培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.882071820598206882062720575206410.30
29.942072520613206690.39
单位质量响应值RSD%判断
2089.172079.380.34数据可信
供试品溶液-2022081701批-培哚普利-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%
5min123501-2350196.20297.211.1596.2097.211.15
223874-2387497.72997.73
324186-2418699.00699.01
423851-2385197.63597.63
523544-2354496.37896.38
623533-2353396.33396.33
10min123494-2349496.17498.541.7197.2499.621.70
224310-2431099.514100.60
324713-24713101.164102.26
423963-2396398.09399.18
523923-2392397.93099.00
624023-2402398.33999.41
15min123354-2335495.60097.821.7397.74100.001.72
223925-2392597.938100.13
324579-24579100.615102.84
424024-2402498.343100.52
523866-2386697.69699.86
623631-2363196.73498.90
20min122995-2299594.13196.571.5997.3399.831.58
223858-2385897.664100.94
324073-2407398.544101.89
423403-2340395.80199.07
523659-2365996.849100.09
623555-2355596.42399.66
30min121804-2180489.25594.443.0693.5098.772.98
223749-2374997.217101.58
323709-2370997.054101.49
422973-2297394.04198.37
523125-2312594.66398.98
623056-2305694.38198.69
45min122213-2221390.93093.331.9996.1798.721.97
223005-2300594.17299.62
323546-2354696.386101.90
422519-2251992.18297.56
522781-2278193.25598.63
622736-2273693.07198.43
极限122234-2223491.01692.721.2697.2699.141.28
222740-2274093.08799.58
323023-2302394.245100.83
422766-2276693.19399.59
522403-2240391.70798.12
622742-2274293.09599.49
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院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2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.851663261664821663891663111665211664060.06
214.891662981662201662590.04
单位质量响应值RSD%判断
11205.7911165.820.26数据可信
供试品溶液-2022081701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%
5min182532-8253247.83046.964.8347.8346.964.84
278451-7845145.46545.46
382854-8285448.01748.02
487308-8730850.59850.60
577723-7772345.04345.04
677295-7729544.79544.79
10min1121246-12124670.26671.882.4170.8072.412.42
2123343-12334371.48171.99
3127733-12773374.02574.56
4127824-12782474.07874.64
5122475-12247570.97871.48
6121602-12160270.47270.97
15min1138699-13869980.38181.932.2881.6983.252.29
2141769-14176982.16083.46
3146090-14609084.66486.02
4144233-14423383.58884.97
5138387-13838780.20081.49
6139095-13909580.61081.89
20min1144751-14475183.88886.311.5786.0988.541.57
2150561-15056187.25589.47
3150443-15044387.18789.48
4151017-15101787.51989.83
5148355-14835585.97688.16
6148471-14847186.04488.22
30min1136836-13683679.30187.664.8682.4490.854.72
2157362-15736291.19694.38
3155212-15521289.95093.22
4153684-15368489.06592.35
5152852-15285288.58391.72
6151636-15163687.87891.01
45min1152177-15217788.19190.641.9292.2194.801.93
2157664-15766491.37195.57
3161055-16105593.33797.60
4157130-15713091.06295.34
5155472-15547290.10194.22
6154895-15489589.76793.88
极限1153893-15389389.18691.661.6894.1896.831.71
2159864-15986492.64697.86
3159821-15982192.62197.92
4161186-16118693.41298.70
5157200-15720091.10296.22
6157042-15704291.01196.12
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.882064420751207042068320547206660.38
29.942060620605206060.01
单位质量响应值RSD%判断
2091.702073.040.64数据可信
供试品溶液-2022081701批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123191-2319195.02196.631.3395.0296.631.33
223396-2339695.86195.86
323381-2338195.80095.80
423962-2396298.18098.18
523659-2365996.93996.94
623916-2391697.99297.99
10min123739-2373997.26798.101.0698.3299.181.06
223742-2374297.27998.34
323758-2375897.34598.41
424327-2432799.676100.77
523918-2391898.00099.08
624174-2417499.049100.14
15min123547-2354796.48096.491.6098.6298.661.58
223077-2307794.55496.70
323281-2328195.39097.54
424182-2418299.082101.28
523575-2357596.59598.76
623640-2364096.86199.05
20min123292-2329295.43595.721.1898.6498.961.18
222967-2296794.10497.30
323337-2333795.62098.83
423577-2357796.60399.90
523241-2324195.22698.47
623758-2375897.345100.61
30min123403-2340395.89094.601.78100.1698.901.74
222543-2254392.36696.61
