替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105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10000
标示量(mg)5供试品稀释倍数10系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.562783127882281632783827786279000.55
214.652767127636276540.09
单位质量响应值RSD%判断
1916.211887.651.07数据可信
供试品溶液-8145822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%
5min110513-1051338.78046.1010.0838.7846.1010.08
211435-1143542.18142.18
312636-1263646.61146.61
413460-1346049.65149.65
513390-1339049.39249.39
613552-1355249.99049.99
10min115733-1573358.03568.799.3558.4269.259.35
217991-1799166.36466.79
318342-1834267.65968.13
419607-1960772.32572.82
519412-1941271.60672.10
620809-2080976.75977.26
15min117887-1788765.98177.008.7266.9578.158.74
219878-1987873.32574.41
320546-2054675.78976.93
422012-2201281.19782.42
522131-2213181.63682.85
622789-2278984.06385.33
20min119176-1917670.73581.667.9172.3683.587.93
221175-2117578.10979.93
322079-2207981.44483.34
423782-2378287.72689.76
523601-2360187.05889.08
623009-2300984.87486.98
30min121220-2122078.27587.966.2380.6190.706.30
223127-2312785.31087.91
324003-2400388.54191.26
425253-2525393.15296.06
524652-2465290.93593.83
624817-2481791.54494.50
极限126896-2689699.21393.883.37102.3397.493.01
225508-2550894.09397.55
325116-2511692.64796.25
425818-2581895.23699.08
524945-2494592.01695.82
624412-2441290.05093.92
替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105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10000
标示量(mg)5供试品稀释倍数10系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.562769827719277002772627675277040.08
214.652769227700276960.03
单位质量响应值RSD%判断
1902.751890.510.46数据可信
供试品溶液-8145822批-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%
5min15326-532619.70020.169.6519.7020.169.66
25730-573021.19521.19
35363-536319.83719.84
46144-614422.72622.73
54564-456416.88216.88
65571-557120.60620.61
10min110691-1069139.54540.936.4939.7441.146.50
211265-1126541.66841.88
311126-1112641.15441.35
412041-1204144.53844.77
59906-990636.64136.81
611369-1136942.05342.26
15min112606-1260646.62848.584.7647.2249.194.78
213130-1313048.56649.19
313708-1370850.70451.31
413818-1381851.11151.78
512218-1221845.19345.73
613322-1332249.27649.90
20min114189-1418952.48353.432.5153.5454.532.58
214380-1438053.19054.30
314715-1471554.42955.55
415006-1500655.50556.69
514003-1400351.79552.78
614380-1438053.19054.31
30min115635-1563557.83259.483.6859.4261.123.70
215727-1572758.17259.82
316451-1645160.85062.51
417042-1704263.03664.78
515484-1548457.27358.78
616149-1614959.73361.38
极限124271-2427189.77590.401.9791.9492.621.95
224168-2416889.39591.62
323899-2389988.40090.67
425199-2519993.20895.58
524834-2483491.85893.94
624262-2426289.74291.99
替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105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10000
标示量(mg)5供试品稀释倍数10系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.562782027845277762775527702277800.21
214.652768927720277040.08
单位质量响应值RSD%判断
1907.971891.060.63数据可信
供试品溶液-8170101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%
5min113152-1315248.57448.7713.2448.5748.7813.25
214712-1471254.33654.34
313951-1395151.52551.53
413984-1398451.64751.65
513647-1364750.40250.40
69792-979236.16536.16
10min118588-1858868.65171.4610.1569.1471.9410.16
220599-2059976.07876.62
319872-1987273.39373.91
420520-2052075.78776.30
520808-2080876.85077.35
615697-1569757.97458.34
15min120962-2096277.41981.139.9478.5982.339.70
222993-2299384.92086.22
322442-2244282.88584.13
418234-1823467.34468.62
522504-2250483.11484.39
624666-2466691.09992.04
20min122797-2279784.19685.858.9186.1487.878.73
224112-2411289.05391.21
324357-2435789.95892.04
419356-1935671.48873.44
523611-2361187.20289.31
625238-2523893.21195.06
30min124052-2405288.83190.696.2091.6293.566.11
225015-2501592.38895.43
325122-2512292.78395.76
421733-2173380.26682.93
525422-2542293.89196.87
625993-2599396.00098.78
极限124407-2440790.14262.4977.5293.8266.2773.05
225711-2571194.95898.93
325710-2571094.95598.86
425697-2569794.90798.37
5-0.0003.91
6-0.0003.74
替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105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10000
标示量(mg)5供试品稀释倍数10系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.562774127691277682767627541276830.32
214.652769327674276840.05
单位质量响应值RSD%判断
1901.301889.690.44数据可信
供试品溶液-8170101批-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%
5min18045-804529.77526.218.2229.7826.218.23
26418-641823.75423.75
37418-741827.45527.45
47034-703426.03326.03
56922-692225.61925.62
66653-665324.62324.62
10min111971-1197144.30641.005.6244.6041.265.63
210088-1008837.33737.57
311263-1126341.68541.96
411298-1129841.81542.08
510814-1081440.02340.28
611028-1102840.81641.06
15min114394-1439453.27348.296.0354.0148.966.03
212162-1216245.01345.62
313197-1319748.84349.53
413314-1331449.27649.95
512704-1270447.01947.67
612518-1251846.33046.98
20min115629-1562957.84453.934.5459.1255.094.58
213791-1379151.04252.10
314696-1469654.39155.57
414912-1491255.19156.36
514371-1437153.18854.31
614034-1403451.94153.06
30min116807-1680762.20460.833.3964.0662.523.41
215357-1535756.83858.41
316787-1678762.13063.85
416515-1651561.12362.85
516770-1677062.06763.73
616375-1637560.60562.24
极限126108-2610896.62894.441.9499.1096.741.98
224961-2496192.38394.52
325359-2535993.85696.20
425641-2564194.89997.23
526025-2602596.32198.60
625005-2500592.54694.79
替米沙坦左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105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10000
标示量(mg)5供试品稀释倍数10系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.562763127652276162767827663276480.09
214.652748727492274900.02
单位质量响应值RSD%判断
1898.901876.450.85数据可信
供试品溶液-8170101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%
5min120392-2039275.78782.316.1775.7982.326.17
221383-2138379.47079.47
322177-2217782.42182.42
422762-2276284.59584.60
521765-2176580.89080.89
624411-2441190.72490.72
10min126643-2664399.01995.802.8399.7896.632.79
226033-2603396.75297.55
325975-2597596.53797.36
426030-2603096.74197.59
524487-2448791.00691.82
625501-2550194.77595.68
15min126330-2633097.85696.582.2799.6098.362.24
226394-2639498.09499.86
326510-2651098.525100.31
425976-2597696.54098.35
524919-2491992.61294.33
625789-2578995.84597.70
20min126524-2652498.57796.701.75101.3099.441.73
225944-2594496.42199.16
326529-2652998.595101.37
425770-2577095.77598.55
525354-2535494.22996.87
625985-2598596.57499.39
30min126045-2604596.79796.172.37100.5199.892.35
225600-2560095.14398.85
326648-2664899.038102.80
425752-2575295.70899.44
524895-2489592.52396.11
626324-2632497.834101.61
极限125576-2557695.05479.1349.0499.7383.8146.25
225486-2548694.71999.38
326331-2633197.860102.61
425051-2505193.10297.80
525306-2530694.05098.56
6-0.0004.76
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