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%
111.159735397557977899729797278974550.23
211.119689796931969140.03
单位质量响应值RSD%判断
8740.368723.130.14数据可信
中间条件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%
5min129142-2914229.96830.983.2029.9730.983.20
229929-2992930.77830.78
331542-3154232.43632.44
430316-3031631.17631.18
530756-3075631.62831.63
629043-2904329.86629.87
10min134498-3449835.47635.952.0935.6436.122.10
234853-3485335.84136.01
335480-3548036.48636.67
434920-3492035.91036.08
536050-3605037.07237.25
633975-3397534.93835.10
15min137355-3735538.41438.471.7638.7838.841.77
237588-3758838.65439.02
338005-3800539.08339.47
437849-3784938.92239.29
537519-3751938.58338.96
636156-3615637.18137.54
20min139011-3901140.11740.061.1940.6940.641.20
238580-3858039.67440.26
339671-3967140.79641.40
438616-3861639.71140.30
539308-3930840.42241.02
638536-3853639.62940.20
30min140100-4010041.23741.680.9642.0442.490.97
240479-4047941.62742.43
340739-4073941.89442.72
440840-4084041.99842.81
540977-4097742.13942.96
640060-4006041.19641.98
45min141925-4192543.11442.881.0944.1443.921.09
241770-4177042.95443.99
342053-4205343.24544.30
441950-4195043.13944.18
541657-4165742.83843.89
640815-4081541.97242.99
60min141980-4198043.17043.391.0644.4444.671.06
242094-4209443.28744.56
342956-4295644.17445.47
441920-4192043.10944.39
542476-4247643.68044.97
641744-4174442.92844.18
90min142439-4243943.64244.031.2245.1545.551.22
242553-4255343.75945.28
343307-4330744.53546.08
443351-4335144.58046.10
543141-4314144.36445.90
642103-4210343.29744.78
120min142855-4285544.07044.411.0345.8246.181.04
243029-4302944.24946.01
343872-4387245.11646.91
443240-4324044.46646.24
543473-4347344.70646.49
642650-4265043.85945.59
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143342-4334244.57144.121.4646.5746.131.43
243346-4334644.57546.58
343117-4311744.33946.38
442870-4287044.08546.10
543057-4305744.27846.31
641683-4168342.86544.84
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%
111.159788098216980579824997701980210.24
211.119750097042972710.34
单位质量响应值RSD%判断
8791.128755.270.29数据可信
中间条件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%
5min129942-2994230.64631.071.5730.6531.071.56
230361-3036131.07431.07
329890-2989030.59230.59
431210-3121031.94331.94
530307-3030731.01931.02
630414-3041431.12931.13
10min135466-3546636.29935.711.2536.4735.891.25
234824-3482435.64235.81
334219-3421935.02335.19
435246-3524636.07436.25
534709-3470935.52535.70
634902-3490235.72235.90
15min137438-3743838.31837.811.9138.6938.181.91
236417-3641737.27337.64
335755-3575536.59536.96
437539-3753938.42138.80
537189-3718938.06338.43
637310-3731038.18738.56
20min138572-3857239.47839.001.9240.0639.581.90
237833-3783338.72239.30
337324-3732438.20138.77
439260-3926040.18240.77
537466-3746638.34638.93
638196-3819639.09339.68
30min139193-3919340.11440.550.7840.9241.350.77
239540-3954040.46941.26
339376-3937640.30141.08
439717-3971740.65041.46
539945-3994540.88441.68
639944-3994440.88341.68
45min140213-4021341.15841.290.6342.1842.320.62
240116-4011641.05942.08
340309-4030941.25642.26
440599-4059941.55342.59
540127-4012741.07042.09
640706-4070641.66242.69
60min140738-4073841.69540.834.3942.9542.084.28
236866-3686637.73238.98
338676-3867639.58540.82
441010-4101041.97443.24
540807-4080741.76643.02
641261-4126142.23143.49
90min142003-4200342.99042.611.8444.4844.091.79
242329-4232943.32444.78
340414-4041441.36442.82
441109-4110942.07543.58
541561-4156142.53844.02
642369-4236943.36544.86
120min143056-4305644.06842.941.8845.7944.651.84
241874-4187442.85844.55
340889-4088941.85043.53
442124-4212443.11444.85
541291-4129142.26143.98
642468-4246843.46645.20
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143030-4303044.04142.772.2046.0144.732.15
241353-4135342.32544.26
340312-4031241.25943.17
441724-4172442.70444.68
542109-4210943.09845.05
642218-4221843.21045.19
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%
111.159757796644968989702496712969710.39
211.119756196620970900.69
单位质量响应值RSD%判断
8696.958738.970.35数据可信
中间条件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%
5min130424-3042431.33630.311.9131.3430.311.92
229412-2941230.29430.29
329629-2962930.51730.52
429252-2925230.12930.13
528864-2886429.72929.73
628985-2898529.85429.85
10min135312-3531236.37135.511.2236.5435.681.21
234134-3413435.15735.33
334324-3432435.35335.52
434401-3440135.43235.60
534356-3435635.38635.55
634355-3435535.38535.55
15min137180-3718038.29537.691.4738.6738.051.46
236217-3621737.30337.67
337272-3727238.39038.76
436660-3666037.75938.12
536136-3613637.21937.58
636073-3607337.15537.52
20min138621-3862139.77939.321.1640.3739.891.15
237915-3791539.05239.62
337924-3792439.06139.64
438831-3883139.99540.57
537991-3799139.13039.70
637757-3775738.88939.46
30min139400-3940040.58140.441.2341.3941.241.21
239040-3904040.21141.00
340109-4010941.31242.11
438808-3880839.97240.77
539352-3935240.53241.32
638874-3887440.04040.82
45min141607-4160742.85441.831.9343.8942.851.90
239879-3987941.07542.09
341156-4115642.39043.42
440738-4073841.95942.98
540780-4078042.00343.01
639528-3952840.71341.72
60min141360-4136042.60042.451.4343.8743.701.42
240650-4065041.86943.11
341840-4184043.09444.36
441950-4195043.20844.46
540744-4074441.96643.21
640722-4072241.94343.18
90min141736-4173642.98742.621.7544.5044.111.72
241318-4131842.55744.03
342545-4254543.82145.32
441113-4111342.34643.84
541201-4120142.43643.91
640375-4037541.58643.05
120min142243-4224343.51043.120.5245.2644.840.51
241869-4186943.12444.83
341582-4158242.82944.57
441804-4180443.05744.78
541866-4186643.12144.83
641826-4182643.08044.78
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142595-4259543.87243.311.4345.8645.281.40
241851-4185143.10645.05
342125-4212543.38845.37
442750-4275044.03246.00
541078-4107842.31044.26
641916-4191643.17345.11
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