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%
114.722834228420282972853528490284170.35
214.662830328499284010.49
单位质量响应值RSD%判断
1930.501937.310.25数据可信
供试品溶液-24D1516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%
5min125761-2576186.35288.251.5986.3588.251.59
225890-2589086.78486.78
326681-2668189.43689.44
426772-2677289.74189.74
526341-2634188.29688.30
626525-2652588.91388.91
10min127753-2775393.02992.320.7193.5192.820.71
227271-2727191.41391.90
327722-2772292.92593.42
427357-2735791.70292.20
527533-2753392.29292.78
627621-2762192.58793.08
15min127475-2747592.09792.401.7293.0993.401.71
227256-2725691.36392.35
327331-2733191.61592.63
427031-2703190.60991.62
528127-2812794.28395.29
628168-2816894.42095.43
20min127873-2787393.43192.380.7894.9493.890.76
227617-2761792.57394.07
327266-2726691.39792.92
427685-2768592.80194.31
527403-2740391.85693.38
627507-2750792.20593.74
30min127095-2709590.82390.481.5892.8592.511.55
227088-2708890.80092.81
326220-2622087.89089.92
426857-2685790.02692.05
527420-2742091.91393.95
627284-2728491.45793.50
45min126512-2651288.86988.011.5791.4090.551.52
226450-2645088.66191.18
326844-2684489.98292.50
425840-2584086.61789.14
526077-2607787.41189.96
625819-2581986.54689.10
60min126384-2638488.44088.431.6091.4791.451.56
226226-2622687.91190.92
326167-2616787.71390.73
426203-2620387.83390.84
527217-2721791.23294.27
626087-2608787.44590.48
90min126309-2630988.18986.432.1391.7189.952.05
225226-2522684.55988.06
326277-2627788.08191.59
425538-2553885.60489.10
525136-2513684.25787.80
626226-2622687.91191.43
120min125238-2523884.59985.792.9088.6189.782.78
225381-2538185.07889.05
325737-2573786.27190.27
425147-2514784.29488.27
525030-2503083.90287.91
627023-2702390.58294.59
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126143-2614387.63286.231.0692.1190.701.02
225729-2572986.24590.68
325834-2583486.59791.07
425600-2560085.81290.25
525314-2531484.85389.33
625733-2573386.25890.77
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%
110.914187654248504236674225984207254221210.58
210.934233814210194222000.40
单位质量响应值RSD%判断
38691.2038627.630.12数据可信
供试品溶液-24D1516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%
5min152644-5264412.25612.943.4112.2612.943.40
258119-5811913.53013.53
356915-5691513.25013.25
455659-5565912.95812.96
554556-5455612.70112.70
655680-5568012.96212.96
10min1119077-11907727.72127.534.7927.7927.604.78
2121718-12171828.33628.41
3124948-12494829.08829.16
4115307-11530726.84426.92
5108688-10868825.30325.37
6119736-11973627.87527.95
15min1183272-18327242.66643.372.5042.8943.592.50
2187323-18732343.60943.84
3193495-19349545.04645.28
4181667-18166742.29342.51
5182485-18248542.48342.69
6189444-18944444.10344.33
20min1242961-24296156.56256.673.3657.0257.143.35
2257287-25728759.89760.37
3243603-24360356.71157.20
4242602-24260256.47856.93
5231602-23160253.91854.36
6242602-24260256.47856.95
30min1309915-30991572.14973.003.5372.9273.783.50
2331925-33192577.27378.08
3299117-29911769.63570.44
4309282-30928272.00272.77
5312050-31205072.64673.39
6319077-31907774.28275.07
45min1373118-37311886.86385.814.1688.0487.004.13
2397161-39716192.46093.70
3362710-36271084.44085.63
4353866-35386682.38183.55
5364050-36405084.75285.90
6360605-36060583.95085.15
60min1410343-41034395.52994.713.2497.1996.373.22
2426386-42638699.264101.01
3397705-39770592.58794.24
4387848-38784890.29291.92
5412099-41209995.93897.56
6406498-40649894.63496.30
90min1414021-41402196.38595.852.5098.5798.042.49
2426231-42623199.228101.53
3406268-40626894.58096.75
4399726-39972693.05795.19
5403828-40382894.01296.17
6420313-42031397.850100.04
120min1404712-40471294.21895.813.0596.9498.533.03
2425464-42546499.049101.90
3410635-41063595.59798.29
4394203-39420391.77194.42
5407571-40757194.88497.56
6426700-42670099.337102.07
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1414223-41422396.43296.182.3599.6899.432.35
2431269-431269100.400103.80
3410281-41028195.51498.74
4402911-40291193.79996.95
5408232-40823295.03798.24
6411887-41188795.88899.17
