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22AD265对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.7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%
115.643094830653304263087830532306870.73
215.633100631044310250.09
单位质量响应值RSD%判断
1962.081984.960.82数据可信
供试品溶液-2批-氨氯地平-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122649-2264974.25063.8017.9874.2563.8017.98
223375-2337576.63076.63
316509-1650954.12154.12
415880-1588052.05952.06
521829-2182971.56171.56
616532-1653254.19654.20
10min128988-2898895.03188.408.2895.4488.768.29
227914-2791491.51091.94
322779-2277974.67674.98
427521-2752190.22190.51
528262-2826292.65193.05
626334-2633486.33086.63
15min129727-2972797.45391.285.9698.3992.125.99
228093-2809392.09693.03
325086-2508682.23982.95
428509-2850993.46094.25
528841-2884194.54995.46
626802-2680287.86488.64
20min129941-2994198.15591.196.0499.6492.556.07
227913-2791391.50692.95
324866-2486681.51882.69
427907-2790791.48792.80
528710-2871094.11995.56
627570-2757090.38291.65
30min129128-2912895.49090.503.7397.5292.363.81
227865-2786591.34993.30
326140-2614085.69487.32
427099-2709988.83890.66
528193-2819392.42494.38
627212-2721289.20890.98
45min127445-2744589.97289.193.0592.5391.553.13
227600-2760090.48092.94
325778-2577884.50786.61
427363-2736389.70392.01
528212-2821292.48794.96
626840-2684087.98990.26
60min127969-2796991.69089.402.6394.7592.262.73
227430-2743089.92392.89
326110-2611085.59688.17
427403-2740389.83492.64
527933-2793391.57294.56
626781-2678187.79590.55
90min127816-2781691.18889.232.0994.7692.582.22
227334-2733489.60893.07
326385-2638586.49789.54
426982-2698288.45491.76
527861-2786191.33694.83
626931-2693188.28791.53
120min126047-2604785.38987.472.7689.4691.322.65
226402-2640286.55390.51
326427-2642786.63590.16
426007-2600785.25889.06
527684-2768490.75694.76
627516-2751690.20593.94
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限128056-2805691.97587.912.7896.5292.252.76
226034-2603485.34789.79
326227-2622785.97989.99
427270-2727089.39893.67
526755-2675587.71092.22
626561-2656187.07491.31
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100320240115对照品来源工作对照品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%
111.454588114593434615854604044620394604360.31
211.434605544567844586690.59
单位质量响应值RSD%判断
40212.7540128.520.15数据可信
供试品溶液-2批-替米沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142537-425379.5308.9115.099.538.9115.06
247111-4711110.55510.55
331011-310116.9486.95
444229-442299.9099.91
535290-352907.9077.91
638465-384658.6188.62
10min183648-8364818.74116.6116.9818.7916.6616.96
286460-8646019.37119.43
366811-6681114.96915.01
483926-8392618.80318.86
569403-6940315.54915.59
654704-5470412.25612.30
15min1128031-12803128.68523.4223.8328.8423.5623.77
2127432-12743228.55028.72
3105070-10507023.54023.66
4109712-10971224.58024.74
596455-9645521.61021.74
660557-6055713.56713.68
20min1170137-17013738.11828.6927.6138.4328.9627.50
2154474-15447434.60934.93
3125863-12586328.19928.45
4132759-13275929.74430.04
5117445-11744526.31326.56
667732-6773215.17515.37
30min1247193-24719355.38237.1134.1455.9137.5433.98
2199345-19934544.66245.18
3173075-17307538.77739.19
4148084-14808433.17733.64
5146962-14696232.92633.32
679122-7912217.72718.00
45min1269422-26942260.36344.1631.7161.2044.8031.60
2239673-23967353.69754.46
3218146-21814648.87449.50
4174958-17495839.19839.84
5190778-19077842.74343.32
689783-8978320.11520.49
60min1291537-29153765.31750.4333.3866.4951.3133.24
2305088-30508868.35369.42
3246023-24602355.12056.02
4190798-19079842.74743.61
5217320-21732048.68949.51
699717-9971722.34122.83
90min1320948-32094871.90757.5631.7073.4458.7231.60
2346746-34674677.68779.13
3275005-27500561.61362.82
4213641-21364147.86548.97
5264981-26498159.36860.45
6120104-12010426.90927.52
120min1336391-33639175.36761.8428.8177.3063.3228.79
2349833-34983378.37880.25
3310698-31069869.61071.15
4245239-24523954.94456.31
5280531-28053162.85164.27
6133364-13336429.87930.64
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1408998-40899891.63485.455.5093.9987.285.89
2402873-40287390.26192.57
3369165-36916582.70984.64
4363434-36343481.42583.10
5384661-38466186.18187.95
6359331-35933180.50681.43
