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%
110.392161221763216502153721742216610.44
210.402183221759217960.24
单位质量响应值RSD%判断
2084.792095.770.38数据可信
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%
5min120007-2000785.92080.239.4285.9280.239.42
217943-1794377.05677.06
318135-1813577.88077.88
418209-1820978.19878.20
516394-1639470.40470.40
621404-2140491.91991.92
10min122262-2226295.60495.222.5395.7595.362.54
221965-2196594.32894.46
321957-2195794.29494.42
422450-2245096.41196.54
521369-2136991.76991.89
623038-2303898.93699.09
15min122893-2289398.31398.291.0798.6298.581.08
222840-2284098.08698.37
322964-2296498.61898.91
422959-2295998.59798.89
522462-2246296.46396.73
623205-2320599.65399.97
20min123189-2318999.58599.050.80100.0599.500.81
223092-2309299.16899.62
323108-2310899.23799.69
423054-2305499.00599.46
522713-2271397.54097.97
623227-2322799.748100.23
30min123437-23437100.65099.690.63101.28100.310.63
223312-23312100.113100.73
323058-2305899.02299.64
423142-2314299.383100.00
523095-2309599.18199.77
623238-2323899.795100.45
45min123486-23486100.86098.154.50101.6698.934.45
223318-23318100.139100.92
323137-2313799.361100.14
423254-2325499.864100.65
523157-2315799.447100.21
620772-2077289.20590.02
60min123291-23291100.02399.670.58100.99100.620.58
223316-23316100.130101.08
323030-2303098.90299.85
423365-23365100.340101.29
523144-2314499.391100.32
623110-2311099.245100.21
90min123375-23375100.38399.810.53101.52100.920.54
223346-23346100.259101.37
323088-2308899.151100.26
423285-2328599.997101.12
523097-2309799.190100.28
623255-2325599.868101.00
极限123200-2320099.63299.530.38100.93100.820.38
223334-23334100.207101.49
323108-2310899.237100.51
423162-2316299.469100.75
523089-2308999.155100.41
623171-2317199.507100.80
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%
110.392185721774218082182721656217840.36
210.402162321495215590.42
单位质量响应值RSD%判断
2096.632072.980.81数据可信
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%
5min119691-1969184.78772.1022.0684.7972.1022.06
217747-1774776.41676.42
313774-1377459.30959.31
410772-1077246.38346.38
518369-1836979.09479.09
620114-2011486.60886.61
10min122513-2251396.93894.346.8397.0894.466.85
222951-2295198.82498.95
320926-2092690.10490.20
419292-1929283.06983.15
522855-2285598.41098.54
622921-2292198.69598.84
15min122605-2260597.33498.651.3097.6498.921.30
223357-23357100.572100.86
322636-2263697.46897.72
422881-2288198.52298.74
523156-2315699.707100.00
622823-2282398.27398.58
20min122636-2263697.46898.991.1897.9399.431.18
223346-23346100.525100.98
322761-2276198.00698.42
422947-2294798.80799.19
523226-23226100.008100.47
623024-2302499.13899.61
30min122755-2275597.98099.421.3598.61100.031.36
223587-23587101.562102.19
322793-2279398.14498.72
423007-2300799.06599.61
523158-2315899.715100.34
623240-23240100.068100.71
45min122685-2268597.67899.011.6798.4799.781.67
223522-23522101.283102.08
322432-2243296.58997.33
423141-2314199.642100.35
523123-2312399.564100.36
623063-2306399.306100.11
60min122662-2266297.57999.251.3198.53100.191.31
223508-23508101.222102.19
322804-2280498.19199.09
423012-2301299.08799.96
523115-2311599.530100.49
623204-2320499.913100.88
90min122552-2255297.10699.391.4698.22100.491.46
223457-23457101.003102.14
323229-23229100.021101.08
422912-2291298.65699.70
523371-23371100.632101.76
622972-2297298.914100.05
极限122374-2237496.33998.561.3697.6299.831.33
223278-23278100.232101.53
323098-2309899.457100.69
422929-2292998.72999.93
522897-2289798.59199.89
622763-2276398.01499.32
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%
110.392179521719216892174621743217380.18
210.402168821651216700.13
单位质量响应值RSD%判断
2092.202083.650.29数据可信
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%
5min121145-2114590.90988.424.6590.9188.424.65
221228-2122891.26691.27
319060-1906081.94581.94
421091-2109190.67790.68
521210-2121091.18891.19
619656-1965684.50784.51
10min123647-23647101.66698.062.50101.8298.202.50
222467-2246796.59296.74
322996-2299698.86799.00
421971-2197194.46094.61
522722-2272297.68997.84
623043-2304399.06999.21
15min123252-2325299.96797.921.49100.2998.231.49
222925-2292598.56298.87
323022-2302298.97999.28
422471-2247196.61096.92
522414-2241496.36596.68
622574-2257497.05297.36
20min123401-23401100.60898.141.75101.1098.611.75
223072-2307299.19499.67
322958-2295898.70399.17
422535-2253596.88597.35
522291-2229195.83696.31
622704-2270497.61198.08
