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%
110.102135321488213862140521493214250.30
210.112187021889218800.07
单位质量响应值RSD%判断
2121.292164.191.42数据可信
供试品溶液-PL4A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%
5min16000-600025.13826.424.6125.1426.424.61
26238-623826.13626.14
36823-682328.58728.59
46436-643626.96526.97
56135-613525.70425.70
66208-620826.01026.01
10min115411-1541164.56863.343.4564.6163.383.45
215259-1525963.93163.97
315701-1570165.78365.83
415383-1538364.45164.50
514581-1458161.09061.13
614375-1437560.22760.27
15min118368-1836876.95777.142.6377.1177.292.63
218631-1863178.05978.21
318998-1899879.59679.75
418532-1853277.64477.80
518400-1840077.09177.24
617542-1754273.49673.64
20min120379-2037985.38283.443.3685.6683.713.35
220654-2065486.53586.81
319256-1925680.67780.97
420345-2034585.24085.52
519862-1986283.21683.49
618991-1899179.56779.83
30min121808-2180891.37091.151.8691.7991.571.86
221873-2187391.64292.07
322188-2218892.96293.39
421969-2196992.04492.47
521692-2169290.88491.30
621009-2100988.02288.42
45min122924-2292496.04595.632.0796.6296.202.07
223316-2331697.68898.26
322960-2296096.19696.78
423008-2300896.39796.97
522820-2282095.61096.17
621926-2192691.86492.41
60min123291-2329197.58398.060.9598.3298.790.95
223435-2343598.18698.93
323640-2364099.04599.78
423659-2365999.12599.86
523079-2307996.69597.42
623321-2332197.70998.41
90min123220-2322097.28598.532.0798.1899.422.06
224173-24173101.278102.18
323519-2351998.53899.44
423715-2371599.359100.26
523722-2372299.389100.27
622757-2275795.34696.21
极限123748-2374899.49898.571.64100.5599.621.64
223725-2372599.401100.47
323860-2386099.967101.04
423752-2375299.514100.58
523106-2310696.80897.86
622964-2296496.21397.23
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%
110.102175221805217722177621673217560.23
210.112153121373214520.53
单位质量响应值RSD%判断
2154.062121.861.07数据可信
供试品溶液-PL4A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%
5min12660-266011.16911.9018.8211.1711.9018.80
23104-310413.03313.03
32476-247610.39710.40
43592-359215.08315.08
52090-20908.7768.78
63084-308412.94912.95
10min16996-699629.37631.197.4929.3931.217.49
27823-782332.84832.87
36754-675428.35928.38
48067-806733.87333.90
57054-705429.61929.63
67874-787433.06233.08
15min110336-1033643.40044.003.2543.4744.073.25
210869-1086945.63845.71
310104-1010442.42642.49
410601-1060144.51344.59
510130-1013042.53542.60
610836-1083645.49945.58
20min112319-1231951.72652.592.3951.8752.732.39
212839-1283953.91054.06
312288-1228851.59651.73
412962-1296254.42654.58
512435-1243552.21452.35
612302-1230251.65551.81
30min114485-1448560.82161.094.7861.0561.324.78
215333-1533364.38264.62
313297-1329755.83356.05
414929-1492962.68662.93
514820-1482062.22862.45
614434-1443460.60760.85
45min116536-1653669.43369.433.2169.7669.773.21
217104-1710471.81872.17
315652-1565265.72166.04
416949-1694971.16771.52
516742-1674270.29870.62
616234-1623468.16568.50
60min118182-1818276.34574.953.6776.7975.403.67
218680-1868078.43678.91
316814-1681470.60171.02
418083-1808375.92976.40
517939-1793975.32475.77
617394-1739473.03673.49
90min119245-1924580.80880.704.5681.3881.274.55
220170-2017084.69285.29
317720-1772074.40574.95
419594-1959482.27482.87
519805-1980583.16083.73
618778-1877878.84779.42
极限119569-1956982.16982.724.1282.8783.434.12
220511-2051186.12486.87
318172-1817276.30376.97
420076-2007684.29785.03
520059-2005984.22684.93
619819-1981983.21883.92
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%
110.102151021585215432145321282214750.55
210.112158421475215300.36
单位质量响应值RSD%判断
2126.242129.570.12数据可信
供试品溶液-PL4A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%
5min115315-1531564.60749.0334.6164.6149.0434.61
212829-1282954.11954.12
314723-1472362.10962.11
46920-692029.19229.19
513763-1376358.05958.06
66192-619226.12126.12
10min121280-2128089.77080.6413.8089.8880.7213.82
220085-2008584.72984.82
320383-2038385.98686.09
415631-1563165.94065.99
521395-2139590.25590.35
615924-1592467.17667.22
15min122492-2249294.88390.796.4895.1491.016.51
221730-2173091.66891.90
322727-2272795.87496.12
419368-1936881.70481.86
522549-2254995.12395.37
620268-2026885.50185.66
20min122897-2289796.59193.533.0397.0193.893.07
222303-2230394.08694.47
322056-2205693.04493.45
420999-2099988.58588.88
522725-2272595.86696.27
622041-2204192.98093.28
30min123246-2324698.06496.211.4098.6496.731.43
222782-2278296.10696.65
322585-2258595.27595.84
422351-2235194.28894.73
523034-2303497.16997.73
622839-2283996.34796.80
45min123283-2328398.22098.180.6998.9698.870.69
223119-2311997.52898.23
323209-2320997.90898.63
423110-2311097.49098.09
523477-2347799.03899.77
623446-2344698.90799.52
60min123403-2340398.72697.890.8999.6398.740.90
222897-2289796.59197.46
323187-2318797.81598.70
423027-2302797.14097.90
523344-2334498.47799.37
623369-2336998.58299.36
90min123351-2335198.50798.631.4899.5799.641.44
223388-2338898.66399.69
322878-2287896.51197.56
423211-2321197.91698.84
523537-2353799.291100.35
623914-23914100.882101.82
极限123270-2327098.16598.200.8599.4099.380.82
223131-2313197.57898.77
323097-2309797.43598.64
423184-2318497.80298.89
523359-2335998.54099.76
623629-2362999.679100.79
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