-4334043.74944.17
643811-4381144.22444.65
20min145146-4514645.57245.470.9946.2446.140.97
244949-4494945.37346.04
344878-4487845.30145.97
444337-4433744.75545.43
545345-4534545.77346.44
645626-4562646.05646.73
30min145426-4542645.85447.292.0946.7848.212.05
246490-4649046.92847.85
347373-4737347.82048.74
447831-4783148.28249.21
547803-4780348.25449.18
646157-4615746.59247.52
45min148162-4816248.61649.031.3549.7950.221.32
247924-4792448.37649.56
349132-4913249.59550.78
448832-4883249.29250.49
549444-4944449.91051.10
647946-4794648.39849.58
60min148697-4869749.15649.501.0850.6050.961.06
249726-4972650.19551.65
349073-4907349.53650.99
449384-4938449.85051.32
549122-4912249.58551.05
648216-4821648.67150.12
90min148377-4837748.83349.891.3850.5551.621.35
249367-4936749.83351.56
349156-4915649.62051.35
450362-5036250.83752.58
549329-4932949.79451.54
649926-4992650.39752.12
120min149759-4975950.22850.150.4552.2252.160.44
249443-4944349.90951.92
349634-4963450.10252.11
450028-5002850.50052.53
549448-4944849.91451.93
649769-4976950.23852.24
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150498-5049850.97450.081.1953.2452.371.12
249871-4987150.34152.63
348999-4899949.46151.75
449001-4900149.46351.77
549410-4941049.87652.17
649903-4990350.37452.66
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%
111.189906398870998939937199390993170.40
211.231013101008081010590.36
单位质量响应值RSD%判断
8883.458999.020.92数据可信
供试品溶液-2025062821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%
5min133653-3365333.79834.993.0733.8035.003.07
233900-3390034.04634.05
334358-3435834.50634.51
435147-3514735.29835.30
535569-3556935.72235.72
636442-3644236.59936.60
10min140495-4049540.66941.020.6440.8641.220.65
240896-4089641.07241.26
340766-4076640.94141.13
441217-4121741.39441.59
540670-4067040.84541.04
641044-4104441.22041.42
15min143558-4355843.74543.720.7844.1644.140.77
243485-4348543.67244.09
343812-4381244.00044.42
442924-4292443.10943.53
543871-4387144.06044.48
643539-4353943.72644.16
20min144875-4487545.06845.250.6745.7245.920.67
244716-4471644.90845.57
345486-4548645.68246.35
444817-4481745.01045.68
545199-4519945.39346.06
645246-4524645.44146.12
30min146393-4639346.59246.970.9147.5047.890.90
246293-4629346.49247.40
347482-4748247.68648.60
446913-4691347.11548.03
546751-4675146.95247.87
646793-4679346.99447.92
45min147638-4763847.84348.901.9349.0150.071.89
248902-4890249.11250.28
349356-4935649.56850.75
448276-4827648.48449.66
550086-5008650.30151.48
647857-4785748.06349.25
60min148905-4890549.11548.471.7950.5549.921.74
248040-4804048.24749.69
349217-4921749.42950.89
447980-4798048.18649.63
548629-4862948.83850.30
646804-4680447.00548.46
90min147492-4749247.69648.802.2849.4050.522.20
247995-4799548.20149.91
348268-4826848.47650.21
448942-4894249.15250.87
548199-4819948.40650.14
650630-5063050.84852.56
120min149591-4959149.80449.921.4851.7751.921.43
250065-5006550.28052.26
349891-4989150.10552.11
448430-4843048.63850.63
549644-4964449.85751.86
650646-5064650.86452.86
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148721-4872148.93049.811.0751.1852.081.04
249356-4935649.56851.82
349559-4955949.77252.05
450158-5015850.37452.63
550080-5008050.29552.58
649695-4969549.90952.19
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