玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109对照品来源工作对照品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)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.959748497664975359753197472975370.08
211.009755397455975040.08
单位质量响应值RSD%判断
8907.498864.000.35数据可信
供试品溶液-2025051221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%
5min116243-1624316.41420.0425.0516.4120.0425.05
215562-1556215.72615.73
314873-1487315.03015.03
422383-2238322.61922.62
522888-2288823.12923.13
627029-2702927.31427.31
10min131264-3126431.59332.927.2531.7833.157.36
230471-3047130.79230.97
329696-2969630.00930.18
434601-3460134.96635.22
534472-3447234.83535.09
634968-3496835.33635.64
15min135983-3598336.36237.294.1636.9037.884.31
235839-3583936.21736.73
334848-3484835.21535.72
438026-3802638.42739.07
538163-3816338.56539.21
638546-3854638.95239.65
20min139203-3920339.61640.432.5440.5541.442.70
239938-3993840.35941.28
338545-3854538.95139.84
440316-4031640.74141.81
540760-4076041.18942.26
641304-4130441.73942.87
30min141978-4197842.42043.201.4543.8044.661.61
242056-4205642.49943.87
342678-4267843.12844.45
443158-4315843.61345.13
543380-4338043.83745.37
643264-4326443.72045.31
45min143588-4358844.04744.910.9745.9046.841.04
244607-4460745.07746.92
344681-4468145.15246.96
444426-4442644.89446.90
544631-4463145.10147.12
644716-4471645.18747.27
60min145045-4504545.52045.810.9747.8648.240.91
245650-4565046.13148.47
345303-4530345.78048.09
445767-4576746.24948.75
545617-4561746.09848.62
644621-4462145.09147.67
90min144575-4457545.04546.191.6647.8949.131.66
245297-4529745.77448.63
346465-4646546.95449.77
445359-4535945.83748.85
546108-4610846.59449.62
646451-4645146.94050.02
120min145512-4551245.99146.891.2049.3450.341.16
247222-4722247.71951.08
346487-4648746.97750.31
446197-4619746.68450.21
546408-4640846.89750.45
646576-4657647.06750.67
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146453-4645346.94246.500.9450.8050.480.82
245494-4549445.97349.87
346440-4644046.92950.79
445574-4557446.05450.10
546270-4627046.75750.83
645870-4587046.35350.48
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109对照品来源工作对照品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)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.959732197550975559758397476974970.11
211.009805798040980480.02
单位质量响应值RSD%判断
8903.848913.450.08数据可信
供试品溶液-2025051321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%
5min120683-2068320.84721.1014.0520.8521.1014.06
216035-1603516.16216.16
323461-2346123.64723.65
419510-1951019.66519.66
524093-2409324.28424.28
621807-2180721.98021.98
10min132536-3253632.79432.953.7233.0333.193.79
230912-3091231.15731.34
333846-3384634.11434.38
431727-3172731.97932.20
534013-3401334.28334.55
633122-3312233.38533.63
15min137058-3705837.35237.760.8437.9538.360.85
237783-3778338.08338.61
337579-3757937.87738.52
437113-3711337.40737.98
537756-3775638.05538.71
637497-3749737.79438.41
20min139628-3962839.94240.041.3540.9541.061.39
239222-3922239.53340.48
339977-3997740.29441.36
439110-3911039.42040.41
539883-3988340.19941.27
640556-4055640.87841.91
30min142767-4276743.10643.501.1344.5644.961.14
243222-4322243.56544.95
343053-4305343.39444.90
442868-4286843.20844.64
544092-4409244.44245.96
642923-4292343.26344.75
45min143730-4373044.07744.891.1146.0146.841.05
245190-4519045.54847.42
344338-4433844.69046.68
444456-4445644.80946.72
544691-4469145.04547.06
644806-4480645.16147.13
60min145412-4541245.77246.181.0248.2048.621.03
245929-4592946.29348.67
346577-4657746.94649.44
445247-4524745.60648.01
545811-4581146.17448.69
645905-4590546.26948.74
90min144979-4497945.33646.261.3448.2749.221.24
246405-4640546.77349.67
345252-4525245.61148.62
446242-4624246.60949.52
546183-4618346.54949.58
646285-4628546.65249.64
120min146778-4677847.14947.331.6850.5850.801.55
248399-4839948.78352.20
346875-4687547.24750.76
445982-4598246.34749.78
546946-4694647.31850.86
646769-4676947.14050.64
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145482-4548245.84346.811.4749.8050.811.37
247492-4749247.86951.82
346288-4628846.65550.70
446076-4607646.44150.39
546493-4649346.86250.93
646822-4682247.19351.22
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109对照品来源工作对照品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)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.959827298509983989826398396983680.11
211.009797098181980760.16
单位质量响应值RSD%判断
8983.388916.000.54数据可信
供试品溶液-2025051421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%
5min117982-1798218.04217.9916.5218.0417.9916.52
214842-1484214.89114.89
314992-1499215.04215.04
417132-1713217.18917.19
520337-2033720.40520.40
622318-2231822.39222.39
10min132047-3204732.15331.075.8632.3531.275.92
229197-2919729.29429.46
328468-2846828.56328.73
431283-3128331.38731.58
531512-3151231.61731.84
633317-3331733.42833.68
15min135961-3596136.08036.032.4936.6436.572.59
235026-3502635.14235.63
334681-3468134.79635.28
436231-3623136.35136.89
536594-3659436.71637.29
636971-3697137.09437.71
20min139039-3903939.16939.102.3640.1340.052.44
237770-3777037.89638.78
338422-3842238.55039.42
439037-3903739.16740.11
539038-3903839.16840.15
640533-4053340.66841.70
30min141257-4125741.39442.071.4442.7943.461.52
241425-4142541.56342.87
341593-4159341.73143.03
442436-4243642.57743.96
542136-4213642.27643.70
642764-4276442.90644.39
45min143765-4376543.91044.590.8845.7646.440.92
244540-4454044.68846.45
344223-4422344.37046.13
444684-4468444.83246.68
544632-4463244.78046.67
644819-4481944.96846.93
60min142722-4272242.86444.722.4045.2147.072.25
245462-4546245.61347.87
344541-4454144.68946.95
445759-4575945.91148.26
544639-4463944.78747.18
644320-4432044.46746.93
90min145535-4553545.68645.641.0948.5048.480.96
245854-4585446.00648.77
345990-4599046.14348.90
445287-4528745.43748.30
544618-4461844.76647.65
645658-4565845.81048.76
120min146284-4628446.43846.880.8449.7650.230.84
246595-4659546.75050.03
346771-4677146.92650.19
447325-4732547.48250.85
546393-4639346.54749.93
646988-4698847.14450.61
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145462-4546245.61346.731.6649.4550.601.57
247582-4758247.74051.54
346552-4655246.70750.49
446200-4620046.35450.25
546360-4636046.51450.41
647316-4731647.47351.46
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