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%
111.169733697229973029702897451972690.17
211.179798697598977920.29
单位质量响应值RSD%判断
8715.868754.880.32数据可信
供试品溶液-02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%
5min121082-2108221.67122.3913.0121.6722.4013.00
224943-2494325.64025.64
323971-2397124.64024.64
421794-2179422.40322.40
516809-1680917.27817.28
622118-2211822.73622.74
10min141986-4198643.15942.556.9843.4042.807.00
245493-4549346.76447.05
342861-4286144.05844.33
441784-4178442.95143.20
537520-3752038.56838.76
638712-3871239.79340.05
15min152372-5237253.83553.373.7254.5654.103.78
254833-5483356.36457.17
353191-5319154.67755.44
451281-5128152.71353.44
549878-4987851.27151.89
649980-4998051.37652.07
20min158187-5818759.81259.623.0061.1360.943.01
260771-6077162.46863.90
357237-5723758.83660.21
458387-5838760.01861.33
557983-5798359.60260.79
655432-5543256.98058.25
30min161570-6157063.29064.631.8765.2766.601.87
264738-6473866.54668.67
362725-6272564.47766.50
462515-6251564.26166.24
563715-6371565.49567.35
661966-6196663.69765.60
45min169380-6938071.31871.091.0774.0073.781.09
269997-6999771.95274.82
369121-6912171.05273.79
468094-6809469.99672.69
569819-6981971.76974.35
668524-6852470.43873.04
60min173716-7371675.77574.471.5979.2577.961.54
273189-7318975.23378.90
370918-7091872.89976.43
472046-7204674.05877.53
573390-7339075.44078.82
671427-7142773.42276.81
90min175001-7500177.09677.371.7881.4281.681.71
276501-7650178.63883.14
374282-7428276.35780.70
473757-7375775.81780.11
577237-7723779.39483.61
674826-7482676.91681.12
极限178590-7859080.78580.101.5085.9685.271.44
278551-7855180.74586.12
377699-7769979.86985.06
475688-7568877.80282.94
578852-7885281.05486.15
678146-7814680.32985.39
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%
111.169781897528976039752497670976290.13
211.179784198171980060.24
单位质量响应值RSD%判断
8748.128774.040.21数据可信
供试品溶液-02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%
5min114695-1469515.06123.4421.2915.0623.4421.29
228914-2891429.63429.63
323529-2352924.11524.12
422509-2250923.07023.07
521259-2125921.78921.79
626339-2633926.99527.00
10min138423-3842339.38042.286.6039.5542.546.67
244633-4463345.74546.07
341264-4126442.29242.56
439066-3906640.03940.30
539681-3968140.66940.91
644460-4446045.56845.87
15min148315-4831549.51951.803.2850.1252.533.38
251555-5155552.83953.68
351935-5193553.22953.97
449162-4916250.38751.09
549876-4987651.11851.81
652399-5239953.70454.51
20min155288-5528856.66557.062.1757.8258.372.15
254806-5480656.17157.60
357789-5778959.22960.56
454370-5437055.72456.99
555735-5573557.12358.39
656067-5606757.46458.87
30min159801-5980161.29162.401.1663.0864.341.24
260895-6089562.41264.46
360856-6085662.37264.36
460509-6050962.01663.90
561389-6138962.91864.81
661827-6182763.36765.41
45min166588-6658868.24768.602.7070.7171.232.59
264161-6416165.75968.50
369399-6939971.12873.81
465973-6597367.61670.19
567992-6799269.68672.28
667465-6746569.14671.89
60min170833-7083372.59771.871.7675.8275.261.69
268810-6881070.52474.00
372096-7209673.89277.36
468928-6892870.64573.97
569892-6989271.63375.00
670182-7018271.93075.44
90min172175-7217573.97375.632.8178.0079.832.75
272711-7271174.52278.78
377718-7771879.65483.95
473637-7363775.47179.58
572371-7237174.17478.34
674151-7415175.99880.31
极限175828-7582877.71777.321.6982.5782.361.57
274043-7404375.88780.97
377272-7727279.19784.37
475690-7569077.57582.52
575913-7591377.80482.79
673926-7392675.76880.92
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%
111.169819298049981839821798113981510.08
211.179833498583984580.18
单位质量响应值RSD%判断
8794.898814.500.16数据可信
供试品溶液-02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%
5min118065-1806518.42318.8224.2018.4218.8224.20
221780-2178022.21222.21
323502-2350223.96823.97
421024-2102421.44121.44
513582-1358213.85113.85
612745-1274512.99813.00
10min136741-3674137.47038.576.6437.6738.786.71
238005-3800538.75939.01
340382-4038241.18341.45
440182-4018240.97941.22
538051-3805138.80638.96
633564-3356434.23034.37
15min147255-4725548.19249.243.2748.8149.883.34
247712-4771248.65849.34
350493-5049351.49452.22
449164-4916450.13950.83
549013-4901349.98550.57
646085-4608546.99947.52
20min152346-5234653.38455.002.2854.5456.182.26
253493-5349354.55455.77
353499-5349954.56055.86
455296-5529656.39357.64
555521-5552156.62257.76
653411-5341154.47055.52
30min161087-6108762.29863.193.5064.0564.993.47
260464-6046461.66363.49
363776-6377665.04166.94
461977-6197763.20665.08
565153-6515366.44568.21
659332-5933260.50962.16
45min167024-6702468.35368.762.0470.8071.261.93
266769-6676968.09370.60
365496-6549666.79569.42
468036-6803669.38571.96
569594-6959470.97473.48
667639-6763968.98071.30
60min169339-6933970.71472.341.9073.9275.601.81
269933-6993371.32074.59
369911-6991171.29774.66
472333-7233373.76777.12
571947-7194773.37476.67
672139-7213973.57076.66
90min174946-7494676.43276.721.1080.4280.791.08
273798-7379875.26279.32
375137-7513776.62780.79
476126-7612677.63681.81
575783-7578377.28681.40
675586-7558677.08580.99
极限176986-7698678.51377.124.2983.3582.044.12
275415-7541576.91181.81
375079-7507976.56881.58
477329-7732978.86383.90
579173-7917380.74385.71
669722-6972271.10575.87
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