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)0
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%
111.079831998374980109783597919980910.25
211.069881898765987920.04
单位质量响应值RSD%判断
8860.988932.370.57数据可信
影响因素30天-供试品溶液-2025051221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%
5min124903-2490325.13520.5715.3025.1320.5715.29
218817-1881718.99218.99
319929-1992920.11420.11
422045-2204522.25022.25
520950-2095021.14521.14
615651-1565115.79715.80
10min134777-3477735.10133.137.5435.3833.367.59
232731-3273133.03633.25
332642-3264232.94633.17
434915-3491535.24035.49
533687-3368734.00034.24
628173-2817328.43528.61
15min140639-4063941.01738.665.1841.6939.265.26
237667-3766738.01738.60
337997-3799738.35138.94
439535-3953539.90340.54
539085-3908539.44940.06
634903-3490335.22835.72
20min142721-4272143.11841.992.6944.2443.012.81
241099-4109941.48142.48
342166-4216642.55843.57
442101-4210142.49343.57
541924-4192442.31443.37
639588-3958839.95640.84
30min146144-4614446.57345.652.1848.1847.142.28
245069-4506945.48846.95
345069-4506945.48846.98
446547-4654746.98048.53
544666-4466645.08246.60
643854-4385444.26245.59
45min147368-4736847.80947.551.5149.9349.551.55
246191-4619146.62148.59
347890-4789048.33650.33
446770-4677047.20549.28
547886-4788648.33250.35
646571-4657147.00448.82
60min149471-4947149.93149.330.7152.5851.860.80
248791-4879149.24551.73
349077-4907749.53452.06
448539-4853948.99151.59
548735-4873549.18851.75
648633-4863349.08551.43
90min149028-4902849.48450.801.6652.6953.881.41
251157-5115751.63354.66
350891-5089151.36454.45
449674-4967450.13653.28
550322-5032250.79053.90
650918-5091851.39254.28
120min150069-5006950.53550.861.0754.2954.500.86
250991-5099151.46555.07
350002-5000250.46754.12
450367-5036750.83654.54
549833-4983350.29753.97
651101-5110151.57655.03
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151306-5130651.78351.311.2556.1055.511.30
250481-5048150.95155.13
351702-5170252.18356.40
450730-5073051.20255.47
550893-5089351.36655.60
649886-4988650.35054.38
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)0
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%
111.079870899163989809908499250990370.22
211.069801897982980000.03
单位质量响应值RSD%判断
8946.438860.760.69数据可信
影响因素30天-供试品溶液-2025051521批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min130576-3057630.83728.548.5830.8428.548.58
229737-2973729.99129.99
325085-2508525.29925.30
425364-2536425.58025.58
529119-2911929.36729.37
629904-2990430.15930.16
10min146501-4650146.89745.545.5047.2445.865.52
246840-4684047.23947.57
341995-4199542.35342.63
441944-4194442.30242.59
547225-4722547.62847.95
646415-4641546.81147.15
15min155451-5545155.92454.403.6956.7955.233.73
254708-5470855.17456.03
351124-5112451.56052.31
451804-5180452.24653.00
555885-5588556.36157.22
654698-5469855.16456.02
20min160462-6046260.97760.042.3962.4661.472.44
259713-5971360.22261.69
357106-5710657.59358.92
458968-5896859.47160.81
561248-6124861.77063.25
659698-5969860.20761.68
30min166555-6655567.12266.651.1269.2968.741.20
266146-6614666.71068.85
364715-6471565.26767.23
466035-6603566.59868.59
566849-6684967.41969.59
666213-6621366.77868.91
45min171049-7104971.65572.021.1474.5674.861.15
270785-7078571.38974.27
370995-7099571.60074.29
471243-7124371.85074.59
573003-7300373.62576.54
671408-7140872.01774.90
60min175579-7557976.22376.160.7479.9379.790.78
275017-7501775.65779.33
375416-7541676.05979.54
475129-7512975.77079.30
576562-7656277.21580.95
675375-7537576.01879.70
90min176516-7651677.16878.371.3281.7282.851.21
276903-7690377.55982.07
379148-7914879.82384.15
477095-7709577.75282.13
578376-7837679.04483.64
678194-7819478.86183.38
120min180129-8012980.81281.081.0186.2286.430.91
278941-7894179.61484.99
380724-8072481.41286.63
481335-8133582.02887.27
580546-8054681.23386.70
680704-8070481.39286.79
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180981-8098181.67181.861.0187.9888.120.94
280071-8007180.75487.02
381410-8141082.10488.23
481027-8102781.71887.87
580951-8095181.64188.02
682561-8256183.26589.57
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