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%
1 15.042943229429292732924529278293310.32
2 14.972926429240292520.06
单位质量响应值RSD%判断
1950.201954.040.14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%
5min123965-2396579.58273.5120.9179.5873.5120.91
218899-1889962.75962.76
315569-1556951.70151.70
425996-2599686.32686.33
520543-2054368.21868.22
627852-2785292.49092.49
10min127117-2711790.04990.925.5790.4991.335.62
227619-2761991.71692.06
324480-2448081.29281.58
428651-2865195.14395.62
527990-2799092.94893.33
628426-2842694.39694.91
15min127877-2787792.57393.202.4693.5294.112.51
228717-2871795.36296.22
326780-2678088.93089.67
428224-2822493.72594.73
528325-2832594.06094.96
628470-2847094.54295.58
20min127454-2745491.16893.031.7692.6294.461.78
228537-2853794.76496.15
327687-2768791.94293.17
427786-2778692.27193.80
527935-2793592.76594.18
628689-2868995.26996.83
30min126895-2689589.31292.062.6091.2794.002.57
228939-2893996.09998.01
327116-2711690.04691.79
427650-2765091.81993.86
527884-2788492.59694.53
627847-2784792.47394.57
45min126305-2630587.35391.153.5489.8193.613.47
228631-2863195.07797.52
327012-2701289.70091.94
426504-2650488.01390.56
528211-2821193.68296.13
628030-2803093.08195.69
60min126023-2602386.41689.512.6089.3692.482.59
227748-2774892.14495.12
326179-2617986.93489.68
427304-2730490.67093.71
527411-2741191.02593.99
627067-2706789.88393.01
极限125906-2590686.02888.913.2289.4592.373.05
227424-2742491.06894.56
327342-2734290.79694.02
425853-2585385.85289.40
527833-2783392.42795.90
626279-2627987.26690.89
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%
111.154466104464294460134449734448204457690.19
2 11.094436854437174437010.01
单位质量响应值RSD%判断
39979.2840009.110.06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%
5min155285-5528512.44112.3913.6012.4412.3913.60
247776-4777610.75110.75
350267-5026711.31211.31
457820-5782013.01113.01
550746-5074611.42011.42
668400-6840015.39215.39
10min1121818-12181827.41326.3014.7927.4826.3714.79
296348-9634821.68121.74
3105050-10505023.64023.70
4129048-12904829.04029.11
5106581-10658123.98424.05
6142455-14245532.05732.14
15min1181150-18115040.76539.9312.2740.9940.1412.28
2158781-15878135.73135.91
3157378-15737835.41535.61
4195776-19577644.05644.29
5162017-16201736.45936.66
6209526-20952647.15047.41
20min1237114-23711453.35852.5111.8853.8152.9511.90
2210375-21037547.34147.72
3210385-21038547.34447.73
4255655-25565557.53158.01
5211106-21110647.50647.90
6275533-27553362.00462.53
30min1333208-33320874.98372.497.8675.7373.227.90
2312802-31280270.39171.03
3289003-28900365.03565.69
4346733-34673378.02678.82
5300346-30034667.58868.25
6350687-35068778.91679.79
45min1386756-38675687.03388.943.4988.1990.083.55
2397179-39717989.37890.41
3381692-38169285.89386.91
4394518-39451888.77990.01
5390295-39029587.82988.87
6421045-42104594.74996.06
60min1422241-42224195.01896.102.0296.6697.732.08
2433094-43309497.46098.99
3414184-41418493.20594.70
4436679-43667998.26799.99
5422987-42298795.18696.71
6433187-43318797.48199.32
极限1434795-43479597.84399.752.85100.02101.912.66
2456767-456767102.788104.86
3450322-450322101.337103.35
4433927-43392797.64899.92
5456010-456010102.617104.67
6427798-42779896.26998.64
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%
1 15.042932629346292842948829261293410.31
2 14.972928629306292960.05
单位质量响应值RSD%判断
1950.861956.980.23数据可信
供试品溶液-24D1516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%
5min112003-1200339.82260.8832.8739.8260.8832.87
223824-2382479.04179.04
313209-1320943.82343.82
424215-2421580.33880.34
523461-2346177.83777.84
613389-1338944.42144.42
10min120866-2086669.22780.8016.2669.4581.1416.33
227451-2745191.07491.51
321844-2184472.47272.72
428649-2864995.04995.50
527594-2759491.54991.98
619730-1973065.45865.70
15min124531-2453181.38686.767.3081.9987.547.44
227565-2756591.45292.40
324063-2406379.83480.48
428721-2872195.28896.26
527146-2714690.06291.00
624876-2487682.53183.14
20min126357-2635787.44588.006.2588.5089.276.38
228222-2822293.63295.09
324780-2478082.21383.30
428232-2823293.66595.17
527144-2714490.05691.50
624412-2441280.99282.06
30min123265-2326577.18686.727.2078.7388.487.30
227679-2767991.83193.80
324727-2472782.03783.58
428161-2816193.43095.45
527105-2710589.92691.87
625902-2590285.93587.45
45min126596-2659688.23888.963.4390.2191.203.62
227374-2737490.81993.30
325853-2585385.77287.77
428151-2815193.39795.94
527122-2712289.98392.42
625793-2579385.57387.57
60min126982-2698289.51888.943.4991.9891.683.66
227444-2744491.05194.04
325684-2568485.21287.69
427992-2799292.86995.93
527044-2704489.72492.67
625704-2570485.27887.75
极限127624-2762491.64889.383.4294.6192.613.51
227816-2781692.28595.78
325980-2598086.19489.15
427808-2780892.25995.84
526569-2656988.14891.59
625852-2585285.76988.71
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%
111.154462274454414446534456004443164452470.18
