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)0
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%
110.392184321853218822183421813218450.12
210.352171321734217240.07
单位质量响应值RSD%判断
2102.502098.940.12数据可信
中间条件6月-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%
5min111894-1189450.82456.616.0150.8256.606.01
213196-1319656.38856.39
314170-1417060.55060.55
413139-1313956.14456.14
513160-1316056.23456.23
613923-1392359.49559.49
10min118802-1880280.34383.162.7980.4383.262.79
219953-1995385.26185.36
319578-1957883.65983.76
420180-2018086.23186.32
518979-1897981.09981.19
619281-1928182.39082.49
15min121031-2103189.86891.481.5590.0991.711.55
221586-2158692.23992.48
321118-2111890.24090.48
421942-2194293.76194.00
521388-2138891.39391.62
621384-2138491.37691.61
20min122141-2214194.61194.692.1594.9895.072.14
222627-2262796.68897.08
321581-2158192.21892.61
422674-2267496.88897.28
521624-2162492.40292.78
622305-2230595.31295.70
30min122708-2270897.03496.861.2797.5697.401.27
222794-2279497.40197.95
322514-2251496.20596.75
423052-2305298.50499.06
522203-2220394.87695.41
622730-2273097.12897.68
45min122909-2290997.89397.551.7798.5898.251.76
223073-2307398.59399.31
322351-2235195.50896.21
423223-2322399.23499.95
522301-2230195.29595.99
623115-2311598.77399.48
60min123005-2300598.30397.951.4099.1598.811.39
223141-2314198.88499.76
322550-2255096.35997.22
423093-2309398.67999.56
522495-2249596.12496.98
623247-2324799.337100.21
90min122858-2285897.67598.251.3698.6999.281.36
223076-2307698.60699.65
322527-2252796.26097.28
423224-2322499.239100.29
522856-2285697.66698.68
623409-23409100.029101.07
极限122916-2291697.92398.011.3199.1099.211.30
223127-2312798.824100.03
322492-2249296.11197.30
422960-2296098.11199.33
522766-2276697.28298.46
623364-2336499.837101.04
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)0
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%
110.392169121640216782162921641216560.13
210.352169221721217060.10
单位质量响应值RSD%判断
2084.312097.200.44数据可信
中间条件6月-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%
5min114733-1473363.25654.9316.2963.2654.9316.30
215356-1535665.93165.93
310717-1071746.01446.01
412109-1210951.99051.99
510328-1032844.34344.34
613522-1352258.05758.06
10min121125-2112590.70084.867.8490.8184.957.85
220872-2087289.61489.72
318424-1842479.10479.18
418480-1848079.34479.43
518190-1819078.09978.17
621492-2149292.27692.37
15min122330-2233095.87492.613.4596.1392.853.47
221888-2188893.97694.24
321478-2147892.21692.42
420738-2073889.03989.26
520665-2066588.72588.93
622324-2232495.84896.10
20min122694-2269497.43795.022.7797.8595.412.78
222101-2210194.89195.31
322334-2233495.89196.25
421358-2135891.70192.07
521478-2147892.21692.57
622828-2282898.01298.42
30min123117-2311799.25396.932.3299.8397.482.34
222659-2265997.28797.86
322652-2265297.25797.78
422006-2200694.48395.00
521910-2191094.07194.58
623115-2311599.24599.82
45min123290-2329099.99698.351.64100.7499.061.65
222733-2273397.60498.34
322918-2291898.39999.08
422367-2236796.03396.71
522766-2276697.74698.41
623369-23369100.335101.07
60min123322-23322100.13398.681.66101.0499.551.68
223027-2302798.86799.77
322858-2285898.14198.99
422478-2247896.51097.35
522716-2271697.53198.36
623498-23498100.889101.80
90min123331-23331100.17298.871.58101.2599.911.60
223140-2314099.352100.42
322770-2277097.76398.78
422552-2255296.82797.83
522863-2286398.16399.15
623509-23509100.936102.01
极限123346-23346100.23698.911.38101.48100.101.40
223160-2316099.438100.67
322799-2279997.88899.06
422667-2266797.32198.48
522821-2282197.98299.13
623423-23423100.567101.81
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)0