322850-2285093.62497.89
423682-2368297.033101.41
523141-2314194.81799.11
622904-2290493.84598.19
45min123176-2317694.96093.311.28100.2998.661.22
222566-2256692.46197.73
322712-2271293.05998.37
422974-2297494.13299.58
522851-2285193.62898.98
622366-2236691.64197.03
极限122327-2232791.48192.201.5397.8798.581.49
222063-2206390.40096.70
322460-2246092.02698.37
422933-2293393.964100.46
522892-2289293.796100.19
622335-2233591.51497.92
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院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2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.851662381663261664631660161661381662360.11
214.891659441660081659760.03
单位质量响应值RSD%判断
11194.3411146.810.31数据可信
供试品溶液-2022081701批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min185251-8525149.47350.822.6149.4750.822.61
284983-8498349.31849.32
387675-8767550.88050.88
487896-8789651.00851.01
588471-8847151.34251.34
691171-9117152.90952.91
10min1123306-12330671.55773.331.5972.1173.891.59
2124535-12453572.27072.82
3127525-12752574.00674.57
4128516-12851674.58175.15
5126806-12680673.58874.16
6127455-12745573.96574.55
15min1138283-13828380.24981.901.6081.5983.281.60
2138742-13874280.51581.87
3142329-14232982.59783.98
4144178-14417883.67085.07
5141930-14193082.36583.75
6141314-14131482.00883.42
20min1146189-14618984.83785.402.0287.0787.691.99
2143410-14341083.22485.47
3150639-15063987.41989.72
4149220-14922086.59688.92
5144308-14430883.74586.05
6149240-14924086.60788.93
30min1154642-15464289.74289.361.5692.9292.591.54
2150169-15016987.14690.32
3155443-15544390.20793.48
4157129-15712991.18694.47
5153754-15375489.22792.46
6152728-15272888.63291.91
45min1159073-15907392.31491.681.0096.4995.911.00
2154880-15488089.88094.02
3158854-15885492.18796.47
4158142-15814291.77396.07
5158911-15891192.22096.44
6158023-15802391.70495.97
极限1157008-15700891.11591.871.8596.3297.121.79
2155418-15541890.19395.33
3159485-15948592.55397.86
4161628-16162893.79699.12
5161330-16133093.62398.87
6154967-15496789.93195.22
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.882079020671207972071820685207320.29
29.942092720815208710.38
单位质量响应值RSD%判断
2098.382099.700.05数据可信
供试品溶液-2022081801批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122754-2275492.48995.332.7292.4995.332.72
223420-2342095.19695.20
323038-2303893.64393.64
423233-2323394.43694.44
523707-2370796.36296.36
624571-2457199.87499.87
10min123506-2350695.54596.121.9096.5797.181.91
223462-2346295.36696.42
323315-2331594.76995.81
423312-2331294.75795.81
523802-2380296.74897.82
624487-2448799.533100.64
15min123191-2319194.26595.142.1896.3597.262.17
222977-2297793.39595.51
323028-2302893.60295.70
423731-2373196.46098.56
523219-2321994.37996.52
624288-2428898.724100.94
20min123031-2303193.61494.941.2196.7598.121.23
223351-2335194.91598.07
323307-2330794.73697.87
423253-2325394.51797.69
523318-2331894.78197.98
623879-2387997.061100.37
30min122887-2288793.02992.742.2597.2196.982.20
221904-2190489.03493.24
322687-2268792.21696.40
423188-2318894.25398.48
522850-2285092.87997.13
623380-2338095.03399.42
45min122481-2248191.37992.361.8696.5997.631.84
222681-2268192.19297.39
322157-2215790.06295.27
422675-2267592.16797.44
522950-2295093.28598.56
623395-2339595.094100.54
极限122467-2246791.32291.682.0197.5597.971.99
222236-2223690.38396.61
322058-2205889.66095.87
422567-2256791.72898.02
522631-2263191.98998.30
623367-2336794.980101.48
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院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2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.851666851664111667121664211666521665760.09
214.891690161667291678720.97
单位质量响应值RSD%判断
11217.2411274.140.36数据可信
供试品溶液-2022081801批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min179952-7995246.08849.744.6346.0949.744.63
290180-9018051.98451.98
384117-8411748.48948.49
485104-8510449.05849.06
588303-8830350.90250.90
690074-9007451.92351.92
10min1121828-12182870.22772.131.9670.7472.681.98
