替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检所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10000
标示量(mg)5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.722829428251283222834828160282750.27
214.662845328426284400.07
单位质量响应值RSD%判断
1920.861939.970.70数据可信
供试品溶液-24A2941批-氨氯地平-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%
5min115965-1596553.61356.463.9553.6156.463.95
216393-1639355.05155.05
317736-1773659.56159.56
416644-1664455.89355.89
517454-1745458.61458.61
616685-1668556.03156.03
10min119476-1947665.40467.831.8465.7068.141.84
220436-2043668.62868.93
320135-2013567.61767.95
420363-2036368.38368.69
520352-2035268.34668.67
620430-2043068.60868.92
15min119672-1967266.06270.674.6466.7271.364.60
221581-2158172.47373.16
321466-2146672.08772.79
421739-2173973.00373.69
519933-1993366.93967.64
621875-2187573.46074.15
20min119578-1957865.74671.994.8966.7773.084.84
221744-2174473.02074.11
320915-2091570.23671.34
422350-2235075.05576.15
522283-2228374.83075.91
621762-2176273.08174.18
30min120913-2091370.23075.594.8971.6277.074.83
223816-2381679.97881.47
321488-2148872.16073.66
423224-2322477.99079.50
522968-2296877.13178.62
622647-2264776.05377.56
45min122675-2267576.14779.532.3977.9381.442.39
223905-2390580.27782.22
324105-2410580.94982.85
424164-2416481.14783.09
523858-2385880.11982.04
623390-2339078.54880.48
60min123084-2308477.52081.242.8079.7383.582.79
224540-2454082.41084.80
324192-2419281.24183.59
425027-2502784.04586.44
524494-2449482.25584.62
623808-2380879.95182.32
极限123924-2392480.34182.731.8282.9885.531.84
224909-2490983.64986.49
324841-2484183.42086.22
425189-2518984.58987.45
524382-2438281.87984.70
624570-2457082.51085.32
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数625
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.918502488460498489688477758474438480970.19
210.938469808470868470330.01
单位质量响应值RSD%判断
77735.7577496.160.22数据可信
供试品溶液-24A2941批-替米沙坦-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%
5min1283338-28333832.85534.024.7032.8534.024.71
2273882-27388231.75831.76
3308189-30818935.73635.74
4293468-29346834.02934.03
5309133-30913335.84635.85
6292210-29221033.88333.88
10min1550882-55088263.87865.261.8364.0665.451.84
2551198-55119863.91564.09
3576054-57605466.79767.00
4563020-56302065.28565.47
5571269-57126966.24266.44
6564264-56426465.43065.62
15min1708563-70856382.16284.231.8782.7084.781.87
2725108-72510884.08084.61
3743769-74376986.24486.81
4726891-72689184.28784.84
5714808-71480882.88683.45
6739183-73918385.71386.26
20min1785109-78510991.03892.482.4192.0393.502.40
2774550-77455089.81490.81
3799593-79959392.71793.77
4791884-79188491.82492.84
5830306-83030696.27997.31
6804052-80405293.23594.26
30min1810663-81066394.00194.822.5095.5096.362.47
2808070-80807093.70095.20
3791093-79109391.73293.30
4827519-82751995.95697.49
5851466-85146698.732100.29
6817629-81762994.80996.35
45min1784146-78414690.92693.783.5092.9595.843.45
2783336-78333690.83292.85
3797263-79726392.44794.52
4826449-82644995.83297.89
5856472-85647299.313101.42
6804899-80489993.33395.41
60min1812146-81214694.17394.533.0196.7097.112.97
2786811-78681191.23593.76
3805802-80580293.43796.02
4838772-83877297.26099.86
5850238-85023898.590101.25
6797711-79771192.49995.09
极限1811290-81129094.07494.442.7797.1297.552.73
2789006-78900691.49094.52
3795417-79541792.23395.34
4833576-83357696.65899.79
5847910-84791098.320101.53
6809728-80972893.89397.00
