培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1102116420908208272111221027210080.67
2102094021053209960.39
单位质量响应值RSD%判断
2100.802099.600.05数据可信
供试品溶液-2025110421批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114188-1418857.63851.9716.6257.6451.9716.62
211444-1144446.49146.49
315770-1577064.06564.07
413364-1336454.29154.29
512248-1224849.75749.76
69737-973739.55639.56
10min123247-2324794.44096.101.9895.0896.681.93
223984-2398497.43497.95
323721-2372196.36697.08
422984-2298493.37293.98
524250-2425098.51599.07
623748-2374896.47696.92
15min123615-2361595.93596.511.2097.6298.161.13
223860-2386096.93198.53
323366-2336694.92496.71
423649-2364996.07397.71
524199-2419998.30899.96
623857-2385796.91898.43
20min124146-2414698.09296.021.76100.8598.731.70
223366-2336694.92497.60
323052-2305293.64896.49
423530-2353095.59098.30
524057-2405797.731100.47
623657-2365796.10698.69
30min122846-2284692.81194.381.2196.6698.161.12
223222-2322294.33998.07
322987-2298793.38497.26
423290-2329094.61598.39
523603-2360395.88699.71
623438-2343895.21698.87
45min122461-2246191.24793.141.3896.1297.971.28
223147-2314794.03498.81
322622-2262291.90196.82
423218-2321894.32299.14
523157-2315794.07598.97
622955-2295593.25497.97
极限122159-2215990.02091.951.2695.9197.821.21
222615-2261591.87397.70
322857-2285792.85698.79
422827-2282792.73498.60
522879-2287992.94598.88
622468-2246891.27697.03
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1108056280660804198044080465805090.13
2108052780444804860.08
单位质量响应值RSD%判断
8050.908048.600.03数据可信
供试品溶液-2025110421批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155634-5563444.80240.6115.6544.8040.6215.64
246165-4616537.17737.18
360707-6070748.88848.89
453055-5305542.72642.73
548884-4888439.36739.37
638142-3814230.71630.72
10min185287-8528768.68270.342.1869.1870.802.11
289138-8913871.78372.20
387311-8731170.31270.86
484808-8480868.29668.77
588974-8897471.65172.09
688575-8857571.33071.67
15min187019-8701970.07770.860.9071.3472.100.82
288625-8862571.37072.58
387400-8740070.38471.71
487466-8746670.43771.67
588710-8871071.43972.67
688760-8876071.47972.61
20min186514-8651469.67070.081.4771.7172.101.38
287509-8750970.47272.48
384808-8480868.29670.40
487244-8724470.25872.27
588621-8862171.36773.39
687430-8743070.40872.34
30min184753-8475368.25269.391.2671.0772.191.16
286570-8657069.71572.50
384843-8484368.32571.19
486738-8673869.85172.65
586946-8694670.01872.84
687159-8715970.19072.90
45min183024-8302466.86068.251.5470.4371.821.44
285741-8574169.04872.61
383120-8312066.93770.56
485506-8550668.85872.43
585620-8562068.95072.55
685485-8548568.84272.33
极限182095-8209566.11267.370.9770.4371.700.92
284329-8432967.91172.24
384063-8406367.69672.06
483558-8355867.29071.63
583856-8385667.53071.89
684072-8407267.70471.96
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1102100921113209602086020943209770.45
2102110321276211900.58
单位质量响应值RSD%判断
2097.702119.000.72数据可信
供试品溶液-2025110521批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19431-943138.16648.1513.5038.1748.1513.50
212375-1237550.08050.08
314122-1412257.15057.15
412252-1225249.58249.58
510789-1078943.66243.66
612419-1241950.25850.26
10min124038-2403897.27995.713.2997.7096.253.25
222308-2230890.27890.83
323238-2323894.04194.68
424035-2403597.26797.82
523778-2377896.22696.71
624508-2450899.18199.74
15min124396-2439698.72797.281.39100.2398.881.35
223886-2388696.66498.22
323538-2353895.25596.94
424110-2411097.57099.20
523898-2389896.71298.27
624400-2440098.744100.40
20min123091-2309193.44695.721.7696.0598.401.78
223362-2336294.54397.18
323719-2371995.98898.73
424142-2414297.700100.42
523499-2349995.09797.73
624097-2409797.517100.28
30min123895-2389596.70094.851.31100.3498.591.26
223201-2320193.89197.58
323270-2327094.17197.98
423357-2335794.52398.32
523160-2316093.72697.41
623740-2374096.07399.91
45min123458-2345894.93193.261.5999.6598.061.52
222983-2298393.00997.74
322549-2254991.25396.10
423054-2305493.29798.15
522769-2276992.14396.87
623461-2346194.94499.85
极限122738-2273892.01892.801.3497.7998.631.31
222519-2251991.13196.89
322744-2274492.04297.91
423249-2324994.08699.97
523101-2310193.48799.24
623238-2323894.041100.00
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1108027880523803878043780734804720.22
