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%
1 11.139954899554994309951299599995290.07
2 11.179951299756996340.18
单位质量响应值RSD%判断
8942.418919.790.18数据可信
供试品溶液-2025051721批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135925-3592536.11936.721.3836.1236.721.38
236186-3618636.38136.38
336504-3650436.70136.70
436544-3654436.74136.74
537410-3741037.61237.61
636565-3656536.76236.76
10min142274-4227442.50242.862.2042.7043.062.19
242277-4227742.50542.71
341126-4112641.34841.55
442982-4298243.21443.42
543510-4351043.74543.95
643605-4360543.84044.04
15min145095-4509545.33845.451.0145.7845.901.00
244699-4469944.94045.38
345492-4549245.73846.17
445272-4527245.51645.96
544779-4477945.02145.47
645913-4591346.16146.61
20min146897-4689747.15047.030.6147.8447.720.61
246650-4665046.90247.59
346527-4652746.77847.47
446507-4650746.75847.46
547264-4726447.51948.22
646801-4680147.05447.76
30min147632-4763247.88948.420.8948.8449.370.89
248316-4831648.57749.53
347726-4772647.98448.93
448050-4805048.30949.27
548528-4852848.79049.76
648685-4868548.94849.91
45min149427-4942749.69449.860.9950.9151.080.98
249048-4904849.31350.53
349600-4960049.86851.08
449176-4917649.44150.67
549965-4996550.23551.47
650331-5033150.60351.84
60min149050-4905049.31549.781.3850.8151.281.33
249479-4947949.74651.24
350740-5074051.01452.51
449123-4912349.38850.89
549770-4977050.03951.55
648897-4889749.16150.68
90min149505-4950549.77250.470.7851.5452.250.76
250588-5058850.86152.63
350328-5032850.60052.37
450252-5025250.52352.30
550041-5004150.31152.11
650493-5049350.76652.56
120min149160-4916049.42550.161.0451.4752.221.01
249823-4982350.09252.14
350311-5031150.58352.64
450236-5023650.50752.56
550418-5041850.69052.76
649409-4940949.67651.75
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151363-5136351.64050.621.2353.9652.961.16
250360-5036050.63252.96
350553-5055350.82653.16
449488-4948849.75552.09
550067-5006750.33752.69
650270-5027050.54152.89
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%
1 11.139933199456999529949799607995690.24
2 11.1710006499912999880.11
单位质量响应值RSD%判断
8946.008951.480.05数据可信
供试品溶液-2025051721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%
5min135387-3538735.50837.132.6635.5137.132.65
236861-3686136.98736.99
337993-3799338.12338.12
437353-3735337.48137.48
537921-3792138.05138.05
636513-3651336.63836.64
10min141674-4167441.81642.531.0842.0142.741.09
242264-4226442.40842.61
342367-4236742.51242.72
442259-4225942.40342.61
542891-4289143.03743.25
642880-4288043.02643.23
15min144056-4405644.20645.021.3044.6445.471.29
245476-4547645.63146.07
344575-4457544.72745.18
444494-4449444.64645.09
545173-4517345.32745.78
645454-4545445.60946.05
20min146460-4646046.61946.681.4147.2947.371.39
245400-4540045.55546.25
346679-4667946.83847.53
446946-4694647.10647.80
547321-4732147.48348.18
646318-4631846.47647.17
30min147951-4795148.11547.920.7249.0548.880.71
247245-4724547.40648.35
348068-4806848.23249.19
447451-4745147.61348.57
548059-4805948.22349.19
647797-4779747.96048.91
45min148600-4860048.76649.130.6749.9750.350.66
248661-4866148.82750.04
349321-4932149.48950.71
449325-4932549.49350.71
549072-4907249.24050.47
648793-4879348.96050.18
60min148290-4829048.45549.341.0349.9350.831.01
249433-4943349.60251.08
349415-4941549.58451.08
449262-4926249.43050.92
548920-4892049.08750.59
649722-4972249.89251.38
90min149609-4960949.77849.880.7951.5251.650.76
249290-4929049.45851.22
349283-4928349.45151.23
449948-4994850.11951.89
549903-4990350.07351.85
650251-5025150.42352.19
120min149884-4988450.05449.980.7652.0752.020.74
249397-4939749.56651.60
349902-4990250.07252.12
450075-5007550.24652.29
550269-5026950.44152.50
649319-4931949.48751.54
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149122-4912249.29049.980.7751.5952.300.75
249948-4994850.11952.43
349757-4975749.92752.25
450231-5023150.40352.73
549752-4975249.92252.26
650049-5004950.22052.54
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%
1 11.139953899469996049949899788995790.13
2 11.179933799780995580.32
单位质量响应值RSD%判断
8946.908912.980.27数据可信
供试品溶液-2025051721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%
5min133300-3330033.48434.952.5633.4834.952.57
234420-3442034.61034.61
335382-3538235.57835.58
435579-3557935.77635.78
535473-3547335.66935.67
634392-3439234.58234.58
10min138526-3852638.73939.411.2038.9339.601.19
239711-3971139.93140.12
339122-3912239.33839.54
438910-3891039.12539.32
539733-3973339.95340.15
639161-3916139.37839.57
15min140688-4068840.91341.301.0141.3141.711.01
241080-4108041.30741.72
341126-4112641.35341.77
441843-4184342.07442.49
540851-4085141.07741.50
640834-4083441.06041.47
20min142108-4210842.34143.061.1742.9743.701.16
243603-4360343.84444.49
342945-4294543.18343.83
442683-4268342.91943.57
542601-4260142.83743.48
643011-4301143.24943.89
30min143648-4364843.88943.760.8544.7544.640.83
243293-4329343.53244.42
342994-4299443.23244.12
443432-4343243.67244.56
544068-4406844.31245.20
643693-4369343.93544.81
45min144814-4481445.06244.820.8746.1745.940.85
245013-4501345.26246.39
344402-4440244.64845.77
444893-4489345.14146.27
544117-4411744.36145.49
644181-4418144.42545.55
60min143930-4393044.17344.961.1145.5346.331.09
245369-4536945.62047.00
344403-4440344.64946.02
444739-4473944.98646.37
544929-4492945.17846.56
644883-4488345.13146.50
90min145158-4515845.40845.410.4447.0147.030.44
245543-4554345.79547.43
345045-4504545.29446.92
445113-4511345.36346.99
545073-4507345.32246.95
645003-4500345.25246.87
120min144862-4486245.11045.370.5846.9747.250.56
245232-4523245.48247.37
345226-4522645.47647.35
445042-4504245.29147.17
544842-4484245.09046.97
645526-4552645.77847.65
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145633-4563345.88545.490.7447.9947.610.70
245097-4509745.34647.49
345520-4552045.77247.90
445336-4533645.58747.72
545113-4511345.36347.49
644713-4471344.96047.09
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