2125233-12523372.19072.77
3124040-12404071.50372.04
4124030-12403071.49772.04
5126771-12677173.07773.64
6128874-12887474.28974.87
15min1136874-13687478.90180.971.7780.1982.321.77
2138377-13837779.76781.15
3141570-14157081.60882.94
4140599-14059981.04882.39
5141613-14161381.63283.01
6143750-14375082.86484.27
20min1143468-14346882.70285.011.5184.8787.261.53
2147552-14755285.05687.32
3147758-14775885.17587.41
4147283-14728384.90187.14
5148659-14865985.69487.98
6150109-15010986.53088.85
30min1150657-15065786.84687.001.9189.9390.201.87
2145993-14599384.15787.37
3152300-15230087.79390.98
4150576-15057686.79989.98
5151266-15126687.19790.43
6154761-15476189.21292.50
45min1154518-15451889.07289.741.4493.1293.901.43
2154449-15444989.03293.18
3153234-15323488.33192.49
4156159-15615990.01794.17
5156023-15602389.93994.14
6159645-15964592.02796.30
极限1156763-15676390.36690.501.6095.4195.671.58
2155088-15508889.40094.54
3154695-15469589.17494.32
4156230-15623090.05895.21
5157612-15761290.85596.06
6161626-16162693.16998.47
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.882063820543205722073920864206710.64
29.942073520463205990.94
单位质量响应值RSD%判断
2092.212072.330.68数据可信
供试品溶液-2022081801批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123108-2310894.68696.321.0894.6996.321.08
223850-2385097.72697.73
323369-2336995.75695.76
423592-2359296.66996.67
523490-2349096.25196.25
623628-2362896.81796.82
10min123566-2356696.56397.512.1597.6198.582.14
224155-2415598.976100.06
322953-2295394.05195.11
424423-24423100.074101.15
523752-2375297.32598.39
623935-2393598.07599.15
15min123864-2386497.78496.911.3899.9199.061.37
223883-2388397.862100.05
323008-2300894.27696.39
423743-2374397.28899.47
523692-2369297.07999.23
623715-2371597.17399.34
20min123807-2380797.55096.441.43100.7699.671.35
222907-2290793.86297.14
323798-2379897.513100.67
423615-2361596.764100.03
523461-2346196.13299.36
623633-2363396.837100.08
30min122809-2280993.46194.731.4497.7699.041.40
223679-2367997.026101.34
322787-2278793.37197.61
423106-2310694.67899.02
523052-2305294.45798.75
623285-2328595.41199.73
45min122422-2242291.87593.261.2097.2198.621.17
222954-2295494.05599.45
322506-2250692.21997.50
423123-2312394.748100.14
522884-2288493.76899.12
622674-2267492.90898.29
极限122343-2234391.55191.981.0797.9198.371.01
222707-2270793.04399.48
322646-2264692.79399.10
422607-2260792.63399.08
522120-2212090.63897.03
622257-2225791.19997.61
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院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2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.851659691658761658261657591654771657810.12
214.891654521646911650720.33
单位质量响应值RSD%判断
11163.7011086.100.50数据可信
供试品溶液-2022081801批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182499-8249948.07350.813.6748.0750.813.68
286770-8677050.56250.56
390759-9075952.88652.89
489167-8916751.95851.96
584497-8449749.23749.24
689449-8944952.12352.12
10min1123602-12360272.02472.812.4572.5673.372.45
2124827-12482772.73873.30
3123735-12373572.10272.69
4130545-13054576.07076.65
5121507-12150770.80371.35
6125470-12547073.11373.69
15min1139533-13953381.30781.461.9082.6482.831.90
2141058-14105882.19683.57
3138816-13881680.88982.28
4144259-14425984.06185.48
5136463-13646379.51880.85
6138612-13861280.77182.16
20min1147058-14705885.69285.322.1887.9387.602.12
2143456-14345683.59385.88
3152487-15248788.85691.14
4145010-14501084.49986.86
5145489-14548984.77887.00
6145065-14506584.53186.82
30min1151152-15115288.07888.762.0191.2791.981.96
2155265-15526590.47493.69
3149137-14913786.90490.18
4156474-15647491.17994.47
5149284-14928486.98990.15
6152600-15260088.92292.15
45min1151673-15167388.38189.861.9092.5594.081.86
2154743-15474390.17094.39
3152206-15220688.69292.93
4159751-15975193.08897.40
5153434-15343489.40893.53
6153507-15350789.45093.67
极限1153304-15330489.33290.651.6594.4895.861.64
2157513-15751391.78497.00
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