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%
111.049594895778959219611495737959000.16
211.049628096094961870.14
单位质量响应值RSD%判断
8686.598712.590.22数据可信
供试品溶液-2025051521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%
5min127138-2713828.01127.735.9728.0127.735.97
227128-2712828.00028.00
325093-2509325.90025.90
429130-2913030.06730.07
524959-2495925.76225.76
627762-2776228.65528.65
10min146365-4636547.85648.192.4548.1748.492.46
246954-4695448.46448.77
344591-4459146.02546.31
447703-4770349.23749.57
546872-4687248.37948.67
647624-4762449.15549.47
15min153421-5342155.13957.792.5255.9858.632.50
256906-5690658.73659.59
355825-5582557.62058.42
456191-5619157.99858.88
556023-5602357.82458.65
657546-5754659.39660.26
20min158462-5846260.34263.402.6061.8064.892.57
261540-6154063.51965.02
361207-6120763.17564.61
463035-6303565.06266.59
562441-6244164.44965.92
661877-6187763.86765.39
30min166362-6636268.49670.441.6070.6272.631.60
268253-6825370.44872.66
368430-6843070.63072.77
469578-6957871.81574.06
568935-6893571.15273.33
667911-6791170.09572.33
45min169387-6938771.61875.012.4274.5177.982.39
273149-7314975.50178.49
372522-7252274.85477.78
474379-7437976.77179.82
573853-7385376.22879.20
672741-7274175.08078.09
60min175349-7534977.77279.361.2081.4583.161.22
278023-7802380.53284.36
376427-7642778.88482.64
477172-7717279.65383.55
577428-7742879.91883.74
676903-7690379.37683.22
90min175418-7541877.84381.432.3582.3986.122.30
280001-8000182.57387.30
378936-7893681.47486.11
478998-7899881.53886.32
580814-8081483.41388.12
679177-7917781.72386.45
120min179066-7906681.60883.911.4287.0289.501.43
282443-8244385.09490.74
381807-8180784.43789.98
481512-8151284.13389.82
581506-8150684.12789.76
681416-8141684.03489.67
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179855-7985582.42384.341.3988.7490.861.39
281973-8197384.60991.20
381822-8182284.45390.93
483095-8309585.76792.39
581074-8107483.68190.25
682428-8242885.07891.65
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%
111.049631396227960969646396167962530.15
211.049644696475964600.03
单位质量响应值RSD%判断
8718.578737.320.16数据可信
供试品溶液-2025051621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%
5min123993-2399324.68425.4414.5524.6825.4414.55
223557-2355724.23524.24
329030-2903029.86629.87
420913-2091321.51521.52
529221-2922130.06330.06
621640-2164022.26322.26
10min143357-4335744.60647.376.8244.8847.666.86
246206-4620647.53747.81
349814-4981451.24951.58
443109-4310944.35144.59
549871-4987151.30751.64
643921-4392145.18645.43
15min152229-5222953.73356.323.5454.5057.133.59
255012-5501256.59657.39
357803-5780359.46860.37
453153-5315354.68455.42
555388-5538856.98357.89
654886-5488656.46757.22
20min158753-5875360.44562.471.7961.8163.901.86
260836-6083662.58864.01
361761-6176163.54065.10
460390-6039062.12963.47
561571-6157163.34464.88
661013-6101362.77064.15
30min166113-6611368.01769.621.8170.0671.761.86
269164-6916471.15673.28
368611-6861170.58772.86
467129-6712969.06271.09
568398-6839870.36872.61
666636-6663668.55570.63
45min170471-7047172.50174.501.6475.2977.411.67
273691-7369175.81378.73
373352-7335275.46578.52
471788-7178873.85676.65
572216-7221674.29677.32
672993-7299375.09577.93
60min176052-7605278.24278.411.0681.8482.141.06
274950-7495077.10980.86
376508-7650878.71182.60
476598-7659878.80482.42
577316-7731679.54383.39
675843-7584378.02781.70
90min178435-7843580.69482.181.2485.1686.781.24
280437-8043782.75487.37
379462-7946281.75186.52
479256-7925681.53986.03
580873-8087383.20287.93
680829-8082983.15787.69
120min181552-8155283.90184.250.8889.2789.760.80
283006-8300685.39790.93
381294-8129483.63589.31
481713-8171384.06689.47
581239-8123983.57989.24
682518-8251884.89590.36
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183133-8313385.52786.150.8091.8392.600.88
284082-8408286.50492.98
384261-8426186.68893.29
482974-8297485.36491.70
584609-8460987.04693.63
683369-8336985.77092.17
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%
111.049630395973959289577096190960330.23
211.049691696543967300.28
单位质量响应值RSD%判断
8698.648761.780.52数据可信
供试品溶液-2025051622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%
5min130434-3043431.30332.4910.6731.3032.4910.68
226886-2688627.65327.65
333605-3360534.56434.56
429507-2950730.34930.35
536474-3647437.51537.52
632629-3262933.56033.56
10min150252-5025251.68649.803.8252.0350.163.85
245863-4586347.17247.48
348896-4889650.29250.68
446475-4647547.80248.14
550139-5013951.57051.99
648880-4888050.27550.65
15min158725-5872560.40158.363.0361.3259.273.03
257035-5703558.66359.49
355864-5586457.45958.40
453808-5380855.34456.21
557826-5782659.47760.47
657179-5717958.81159.74
20min164318-6431866.15463.772.2467.7565.332.26
261069-6106962.81264.30
361361-6136163.11364.69
460406-6040662.13063.61
562565-6256564.35166.00
662265-6226564.04265.63
30min167840-6784069.77769.311.5272.1071.581.54
267595-6759569.52571.71
367175-6717569.09371.38
465444-6544467.31269.49
568221-6822170.16872.53
668036-6803669.97872.27
45min174028-7402876.14175.130.9979.2478.171.03
273234-7323475.32578.28
372592-7259274.66477.71
471909-7190973.96276.88
573271-7327175.36378.51
673221-7322175.31178.39
60min177825-7782580.04778.731.4384.0082.611.44
276820-7682079.01382.80
376166-7616678.34082.22
474729-7472976.86280.61
576309-7630978.48782.47
677415-7741579.62583.54
90min180934-8093483.24482.091.4888.0886.841.45
280698-8069883.00287.67
380804-8080483.11187.86
478015-7801580.24284.84
579209-7920981.47086.32
679225-7922581.48786.28
120min182379-8237984.73184.151.0190.4989.811.02
282381-8238184.73390.32
381714-8171484.04789.72
480315-8031582.60888.10
581641-8164183.97189.73
682465-8246584.81990.52
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182492-8249284.84785.090.4591.5591.680.45
282656-8265685.01591.55
382170-8217084.51691.12
482801-8280185.16591.57
583113-8311385.48692.18
683125-8312585.49892.14
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