佩玛贝特片项目信息
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HX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
110.042094720932209972096720956209600.12
210.292073020827207780.34
单位质量响应值RSD%判断
2087.652019.242.36数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-24101101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%
5min112761-1276155.72254.7412.1655.7254.7412.16
210717-1071746.79646.80
313973-1397361.01461.01
414541-1454163.49463.49
511135-1113548.62248.62
612088-1208852.78352.78
10min115192-1519266.33770.616.0266.4370.706.02
216114-1611470.36370.44
316619-1661972.56872.67
417763-1776377.56377.67
515157-1515766.18466.26
616178-1617870.64270.73
15min116149-1614970.51674.523.9170.7274.733.91
216885-1688573.72973.92
316928-1692873.91774.14
418133-1813379.17979.41
516857-1685773.60773.80
617448-1744876.18876.39
20min116566-1656672.33676.504.2472.6676.834.24
217224-1722475.21075.53
317266-1726675.39375.74
418567-1856781.07481.44
517251-1725175.32775.64
618243-1824379.65979.99
30min116864-1686473.63877.484.4974.0877.944.49
217496-1749676.39776.84
317378-1737875.88276.35
419131-1913183.53784.04
517430-1743076.10976.55
618161-1816179.30179.77
45min117209-1720975.14479.114.7475.7179.704.74
217601-1760176.85677.43
317700-1770077.28877.89
419626-1962685.69886.34
518075-1807578.92679.49
618493-1849380.75181.35
60min117795-1779577.70379.614.3678.3980.334.36
217606-1760676.87877.58
317961-1796178.42879.15
419628-1962885.70786.49
517679-1767977.19677.89
618718-1871881.73382.47
极限117604-1760476.86979.695.0377.6980.545.02
217622-1762276.94777.77
317516-1751676.48577.34
419838-1983886.62487.55
518114-1811479.09679.92
618803-1880382.10482.97
佩玛贝特片项目信息
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HX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
110.042191521870218232190321783218590.26
210.292237522442224080.22
单位质量响应值RSD%判断
2177.192177.650.02数据可信
供试品溶液-24101102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%
5min113840-1384056.97759.4110.0956.9859.4110.09
214085-1408557.98557.99
316310-1631067.14567.14
412294-1229450.61250.61
514218-1421858.53358.53
615841-1584165.21465.21
10min118479-1847976.07479.223.1476.1779.323.15
219474-1947480.17180.27
320073-2007382.63782.75
418681-1868176.90676.99
519106-1910678.65678.75
619641-1964180.85880.97
15min120505-2050584.41587.012.5284.6487.242.52
221664-2166489.18689.42
321557-2155788.74689.00
421490-2149088.47088.68
520481-2048184.31684.54
621116-2111686.93087.17
20min121224-2122487.37590.962.4787.7491.332.47
222633-2263393.17693.55
322575-2257592.93793.33
422276-2227691.70692.07
521686-2168689.27789.65
622171-2217191.27491.66
30min121714-2171489.39295.853.4989.9096.383.48
223428-2342896.44896.98
323879-2387998.30598.86
423533-2353396.88197.39
523903-2390398.40498.92
623239-2323995.67096.21
45min122349-2234992.006100.034.1392.66100.724.12
224391-24391100.413101.11
324915-24915102.570103.29
424361-24361100.289100.96
525161-25161103.583104.26
624610-24610101.314102.01
60min122405-2240592.237102.685.3593.05103.545.33
224897-24897102.496103.36
325906-25906106.650107.54
424832-24832102.228103.07
525817-25817106.283107.14
625798-25798106.205107.07
极限122539-2253992.789104.395.7293.75105.415.69
225295-25295104.134105.17
326286-26286108.214109.28
425484-25484104.913105.92
526315-26315108.334109.37
626221-26221107.947108.99
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