非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.093808443810093807933809873807973808860.03
211.083794223794223794220.00
单位质量响应值RSD%判断
34345.0034243.860.21数据可信
供试品溶液-24072301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%
5min188513-8851323.21018.5540.6723.2118.5540.66
237553-375539.8479.85
386173-8617322.59722.60
10min1103041-10304127.02031.7022.3827.0631.7322.32
2152019-15201939.86339.88
3107619-10761928.22028.26
15min1188376-18837649.39744.0122.6349.4844.1022.60
2124021-12402132.52132.60
3191153-19115350.12550.21
20min1178758-17875846.87554.6716.9647.0454.8316.88
2247594-24759464.92565.06
3199146-19914652.22152.39
30min1235600-23560061.78058.5111.5762.0258.7511.53
2193451-19345150.72750.97
3240327-24032763.01963.27
45min1219142-21914257.46465.4812.5057.8165.8312.42
2281531-28153173.82474.15
3248484-24848465.15865.52
60min1265034-26503469.49867.726.2569.9468.176.21
2239838-23983862.89163.34
3269857-26985770.76371.23
极限1249709-24970965.48072.428.9066.0472.998.83
2298214-29821478.19978.76
3280594-28059473.57874.17
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.093797113796973799873794823798913797540.06
211.083787083786443786760.02
单位质量响应值RSD%判断
34242.9234176.530.14数据可信
供试品溶液-24073101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%
5min1166189-16618943.68740.109.3143.6940.109.31
2137861-13786136.24036.24
3153528-15352840.35840.36
10min174194-7419419.50432.6434.9619.5832.7034.87
2145711-14571138.30338.36
3152560-15256040.10440.17
15min1258486-25848667.94965.693.0268.0565.813.00
2246878-24687864.89865.02
3244330-24433064.22864.36
20min1180629-18062947.48259.2417.2647.7059.4717.21
2251051-25105165.99466.23
3244406-24440664.24864.49
30min1290817-29081776.44874.971.9676.7575.301.92
2285124-28512474.95175.29
3279661-27966173.51573.86
45min1235836-23583661.99570.1610.2362.4270.6210.20
2286999-28699975.44475.91
3277873-27787373.04573.52
60min1307113-30711380.73279.621.6581.2680.191.60
2304117-30411779.94480.54
3297394-29739478.17778.77
极限1263801-26380169.34675.797.5670.0176.497.53
2305402-30540280.28281.01
3295729-29572977.73978.46
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.093789983793703788783789803788553790160.06
211.083785093786543785820.03
单位质量响应值RSD%判断
34176.3834168.050.02数据可信
供试品溶液-24082601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%
5min1139502-13950236.71228.4470.4536.7128.4470.46
2163438-16343843.01143.01
321250-212505.5925.59
10min173608-7360819.37131.1032.8919.4331.1532.80
2136018-13601835.79535.87
3144959-14495938.14838.16
15min1245384-24538464.57651.5947.7764.6751.6947.72
2254698-25469867.02767.16
388063-8806323.17523.25
20min1185489-18548948.81454.739.5649.0154.919.48
2215196-21519656.63156.87
3223222-22322258.74358.85
30min1281796-28179674.15865.8323.1374.4466.1123.12
2285264-28526475.07075.41
3183372-18337248.25648.47
45min1238625-23862562.79765.543.6363.2065.933.59
2254418-25441866.95367.42
3254119-25411966.87467.16
60min1299356-29935678.77973.4013.1979.2973.8913.21
2300918-30091879.19079.76
3236468-23646862.22962.63
极限1266740-26674070.19672.012.1970.8472.632.14
2276742-27674272.82873.53
3277437-27743773.01173.52
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.093790553790133794983792443789363791490.06
211.083781983778343780160.07
单位质量响应值RSD%判断
34188.3734116.970.15数据可信
供试品溶液-24082602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%
5min198500-9850025.93628.4913.3925.9428.5013.39
2101278-10127826.66826.67
3124868-12486832.87932.88
10min185940-8594022.62919.7022.0122.6719.7521.90
282592-8259221.74721.79
355905-5590514.72014.78
15min1185156-18515648.75452.637.0048.8352.716.99
2201535-20153553.06753.15
3212967-21296756.07756.16
20min1231015-23101560.82958.456.1060.9958.626.07
2228505-22850560.16860.34
3206421-20642154.35354.53
30min1226728-22672859.70063.725.5959.9663.995.58
2246834-24683464.99465.26
3252448-25244866.47366.74
45min1276827-27682772.89271.542.4573.2571.912.44
2274054-27405472.16272.54
3264169-26416969.55969.93
60min1251074-25107466.11170.255.1166.6070.745.08
2273954-27395472.13572.63
3275325-27532572.49672.99
极限1298879-29887978.69877.541.5879.2978.141.55
2294850-29485077.63878.26
3289651-28965176.26976.88
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