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%
110.392176721714217412173421749217410.09
210.352170021694216970.02
单位质量响应值RSD%判断
2092.492096.330.13数据可信
中间条件6月-供试品溶液-2025041421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%
5min115511-1551166.48060.7813.7666.4860.7813.77
213693-1369358.68858.69
312948-1294855.49555.49
412790-1279054.81854.82
517522-1752275.09975.10
612627-1262754.11954.12
10min121388-2138891.66987.174.8891.7887.274.89
220490-2049087.82087.92
320201-2020186.58186.67
419085-1908581.79881.89
521479-2147992.05992.18
619386-1938683.08883.18
15min122524-2252496.53792.744.1396.8092.994.13
221989-2198994.24494.49
321985-2198594.22794.46
420017-2001785.79386.02
522058-2205894.54094.82
621261-2126191.12491.35
20min122757-2275797.53695.822.0797.9696.222.08
222910-2291098.19298.59
322521-2252196.52596.92
421771-2177193.31093.68
522306-2230695.60396.04
621876-2187693.76094.14
30min123150-2315099.22097.621.3399.8198.181.33
223087-2308798.95099.52
322786-2278697.66098.22
422647-2264797.06597.59
522632-2263297.00097.60
622354-2235495.80996.35
45min123493-23493100.69199.151.48101.4499.871.47
223531-23531100.853101.58
323149-2314999.21699.93
423126-2312699.11899.81
522720-2272097.37898.13
622781-2278197.63998.34
60min123522-23522100.81599.791.29101.74100.681.29
223682-23682101.501102.40
323101-2310199.01099.89
423401-23401100.296101.15
523095-2309598.98599.90
622894-2289498.12398.98
90min123593-23593101.119100.091.35102.21101.141.35
223858-23858102.255103.32
323283-2328399.791100.84
423242-2324299.615100.64
523117-2311799.079100.16
623023-2302398.67699.70
极限123558-23558100.969100.370.91102.23101.590.91
223767-23767101.865103.10
323222-2322299.529100.74
423424-23424100.395101.58
523295-2329599.842101.09
623245-2324599.628100.81
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)0
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%
110.392171521797217182172821736217390.16
210.352179621774217850.08
单位质量响应值RSD%判断
2092.302104.830.43数据可信
中间条件6月-供试品溶液-SI4S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%
5min112822-1282254.84737.4040.3954.8537.4040.39
212420-1242053.12753.13
34444-444419.00919.01
45172-517222.12322.12
59485-948540.57240.57
68118-811834.72534.72
10min120883-2088389.32871.2519.5889.4271.3119.60
218804-1880480.43580.52
312549-1254953.67953.71
413141-1314156.21156.25
517864-1786476.41476.48
616695-1669571.41371.47
15min122338-2233895.55185.349.7395.7985.529.77
220984-2098489.76089.98
317303-1730374.01474.14
418157-1815777.66777.80
521274-2127491.00091.20
619651-1965184.05884.23
20min123024-2302498.48691.816.0798.8992.136.11
221715-2171592.88793.26
319637-1963783.99884.24
420358-2035887.08287.34
522652-2265296.89597.24
621392-2139291.50591.82
30min123155-2315599.04695.872.7099.6196.352.74
222196-2219694.94495.47
321394-2139491.51491.90
422529-2252996.36996.77
522834-2283497.67398.18
622367-2236795.67696.15
45min123322-2332299.76197.391.84100.4998.031.88
222377-2237795.71896.40
322237-2223795.11995.66
422794-2279497.50298.07
523132-2313298.94899.62
622744-2274497.28897.92
60min123163-2316399.08098.100.7899.9898.900.80
222656-2265696.91297.76
322819-2281997.60998.30
422936-2293698.10998.84
523042-2304298.56399.40
622982-2298298.30699.10
90min122905-2290597.97798.250.9499.0499.210.92
222691-2269197.06198.07
323084-2308498.74399.60
422883-2288397.88398.77
523325-2332599.773100.77
622928-2292898.07599.03
极限123003-2300398.39698.250.9599.6299.370.95
222656-2265696.91298.08
322961-2296198.21699.24
422912-2291298.00799.06
523335-2333599.816100.98
622944-2294498.14499.26
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