奥美沙坦酯左氨氯地平片项目信息
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100546-202406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4000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.791741517396174201746817422174240.16
215.861751617399174580.48
单位质量响应值RSD%判断
1103.481100.760.18数据可信
供试品溶液-8170102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%
5min126923-2692377.11874.272.7377.1274.272.73
225006-2500671.62771.63
325490-2549073.01373.01
426298-2629875.32875.33
525523-2552373.10873.11
626333-2633375.42875.43
10min131874-3187491.30088.002.2091.4388.132.20
230823-3082388.28988.41
330118-3011886.27086.39
430564-3056487.54787.67
530013-3001385.96986.09
630948-3094888.64788.77
15min133635-3363596.34493.531.8596.6293.801.85
232663-3266393.56093.83
331926-3192691.44991.71
432627-3262793.45793.73
532156-3215692.10792.37
632916-3291694.28494.56
20min134683-3468399.34696.821.5799.7997.251.57
234052-3405297.53897.96
333553-3355396.10996.53
433791-3379196.79197.22
533121-3312194.87295.29
633613-3361396.28196.71
30min135218-35218100.87899.350.92101.4899.930.93
234675-3467599.32399.91
334541-3454198.93999.52
434385-3438598.49299.08
534408-3440898.55899.13
634873-3487399.890100.48
45min135564-35564101.869100.710.90102.64101.460.90
235545-35545101.815102.57
335070-35070100.454101.20
434971-34971100.171100.92
534906-3490699.984100.73
634895-3489599.953100.71
60min135422-35422101.462100.930.91102.41101.850.91
235780-35780102.488103.41
335093-35093100.520101.43
435205-35205100.841101.76
534942-34942100.088101.00
634973-34973100.176101.10
极限135315-35315101.156100.421.09102.27101.511.08
235634-35634102.070103.16
335028-35028100.334101.41
434974-34974100.179101.27
534866-3486699.870100.94
634531-3453198.910100.00
奥美沙坦酯左氨氯地平片项目信息
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100546-202406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4000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.791740117437174361765417409174670.61
215.861740317505174540.42
单位质量响应值RSD%判断
1106.211100.500.37数据可信
供试品溶液-8170102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%
5min126497-2649775.81372.832.7275.8172.832.72
225812-2581273.85373.85
324417-2441769.86269.86
425314-2531472.42872.43
525177-2517772.03672.04
625506-2550672.97872.98
10min132103-3210391.85387.923.2791.9888.053.27
231383-3138389.79389.92
329151-2915183.40783.52
430461-3046187.15587.28
530375-3037586.90987.03
630907-3090788.43188.55
15min134348-3434898.27694.233.1798.5694.503.17
233784-3378496.66396.94
331350-3135089.69989.95
432533-3253393.08393.35
532761-3276193.73694.00
632829-3282993.93094.20
20min135622-35622101.92297.792.63102.3698.212.63
234740-3474099.39899.83
333049-3304994.56094.96
433661-3366196.31196.73
533955-3395597.15297.57
634038-3403897.38997.82
30min136485-36485104.391100.802.35105.00101.392.35
235860-35860102.603103.20
334190-3419097.82498.39
434681-3468199.22999.81
535136-35136100.531101.11
635033-35033100.236100.82
45min136634-36634104.817102.001.96105.60102.761.97
236449-36449104.288105.06
335212-35212100.749101.47
435071-35071100.345101.09
535325-35325101.072101.82
635206-35206100.731101.49
60min136587-36587104.683101.751.50105.64102.681.51
235694-35694102.128103.07
335315-35315101.043101.94
435200-35200100.714101.63
535237-35237100.820101.74
635336-35336101.103102.03
极限136538-36538104.542101.371.85105.68102.461.85
235751-35751102.291103.41
334969-34969100.053101.12
434990-34990100.113101.20
535519-35519101.627102.71
