玛巴洛沙韦混悬剂项目信息
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%
111.159578396505962599631596171962070.28
211.119637596302963380.06
单位质量响应值RSD%判断
8628.438671.290.36数据可信
长期6月-供试品溶液-2025062621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%
5min130794-3079431.96732.873.6231.9732.873.62
230527-3052731.69031.69
333200-3320034.46534.46
432950-3295034.20534.21
531545-3154532.74732.75
630970-3097032.15032.15
10min135641-3564136.99938.182.1637.1838.362.15
237255-3725538.67438.85
337370-3737038.79438.98
437639-3763939.07339.26
536057-3605737.43137.61
636732-3673238.13138.31
15min138126-3812639.57840.711.4339.9641.101.43
239479-3947940.98341.37
339709-3970941.22241.63
439384-3938440.88441.29
539216-3921640.71041.10
639375-3937540.87541.27
20min140290-4029041.82542.122.0642.4342.742.05
240216-4021641.74842.37
340649-4064942.19742.83
442215-4221543.82344.46
539981-3998141.50442.12
640107-4010741.63542.25
30min141904-4190443.50043.851.7444.3444.711.73
242035-4203543.63644.49
343202-4320244.84845.72
443074-4307444.71545.59
541856-4185643.45044.30
641371-4137142.94743.80
45min143606-4360645.26745.040.9846.3446.140.99
243221-4322144.86745.96
343650-4365045.31346.43
443981-4398145.65646.78
543031-4303144.67045.76
642858-4285844.49145.58
60min143436-4343645.09145.161.5446.4246.511.50
242593-4259344.21545.56
343802-4380245.47146.84
443675-4367545.33946.72
544515-4451546.21147.55
643007-4300744.64545.98
90min143554-4355445.21348.042.9746.7949.642.89
246913-4691348.70050.29
346707-4670748.48650.11
446335-4633548.10049.73
547340-4734049.14350.74
646798-4679848.58150.16
120min142855-4285544.48745.782.1946.3247.652.16
244129-4412945.81047.67
344918-4491846.62948.52
445398-4539847.12749.03
544059-4405945.73747.60
643237-4323744.88446.74
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143492-4349245.14945.821.3447.2347.951.34
243865-4386545.53647.65
344750-4475046.45548.61
444924-4492446.63548.80
544176-4417645.85947.98
643649-4364945.31247.41
玛巴洛沙韦混悬剂项目信息
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%
111.159607496422957949607395557959840.35
211.119667997034968560.26
单位质量响应值RSD%判断
8608.438717.910.90数据可信
长期6月-供试品溶液-2025062721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%
5min130128-3012831.22931.961.3631.2331.961.36
231160-3116032.29832.30
330905-3090532.03432.03
430815-3081531.94131.94
531322-3132232.46632.47
630667-3066731.78731.79
10min136039-3603937.35637.061.0437.5337.241.03
236036-3603637.35237.53
335789-3578937.09637.27
435600-3560036.90137.08
535970-3597037.28437.46
635084-3508436.36636.54
15min137506-3750638.87639.020.9639.2639.400.95
237798-3779839.17939.57
337032-3703238.38538.77
438067-3806739.45839.84
537860-3786039.24339.63
637586-3758638.95939.34
20min139287-3928740.72240.321.3441.3240.921.33
239471-3947140.91341.52
339181-3918140.61241.21
438340-3834039.74140.34
538929-3892940.35140.96
638210-3821039.60640.20
30min140700-4070042.18741.740.8243.0142.560.79
239935-3993541.39442.23
339839-3983941.29442.12
440383-4038341.85842.68
540462-4046241.94042.77
640284-4028441.75642.57
45min141658-4165843.18042.762.1844.2443.822.14
242284-4228443.82944.89
341604-4160443.12444.18
441125-4112542.62743.68
541222-4122242.72843.79
639620-3962041.06742.11
60min141997-4199743.53143.731.0744.8345.031.05
242124-4212443.66344.97
342212-4221243.75445.05
442391-4239143.94045.23
542892-4289244.45945.76
641538-4153843.05544.33
90min143070-4307044.64343.811.3546.1845.351.31
242554-4255444.10945.66
342591-4259144.14745.68
442045-4204543.58145.12
541767-4176743.29344.84
641577-4157743.09644.61
120min143646-4364645.24044.241.5447.0346.021.50
242631-4263144.18845.98
342081-4208143.61845.40
442862-4286244.42846.21
543018-4301844.59046.38
641848-4184843.37745.13
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142327-4232743.87344.021.2545.9146.051.20
242507-4250744.06046.10
342269-4226943.81345.84
441703-4170343.22745.25
543290-4329044.87146.91
642733-4273344.29446.29
玛巴洛沙韦混悬剂项目信息
