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%
110.072156021649215882152321589215820.22
210.052132121363213420.14
单位质量响应值RSD%判断
2143.202123.580.66数据可信
供试品溶液-25022201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%
5min113399-1339956.38053.596.3956.3853.596.40
213491-1349156.76756.77
312883-1288354.20954.21
412679-1267953.35053.35
512733-1273353.57753.58
611228-1122847.24547.24
10min120080-2008084.49281.722.7784.5981.812.77
219895-1989583.71383.81
318737-1873778.84178.93
419564-1956482.32182.41
519366-1936681.48781.58
618883-1888379.45579.53
15min122099-2209992.98791.851.5793.2292.081.57
222138-2213893.15193.39
321627-2162791.00191.22
422143-2214393.17293.40
521356-2135689.86190.09
621609-2160990.92591.14
20min122791-2279195.89994.951.5696.2995.331.56
222595-2259595.07495.46
322345-2234594.02294.40
422951-2295196.57296.95
521982-2198292.49592.87
622731-2273195.64796.01
30min122993-2299396.74996.651.8997.3097.181.89
223130-2313097.32597.87
322755-2275595.74896.28
423586-2358699.24499.79
522277-2227793.73694.27
623071-2307197.07797.60
45min123030-2303096.90597.913.0097.6298.612.99
223489-2348998.83699.55
323055-2305597.01097.70
424189-24189101.781102.49
522150-2215093.20293.89
623696-2369699.707100.39
60min123404-2340498.47898.652.9099.3599.512.89
223582-2358299.227100.10
323466-2346698.73999.59
424521-24521103.178104.06
522392-2239294.22095.06
623298-2329898.03298.88
极限123063-2306397.04498.643.7198.0899.673.69
223619-2361999.383100.42
323230-2323097.74698.76
424986-24986105.135106.18
522361-2236194.09095.09
623401-2340198.46699.48
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%
110.072175121755216652161321657216880.29
210.052152121485215030.12
单位质量响应值RSD%判断
2153.722139.600.47数据可信
供试品溶液-25022202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%
5min112828-1282853.64355.2213.1053.6455.2213.10
213459-1345956.28156.28
316000-1600066.90766.91
412142-1214250.77450.77
513903-1390358.13858.14
610900-1090045.58145.58
10min119154-1915480.09681.394.0780.1981.484.08
219544-1954481.72781.82
320929-2092987.51987.63
419406-1940681.15081.23
519173-1917380.17680.27
618572-1857277.66377.74
15min122023-2202392.09491.302.9492.3291.522.94
222460-2246093.92194.15
322186-2218692.77593.03
422244-2224493.01893.24
521222-2122288.74488.97
620858-2085887.22287.43
20min122744-2274495.10994.532.0395.4894.902.04
222738-2273895.08395.47
322897-2289795.74896.16
422796-2279695.32695.70
522778-2277895.25195.63
621676-2167690.64290.99
30min123286-2328697.37596.641.7697.9197.181.77
223324-2332497.53498.08
323476-2347698.17098.74
423233-2323397.15397.69
522994-2299496.15496.69
622344-2234493.43693.94
45min123289-2328997.38897.301.7698.0898.001.76
223370-2337097.72698.43
323930-23930100.068100.80
423351-2335197.64798.34
522860-2286095.59496.29
622812-2281295.39396.05
60min123252-2325297.23398.152.6598.0999.012.65
223462-2346298.11198.98
324684-24684103.221104.12
423385-2338597.78998.65
523073-2307396.48497.34
622976-2297696.07996.90
极限123321-2332197.52198.251.5998.5499.271.60
223465-2346598.12499.16
324122-24122100.871101.94
423646-2364698.88099.90
523407-2340797.88198.90
623010-2301096.22197.20
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%
110.072153921602215182154021696215790.34
210.052155021506215280.15
单位质量响应值RSD%判断
2142.902142.090.03数据可信
供试品溶液-25022203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%
5min116315-1631568.35657.0716.2968.3657.0716.29
213539-1353956.72656.73
312293-1229351.50551.51
413948-1394858.43958.44
510154-1015442.54342.54
615480-1548064.85864.86
10min120702-2070286.73781.917.1086.8582.017.11
219251-1925180.65880.75
319255-1925580.67480.76
420514-2051485.94986.05
517053-1705371.44871.52
620529-2052986.01286.12
15min122059-2205992.42390.023.8592.6890.253.87
220911-2091187.61387.84
321853-2185391.55991.78
422009-2200992.21392.45
520051-2005184.00984.20
622028-2202892.29392.54
20min122536-2253694.42193.561.8294.8393.941.84
221743-2174391.09991.47
322441-2244194.02394.40
422723-2272395.20595.60
521907-2190791.78692.12
622635-2263594.83695.24
30min122664-2266494.95795.962.1495.5396.502.14
222232-2223293.14793.67
322876-2287695.84696.38
423720-2372099.38299.93
522876-2287695.84696.33
623059-2305996.61297.18
45min122951-2295196.16097.353.2896.8998.043.27
222691-2269195.07195.75
322926-2292696.05596.74
424736-24736103.639104.36
522829-2282995.64996.29
623274-2327497.51398.24
60min122831-2283195.65798.633.6096.5599.503.58
223159-2315997.03197.87
323463-2346398.30599.15
425211-25211105.629106.52
523379-2337997.95398.76
623206-2320697.22898.12
极限122831-2283195.65799.015.2996.70100.035.25
223105-2310596.80597.81
323087-2308796.73097.74
426141-26141109.525110.59
523504-2350498.47799.44
623116-2311696.85197.90
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