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检所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10000
标示量(mg)5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.722835728394281212856528368283610.56
214.662804128208281240.42
单位质量响应值RSD%判断
1926.701918.420.31数据可信
供试品溶液-24A2941批-氨氯地平-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%
5min116806-1680656.66756.322.4856.6756.322.48
215963-1596353.82553.82
317191-1719157.96557.97
416783-1678356.58956.59
516894-1689456.96456.96
616588-1658855.93255.93
10min120818-2081870.19570.391.7970.5170.701.78
221088-2108871.10571.40
321508-2150872.52172.84
420734-2073469.91270.23
520651-2065169.63269.95
620460-2046068.98869.30
15min122597-2259776.19374.662.8876.9075.372.86
222444-2244475.67776.37
322872-2287277.12177.85
421136-2113671.26771.97
522103-2210374.52875.23
621710-2171073.20273.90
20min123335-2333578.68276.693.8579.8177.803.82
222997-2299777.54278.66
323921-2392180.65881.81
421410-2141072.19173.29
522339-2233975.32376.44
622457-2245775.72176.82
30min123872-2387280.49277.326.3182.0678.876.23
223419-2341978.96580.51
324205-2420581.61583.22
420191-2019168.08169.58
522636-2263676.32577.86
623267-2326778.45279.97
45min123670-2367079.81181.082.1381.8283.062.13
224281-2428181.87183.86
324932-2493284.06686.12
423538-2353879.36681.24
523794-2379480.22982.19
624069-2406981.15783.11
60min124841-2484183.76082.224.2986.2284.644.23
225113-2511384.67787.12
325224-2522485.05187.57
422783-2278376.82079.14
523348-2334878.72681.13
624994-2499484.27686.68
极限124804-2480483.63583.572.5286.5686.462.52
224955-2495584.14487.05
325555-2555586.16789.16
424048-2404881.08683.83
524064-2406481.14083.98
625291-2529185.27788.15
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数625
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.918474828459108458438441338454068457550.15
210.938418658415888417260.03
单位质量响应值RSD%判断
77521.0877010.610.47数据可信
供试品溶液-24A2941批-替米沙坦-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%
5min1261156-26115630.42031.233.9730.4231.233.97
2252737-25273729.43929.44
3274483-27448331.97231.97
4270217-27021731.47531.48
5283400-28340033.01133.01
6266466-26646631.03931.04
10min1502171-50217158.49460.512.9658.6660.682.96
2504171-50417158.72758.89
3533990-53399062.20062.38
4524022-52402261.03961.21
5538901-53890162.77262.96
6513721-51372159.83960.01
15min1685928-68592879.89881.572.0680.3982.082.06
2706549-70654982.30082.79
3715145-71514583.30283.82
4686082-68608279.91680.43
5717142-71714283.53484.07
6690950-69095080.48380.99
20min1760413-76041388.57592.713.5889.5193.673.55
2822678-82267895.82796.77
3836836-83683697.47798.46
4779329-77932990.77891.74
5788042-78804291.79392.79
6788063-78806391.79592.75
30min1787001-78700191.67295.153.9793.1096.633.93
2858832-858832100.039101.52
3845548-84554898.491100.02
4776054-77605490.39791.86
5810058-81005894.35795.86
6823603-82360395.93597.40
45min1757841-75784188.27594.604.3790.2196.604.33
2855022-85502299.595101.63
3843080-84308098.204100.28
4789185-78918591.92693.89
5812008-81200894.58596.61
6815523-81552394.99496.99
60min1778238-77823890.65194.774.2093.0897.304.15
2865235-865235100.785103.37
3837962-83796297.608100.23
4782375-78237591.13393.61
5796743-79674392.80695.36
6821094-82109495.64398.17
极限1766769-76676989.31594.414.0592.2597.464.01
2854178-85417899.497102.64
3834116-83411697.160100.32
4784016-78401691.32494.31
5799828-79982893.16696.24
6823949-82394995.97599.03
