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%
110.141034661042071040211041021038691039330.28
210.121041801043621042710.13
单位质量响应值RSD%判断
10249.8010303.460.37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%
5min14045-40453.5323.2421.483.533.2421.46
24498-44983.9273.93
32840-28402.4802.48
44665-46654.0734.07
52973-29732.5962.60
63233-32332.8232.82
10min111143-111439.7308.7511.989.758.7611.97
211054-110549.6529.67
39576-95768.3618.38
410994-109949.5999.62
58848-88487.7267.74
68489-84897.4127.43
15min115079-1507913.16612.378.3913.2412.448.41
214948-1494813.05213.13
313223-1322311.54611.61
415646-1564613.66113.74
513309-1330911.62111.68
612826-1282611.19911.26
20min117845-1784515.58114.835.7615.7314.975.82
217703-1770315.45715.61
315963-1596313.93814.06
418022-1802215.73615.89
516445-1644514.35914.48
615932-1593213.91114.03
30min120926-2092618.27217.663.2518.5017.883.31
220763-2076318.12918.36
319596-1959617.11017.31
420752-2075218.12018.36
519853-1985317.33517.54
619472-1947217.00217.20
45min123184-2318420.24320.061.8920.5820.371.98
223277-2327720.32420.66
322428-2242819.58319.88
423553-2355320.56520.91
522776-2277619.88720.18
622610-2261019.74220.03
60min124251-2425121.17520.981.5721.6221.411.63
224413-2441321.31621.76
323880-2388020.85121.26
424292-2429221.21121.66
523976-2397620.93521.34
623381-2338120.41520.82
极限124626-2462621.50221.921.6422.0722.471.62
225478-2547822.24622.81
325460-2546022.23022.75
425462-2546222.23222.80
524656-2465621.52822.05
624971-2497121.80322.32
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%
110.141037181032151030311032161034781033320.26
210.121042251028591035420.94
单位质量响应值RSD%判断
10190.5310231.420.29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%
5min13296-32962.8963.3411.882.903.3411.83
23460-34603.0413.04
34291-42913.7713.77
44419-44193.8833.88
53717-37173.2663.27
63655-36553.2123.21
10min110523-105239.2478.985.489.269.005.48
210107-101078.8828.90
311094-110949.7499.77
410279-102799.0339.05
59492-94928.3418.36
69814-98148.6248.64
15min114570-1457012.80412.582.5712.8712.652.57
214412-1441212.66512.73
314345-1434512.60612.68
414336-1433612.59812.67
513607-1360711.95712.02
614628-1462812.85512.92
20min117167-1716715.08614.971.4715.2215.111.46
217023-1702314.95915.10
317365-1736515.26015.40
417030-1703014.96515.11
516608-1660814.59514.73
617008-1700814.94615.08
30min120522-2052218.03417.952.0618.2618.172.07
220512-2051218.02518.24
320983-2098318.43918.67
420381-2038117.91018.13
519682-1968217.29617.51
620454-2045417.97418.19
45min122334-2233419.62620.001.9919.9520.321.97
222561-2256119.82620.15
323245-2324520.42720.76
422711-2271119.95820.28
522339-2233919.63119.94
623377-2337720.54320.86
60min123819-2381920.93121.130.9021.3621.560.91
224210-2421021.27521.70
324308-2430821.36121.81
423811-2381120.92421.36
523931-2393121.03021.45
624180-2418021.24921.68
极限124461-2446121.49522.041.3822.0422.581.35
225040-2504022.00422.55
325021-2502121.98822.55
425311-2531122.24222.79
525160-2516022.11022.64
625468-2546822.38022.93
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%
110.141032711033481037351037621031041034440.29
210.121035921026701031310.64
单位质量响应值RSD%判断
10201.5810190.810.08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%
5min15086-50864.4765.0011.654.485.0011.65
26786-67865.9725.97
36066-60665.3385.34
45016-50164.4144.41
55618-56184.9444.94
65534-55344.8704.87
10min18529-85297.5069.0411.357.539.0611.34
211543-1154310.15810.19
310607-106079.3359.36
49826-98268.6478.67
59653-96538.4958.52
611474-1147410.09810.12
15min111909-1190910.48012.149.9510.5512.229.95
215564-1556413.69713.79
313731-1373112.08412.17
413642-1364212.00512.08
512824-1282411.28611.36
615121-1512113.30713.39
20min114717-1471712.95114.547.1713.0814.687.18
217828-1782815.68915.85
316386-1638614.42014.57
416477-1647714.50014.64
515904-1590413.99614.13
617798-1779815.66315.82
30min119386-1938617.06017.563.6917.2617.793.74
220502-2050218.04218.30
319549-1954917.20417.43
420014-2001417.61317.83
519183-1918316.88217.10
621103-2110318.57118.82
45min121192-2119218.65019.673.1818.9419.993.22
222755-2275520.02520.38
322742-2274220.01420.34
422807-2280720.07120.39
521734-2173419.12719.44
622871-2287120.12720.47
60min122423-2242319.73320.983.4820.1321.423.53
224698-2469821.73522.20
323689-2368920.84721.28
424096-2409621.20521.63
523576-2357620.74821.16
624575-2457521.62722.09
极限124641-2464121.68521.990.8322.1922.540.91
225118-2511822.10522.69
324833-2483321.85422.41
425049-2504922.04422.59
525075-2507522.06722.60
625187-2518722.16522.74
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