2 11.094444814452744448780.13
单位质量响应值RSD%判断
39932.4740115.240.33数据可信
供试品溶液-24D1516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%
5min120308-203084.5675.197.554.575.197.54
224335-243355.4725.47
322193-221934.9904.99
422516-225165.0635.06
524305-243055.4655.47
624899-248995.5995.60
10min154886-5488612.34215.0610.9212.3715.0910.91
267231-6723115.11815.15
365217-6521714.66514.69
471427-7142716.06216.09
576867-7686717.28517.32
666294-6629414.90714.94
15min188062-8806219.80223.049.7119.9023.169.70
295301-9530121.43021.54
399109-9910922.28622.40
4108311-10831124.35624.47
5113890-11389025.61025.74
6110180-11018024.77624.89
20min1127406-12740628.64929.476.1928.8529.716.19
2119378-11937826.84427.08
3127090-12709028.57828.81
4135630-13563030.49930.75
5142544-14254432.05332.32
6134306-13430630.20130.45
30min1152756-15275634.35037.447.7234.7137.847.71
2153422-15342234.50034.88
3164455-16445536.98137.37
4165076-16507637.12037.54
5182000-18200040.92641.37
6181278-18127840.76341.18
45min1205203-20520346.14345.075.0346.7045.685.00
2183296-18329641.21741.79
3203716-20371645.80946.41
4194380-19438043.71044.34
5204008-20400845.87546.55
6211846-21184647.63748.28
60min1220124-22012449.49947.913.5850.3148.783.55
2202211-20221145.47146.27
3215654-21565448.49349.35
4206688-20668846.47747.35
5212120-21212047.69948.63
6221651-22165149.84250.75
极限1227922-22792251.25248.903.5352.3450.033.43
2213053-21305347.90948.96
3221755-22175549.86550.99
4210453-21045347.32448.45
5209069-20906947.01348.21
6222588-22258850.05351.24
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%
1 15.042941129374293162940029218293440.28
2 14.972922129125291730.24
单位质量响应值RSD%判断
1951.061948.760.09数据可信
供试品溶液-24D1516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%
5min113266-1326644.10339.8728.9144.1039.8728.91
213776-1377645.79845.80
313327-1332744.30644.31
44958-495816.48316.48
513824-1382445.95845.96
612805-1280542.57042.57
10min121572-2157271.71668.5916.4371.9668.8116.48
222256-2225673.99074.24
321850-2185072.64172.89
413828-1382845.97146.06
523032-2303276.57076.83
621252-2125270.65370.89
15min123843-2384379.26676.2110.8079.9176.8110.88
224143-2414380.26480.93
323348-2334877.62178.27
417921-1792159.57959.93
524367-2436781.00881.69
623919-2391979.51980.15
20min123565-2356578.34277.469.6979.4378.499.76
224259-2425980.64981.76
322206-2220673.82474.91
419355-1935564.34665.02
525662-2566285.31486.44
624758-2475882.30883.38
30min125782-2578285.71383.706.5487.2385.166.67
225703-2570385.45087.01
325144-2514483.59285.08
421955-2195572.99074.03
526606-2660688.45290.06
625871-2587186.00887.54
45min126341-2634187.57186.774.6489.5788.694.80
226849-2684989.26091.29
326825-2682589.18091.14
423689-2368978.75480.20
526686-2668688.71890.81
626214-2621487.14989.15
60min126274-2627487.34887.452.9189.8389.863.12
226666-2666688.65191.18
326297-2629787.42589.88
424845-2484582.59884.48
526949-2694989.59292.18
626802-2680289.10491.59
极限125112-2511283.48587.623.1186.4590.513.16
226997-2699789.75292.77
327176-2717690.34793.28
425640-2564085.24087.58
526818-2681889.15792.24
626399-2639987.76490.75
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%
111.154437904453604442934436504457394445660.22
2 11.094415964410024412990.10
单位质量响应值RSD%判断
39871.3939792.520.15数据可信
供试品溶液-24D1516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%
5min1120379-12037927.20026.0910.6227.2026.1010.61
2120546-12054627.23727.24
3116205-11620526.25626.26
492217-9221720.83620.84
5128133-12813328.95228.95
6115432-11543226.08226.08
10min1254601-25460157.52752.7612.2357.6852.9012.23
2248923-24892356.24456.40
3238966-23896653.99454.14
4177713-17771340.15440.27
5249214-24921456.31056.47
6231484-23148452.30452.45
15min1354453-35445380.08872.1713.2380.5672.6113.21
2350225-35022579.13379.60
3334177-33417775.50775.95
4240024-24002454.23354.57
5308276-30827669.65570.13
6329231-32923174.39074.83
20min1395926-39592689.45983.5011.8390.3784.3411.82
2398396-39839690.01790.92
3365149-36514982.50583.37
4284698-28469864.32764.97
5376144-37614484.99085.85
6396981-39698189.69890.55
30min1435767-43576798.46195.966.8499.8797.266.89
2437945-43794598.953100.36
3418918-41891894.65495.98
4369277-36927783.43884.44
5451200-451200101.948103.28
6435034-43503498.29699.64
45min1432695-43269597.76799.732.1299.73101.561.98
2448336-448336101.301103.25
3434203-43420398.10899.96
4454028-454028102.587104.05
5446319-446319100.846102.74
6432618-43261897.75099.64
60min1432742-43274297.77899.182.82100.28101.572.64
2439086-43908699.211101.73
3422127-42212795.37997.77
4457802-457802103.440105.47
5447094-447094101.021103.48
6434753-43475398.232100.67
极限1412721-41272193.25498.573.7396.30101.513.50
2443254-443254100.153103.22
3433790-43379098.015100.94
4460970-460970104.156106.76
5439883-43988399.391102.41
6426884-42688496.45499.44
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