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22AD265对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.7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%
115.643054330755307613078230680307040.32
215.633057330476305240.23
单位质量响应值RSD%判断
1963.171952.910.38数据可信
供试品溶液-2批-氨氯地平-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112560-1256041.50047.2134.3041.5047.2134.30
210546-1054634.84534.85
314035-1403546.37346.37
422235-2223573.46773.47
58853-885329.25129.25
617495-1749557.80557.81
10min125748-2574885.07479.4915.4485.3079.7515.48
219817-1981765.47765.67
326058-2605886.09886.36
427165-2716589.75690.16
518833-1883362.22662.39
626724-2672488.29988.62
15min127257-2725790.06089.325.3890.7690.025.41
224165-2416579.84480.40
328187-2818793.13393.87
427170-2717089.77390.68
527601-2760191.19791.70
627812-2781291.89492.71
20min128171-2817193.08091.034.1094.2892.234.12
225444-2544484.07085.07
328351-2835193.67594.93
427096-2709689.52890.93
528015-2801592.56593.58
628233-2823393.28594.61
30min128067-2806792.73691.353.4394.4693.063.44
226583-2658387.83389.30
328285-2828593.45795.23
426623-2662387.96589.87
527401-2740190.53692.06
628932-2893295.59497.43
45min126049-2604986.06988.582.5188.3090.802.49
226406-2640687.24889.20
327446-2744690.68592.98
426194-2619486.54888.94
527183-2718389.81691.85
627581-2758191.13193.50
60min127044-2704489.35688.082.7492.0790.792.62
226301-2630186.90189.34
326025-2602585.98988.79
425761-2576185.11787.99
527575-2757591.11193.64
627245-2724590.02092.90
90min125782-2578285.18687.432.7588.4090.632.72
226021-2602185.97688.90
326849-2684988.71291.99
425785-2578585.19688.54
526733-2673388.32991.37
627604-2760491.20794.58
120min126591-2659187.86088.462.0091.5492.141.94
226916-2691688.93392.33
327143-2714389.68393.45
425881-2588185.51489.33
526675-2667588.13791.67
627430-2743090.63294.52
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限125723-2572384.99288.762.4889.1692.942.40
227300-2730090.20294.10
327232-2723289.97794.24
426691-2669188.19092.48
526666-2666688.10792.12
627577-2757791.11795.51
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100320240115对照品来源工作对照品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%
111.454583154585734594794558764573604579210.30
211.434568994574344571660.09
单位质量响应值RSD%判断
39993.1039997.030.01数据可信
供试品溶液-2批-替米沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148260-4826010.86011.3517.5310.8611.3517.54
245834-4583410.31410.31
356453-5645312.70312.70
445662-4566210.27510.28
541119-411199.2539.25
665232-6523214.67914.68
10min192886-9288620.90220.9218.5020.9620.9918.48
288562-8856219.92919.99
398274-9827422.11422.18
490810-9081020.43520.49
566996-6699615.07615.13
6120383-12038327.09027.17
15min1128583-12858328.93530.2716.8429.1130.4516.84
2139778-13977831.45431.62
3136764-13676430.77630.97
4125938-12593828.34028.51
5103397-10339723.26723.40
6172632-17263238.84739.08
20min1155317-15531734.95138.3313.5535.2938.6713.55
2185929-18592941.83942.18
3159702-15970235.93736.30
4156076-15607635.12135.45
5154314-15431434.72534.99
6210571-21057147.38447.83
30min1219202-21920249.32751.8111.4749.8652.3711.46
2245043-24504355.14155.72
3203773-20377345.85546.42
4211017-21101747.48548.01
5226819-22681951.04151.50
6275622-27562262.02362.73
45min1311074-31107470.00067.087.6770.8167.937.69
2314128-31412870.68871.57
3267554-26755460.20761.03
4280576-28057663.13763.92
5288074-28807464.82565.57
6327120-32712073.61174.67
60min1360799-36079981.19078.699.0282.3879.919.00
2375867-37586784.58185.85
3300873-30087367.70568.86
4325369-32536973.21774.35
5351035-35103578.99380.09
6384147-38414786.44487.91
90min1385983-38598386.85787.863.8388.5089.523.92
2392913-39291388.41690.16
3370440-37044083.35984.89
4389714-38971487.69689.24
5387086-38708687.10588.64
6416467-41646793.71795.66
120min1398522-39852289.67990.951.6091.8193.101.73
2405576-40557691.26693.50
3397640-39764089.48091.47
4404163-40416390.94892.98
5403544-40354490.80992.83
6415559-41555993.51295.98
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1398267-39826789.62192.022.0092.2594.672.07
2410503-41050392.37595.12
3404452-40445291.01393.50
4416258-41625893.67096.21
5404176-40417690.95193.48
6419877-41987794.48497.47
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