非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数500
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%
110.973808063804743806563804223802163805150.06
211.033769133773783771460.09
单位质量响应值RSD%判断
34686.8734192.751.02数据可信
供试品溶液-24122701批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19606-960612.54210.5411.3712.5410.5411.36
27406-74069.6709.67
37899-789910.31310.31
47899-789910.31310.31
58602-860211.23111.23
67036-70369.1879.19
10min132059-3205941.85830.2429.9341.9330.2929.89
213798-1379818.01518.07
323450-2345030.61730.67
422199-2219928.98429.04
529703-2970338.78238.84
617739-1773923.16123.21
15min154581-5458171.26458.1420.3171.5758.3720.33
231637-3163741.30741.46
342031-4203154.87855.11
442163-4216355.05055.27
555450-5545072.39872.68
641305-4130553.93054.11
20min162941-6294182.17979.334.9082.8879.884.99
258321-5832176.14776.53
357217-5721774.70575.24
460561-6056179.07179.60
565297-6529785.25585.94
660211-6021178.61479.09
30min171992-7199293.99694.621.8595.1595.611.85
273460-7346095.91396.72
370321-7032191.81592.76
472552-7255294.72795.69
574209-7420996.89198.04
672277-7227794.36895.28
45min176605-76605100.019100.071.01101.70101.580.93
278065-78065101.926103.26
376003-7600399.233100.69
476852-76852100.342101.83
576246-7624699.551101.24
676092-7609299.349100.79
60min176892-76892100.394102.472.28102.63104.542.12
280572-80572105.199107.10
377247-77247100.857102.87
479712-79712104.076106.12
576521-7652199.910102.15
679932-79932104.363106.36
极限178712-78712102.770104.621.74105.56107.261.61
280820-80820105.523108.01
382372-82372107.549110.12
479296-79296103.533106.16
578995-78995103.140105.94
680563-80563105.187107.76
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数500
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%
110.973771193772603775373773233771293772740.05
211.033772523772253772380.01
单位质量响应值RSD%判断
34391.4334201.090.40数据可信
供试品溶液-24122701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%
5min18814-881411.5569.9915.3511.569.9915.35
29085-908511.91111.91
37740-774010.14810.15
47337-73379.6199.62
56544-65448.5808.58
66200-62008.1298.13
10min132996-3299643.26033.3320.8443.3233.3920.81
226223-2622334.38034.45
319529-1952925.60425.66
426966-2696635.35435.41
519106-1910625.04925.10
627718-2771836.34036.39
15min153976-5397670.76661.9313.6871.0762.1713.68
253792-5379270.52470.78
337774-3777449.52449.72
446756-4675661.30061.55
542043-4204355.12155.31
649062-4906264.32364.57
20min162367-6236781.76776.709.6582.4677.289.67
264338-6433884.35185.00
348524-4852463.61864.09
455984-5598473.39873.99
559362-5936277.82778.32
660416-6041679.20979.81
30min172333-7233394.83391.007.8895.9892.007.89
275220-7522098.61899.74
360808-6080879.72380.55
464860-6486085.03586.03
572765-7276595.39996.32
670454-7045492.36993.41
45min175852-7585299.44697.355.30101.1398.875.34
278567-78567103.006104.67
368406-6840689.68490.95
470737-7073792.74094.21
577309-77309101.356102.81
674654-7465497.87699.43
60min177787-77787101.983100.493.74104.21102.553.79
280082-80082104.992107.23
373718-7371896.64898.42
472765-7276595.39997.38
578672-78672103.143105.16
676870-76870100.781102.88
极限178565-78565103.003104.042.15105.80106.662.13
281288-81288106.573109.39
379696-79696104.486106.79
477592-77592101.728104.24
581352-81352106.657109.25
677649-77649101.802104.46
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