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检所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10000
标示量(mg)5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.722817728182281732813628201281740.09
214.662828128330283060.13
单位质量响应值RSD%判断
1913.991930.830.62数据可信
供试品溶液-24A2941批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126022-2602287.75088.632.8887.7588.632.88
227033-2703391.15991.16
325365-2536585.53485.53
427249-2724991.88791.89
526395-2639589.00789.01
625627-2562786.41886.42
10min126804-2680490.38792.422.5090.8792.902.50
228416-2841695.82396.33
327042-2704291.18991.66
427808-2780893.77294.28
527712-2771293.44993.94
626652-2665289.87490.35
15min127105-2710591.40291.821.8592.3992.831.86
228039-2803994.55195.59
326862-2686290.58291.56
427453-2745392.57593.61
527326-2732692.14793.16
626594-2659489.67990.66
20min127593-2759393.04793.372.1994.5494.882.17
228103-2810394.76796.33
326824-2682490.45491.94
427275-2727591.97593.52
528532-2853296.21497.74
627803-2780393.75595.23
30min127758-2775893.60491.811.9495.6293.851.92
227925-2792594.16796.26
326736-2673690.15792.14
427322-2732292.13394.19
526691-2669190.00692.07
626931-2693190.81592.81
45min126113-2611388.05790.192.2390.5992.732.20
227421-2742192.46795.08
325909-2590987.36989.86
426972-2697290.95393.52
527005-2700591.06493.62
627051-2705191.22093.72
60min126228-2622888.44490.361.8991.4793.401.88
227564-2756492.94996.08
326532-2653289.46992.44
427215-2721591.77394.85
526785-2678590.32393.39
626450-2645089.19392.20
极限126552-2655289.53790.111.7093.0593.651.68
227616-2761693.12596.77
326637-2663789.82493.29
426638-2663889.82793.41
526538-2653889.49093.06
626342-2634288.82992.33
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数625
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.918439148438518436668447458425838437520.10
210.938467968460758464360.07
单位质量响应值RSD%判断
77337.4977441.540.10数据可信
供试品溶液-24A2941批-替米沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186060-8606010.00810.1216.8310.0110.1216.83
297350-9735011.32111.32
360033-600336.9826.98
497939-9793911.39011.39
597130-9713011.29611.30
683393-833939.6989.70
10min1143484-14348416.68618.799.6116.7418.849.62
2175532-17553220.41320.48
3144959-14495916.85816.90
4177396-17739620.63020.69
5172387-17238720.04820.11
6155452-15545218.07818.13
15min1168133-16813319.55321.666.6319.7021.826.67
2199852-19985223.24223.42
3176366-17636620.51020.64
4196553-19655322.85823.04
5192654-19265422.40522.58
6184146-18414621.41521.57
20min1183939-18393921.39123.215.5821.6523.495.61
2212095-21209524.66624.97
3189265-18926522.01122.26
4204564-20456423.79024.09
5208848-20884824.28824.59
6198872-19887223.12823.40
30min1200238-20023823.28723.593.8223.6624.003.88
2214506-21450624.94625.39
3191756-19175622.30022.67
4207281-20728124.10624.54
5204029-20402923.72824.16
6199214-19921423.16823.57
45min1194720-19472022.64522.827.2223.1523.367.18
2209639-20963924.38024.96
3169062-16906219.66120.15
4199312-19931223.17923.75
5201650-20165023.45124.02
6202778-20277823.58224.11
60min1186022-18602221.63322.914.7522.2623.584.80
2210234-21023424.44925.17
3187989-18798921.86222.46
4204580-20458023.79224.49
5197652-19765222.98623.68
6195671-19567122.75623.42
极限1187937-18793721.85622.714.3522.6123.504.39
2209256-20925624.33525.19
3186481-18648121.68722.41
4199328-19932823.18124.01
5191490-19149022.26923.09
6197009-19700922.91123.70
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检所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10000
