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%
111.15957839631596171960900.29
211.119637596302963380.06
单位质量响应值RSD%判断
8617.948671.290.44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%
5min130794-3079431.98732.893.6231.9932.893.63
230527-3052731.70931.71
333200-3320034.48634.49
432950-3295034.22634.23
531545-3154532.76732.77
630970-3097032.16932.17
10min135641-3564137.02138.212.1637.2038.392.16
237255-3725538.69838.87
337370-3737038.81739.01
437639-3763939.09739.29
536057-3605737.45337.64
636732-3673238.15438.33
15min138126-3812639.60240.731.4339.9941.131.42
239479-3947941.00841.40
339709-3970941.24741.65
439384-3938440.90941.32
539216-3921640.73541.12
639375-3937540.90041.29
20min140290-4029041.85042.152.0642.4542.772.04
240216-4021641.77342.39
340649-4064942.22342.86
442215-4221543.85044.48
539981-3998141.52942.15
640107-4010741.66042.28
30min141904-4190443.52743.881.7444.3644.731.74
242035-4203543.66344.51
343202-4320244.87545.75
443074-4307444.74245.62
541856-4185643.47744.32
641371-4137142.97343.82
45min143606-4360645.29545.070.9846.3746.170.99
243221-4322144.89545.99
343650-4365045.34046.46
443981-4398145.68446.81
543031-4303144.69745.79
642858-4285844.51845.61
60min143436-4343645.11845.191.5446.4546.541.50
242593-4259344.24245.59
343802-4380245.49846.87
443675-4367545.36646.75
544515-4451546.23947.58
643007-4300744.67246.01
90min143554-4355445.24148.072.9746.8249.672.89
246913-4691348.73050.32
346707-4670748.51650.14
446335-4633548.12949.76
547340-4734049.17350.77
646798-4679848.61050.19
120min142855-4285544.51545.812.1946.3547.682.16
244129-4412945.83847.70
344918-4491846.65848.55
445398-4539847.15649.06
544059-4405945.76547.63
643237-4323744.91146.77
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143492-4349245.17645.851.3447.2547.981.35
243865-4386545.56447.68
344750-4475046.48348.64
444924-4492446.66448.83
544176-4417645.88748.01
643649-4364945.33947.44
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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