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%
111.159742597391973179778797460974760.19
211.119783897754977960.07
单位质量响应值RSD%判断
8742.248802.520.49数据可信
加速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%
5min127117-2711727.75730.053.9327.7630.063.92
229370-2937030.06330.06
329535-2953530.23230.23
430269-3026930.98330.98
530125-3012530.83630.84
629755-2975530.45730.46
10min135730-3573036.57336.530.9636.7336.700.96
235519-3551936.35736.52
335318-3531836.15136.32
436248-3624837.10337.28
535874-3587436.72136.89
635433-3543336.26936.44
15min138628-3862839.54039.531.9839.9039.901.97
237359-3735938.24138.61
339078-3907840.00040.37
439439-3943940.37040.75
539062-3906239.98440.36
638137-3813739.03739.41
20min140166-4016641.11441.401.3541.6941.991.35
240071-4007141.01741.60
340657-4065741.61642.21
440444-4044441.39842.00
541426-4142642.40443.00
639934-3993440.87641.46
30min142328-4232843.32743.371.2744.1344.191.27
241867-4186742.85543.66
342461-4246143.46344.29
443081-4308144.09844.93
542805-4280543.81544.65
641679-4167942.66343.48
45min143067-4306744.08345.121.9845.1346.191.95
243961-4396144.99846.05
344137-4413745.17946.24
445656-4565646.73347.81
543571-4357144.59945.68
644113-4411345.15446.21
60min144034-4403445.07345.730.9546.3647.040.95
244846-4484645.90447.20
344436-4443645.48546.80
445130-4513046.19547.53
544504-4450445.55446.88
645079-4507946.14347.45
90min145745-4574546.82546.681.6448.3748.251.60
245244-4524446.31247.86
344982-4498246.04447.61
445684-4568446.76248.36
546977-4697748.08649.66
645007-4500746.06947.63
120min146209-4620947.30047.180.7749.1049.000.75
246092-4609247.18048.99
345962-4596247.04748.87
446685-4668547.78749.64
545607-4560746.68348.53
645999-4599947.08548.90
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146104-4610447.19247.110.2749.2649.190.26
245967-4596747.05249.12
345934-4593447.01849.10
446085-4608547.17349.29
545855-4585546.93749.04
646187-4618747.27749.35
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%
111.159772397445976059767397592976080.11
211.119751097493975020.02
单位质量响应值RSD%判断
8754.088776.060.18数据可信
加速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%
5min129598-2959830.32131.392.6030.3231.392.60
230023-3002330.75730.76
330336-3033631.07831.08
431314-3131432.07932.08
530852-3085231.60631.61
631695-3169532.47032.47
10min135718-3571836.59137.352.2236.7637.522.21
236162-3616237.04637.22
335877-3587736.75436.93
436059-3605936.94037.12
537243-3724338.15338.33
637683-3768338.60438.78
15min138164-3816439.09739.993.9439.4740.373.92
238349-3834939.28639.66
337314-3731438.22638.60
438855-3885539.80540.19
539902-3990240.87741.26
641643-4164342.66143.06
20min139154-3915440.11141.522.6540.7042.122.66
240359-4035941.34541.94
339793-3979340.76641.35
440322-4032241.30841.91
541442-4144242.45543.07
642087-4208743.11643.75
30min141092-4109242.09643.342.4942.9144.182.49
242176-4217643.20744.03
341738-4173842.75843.57
441729-4172942.74943.58
543228-4322844.28545.14
643900-4390044.97345.84
45min142075-4207543.10344.783.0244.1545.853.01
243968-4396845.04346.11
342792-4279243.83844.89
443127-4312744.18145.25
544566-4456645.65546.75
645722-4572246.84047.96
60min144196-4419645.27646.121.7346.5647.441.74
244320-4432045.40346.72
344574-4457445.66446.96
445802-4580246.92248.24
545160-4516046.26447.61
646036-4603647.16148.54
90min143679-4367944.74746.662.5546.2848.242.54
245773-4577346.89248.46
345293-4529346.40047.95
445142-4514246.24547.82
546286-4628647.41749.02
647095-4709548.24649.89
120min144955-4495546.05446.911.9447.8448.751.95
245671-4567146.78748.61
345649-4564946.76548.57
444934-4493446.03247.87
546260-4626047.39149.26
647289-4728948.44550.36
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145455-4545546.56646.811.4048.6148.911.42
245188-4518846.29348.38
345204-4520446.30948.38
445755-4575546.87348.96
545671-4567146.78748.92
646907-4690748.05450.23
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%
111.159724697215970299738197281972300.14
211.119770097737977180.03
单位质量响应值RSD%判断
8720.188795.500.61数据可信
加速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%
5min129527-2952730.27430.612.7630.2730.612.76
230943-3094331.72631.73
330798-3079831.57731.58
429355-2935530.09830.10
529569-2956930.31730.32
628924-2892429.65629.66
10min135958-3595836.86836.312.4937.0436.482.49
236098-3609837.01137.19
336493-3649337.41637.59
434347-3434735.21635.38
534989-3498935.87436.04
634620-3462035.49635.66
15min137772-3777238.72839.521.8639.1039.891.85
239098-3909840.08740.47
339193-3919340.18540.57
438535-3853539.51039.87
537578-3757838.52938.90
639089-3908940.07840.44
20min139263-3926340.25740.871.5340.8441.461.53
240902-4090241.93742.54
339830-3983040.83841.44
440025-4002541.03841.62
539897-3989740.90741.49
639240-3924040.23340.82
30min142200-4220043.26843.220.8044.0844.030.79
241837-4183742.89643.73
342638-4263843.71744.55
442284-4228443.35444.16
541708-4170842.76343.57
642229-4222943.29844.11
45min143137-4313744.22944.540.9045.2845.600.88
243456-4345644.55645.63
343522-4352244.62345.70
443871-4387144.98146.03
542865-4286543.95045.00
643821-4382144.93045.98
60min143340-4334044.43745.020.8345.7346.320.83
244223-4422345.34246.67
344100-4410045.21646.54
444283-4428345.40446.70
543769-4376944.87746.17
643708-4370844.81446.11
90min142685-4268543.76545.062.3145.3146.622.24
243039-4303944.12845.70
344796-4479645.93047.51
445329-4532946.47648.03
544109-4410945.22546.77
643734-4373444.84146.39
120min145479-4547946.63045.981.1248.4247.791.07
244842-4484245.97747.80
344570-4457045.69847.53
445089-4508946.23048.04
545058-4505846.19847.99
644034-4403445.14846.94
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143346-4334644.44345.931.9246.4947.991.85
244617-4461745.74647.82
345362-4536246.51048.59
445738-4573846.89548.96
544461-4446145.58647.63
645272-4527246.41848.46
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