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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
111.159664196159968569648096494965260.27
211.199687396910968920.03
单位质量响应值RSD%判断
8657.048658.800.02数据可信
供试品溶液-B0012N01批-pH6.8(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18251-82518.62816.6834.178.6316.6834.16
213391-1339114.00414.00
313577-1357714.19814.20
416219-1621916.96116.96
522695-2269523.73323.73
621555-2155522.54122.54
10min134777-3477736.36851.6719.6536.4651.8519.70
241626-4162643.53043.69
349184-4918451.43451.59
454130-5413056.60656.79
560994-6099463.78464.05
655729-5572958.27858.53
15min165675-6567568.67976.868.2469.1877.628.36
266693-6669369.74470.38
375329-7532978.77579.50
478261-7826181.84182.66
580479-8047984.16185.13
674536-7453677.94678.84
20min178441-7844182.02985.295.4083.2986.905.52
277148-7714880.67782.09
377376-7737680.91682.52
487176-8717691.16492.89
584907-8490788.79190.70
684296-8429688.15289.92
30min188993-8899393.06493.922.6795.2496.482.83
287167-8716791.15593.47
387015-8701590.99693.50
491777-9177795.97698.72
592275-9227596.49699.39
691619-9161995.81098.55
45min192999-9299997.25397.052.32100.46100.652.38
289535-8953593.63196.95
394596-9459698.924102.44
491478-9147895.66399.47
595516-9551699.886103.85
692698-9269896.939100.75
60min194537-9453798.86298.081.04103.15102.760.97
292843-9284397.090101.45
395255-9525599.613104.23
492760-9276097.004101.87
593599-9359997.881102.96
693757-9375798.046102.93
90min187280-8728091.27393.582.2396.6699.352.19
289883-8988393.99599.44
389179-8917993.25998.98
491472-9147295.657101.60
587228-8722891.21897.38
691872-9187296.075102.05
120min190835-9083594.99094.780.95101.39101.591.08
288998-8899893.06999.56
391280-9128095.456102.21
490469-9046994.608101.62
591275-9127595.451102.63
690938-9093895.098102.14
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189151-8915193.22992.623.12100.69100.483.01
288028-8802892.05599.58
383983-8398387.82595.64
487574-8757491.58099.64
591318-9131895.496103.73
691356-9135695.535103.63
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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
111.159683397115969269642996442967490.32
211.199690096720968100.14
单位质量响应值RSD%判断
8677.048651.470.21数据可信
供试品溶液-B0012N01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%
5min114030-1403014.66115.6918.2414.6615.6918.25
217547-1754718.33618.34
312825-1282513.40213.40
418584-1858419.42019.42
515590-1559016.29116.29
611516-1151612.03412.03
10min133268-3326834.76534.833.7934.9335.013.83
232799-3279934.27434.48
333535-3353535.04435.19
435558-3555837.15837.37
533124-3312434.61434.80
631707-3170733.13333.27
15min139842-3984241.63442.421.8542.1842.981.91
240630-4063042.45843.04
340010-4001041.81042.35
441970-4197043.85844.49
540473-4047342.29442.86
640653-4065342.48242.98
20min141278-4127843.13544.032.8344.1545.062.78
240582-4058242.40843.46
341441-4144143.30544.31
443254-4325445.20046.32
542748-4274844.67145.71
643486-4348645.44246.42
30min147144-4714449.26548.840.6250.7650.360.58
247050-4705049.16750.69
346517-4651748.61050.09
446456-4645648.54650.16
546636-4663648.73450.27
646632-4663248.73050.21
45min148522-4852250.70551.301.6852.7453.361.62
248235-4823550.40552.48
349393-4939351.61553.64
449815-4981552.05654.21
548377-4837750.55352.63
650185-5018552.44354.46
60min149858-4985852.10152.090.9454.7054.730.92
249556-4955651.78554.42
349523-4952351.75154.35
449983-4998352.23154.97
550707-5070752.98855.62
649481-4948151.70754.31
90min151350-5135053.66053.302.2056.8456.512.09
250312-5031252.57555.78
349236-4923651.45154.62
450894-5089453.18356.50
552044-5204454.38557.61
652203-5220354.55157.73
120min150209-5020952.46854.351.9956.2458.161.89
251368-5136853.67957.47
352899-5289955.27959.02
452746-5274655.11959.03
552360-5236054.71558.54
652496-5249654.85858.64
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153578-5357855.98855.191.5960.3559.601.52
251499-5149953.81658.21
352162-5216254.50958.87
453641-5364156.05460.57
553005-5300555.38959.83
653011-5301155.39659.79
