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%
110.002114221055211432105421090210970.21
210.082100520907209560.34
单位质量响应值RSD%判断
2109.702078.971.04数据可信
供试品溶液-2025041221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%
5min117939-1793976.89364.7710.6476.8964.7610.64
215394-1539465.98465.98
314827-1482763.55463.55
413175-1317556.47356.47
514112-1411260.48960.49
615213-1521365.20865.21
10min120535-2053588.02183.723.3788.1583.833.38
219664-1966484.28784.40
318773-1877380.46880.57
418996-1899681.42481.52
519251-1925182.51782.62
619977-1997785.62985.74
15min121144-2114490.63189.581.7990.9189.831.79
221024-2102490.11790.37
320425-2042587.54987.79
420588-2058888.24888.48
520777-2077789.05889.30
621431-2143191.86192.11
20min121441-2144191.90491.550.8992.3391.940.89
221287-2128791.24491.64
321106-2110690.46890.85
421214-2121490.93191.31
521482-2148292.08092.47
621614-2161492.64693.05
30min121841-2184193.61993.700.6594.2094.240.64
221680-2168092.92893.48
321751-2175193.23393.77
421945-2194594.06494.59
521860-2186093.70094.24
622076-2207694.62695.18
45min122151-2215194.94795.100.5495.6895.810.54
222006-2200694.32695.03
322342-2234295.76696.46
422121-2212194.81995.50
522262-2226295.42396.12
622244-2224495.34696.06
60min122325-2232595.69396.210.9796.5997.070.95
222249-2224995.36796.23
322732-2273297.43898.29
422316-2231695.65596.50
522711-2271197.34898.20
622334-2233495.73296.61
90min122428-2242896.13596.580.9397.1997.610.91
222324-2232495.68996.71
322787-2278797.67398.69
422427-2242796.13097.13
522805-2280597.75198.77
622425-2242596.12297.16
极限122291-2229195.54796.431.3196.7697.621.29
222268-2226895.44996.63
322803-2280397.74298.92
422188-2218895.10696.27
522878-2287898.06399.24
622553-2255396.67097.87
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%
110.002098020869208642093420907209110.24
210.082119021136211630.19
单位质量响应值RSD%判断
2091.102099.500.29数据可信
供试品溶液-2025041221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%
5min117025-1702572.93865.5311.1472.9465.5311.15
214945-1494564.02764.03
313770-1377058.99358.99
414943-1494364.01864.02
517649-1764975.61175.61
613448-1344857.61457.61
10min120490-2049087.78383.773.7887.9083.883.79
219422-1942283.20783.31
319466-1946683.39683.49
419288-1928882.63382.74
520236-2023686.69586.82
618420-1842078.91479.01
15min121478-2147892.01589.382.3092.2889.632.30
220891-2089189.50189.75
321231-2123190.95791.19
420377-2037787.29987.54
520955-2095589.77590.05
620244-2024486.72986.96
20min121888-2188893.77291.541.9794.1991.941.98
221358-2135891.50191.90
321845-2184593.58893.98
420968-2096889.83190.22
521229-2122990.94991.37
620912-2091289.59189.96
30min122272-2227295.41794.151.8195.9994.701.81
221820-2182093.48194.03
322616-2261696.89197.44
421570-2157092.41092.95
521923-2192393.92294.49
621659-2165992.79193.31
45min122539-2253996.56195.491.7697.3096.201.75
222227-2222795.22495.93
322944-2294498.29699.00
421916-2191693.89294.59
522135-2213594.83095.56
621967-2196794.11094.79
60min122655-2265597.05896.222.0997.9697.092.08
222405-2240595.98796.85
323293-2329399.791100.66
422013-2201394.30795.16
522087-2208794.62595.51
622307-2230795.56796.40
90min122817-2281797.75296.781.8698.8197.801.85
222522-2252296.48897.51
323314-2331499.881100.92
422204-2220495.12696.13
522239-2223995.27696.32
622438-2243896.12897.12
极限122795-2279597.65897.371.7698.8898.561.75
222932-2293298.24599.43
323308-2330899.856101.06
422263-2226395.37996.54
522285-2228595.47396.68
622790-2279097.63698.79
