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)0
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%
111.151015991013511013031010291012271013020.21
211.119934099260993000.06
单位质量响应值RSD%判断
9085.388937.891.16数据可信
长期6月-供试品溶液-2025062621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%
5min132126-3212632.01332.041.6432.0132.041.64
232373-3237332.25932.26
332313-3231332.19932.20
432781-3278132.66632.67
531198-3119831.08831.09
632112-3211231.99932.00
10min139728-3972839.58839.001.7639.7739.181.75
239874-3987439.73439.91
338294-3829438.15938.34
439646-3964639.50639.69
538682-3868238.54638.72
638607-3860738.47138.65
15min142842-4284242.69142.590.7643.0942.980.76
242638-4263842.48842.89
342879-4287942.72843.12
443136-4313642.98443.39
542170-4217042.02142.41
642756-4275642.60543.00
20min145324-4532445.16444.391.4445.8045.021.42
244387-4438744.23144.87
343612-4361243.45844.09
444971-4497144.81345.45
544085-4408543.93044.55
644917-4491744.75945.39
30min146439-4643946.27546.360.9747.1647.240.95
246514-4651446.35047.23
347211-4721147.04547.91
446441-4644146.27747.17
546726-4672646.56147.43
645829-4582945.66846.54
45min146908-4690846.74347.661.1447.8948.801.09
247916-4791647.74748.89
347632-4763247.46448.60
447794-4779447.62648.77
548371-4837148.20149.32
648353-4835348.18349.31
60min147420-4742047.25347.620.7248.6649.020.70
247987-4798747.81849.22
347720-4772047.55248.95
447973-4797347.80449.21
547392-4739247.22548.62
648245-4824548.07549.47
90min148122-4812247.95348.781.9749.6250.441.91
248370-4837048.20049.87
348233-4823348.06349.72
450584-5058450.40652.08
549572-4957249.39751.05
648808-4880848.63650.30
120min149033-4903348.86048.661.0150.7950.590.98
248424-4842448.25350.19
348872-4887248.70050.63
449124-4912448.95150.91
548088-4808847.91949.85
649433-4943349.25951.19
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146487-4648746.32348.382.3848.5350.592.28
248375-4837548.20550.41
349290-4929049.11651.31
449775-4977549.60051.83
549069-4906948.89651.09
648310-4831048.14050.35
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)0
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%
111.159860898481984019845198556984990.09
211.119797198138980540.13
单位质量响应值RSD%判断
8833.998825.740.07数据可信
长期6月-供试品溶液-2025062721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%
5min131889-3188932.42933.662.1532.4333.662.15
233257-3325733.82033.82
332938-3293833.49533.50
434039-3403934.61534.62
533445-3344534.01134.01
633016-3301633.57533.57
10min139711-3971140.38340.690.9840.5640.870.98
239650-3965040.32140.51
340670-4067041.35841.54
440183-4018340.86341.06
540100-4010040.77940.97
639745-3974540.41840.60
15min142254-4225442.96943.041.5743.3743.451.56
242347-4234743.06443.48
343223-4322343.95444.37
441894-4189442.60343.02
542855-4285543.58044.00
641371-4137142.07142.48
20min145219-4521945.98445.501.0346.6346.151.01
244343-4434345.09345.74
344272-4427245.02145.68
445274-4527446.04046.70
544390-4439045.14145.80
644946-4494645.70746.35
30min146985-4698547.78047.531.7248.6848.441.69
247155-4715547.95348.85
346818-4681847.61048.52
447731-4773148.53949.45
546366-4636647.15148.06
645382-4538246.15047.05
45min146648-4664847.43747.750.7748.6048.920.76
247518-4751848.32249.49
346952-4695247.74748.92
447246-4724648.04649.23
546743-4674347.53448.70
646643-4664347.43248.59
60min147729-4772948.53748.770.7449.9650.210.72
248469-4846949.28950.73
347521-4752148.32549.77
448228-4822849.04450.49
548040-4804048.85350.29
647779-4777948.58850.01
90min149121-4912149.95250.420.9151.6552.130.87
250201-5020151.05152.76
349465-4946550.30252.01
449186-4918650.01851.74
549471-4947150.30852.01
650051-5005150.89852.59
120min150109-5010950.95750.461.5252.9352.441.46
248787-4878749.61351.61
349910-4991050.75552.74
450554-5055451.41053.41
548656-4865649.47951.46
649700-4970050.54152.51
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149951-4995150.79650.762.3353.0553.032.23
249469-4946950.30652.58
349648-4964850.48852.76
449304-4930450.13852.42
552185-5218553.06855.33
648953-4895349.78152.03
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)0
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%
111.159545895757956549583295864957130.18
211.119562095373954960.19
单位质量响应值RSD%判断
8584.138595.500.10数据可信
长期6月-供试品溶液-2025062821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%
5min131292-3129232.71133.962.1632.7133.962.16
233284-3328434.79334.79
332573-3257334.05034.05
433011-3301134.50834.51
532561-3256134.03734.04
632182-3218233.64133.64
10min138837-3883740.59840.111.1340.7840.301.12
238298-3829840.03540.23
338945-3894540.71140.90
437989-3798939.71239.90
537899-3789939.61739.81
638233-3823339.96740.15
15min140933-4093342.78943.101.5343.2043.511.52
242044-4204443.95044.37
340453-4045342.28742.70
441496-4149643.37843.79
541755-4175543.64844.06
640710-4071042.55642.96
20min142631-4263144.56444.261.0045.2144.910.99
241776-4177643.67044.33
342553-4255344.48245.13
442557-4255744.48745.14
542698-4269844.63445.29
641818-4181843.71444.36
30min144455-4445546.47146.561.2147.3647.461.19
244926-4492646.96347.87
344053-4405346.05146.95
445426-4542647.48648.39
544159-4415946.16147.06
644210-4421046.21547.10
45min145513-4551347.57747.881.1548.7349.041.12
245404-4540447.46348.63
346208-4620848.30349.46
446514-4651448.62349.79
545166-4516647.21448.37
646016-4601648.10349.25
60min146429-4642948.53448.760.9449.9550.180.93
247013-4701349.14550.57
345852-4585247.93149.35
446954-4695449.08350.52
546850-4685048.97450.39
646756-4675648.87650.29
90min148039-4803950.21749.553.5651.9051.243.45
246382-4638248.48550.19
348308-4830850.49852.19
448641-4864150.84752.55
548617-4861750.82152.51
644416-4441646.43048.11
120min148573-4857350.77550.621.8852.7452.581.81
249651-4965151.90253.87
347595-4759549.75351.72
448976-4897651.19753.19
547173-4717349.31251.28
648557-4855750.75952.70
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148095-4809550.27650.041.3052.5252.291.25
246894-4689449.02051.28
347979-4797950.15552.40
448755-4875550.96653.24
547545-4754549.70151.95
647943-4794350.11752.34
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