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)5
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%
111.209880699038993429894398388989030.36
211.169962199881997510.19
单位质量响应值RSD%判断
8830.628938.260.86数据可信
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%
5min132100-3210032.44433.932.8332.4433.932.84
233518-3351833.87733.88
333123-3312333.47833.48
433477-3347733.83633.84
534557-3455734.92734.93
634646-3464635.01735.02
10min137798-3779838.20339.041.6238.3839.231.62
238231-3823138.64138.83
338378-3837838.78938.98
438713-3871339.12839.32
539524-3952439.94740.14
639095-3909539.51439.71
15min141092-4109241.53241.371.2541.9241.771.25
240974-4097441.41341.82
340024-4002440.45340.85
440862-4086241.30041.71
541018-4101841.45741.87
641590-4159042.03642.45
20min140247-4024740.67841.992.0141.3042.622.00
241829-4182942.27742.91
341370-4137041.81342.44
441055-4105541.49542.13
542204-4220442.65643.30
642551-4255143.00743.65
30min141215-4121541.65742.661.6742.5143.531.66
242370-4237042.82443.69
341514-4151441.95942.82
443014-4301443.47544.34
542410-4241042.86443.75
642750-4275043.20844.09
45min143663-4366344.13143.771.3245.2144.871.26
243723-4372344.19145.30
343196-4319643.65944.75
443951-4395144.42245.53
542583-4258343.03944.16
642702-4270243.16044.29
60min143894-4389444.36444.460.7345.6945.810.72
243880-4388044.35045.70
343964-4396444.43545.77
443676-4367644.14445.50
544609-4460945.08746.45
643920-4392044.39145.76
90min143442-4344243.90745.512.2445.4847.102.18
244625-4462545.10346.70
346227-4622746.72248.30
445790-4579046.28147.88
544604-4460445.08246.69
645478-4547845.96547.58
120min144730-4473045.20945.661.3447.0347.511.31
244796-4479645.27647.12
344697-4469745.17647.02
445397-4539745.88347.74
546275-4627546.77148.63
645164-4516445.64847.52
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145889-4588946.38146.060.6148.4548.160.58
245266-4526645.75147.85
345310-4531045.79547.89
445634-4563446.12348.23
545440-4544045.92748.05
645875-4587546.36648.49
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)5
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%
111.209891699515990009898099086990990.25
211.169905899459992580.29
单位质量响应值RSD%判断
8848.128894.090.37数据可信
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%
5min132924-3292433.32634.262.2733.3334.262.26
233403-3340333.81133.81
334481-3448134.90234.90
434995-3499535.42235.42
533440-3344033.84833.85
633867-3386734.28034.28
10min137971-3797138.43438.801.1438.6239.001.15
237917-3791738.38038.57
338705-3870539.17739.37
438956-3895639.43139.63
538010-3801038.47438.66
638462-3846238.93139.12
15min140126-4012640.61640.880.9141.0141.280.90
241021-4102141.52241.92
339993-3999340.48140.89
440209-4020940.70041.12
540462-4046240.95641.36
640487-4048740.98141.39
20min141391-4139141.89642.021.5342.5242.661.51
241376-4137641.88142.51
340481-4048140.97541.61
442410-4241042.92843.57
541753-4175342.26342.89
641693-4169342.20242.84
30min141242-4124241.74542.761.3842.6043.621.36
241900-4190042.41143.28
342828-4282843.35144.21
442535-4253543.05443.93
542350-4235042.86743.73
642601-4260143.12143.99
45min143287-4328743.81543.680.2844.9044.780.25
243285-4328543.81344.91
343088-4308843.61444.72
443006-4300643.53144.65
543062-4306243.58744.69
643192-4319243.71944.83
60min143432-4343243.96244.503.2345.2945.843.15
243530-4353044.06145.40
346758-4675847.32948.68
443867-4386744.40245.76
542727-4272743.24844.59
643472-4347244.00245.35
90min143679-4367944.21245.381.5045.7946.981.48
244573-4457345.11746.71
345367-4536745.92147.53
445255-4525545.80747.42
544679-4467945.22446.81
645438-4543845.99247.59
120min145247-4524745.79946.251.4347.6248.091.40
245223-4522345.77547.61
345907-4590746.46748.33
445906-4590646.46648.33
545063-4506345.61347.45
646795-4679547.36649.22
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145166-4516645.71745.811.1847.7947.911.13
244875-4487545.42347.52
344472-4447245.01547.14
445619-4561946.17648.30
545448-4544846.00348.09
645943-4594346.50448.62
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)5
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%
111.2010001699642996999962199593997140.18
211.161008221003201005710.36
单位质量响应值RSD%判断
8903.049011.740.86数据可信
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%
5min133414-3341433.49734.612.7433.5034.612.74
233348-3334833.43133.43
335222-3522235.30935.31
435372-3537235.46035.46
534472-3447234.55834.56
635319-3531935.40735.41
10min138840-3884038.93638.741.2539.1238.941.25
238429-3842938.52438.71
337820-3782037.91438.11
439201-3920139.29839.50
538939-3893939.03639.23
638654-3865438.75038.95
15min140082-4008240.18240.540.9840.5840.950.99
239853-3985339.95240.35
340485-4048540.58640.99
440699-4069940.80041.22
540887-4088740.98941.40
640642-4064240.74341.15
20min141154-4115441.25641.981.6741.8842.611.63
242747-4274742.85343.47
342735-4273542.84143.47
441379-4137941.48242.12
541704-4170441.80842.44
641518-4151841.62142.26
30min141837-4183741.94142.961.4242.8043.831.39
243400-4340043.50844.37
342887-4288742.99343.86
443305-4330543.41344.28
542474-4247442.57943.45
643245-4324543.35244.22
45min143155-4315543.26243.641.4044.3544.741.37
244344-4434444.45445.56
342714-4271442.82043.93
443609-4360943.71744.83
544081-4408144.19045.30
643274-4327443.38144.49
60min143361-4336143.46943.791.2144.8045.141.18
244104-4410444.21445.56
342953-4295343.06044.41
444184-4418444.29445.65
544149-4414944.25945.61
643351-4335143.45944.81
90min145141-4514145.25344.950.8246.8246.540.78
244451-4445144.56146.16
344369-4436944.47946.07
444831-4483144.94246.54
545284-4528445.39646.99
644946-4494645.05846.65
120min143380-4338043.48844.713.2645.3146.553.14
242530-4253042.63644.48
346511-4651146.62648.46
445181-4518145.29347.15
545490-4549045.60347.45
644483-4448344.59346.44
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144581-4458144.69244.990.6246.7547.080.61
244959-4495945.07147.15
344946-4494645.05847.15
445344-4534445.45747.56
544651-4465144.76246.86
644791-4479144.90246.99
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