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DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74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%
1 10.072098021007209752095820998209840.10
210.052098621002209940.06
单位质量响应值RSD%判断
2083.812088.960.18数据可信
供试品溶液-25022201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%
5min16808-680829.29130.678.7629.2930.678.77
28202-820235.28935.29
36664-666428.67228.67
46889-688929.64029.64
56646-664628.59428.59
67561-756132.53132.53
10min113520-1352058.16957.864.6858.2257.914.69
214092-1409260.63060.69
313228-1322856.91356.96
412328-1232853.04153.09
513579-1357958.42358.47
613938-1393859.96860.02
15min117112-1711273.62472.902.5173.7773.052.52
217455-1745575.10075.26
317072-1707273.45273.59
416199-1619969.69669.83
517053-1705373.37073.52
616773-1677372.16572.32
20min118935-1893581.46779.651.9681.7479.921.96
218775-1877580.77981.06
318484-1848479.52779.79
417944-1794477.20477.46
518663-1866380.29780.56
618271-1827178.61078.88
30min120192-2019286.87686.161.0387.2886.561.03
220296-2029687.32387.74
319758-1975885.00885.41
419836-1983685.34485.73
520006-2000686.07586.48
620063-2006386.32186.73
45min121251-2125191.43290.010.9391.9890.550.92
221032-2103290.49091.05
320783-2078389.41889.96
420869-2086989.78890.31
520861-2086189.75490.30
620724-2072489.16489.71
60min120932-2093290.05991.961.7890.7692.651.77
221942-2194294.40595.12
321173-2117391.09691.78
421585-2158592.86993.54
521538-2153892.66793.36
621073-2107390.66691.36
90min121779-2177993.70493.371.1094.5694.221.10
221986-2198694.59495.47
321429-2142992.19893.04
421952-2195294.44895.28
521573-2157392.81793.67
621495-2149592.48293.33
极限122024-2202494.75894.231.8895.7795.241.86
221976-2197694.55195.58
321217-2121791.28692.28
422131-2213195.21896.20
522399-2239996.37197.37
621667-2166793.22294.22
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DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74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%
1 10.072107521025210532105921075210570.10
210.052100621003210040.02
单位质量响应值RSD%判断
2091.062089.950.04数据可信
供试品溶液-25022202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%
5min17167-716730.77532.3710.3330.7732.3710.34
26845-684529.39229.39
37041-704130.23430.23
47890-789033.88033.88
57333-733331.48831.49
68952-895238.44038.44
10min113838-1383859.42061.083.7059.4761.133.70
214137-1413760.70460.75
313646-1364658.59658.65
414306-1430661.43061.49
514254-1425461.20661.26
615163-1516365.11065.17
15min117478-1747875.05075.132.1075.2075.282.10
217467-1746775.00375.15
317325-1732574.39374.54
417657-1765775.81975.98
516970-1697072.86973.02
618077-1807777.62277.79
20min118472-1847279.31881.371.4379.5981.651.43
219051-1905181.80582.08
319228-1922882.56582.84
419144-1914482.20482.49
518955-1895581.39281.67
618845-1884580.92081.22
30min120511-2051188.07487.780.7488.4888.200.74
220387-2038787.54187.95
320587-2058788.40088.81
420541-2054188.20388.62
520169-2016986.60587.02
620462-2046287.86388.30
45min121327-2132791.57891.711.1692.1392.271.15
221132-2113290.74091.30
321451-2145192.11092.67
421803-2180393.62294.19
521183-2118390.95991.52
621247-2124791.23491.82
60min121889-2188993.99193.751.0294.7094.461.01
221797-2179793.59694.30
322084-2208494.82895.54
422013-2201394.52395.25
521747-2174793.38194.09
621461-2146192.15392.89
90min122182-2218295.24994.400.7096.1195.270.69
221938-2193894.20195.07
322043-2204394.65295.52
422097-2209794.88495.77
521771-2177193.48494.35
621873-2187393.92294.81
极限122335-2233595.90694.690.8796.9395.720.86
221886-2188693.97895.00
321973-2197394.35295.38
422249-2224995.53796.58
521947-2194794.24095.26
621919-2191994.12095.17
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DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74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%
1 10.072102121034210562101721042210340.08
210.052093820941209400.02
单位质量响应值RSD%判断
2088.782083.580.18数据可信
供试品溶液-25022203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%
5min17112-711230.60232.828.2530.6032.828.25
28423-842336.24336.24
37611-761132.74932.75
47877-787733.89433.89
58037-803734.58234.58
66705-670528.85128.85
10min113986-1398660.18061.573.5060.2361.623.50
214540-1454062.56462.62
314041-1404160.41760.47
414770-1477063.55463.61
514890-1489064.07064.13
613624-1362458.62358.67
15min117543-1754375.48674.332.6975.6474.492.69
217769-1776976.45876.62
317147-1714773.78273.94
416620-1662071.51471.68
517682-1768276.08476.25
616889-1688972.67272.82
20min119117-1911782.25881.111.7382.5481.391.74
219163-1916382.45682.75
318634-1863480.18080.46
418723-1872380.56380.84
519100-1910082.18582.48
618363-1836379.01479.28
30min120327-2032787.46586.961.2387.8887.381.24
220334-2033487.49587.92
319850-1985085.41285.82
420335-2033587.49987.92
520464-2046488.05488.48
619949-1994985.83886.24
45min121105-2110590.81390.351.1491.3790.911.14
221221-2122191.31291.89
320559-2055988.46389.02
421127-2112790.90791.47
521068-2106890.65391.23
620904-2090489.94890.49
60min121457-2145792.32791.621.2293.0492.331.22
221405-2140592.10392.83
320988-2098890.30991.01
421574-2157492.83193.54
521377-2137791.98392.71
620953-2095390.15990.85
90min121491-2149192.47492.491.2093.3493.361.19
221677-2167793.27494.15
321110-2111090.83491.69
421856-2185694.04494.91
521469-2146992.37993.26
621371-2137191.95792.80
极限121425-2142592.19092.671.0593.2193.691.05
221517-2151792.58593.62
321338-2133891.81592.82
421950-2195094.44995.47
521612-2161292.99494.03
621379-2137991.99292.99
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