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%
110.002101521265212852114721397212220.69
210.082109921035210670.22
单位质量响应值RSD%判断
2122.202089.981.09数据可信
供试品溶液-2025041321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%
5min110494-1049444.73055.7719.7044.7355.7719.70
215454-1545465.87265.87
313758-1375858.64358.64
412527-1252753.39653.40
516304-1630469.49569.50
69964-996442.47142.47
10min117295-1729573.71980.739.2973.7980.829.30
220060-2006085.50585.61
319433-1943382.83282.93
419361-1936182.52582.61
521095-2109589.91790.03
616401-1640169.90969.98
15min120346-2034686.72489.864.6486.9290.094.66
221786-2178692.86293.11
321069-2106989.80690.04
421528-2152891.76291.99
522198-2219894.61894.88
619568-1956883.40883.60
20min121858-2185893.16993.762.5693.5194.142.58
222202-2220294.63595.04
322119-2211994.28194.67
422119-2211994.28194.66
522691-2269196.71997.14
620996-2099689.49589.82
30min122231-2223194.75996.301.6795.2696.831.69
222518-2251895.98296.55
322760-2276097.01497.56
422402-2240295.48896.02
523268-2326899.17999.76
622376-2237695.37795.85
45min122474-2247495.79596.601.4796.4597.301.49
222558-2255896.15396.88
322651-2265196.54997.25
422378-2237895.38596.08
523311-2331199.362100.11
622608-2260896.36697.00
60min122727-2272796.87396.761.2297.6997.621.23
222592-2259296.29897.18
322726-2272696.86997.73
422384-2238495.41196.27
523201-2320198.89399.81
622575-2257596.22597.02
90min122585-2258596.26896.861.2797.2497.881.28
222516-2251695.97497.02
322952-2295297.83298.86
422376-2237695.37796.39
523143-2314398.64699.73
622771-2277197.06098.02
极限122580-2258096.24696.231.4197.3897.411.42
222379-2237995.39096.60
322596-2259696.31597.50
422164-2216494.47395.65
523119-2311998.54499.79
622620-2262096.41797.53
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%
110.002141121438214022131921438214020.23
210.082139421204212990.64
单位质量响应值RSD%判断
2140.202113.000.91数据可信
供试品溶液-2025041321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%
5min115908-1590867.15251.5318.9767.1551.5318.97
214066-1406659.37759.38
310721-1072145.25645.26
49754-975441.17441.17
511620-1162049.05149.05
611170-1117047.15247.15
10min120504-2050486.55377.6910.0386.6777.7810.03
219656-1965682.97383.07
316603-1660370.08670.16
416222-1622268.47868.55
519912-1991284.05484.14
617536-1753674.02474.10
15min121518-2151890.83487.725.4591.0987.945.46
221329-2132990.03690.27
319512-1951282.36682.56
419793-1979383.55283.73
522385-2238594.49394.72
620151-2015185.06385.26
20min121994-2199492.84391.413.8993.2591.773.90
221814-2181492.08392.47
320762-2076287.64287.97
421229-2122989.61489.94
523083-2308397.44097.82
621041-2104188.82089.16
30min122196-2219693.69694.162.3894.2694.682.38
222180-2218093.62894.17
321903-2190392.45992.93
422205-2220593.73494.20
523358-2335898.60199.14
621999-2199992.86493.36
45min122524-2252495.08095.832.0095.8096.502.00
222500-2250094.97995.68
322343-2234394.31694.95
422811-2281196.29296.92
523571-2357199.500100.21
622464-2246494.82795.47
60min122449-2244994.76496.052.0695.6496.882.05
222271-2227194.01294.87
322741-2274195.99696.78
422625-2262595.50696.29
523616-2361699.690100.56
622827-2282796.35997.16
90min122249-2224993.91996.141.9094.9597.131.89
222609-2260995.43996.45
322907-2290796.69797.64
422489-2248994.93295.88
523492-2349299.166100.20
622911-2291196.71497.68
极限122414-2241494.61695.831.5595.8196.981.55
222577-2257795.30496.47
322603-2260395.41496.52
422596-2259695.38496.49
523399-2339998.77499.98
622617-2261795.47396.60
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