30min123344-23344100.36398.581.23101.0299.221.23
223050-2305099.09999.74
323057-2305799.12999.76
422864-2286498.29998.93
522546-2254696.93297.57
622721-2272197.68498.31
45min123404-23404100.62198.181.77101.4498.981.77
223041-2304199.06099.87
323094-2309499.288100.08
422556-2255696.97597.77
522354-2235496.10796.90
622564-2256497.00997.80
60min123288-23288100.12298.141.69101.1199.111.69
223123-2312399.413100.39
323097-2309799.301100.26
422396-2239696.28797.24
522473-2247396.61897.58
622586-2258697.10498.06
90min123156-2315699.55598.261.35100.7199.391.34
222999-2299998.880100.02
323175-2317599.636100.76
422427-2242796.42097.54
522774-2277497.91299.03
622594-2259497.13898.26
极限123313-23313100.23097.681.81101.5598.971.80
222929-2292998.57999.88
322969-2296998.751100.04
422412-2241296.35697.63
522275-2227595.76797.05
622425-2242596.41297.69
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%
110.392172421703216982168321633216880.16
210.402155721489215230.23
单位质量响应值RSD%判断
2087.392069.520.61数据可信
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%
5min110629-1062945.90653.5313.5645.9153.5313.56
211736-1173650.68750.69
312101-1210152.26452.26
415606-1560667.40267.40
512299-1229953.11953.12
611994-1199451.80251.80
10min118803-1880381.20984.286.6881.2984.376.69
219666-1966684.93785.02
319218-1921883.00283.09
422050-2205095.23395.35
518801-1880181.20181.29
618548-1854880.10880.19
15min121153-2115391.35993.503.5791.5793.743.58
222057-2205795.26395.49
321185-2118591.49791.72
422924-2292499.00899.28
521770-2177094.02494.25
620810-2081089.87890.10
20min122129-2212995.57496.842.9395.9497.232.94
222690-2269097.99798.38
321933-2193394.72895.11
423618-23618102.005102.44
522290-2229096.27096.65
621873-2187394.46994.84
30min121996-2199695.00098.002.2195.5298.552.23
222943-2294399.09099.64
322530-2253097.30697.84
423491-23491101.457102.06
522704-2270498.05898.60
622480-2248097.09097.62
45min122280-2228096.22698.572.2396.9199.282.24
223002-2300299.345100.06
322501-2250197.18197.88
423716-23716102.428103.20
522581-2258197.52698.23
622851-2285198.69399.38
60min122284-2228496.24498.822.1997.0999.692.20
223090-2309099.725100.60
322743-2274398.22699.09
423753-23753102.588103.53
522634-2263497.75598.62
622779-2277998.38299.23
90min122356-2235696.55598.301.8097.5699.341.81
223026-2302699.448100.49
322790-2279098.42999.45
423425-23425101.172102.29
522464-2246497.02198.05
622503-2250397.19098.21
极限122197-2219795.86898.382.1297.0399.582.13
223131-2313199.902101.11
322743-2274398.22699.41
423508-23508101.530102.82
522385-2238596.68097.87
622711-2271198.08899.27
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%
110.392145121338213902125821430213730.37
210.402127421332213030.20
单位质量响应值RSD%判断
2057.072048.370.30数据可信
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%
5min115463-1546367.62064.7412.5167.6264.7412.51
216772-1677273.34573.34
312624-1262455.20555.21
416112-1611270.45970.46
515485-1548567.71767.72
612372-1237254.10354.10
10min120626-2062690.19887.323.6890.3187.433.69
220390-2039089.16689.29
319591-1959185.67285.76
419976-1997687.35687.47
520534-2053489.79689.91
618693-1869381.74581.84
15min121865-2186595.61794.461.5395.8894.711.53
221591-2159194.41894.69
321922-2192295.86696.10
421085-2108592.20692.47
521795-2179595.31195.57
621339-2133993.31693.54
20min122441-2244198.13697.061.8898.5697.471.87
222025-2202596.31696.74
322752-2275299.49699.89
421554-2155494.25794.67
522368-2236897.81698.24
622032-2203296.34796.73
30min122767-2276799.56198.491.89100.1599.061.88
222249-2224997.29697.88
323072-23072100.895101.46
421951-2195195.99396.57
522805-2280599.727100.31
622283-2228397.44597.99
45min122938-22938100.30998.551.48101.0699.281.48
222392-2239297.92198.67
322852-2285299.933100.66
422048-2204896.41797.15
522614-2261498.89299.64
622367-2236797.81298.52
60min123129-23129101.14499.151.79102.06100.051.79
222352-2235297.74698.66
322929-22929100.270101.16
422247-2224797.28798.18
523054-23054100.816101.73
622331-2233197.65598.52
90min123067-23067100.87399.381.51101.96100.441.51
222459-2245998.21499.29
323039-23039100.751101.81
422393-2239397.92698.98
523007-23007100.611101.69
622390-2239097.91398.94
极限123154-23154101.25499.571.74102.51100.801.73
222331-2233197.65598.90
323215-23215101.520102.75
422333-2233397.66398.88
522946-22946100.344101.60
622638-2263898.997100.19
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