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%
114.722808028209280852800827985280730.32
214.662843928270283540.43
单位质量响应值RSD%判断
1907.131934.111.00数据可信
供试品溶液-24D1516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%
5min124356-2435682.21184.191.8582.2184.191.85
224812-2481283.75083.75
324903-2490384.05784.06
425633-2563386.52186.52
525303-2530385.40785.41
624640-2464083.16983.17
10min127349-2734992.31391.910.8892.7792.380.88
226970-2697091.03491.50
327223-2722391.88892.36
427636-2763693.28293.76
527153-2715391.65292.13
627045-2704591.28791.75
15min126829-2682990.55890.621.0691.5391.601.05
226416-2641689.16490.14
327116-2711691.52792.50
426846-2684690.61691.61
526682-2668290.06291.05
627188-2718891.77092.74
20min128331-2833195.62889.583.6097.1091.063.53
226798-2679890.45491.92
325690-2569086.71488.20
426326-2632688.86090.36
526119-2611988.16289.65
625972-2597287.66589.14
30min126113-2611388.14186.251.9690.1588.231.93
225638-2563886.53888.51
324706-2470683.39285.36
425777-2577787.00789.00
525826-2582687.17389.15
625260-2526085.26287.23
45min125902-2590287.42987.082.8089.9289.532.73
224901-2490184.05086.50
324925-2492584.13186.56
426210-2621088.46990.95
526233-2623388.54691.00
626612-2661289.82692.27
60min126274-2627488.68588.021.5591.6690.971.51
226299-2629988.76991.69
325613-2561386.45489.35
425588-2558886.36989.34
526595-2659589.76892.72
626100-2610088.09891.04
90min125661-2566186.61685.971.8490.0989.401.78
225137-2513784.84788.26
325184-2518485.00688.38
424906-2490684.06787.52
525807-2580787.10990.56
626125-2612588.18291.61
120min125851-2585187.25786.160.8091.2190.070.80
225498-2549886.06689.95
325233-2523385.17189.02
425452-2545285.91089.83
525523-2552386.15090.08
625602-2560286.41790.33
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125878-2587887.34886.171.2191.7990.561.19
225227-2522785.15189.51
325331-2533185.50289.83
425388-2538885.69490.09
525957-2595787.61592.03
625386-2538685.68890.09
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%
110.914223174222784227634221954216764222460.10
210.934207334199454203390.14
单位质量响应值RSD%判断
38702.6638457.370.45数据可信
供试品溶液-24D1516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%
5min146670-4667010.88711.874.4110.8911.874.39
251105-5110511.92211.92
352829-5282912.32412.32
451431-5143111.99812.00
552645-5264512.28112.28
650564-5056411.79611.80
10min198758-9875823.03925.915.9623.1025.975.95
2117595-11759527.43327.50
3115957-11595727.05127.12
4111482-11148226.00726.07
5111639-11163926.04426.11
6110916-11091625.87525.94
15min1149268-14926834.82240.257.2635.0140.467.24
2180931-18093142.20842.43
3181804-18180442.41242.63
4181459-18145942.33142.54
5170995-17099539.89040.10
6170856-17085639.85840.07
20min1200528-20052846.78051.835.9347.1652.265.92
2232886-23288654.32954.78
3224525-22452552.37852.83
4238000-23800055.52255.97
5218850-21885051.05451.49
6218333-21833350.93451.36
30min1276674-27667464.54467.563.3665.1968.283.38
2293503-29350368.46969.22
3292564-29256468.25069.00
4304487-30448771.03271.79
5282031-28203165.79366.51
6288358-28835867.26967.98
45min1329824-32982476.94381.353.4577.9482.453.46
2355315-35531582.88984.02
3355690-35569082.97784.10
4359877-35987783.95385.10
5337717-33771778.78479.87
6353909-35390982.56183.65
60min1369508-36950886.20091.092.9887.6392.643.00
2404294-40429494.31595.91
3396267-39626792.44394.03
4393562-39356291.81293.43
5388835-38883590.70992.23
6390436-39043691.08292.63
90min1408221-40822195.23194.551.9097.1496.611.85
2399210-39921093.12995.25
3413228-41322896.39998.50
4403227-40322794.06696.19
5394555-39455592.04394.07
6413413-41341396.44398.49
120min1409507-40950795.53195.581.8697.9798.161.85
2407851-40785195.14597.78
3417550-41755097.408100.04
4414396-41439696.67299.32
5395900-39590092.35794.89
6412964-41296496.33898.93
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1423340-42334098.75896.101.54101.7299.211.44
2405423-40542394.57997.74
3413369-41336996.43299.61
4411872-41187296.08399.27
5407123-40712394.97598.02
6410517-41051795.76798.89
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