2108121181249812300.04
单位质量响应值RSD%判断
8047.208123.000.67数据可信
供试品溶液-2025110521批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136528-3652829.28837.9414.5829.2937.9414.58
248593-4859338.96238.96
356714-5671445.47345.47
449508-4950839.69639.70
542779-4277934.30034.30
649823-4982339.94839.95
10min189207-8920771.52669.803.9471.8570.223.90
281495-8149565.34365.78
385400-8540068.47468.98
488002-8800270.56071.00
586742-8674269.55069.93
691472-9147273.34273.79
15min190302-9030272.40470.821.7773.5272.021.71
287628-8762870.26071.42
386130-8613069.05970.33
488583-8858371.02672.25
587506-8750670.16371.32
689816-8981672.01573.27
20min187514-8751470.16970.141.1772.0972.121.20
286035-8603568.98370.92
387497-8749770.15572.19
488398-8839870.87872.89
586657-8665769.48271.42
688741-8874171.15373.21
30min187257-8725769.96369.111.3072.6771.871.30
285023-8502368.17270.88
385905-8590568.87971.69
486038-8603868.98571.79
585152-8515268.27570.98
687779-8777970.38173.23
45min186193-8619369.11068.261.5872.5971.791.55
284611-8461167.84171.30
383650-8365067.07170.65
484876-8487668.05471.62
584192-8419267.50570.97
687249-8724969.95673.59
极限184999-8499968.15267.741.3072.4072.031.27
283213-8321366.72070.94
383170-8317066.68671.01
484867-8486768.04772.37
584726-8472667.93472.15
685944-8594468.91073.32
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1102131821169211122120321162211930.37
2102087120798208340.25
单位质量响应值RSD%判断
2119.302083.401.21数据可信
供试品溶液-2025110621批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19607-960739.01048.0225.0939.0148.0225.09
210089-1008940.96740.97
312665-1266551.42751.43
411377-1137746.19746.20
517403-1740370.66670.67
69815-981539.85439.85
10min124065-2406597.71796.051.5798.1596.591.52
224122-2412297.94898.40
323351-2335194.81895.39
423637-2363795.97996.49
523544-2354495.60196.39
623215-2321594.26694.71
15min124624-2462499.98796.242.19101.5197.842.09
223500-2350095.42396.97
323213-2321394.25795.88
423465-2346595.28196.86
523419-2341995.09496.94
623980-2398097.37298.86
20min123907-2390797.07595.341.3099.7198.021.22
223500-2350095.42398.03
323216-2321694.27096.94
423190-2319094.16496.80
523292-2329294.57897.48
623779-2377996.55699.13
30min123863-2386396.89793.223.98100.6196.953.72
223159-2315994.03897.70
322621-2262191.85495.57
423120-2312093.88097.56
521324-2132486.58790.54
623661-2366196.07799.72
45min123690-2369096.19492.492.73100.9897.262.61
223011-2301193.43798.15
322290-2229090.51095.25
421911-2191188.97193.70
522761-2276192.42297.34
623002-2300293.40198.11
极限123458-2345895.25292.652.48101.1198.452.32
223420-2342095.098100.84
322203-2220390.15695.90
422493-2249391.33497.05
522288-2228890.50196.45
623047-2304793.58399.33
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1108267082973826788274882970828080.19
2107985680315800860.41
单位质量响应值RSD%判断
8280.808008.602.37数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2025110621批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138088-3808830.32337.2522.4130.3237.2522.41
239864-3986431.73731.74
350767-5076740.41840.42
445343-4534336.09936.10
566017-6601752.55952.56
640635-4063532.35132.35
10min187575-8757569.72268.961.0970.0669.371.00
287660-8766069.79070.14
385310-8531067.91968.37
486102-8610268.54968.95
586059-8605968.51569.10
686991-8699169.25769.62
15min190091-9009171.72569.272.6472.8470.452.51
287043-8704369.29870.43
384819-8481967.52868.73
485412-8541268.00069.16
585199-8519967.83069.18
689483-8948371.24172.37
20min188198-8819870.21868.582.2672.1370.532.16
285972-8597268.44670.34
384229-8422967.05869.01
484713-8471367.44369.36
584877-8487767.57469.67
688847-8884770.73572.66
30min187385-8738569.57167.472.7372.2670.182.59
285196-8519667.82870.49
382123-8212365.38168.08
483565-8356566.52969.20
582772-8277265.89868.75
687454-8745469.62672.33
45min186236-8623668.65666.752.4472.1270.222.32
283903-8390366.79970.21
381562-8156264.93568.36
482977-8297766.06169.47
582088-8208865.35468.94
686313-8631368.71772.20
极限185739-8573968.26066.333.1372.4870.542.96
285765-8576568.28172.44
380173-8017363.82967.98
481552-8155264.92769.07
581195-8119564.64368.95
685466-8546668.04372.29
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