阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制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5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.141029041027981028601030861027561028810.13
210.121034221031451032840.19
单位质量响应值RSD%判断
10146.0610205.930.42数据可信
长期24月-供试品溶液-2023111721批-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%
5min13961-39613.4933.6220.283.493.6220.32
23259-32592.8742.87
33831-38313.3783.38
44464-44643.9363.94
53517-35173.1013.10
65578-55784.9194.92
10min110323-103239.1039.3212.409.129.3412.43
28719-87197.6887.70
310522-105229.2789.30
411722-1172210.33610.36
59775-97758.6198.64
612336-1233610.87810.91
15min114504-1450412.78912.849.3012.8612.919.34
212332-1233210.87410.93
314602-1460212.87612.95
415647-1564713.79713.88
514052-1405212.39112.46
616220-1622014.30314.39
20min117286-1728615.24315.316.6615.3815.456.70
215405-1540513.58413.70
317357-1735715.30515.45
418437-1843716.25816.41
517074-1707415.05615.19
618628-1862816.42616.59
30min120289-2028917.89118.264.2818.1218.494.32
219223-1922316.95117.15
320763-2076318.30918.54
421655-2165519.09519.34
520843-2084318.37918.60
621493-2149318.95219.21
45min122693-2269320.01020.452.5020.3420.782.56
222451-2245119.79720.09
322979-2297920.26320.59
423953-2395321.12121.47
523403-2340320.63720.96
623652-2365220.85621.22
60min123851-2385121.03221.802.5021.4722.242.52
224063-2406321.21821.62
324848-2484821.91122.35
425163-2516322.18822.66
525353-2535322.35622.79
625043-2504322.08322.56
极限125044-2504422.08422.441.2822.6423.011.29
225362-2536222.36422.88
325733-2573322.69123.25
425929-2592922.86423.46
525355-2535522.35822.92
625271-2527122.28422.89
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制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5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.141027451025791026651027661026541026820.08
210.121026921022631024780.30
单位质量响应值RSD%判断
10126.4310126.280.01数据可信
长期24月-供试品溶液-2023111821批-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%
5min13071-30712.7213.1123.212.723.1123.22
23475-34753.0793.08
33038-30382.6922.69
45110-51104.5284.53
53405-34053.0173.02
62942-29422.6072.61
10min18819-88197.8158.7510.307.838.7710.32
29765-97658.6538.67
39261-92618.2068.22
411608-1160810.28610.31
510480-104809.2869.30
69330-93308.2678.28
15min112986-1298611.50712.476.1411.5712.536.16
213740-1374012.17512.24
313795-1379512.22412.28
415393-1539313.64013.72
514774-1477413.09113.16
613718-1371812.15612.22
20min115594-1559413.81814.874.4513.9415.014.48
216395-1639514.52814.66
316660-1666014.76214.89
417641-1764115.63215.79
517438-1743815.45215.59
616985-1698515.05015.18
30min118934-1893416.77717.723.4516.9817.943.48
219743-1974317.49417.71
320025-2002517.74417.95
420823-2082318.45118.70
520672-2067218.31818.54
619800-1980017.54517.76
45min121751-2175119.27419.821.6519.5720.141.71
222221-2222119.69020.00
322423-2242319.86920.18
422842-2284220.24020.59
522590-2259020.01720.35
622381-2238119.83220.14
60min123307-2330720.65221.031.3821.0521.461.43
223396-2339620.73121.15
323983-2398321.25121.67
424086-2408621.34321.80
523945-2394521.21821.66
623683-2368320.98621.40
极限124274-2427421.50922.011.8222.0222.551.87
224409-2440921.62922.16
325122-2512222.26122.80
425111-2511122.25122.83
525423-2542322.52723.09
624695-2469521.88222.42
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制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5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.141033761033381033001029521030811032090.18
210.121018811016201017500.19
单位质量响应值RSD%判断
10178.4010054.350.87数据可信
长期24月-供试品溶液-2023111921批-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%
5min14097-40973.6345.7219.243.635.7219.29
27166-71666.3566.36
36134-61345.4415.44
46736-67365.9755.97
57449-74496.6076.61
67143-71436.3366.34
10min18448-84487.4939.7411.557.519.7711.59
211575-1157510.26710.30
311119-111199.8639.89
411340-1134010.05910.09
511549-1154910.24410.28
611876-1187610.53410.57
15min112461-1246111.05312.977.5811.1113.067.64
214839-1483913.16213.25
314671-1467113.01313.10
415090-1509013.38513.47
515089-1508913.38413.48
615617-1561713.85213.95
20min115420-1542013.67815.185.1913.8015.345.24
216950-1695015.03515.20
317266-1726615.31515.47
417633-1763315.64115.80
517683-1768315.68515.85
617763-1776315.75615.93
30min118845-1884516.71617.743.6516.9117.983.71
219552-1955217.34317.59
320147-2014717.87118.11
420689-2068918.35118.60
519989-1998917.73017.99
620792-2079218.44318.70
45min121634-2163419.19020.062.7719.4820.402.83
222108-2210819.61019.96
322705-2270520.14020.48
423269-2326920.64020.99
522844-2284420.26320.62
623107-2310720.49620.86
60min123143-2314320.52821.232.0120.9321.682.08
223701-2370121.02321.48
323955-2395521.24821.70
424525-2452521.75422.22
523991-2399121.28021.75
624285-2428521.54122.02
极限123940-2394021.23522.032.2221.7522.612.28
224404-2440421.64722.22
324990-2499022.16622.74
425333-2533322.47123.06
525144-2514422.30322.89
625234-2523422.38322.98
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