标示量(mg)5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.722829828180280322824328057281620.41
214.662847928390284340.23
单位质量响应值RSD%判断
1913.181939.560.97数据可信
供试品溶液-24A2941批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126289-2628988.47089.841.4988.4789.841.50
226494-2649489.16089.16
326703-2670389.86489.86
426695-2669589.83789.84
527447-2744792.36792.37
626556-2655689.36989.37
10min126966-2696690.74991.941.9391.2492.441.93
227920-2792093.95994.45
326797-2679790.18090.68
426932-2693290.63491.13
528010-2801094.26294.78
627291-2729191.84292.34
15min127711-2771193.25692.140.9494.2593.140.93
227354-2735492.05493.07
327154-2715491.38192.38
427057-2705791.05592.06
527364-2736492.08893.12
627628-2762892.97693.98
20min126150-2615088.00390.321.4689.5291.841.44
227219-2721991.60093.13
326831-2683190.29491.80
426895-2689590.51092.02
527194-2719491.51693.06
626741-2674189.99191.51
30min126676-2667689.77390.472.1691.7892.492.13
227966-2796694.11496.15
326700-2670089.85391.86
426722-2672289.92891.94
526981-2698190.79992.86
626253-2625388.34990.37
45min126479-2647989.11090.111.1091.6192.641.10
227023-2702390.94093.50
326498-2649889.17491.68
426604-2660489.53092.04
527187-2718791.49294.05
626866-2686690.41292.93
60min125811-2581186.86288.721.6089.8691.741.57
226796-2679690.17793.24
326585-2658589.46692.47
426346-2634688.66291.67
526733-2673389.96593.03
625906-2590687.18190.20
极限126656-2665689.70589.911.7893.1893.431.74
227373-2737392.11895.69
326914-2691490.57494.07
425938-2593887.28990.79
526858-2685890.38593.95
626560-2656089.38292.88
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数625
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.918439228427678387138423108398178415060.26
210.938461978444608453280.15
单位质量响应值RSD%判断
77131.6277340.160.20数据可信
供试品溶液-24A2941批-替米沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100571-10057111.71911.615.2211.7211.615.20
294478-9447811.00911.01
398753-9875311.50711.51
495155-9515511.08811.09
5108935-10893512.69412.69
699905-9990511.64211.64
10min1182144-18214421.22521.184.0621.2921.244.05
2187405-18740521.83821.90
3176298-17629820.54320.61
4171509-17150919.98520.05
5191980-19198022.37122.44
6181236-18123621.11921.18
15min1210275-21027524.50323.913.1624.6924.103.16
2205617-20561723.96024.14
3204250-20425023.80123.98
4192979-19297922.48722.66
5210348-21034824.51124.71
6207725-20772524.20524.39
20min1208119-20811924.25124.152.3424.5724.462.34
2209463-20946324.40824.72
3204915-20491523.87824.19
4198838-19883823.17023.47
5212854-21285424.80325.13
6209114-20911424.36724.68
30min1210555-21055524.53524.311.5724.9924.761.57
2213940-21394024.93025.38
3206089-20608924.01524.46
4205472-20547223.94324.37
5209196-20919624.37724.85
6206442-20644224.05624.51
45min1211327-21132724.62524.243.5625.2224.823.54
2210511-21051124.53025.12
3205585-20558523.95624.53
4194052-19405222.61223.17
5213370-21337024.86325.47
6213112-21311224.83325.42
60min1203247-20324723.68423.233.7924.4123.953.74
2206984-20698424.11924.85
3201294-20129423.45624.17
4184938-18493821.55022.24
5199724-19972423.27324.02
6199848-19984823.28824.01
极限1209730-20973024.43923.713.9825.3024.563.92
2208029-20802924.24125.10
3203415-20341523.70324.54
4189394-18939422.06922.87
5199504-19950423.24724.12
6210723-21072324.55525.41
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原始图谱下载图谱(谢鑫慧 于 2025-01-03 15:27:04 完成)
生成报告数据部分下载报告(谢鑫慧 于 2025-01-03 15:27:45 完成)
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