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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
111.159707497007964039668196803967940.28
211.199709596427967610.49
单位质量响应值RSD%判断
8681.088647.100.28数据可信
供试品溶液-B0012N01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%
5min113936-1393614.56317.8717.0314.5617.8717.04
221226-2122622.18122.18
317913-1791318.71918.72
415023-1502315.69915.70
519536-1953620.41520.42
614986-1498615.66015.66
10min133223-3322334.71836.146.4334.8836.346.48
236884-3688438.54438.79
334140-3414035.67735.88
433037-3303734.52434.70
537783-3778339.48439.71
632417-3241733.87634.05
15min141061-4106142.90943.222.5843.4643.822.65
242905-4290544.83645.51
340486-4048642.30842.91
441588-4158843.46044.02
542096-4209643.99144.66
640004-4000441.80442.35
20min143235-4323545.18145.903.4246.2146.983.43
244229-4422946.22047.39
342661-4266144.58145.66
442838-4283844.76645.81
546735-4673548.83849.99
643833-4383345.80646.82
30min147662-4766249.80749.355.7551.3350.945.66
249661-4966151.89653.58
347822-4782249.97451.54
447804-4780449.95651.49
548491-4849150.67352.37
641898-4189843.78445.31
45min150601-5060152.87852.921.4954.9655.061.29
249540-4954051.77054.03
351080-5108053.37955.50
450454-5045452.72554.82
550399-5039952.66754.93
651800-5180054.13156.14
60min148941-4894151.14452.812.1153.8155.542.08
250016-5001652.26755.11
351348-5134853.65956.38
451158-5115853.46056.14
551757-5175754.08656.93
649990-4999052.24054.85
90min151168-5116853.47154.101.1656.7157.411.14
252521-5252154.88558.30
352103-5210354.44857.76
452236-5223654.58757.86
551128-5112853.42956.88
651436-5143653.75156.94
120min151845-5184554.17854.201.1358.0158.121.04
251304-5130453.61357.64
351050-5105053.34857.27
452208-5220854.55858.44
552505-5250554.86858.91
652309-5230954.66358.45
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152820-5282055.19755.430.7559.6359.950.81
253158-5315855.55160.18
353651-5365156.06660.58
452908-5290855.28959.78
553218-5321855.61360.26
652496-5249654.85959.26
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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
111.159651496834965039643096366965290.19
211.199737697532974540.12
单位质量响应值RSD%判断
8657.318709.030.43数据可信
供试品溶液-B0012N01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%
5min119121-1912119.93818.1111.3919.9418.1111.38
218655-1865519.45219.45
319147-1914719.96519.96
417309-1730918.04818.05
515427-1542716.08616.09
614561-1456115.18315.18
10min134064-3406435.51935.091.5935.7435.301.59
232905-3290534.31134.53
333835-3383535.28035.50
434175-3417535.63535.84
533070-3307034.48334.66
633892-3389235.34035.51
15min139910-3991041.61541.161.7542.2341.751.77
239280-3928040.95841.56
340301-4030142.02342.64
439768-3976841.46742.06
538328-3832839.96540.53
639244-3924440.92041.48
20min142399-4239944.21043.682.6245.2944.732.54
241084-4108442.83943.89
340386-4038642.11143.19
443334-4333445.18546.24
541501-4150143.27444.28
642651-4265144.47345.49
30min145484-4548447.42746.632.5949.0048.172.52
245353-4535347.29048.82
343040-4304044.87946.43
445658-4565847.60849.17
545344-4534447.28148.77
643447-4344745.30346.81
45min146498-4649848.48447.611.9250.5849.671.89
245373-4537347.31149.37
344828-4482846.74348.79
446729-4672948.72550.81
545959-4595947.92249.93
644597-4459746.50248.52
60min145424-4542447.36446.981.8250.0049.571.76
244257-4425746.14748.73
344165-4416546.05248.62
445931-4593147.89350.52
545963-4596347.92650.47
644620-4462046.52649.06
90min145485-4548547.42847.871.4250.5950.971.37
246095-4609548.06451.16
346561-4656148.55051.63
446699-4669948.69451.86
545509-4550947.45350.53
645083-4508347.00950.06
120min145005-4500546.92747.762.6150.6251.402.47
245358-4535847.29650.92
347175-4717549.19052.81
447237-4723749.25552.96
545795-4579547.75151.36
644272-4427246.16349.73
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146479-4647948.46449.092.2852.6753.252.16
246902-4690248.90553.06
347447-4744749.47453.64
447995-4799550.04554.30
548276-4827650.33854.47
645358-4535847.29651.38
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