替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5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%
114.562774227739277572775827742277480.04
214.652817928185281820.02
单位质量响应值RSD%判断
1905.771923.690.67数据可信
供试品溶液-2024070321批-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%
5min124309-2430989.06791.341.5989.0791.341.59
224798-2479890.85990.86
325206-2520692.35492.35
425419-2541993.13493.13
524742-2474290.65490.65
625103-2510391.97691.98
10min125489-2548993.39193.871.2694.2894.781.25
225281-2528192.62993.54
325326-2532692.79393.72
425762-2576294.39195.32
525711-2571194.20495.11
626142-2614295.78396.70
15min125771-2577194.42494.580.4596.2596.430.45
225990-2599095.22697.06
325694-2569494.14295.99
425921-2592194.97396.85
525732-2573294.28196.13
625772-2577294.42896.31
20min125548-2554893.60794.302.4296.3897.102.35
226739-2673997.971100.76
326030-2603095.37398.17
425046-2504691.76894.59
525179-2517992.25595.05
625887-2588794.84997.67
30min125682-2568294.09894.281.4597.8098.021.38
225610-2561093.83497.60
325949-2594995.07698.82
425927-2592794.99598.74
526144-2614495.79199.50
625085-2508591.91095.68
极限125779-2577994.45393.681.0299.1098.370.96
225434-2543493.18997.89
325684-2568494.10598.80
425801-2580194.53499.23
525602-2560293.80598.48
625114-2511492.01796.71
替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5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%
114.562782227713276782770627575276990.32
214.652772727721277240.02
单位质量响应值RSD%判断
1902.401892.420.38数据可信
供试品溶液-2024070421批-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%
5min125009-2500992.46791.692.4792.4791.692.47
224360-2436090.06790.07
324333-2433389.96789.97
424213-2421389.52489.52
525789-2578995.35195.35
625095-2509592.78592.78
10min125246-2524693.34392.911.8494.2793.831.84
225075-2507592.71193.61
324902-2490292.07192.97
424425-2442590.30791.20
525808-2580895.42196.37
625318-2531893.60994.54
15min124903-2490392.07592.951.0893.9394.801.09
225154-2515493.00394.83
325003-2500392.44594.26
425041-2504192.58594.38
525665-2566594.89296.80
625078-2507892.72294.59
20min125020-2502092.50793.211.0095.2995.991.00
225108-2510892.83395.59
324939-2493992.20894.95
425171-2517193.06695.79
525440-2544094.06096.92
625584-2558494.59397.38
30min124592-2459290.92593.101.4394.6396.811.41
225453-2545394.10897.79
325049-2504992.61596.28
425028-2502892.53796.19
525540-2554094.43098.23
625420-2542093.98697.72
极限124472-2447290.48192.341.6295.0996.981.58
225484-2548494.22398.85
324531-2453190.69995.29
424944-2494492.22696.81
525209-2520993.20697.95
625203-2520393.18497.86
替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5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%
114.562778027765277092769027655277200.19
214.652776927757277630.04
单位质量响应值RSD%判断
1903.851895.090.33数据可信
供试品溶液-2024070521批-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%
5min123721-2372187.61090.862.2087.6190.862.19
224856-2485691.80291.80
324992-2499292.30492.30
424247-2424789.55289.55
525179-2517992.99592.99
624613-2461390.90490.90
10min124421-2442190.19593.722.5591.0794.632.54
225887-2588795.60996.53
324879-2487991.88792.81
425186-2518693.02093.92
525919-2591995.72896.66
625954-2595495.85796.77
15min124946-2494692.13495.181.8993.9197.031.90
226111-2611196.43798.31
325527-2552794.28096.12
425709-2570994.95296.78
526106-2610696.41898.31
626229-2622996.87398.74
20min125273-2527393.34295.731.6796.0498.531.68
226136-2613696.52999.37
325958-2595895.87298.66
425551-2555194.36897.14
526441-2644197.656100.51
626161-2616196.62199.46
30min125101-2510192.70693.671.4896.3497.431.48
225644-2564494.71298.52
324965-2496592.20495.95
425046-2504692.50396.22
525872-2587295.55499.38
625549-2554994.36198.16
极限124761-2476191.45193.511.3896.0198.201.39
225699-2569994.91599.67
325414-2541493.86298.53
425076-2507692.61497.26
525350-2535093.62698.41
625604-2560494.56499.31
替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5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%
114.562784227746277522776827771277760.14
214.652767927556276180.32
单位质量响应值RSD%判断
1907.691885.190.84数据可信
供试品溶液-2024070321批-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%
5min121425-2142579.25882.636.4479.2682.636.45
220213-2021374.77574.77
323782-2378287.97887.98
423183-2318385.76285.76
521727-2172780.37680.38
623687-2368787.62687.63
10min123690-2369087.63788.852.2588.4389.672.28
223109-2310985.48886.24
324192-2419289.49490.37
424277-2427789.80990.67
524185-2418589.46990.27
624648-2464891.18192.06
15min123273-2327386.09587.392.4987.7689.102.52
222818-2281884.41286.01
324176-2417689.43591.21
423637-2363787.44189.20
523426-2342686.66188.36
624403-2440390.27592.06
20min123163-2316385.68886.571.7388.2289.161.73
223451-2345186.75389.20
323155-2315585.65888.33
423466-2346686.80989.44
523027-2302785.18587.75
624145-2414589.32192.01
30min122116-2211681.81584.432.4185.2087.882.43
222312-2231282.54085.85
323227-2322785.92589.45
422936-2293684.84888.35
522768-2276884.22787.64
623579-2357987.22790.81
极限122339-2233982.64083.921.2686.8488.221.28
222415-2241582.92187.06
322558-2255883.45087.83
422920-2292084.78989.14
523015-2301585.14089.40
622859-2285984.56389.02
替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5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%
114.562757627591274972750527495275330.17
214.652737827364273710.04
单位质量响应值RSD%判断
1891.001868.330.86数据可信
供试品溶液-2024070421批-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%
5min124418-2441891.13789.194.9891.1489.194.98
222167-2216782.73582.74
323533-2353387.83487.83
423043-2304386.00586.00
525004-2500493.32493.32
625208-2520894.08594.09
10min124034-2403489.70488.024.1790.6188.924.17
222277-2227783.14683.97
323226-2322686.68887.57
422778-2277885.01685.88
524389-2438991.02991.96
624799-2479992.55993.50
15min123351-2335187.15487.073.6088.9688.843.61
222489-2248983.93785.60
323169-2316986.47588.22
422376-2237683.51585.23
524390-2439091.03292.88
624191-2419190.28992.16
20min123035-2303585.97585.193.3088.6587.843.32
221705-2170581.01183.51
322690-2269084.68787.30
422401-2240183.60986.15
523911-2391189.24492.00
623214-2321486.64389.41
30min122963-2296385.70685.323.9489.2588.813.93
222162-2216282.71786.02
322511-2251184.01987.48
421766-2176681.23984.62
523584-2358488.02491.67
624165-2416590.19293.83
极限122609-2260984.38582.644.5188.7886.994.46
221391-2139179.83983.97
321404-2140479.88784.18
421004-2100478.39482.59
523218-2321886.65891.18
623231-2323186.70691.24
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