634800-3480099.570100.66
奥美沙坦酯左氨氯地平片项目信息
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100546-202406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4000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.791728417265172811742017358173220.38
215.861755917639175990.33
单位质量响应值RSD%判断
1097.021109.650.81数据可信
供试品溶液-8170102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%
5min121000-2100060.08860.772.0460.0960.772.04
221609-2160961.83061.83
320851-2085159.66259.66
420731-2073159.31859.32
521755-2175562.24862.25
621489-2148961.48761.49
10min126929-2692977.05376.642.0477.1576.742.04
227442-2744278.52178.62
326312-2631275.28775.39
426082-2608274.62974.73
527319-2731978.16978.27
626615-2661576.15476.26
15min129585-2958584.65283.952.1784.8884.182.17
229736-2973685.08485.32
328547-2854781.68281.91
428724-2872482.18982.41
530223-3022386.47886.71
629228-2922883.63183.86
20min131584-3158490.37290.042.3590.7490.402.35
232372-3237292.62793.00
330582-3058287.50587.87
430993-3099388.68189.04
532277-3227792.35592.73
630989-3098988.67089.04
30min133131-3313194.79995.441.5195.3295.961.51
233675-3367596.35596.89
332726-3272693.64094.15
433282-3328295.23195.74
534172-3417297.77798.31
633142-3314294.83095.35
45min134018-3401897.33797.671.0398.0198.351.03
234428-3442898.51099.20
333744-3374496.55397.22
433893-3389396.97997.65
534672-3467299.20899.90
634052-3405297.43498.11
60min134112-3411297.60698.192.3698.4599.032.35
234490-3449098.68799.54
334123-3412397.63798.46
434517-3451798.76499.59
535580-35580101.806102.67
633080-3308094.65395.49
极限134302-3430298.14998.801.6799.1599.801.66
234237-3423797.96398.98
334088-3408897.53798.52
434590-3459098.97399.97
535650-35650102.006103.04
634302-3430298.14999.14
奥美沙坦酯左氨氯地平片项目信息
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100546-202406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4000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.791752917205172691740017392173590.73
215.861737917408173940.12
单位质量响应值RSD%判断
1099.371096.720.18数据可信
供试品溶液-8170102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%
5min121860-2186062.84860.006.8062.8560.006.80
221407-2140761.54661.55
321529-2152961.89661.90
420813-2081359.83859.84
521546-2154661.94561.95
618062-1806251.92951.93
10min128098-2809880.78275.168.5980.8975.268.59
225486-2548673.27373.38
327052-2705277.77577.88
425749-2574974.02974.13
528252-2825281.22581.33
622207-2220763.84663.93
15min130808-3080888.57482.478.6888.8182.708.68
227994-2799480.48380.71
329629-2962985.18485.42
428567-2856782.13182.35
530914-3091488.87889.12
624198-2419869.57069.76
20min132586-3258693.68688.367.2294.0788.727.22
230409-3040987.42787.79
331368-3136890.18490.56
431016-3101689.17289.53
532469-3246993.34993.74
626547-2654776.32376.63
30min134189-3418998.29494.075.6798.8494.585.68
232649-3264993.86794.37
333288-3328895.70496.23
432910-3291094.61795.13
534129-3412998.12298.66
629158-2915883.83084.27
45min134237-3423798.43296.383.6099.1497.043.63
233628-3362896.68197.34
334144-3414498.16598.85
433561-3356196.48997.15
534404-3440498.91299.62
631160-3116089.58690.16
60min134125-3412598.11097.771.8698.9898.591.89
233844-3384497.30298.12
334575-3457599.404100.25
434231-3423198.41599.24
534432-3443298.99399.86
632827-3282794.37895.10
极限134575-3457599.40499.151.65100.44100.141.61
233594-3359496.58497.57
334513-3451399.226100.24
434154-3415498.19499.18
534859-34859100.220101.26
635225-35225101.273102.16
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