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%
111.159608095768960379654795540959940.40
211.119594495474957090.35
单位质量响应值RSD%判断
8609.338614.670.05数据可信
长期6月-供试品溶液-2025062821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%
5min129381-2938130.63431.751.8230.6331.751.82
230515-3051531.81631.82
330971-3097132.29232.29
430603-3060331.90831.91
530530-3053031.83231.83
630727-3072732.03832.04
10min136170-3617037.71337.101.8437.8837.281.83
235043-3504336.53836.71
336413-3641337.96638.15
435797-3579737.32437.50
534748-3474836.23036.41
635339-3533936.84637.02
15min137244-3724438.83238.940.7439.2139.320.74
237035-3703538.61538.99
337339-3733938.93239.32
437844-3784439.45839.84
537428-3742839.02439.40
637210-3721038.79739.18
20min139225-3922540.89840.560.8741.4941.160.86
238501-3850140.14340.74
339175-3917540.84641.45
439048-3904840.71341.32
538987-3898740.65041.24
638461-3846140.10140.70
30min140003-4000341.70941.901.2042.5342.721.18
240729-4072942.46643.28
340367-4036742.08942.92
440622-4062242.35543.18
539440-3944041.12241.94
639978-3997841.68342.50
45min141498-4149843.26843.390.8444.3244.440.83
241872-4187243.65844.71
342141-4214143.93845.01
441561-4156143.33444.40
541154-4115442.90943.96
641441-4144143.20844.26
60min141632-4163243.40843.641.1144.7044.941.09
241377-4137743.14244.44
342161-4216143.95945.27
442479-4247944.29145.60
542112-4211243.90845.20
641369-4136943.13344.43
90min142816-4281644.64244.281.4246.1845.821.37
242357-4235744.16445.70
341673-4167343.45045.01
443270-4327045.11546.67
541911-4191143.69945.23
642768-4276844.59246.12
120min143444-4344445.29744.532.1647.0846.322.09
243866-4386645.73747.52
342195-4219543.99545.79
443025-4302544.86046.66
541327-4132743.09044.86
642399-4239944.20745.99
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142522-4252244.33644.591.3946.3746.621.35
243489-4348945.34447.38
343189-4318945.03147.07
442858-4285844.68646.74
541773-4177343.55545.57
642775-4277544.59946.62
玛巴洛沙韦混悬剂项目信息
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%
111.159629096627951279529695537957750.69
211.119555295977957640.32
单位质量响应值RSD%判断
8589.698619.620.25数据可信
中间条件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%
5min131189-3118932.54733.201.2332.5533.201.23
231817-3181733.20233.20
332399-3239933.81033.81
431960-3196033.35233.35
531770-3177033.15333.15
631765-3176533.14833.15
10min137960-3796039.61339.161.4639.7939.341.46
237315-3731538.94039.12
338168-3816839.83040.02
436882-3688238.48838.67
537873-3787339.52239.71
636968-3696838.57838.76
15min140154-4015441.90242.051.3542.3042.451.34
239338-3933841.05141.45
340296-4029642.05142.46
440393-4039342.15242.55
540877-4087742.65743.06
640724-4072442.49742.90
20min141497-4149743.30443.601.3443.9444.241.32
241472-4147243.27843.91
341319-4131943.11843.76
441689-4168943.50444.14
542858-4285844.72445.36
641862-4186243.68544.32
30min142742-4274244.60345.341.2845.4846.221.25
243169-4316945.04945.92
343523-4352345.41846.30
443998-4399845.91446.79
543102-4310244.97945.87
644180-4418046.10446.98
45min145631-4563147.61847.181.5048.7448.311.47
243954-4395445.86846.99
345300-4530047.27348.41
445652-4565247.64048.77
545731-4573147.72248.86
644981-4498146.94048.07
60min145156-4515647.12247.321.1048.5148.711.09
244702-4470246.64848.02
346164-4616448.17449.57
445144-4514447.11048.50
545628-4562847.61549.02
645295-4529547.26748.66
90min147541-4754149.61149.030.9951.2650.680.96
246877-4687748.91850.55
346521-4652148.54750.21
446385-4638548.40550.06
547330-4733049.39151.06
647229-4722949.28550.94
120min146192-4619248.20348.562.0950.1350.492.02
245155-4515547.12149.03
346210-4621048.22250.16
448084-4808450.17852.10
546941-4694148.98550.93
646628-4662848.65850.59
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147274-4727449.33248.741.5451.5250.941.48
246307-4630748.32350.49
347310-4731049.37051.57
446558-4655848.58550.79
547266-4726649.32451.54
645527-4552747.50949.71
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