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%
19.959948799234992669930099300993170.10
29.989983299661997460.13
单位质量响应值RSD%判断
9981.619994.590.10数据可信
加速6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%
5min13771-37713.3882.7913.193.392.7913.22
23276-32762.9432.94
32696-26962.4222.42
42782-27822.4992.50
53246-32462.9162.92
62838-28382.5502.55
10min18514-85147.6497.064.947.677.084.96
27868-78687.0687.08
37723-77236.9386.95
47373-73736.6246.64
57651-76516.8736.89
68017-80177.2027.22
15min112199-1219910.95910.343.9211.0210.393.92
211197-1119710.05910.11
311665-1166510.47910.53
410929-109299.8189.87
511333-1133310.18110.24
611730-1173010.53810.59
20min114651-1465113.16212.772.9613.2812.882.97
214040-1404012.61312.72
314415-1441512.95013.06
413708-1370812.31512.42
513816-1381612.41212.52
614670-1467013.17913.29
30min117161-1716115.41715.431.2715.6115.611.27
217081-1708115.34515.53
317045-1704515.31315.49
416901-1690115.18315.36
517437-1743715.66515.84
617433-1743315.66115.85
45min120054-2005418.01617.702.0918.3017.972.08
219181-1918117.23217.50
319900-1990017.87818.14
419202-1920217.25017.51
519779-1977917.76918.04
620093-2009318.05118.32
60min121142-2114218.99318.921.3919.3719.281.38
220698-2069818.59418.96
321255-2125519.09519.46
421202-2120219.04719.40
520690-2069018.58718.95
621364-2136419.19319.57
极限121857-2185719.63619.761.8320.1220.231.81
221734-2173419.52519.99
321984-2198419.75020.22
421606-2160619.41019.87
522748-2274820.43620.91
622028-2202819.78920.27
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%
19.959947899354992179931499262993250.11
29.989885499033989440.13
单位质量响应值RSD%判断
9982.419914.230.49数据可信
加速6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%
5min15292-52924.7734.5510.904.774.5510.91
24354-43543.9273.93
34934-49344.4504.45
45298-52984.7794.78
55853-58535.2795.28
64551-45514.1054.10
10min19523-95238.5898.268.728.628.298.73
27992-79927.2097.23
39197-91978.2958.32
49740-97408.7858.81
510079-100799.0919.12
68444-84447.6167.64
15min113111-1311111.82611.167.2011.9011.237.22
211085-110859.99810.06
312516-1251611.28911.36
413218-1321811.92212.00
512835-1283511.57711.66
611474-1147410.34910.41
20min115319-1531913.81713.346.1013.9613.476.11
213443-1344312.12512.24
314875-1487513.41713.55
415799-1579914.25014.39
515309-1530913.80813.95
613973-1397312.60312.73
30min117816-1781616.07015.774.6016.2915.984.62
216503-1650314.88515.07
316534-1653414.91315.12
418432-1843216.62516.85
518075-1807516.30316.52
617524-1752415.80616.00
45min120285-2028518.29718.331.8318.6018.621.88
220055-2005518.08918.36
319986-1998618.02718.32
420689-2068918.66118.97
520860-2086018.81519.13
620041-2004118.07618.36
60min121835-2183519.69519.582.1520.1019.972.18
221228-2122819.14719.52
322004-2200419.84720.24
421924-2192419.77520.19
522198-2219820.02220.44
621031-2103118.96919.35
极限122489-2248920.28419.961.6520.8020.471.69
221634-2163419.51319.99
322468-2246820.26620.77
422333-2233320.14420.67
522088-2208819.92320.45
621766-2176619.63220.12
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%
19.959919198942990219899598976990250.10
29.989918499096991400.07
单位质量响应值RSD%判断
9952.269933.870.14数据可信
加速6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%
5min15520-55204.9814.7511.494.984.7511.45
24688-46884.2314.23
36266-62665.6555.65
45055-50554.5624.56
55416-54164.8884.89
64662-46624.2074.21
10min110400-104009.3858.2911.249.418.3211.26
28944-89448.0718.09
310566-105669.5359.57
48596-85967.7577.78
58373-83737.5567.58
68246-82467.4427.46
15min113466-1346612.15211.286.4712.2311.366.48
212247-1224711.05211.12
313566-1356612.24212.33
412122-1212210.93911.01
511720-1172010.57710.65
611885-1188510.72510.79
20min115853-1585314.30613.653.5214.4513.783.54
215139-1513913.66213.79
315655-1565514.12814.28
414634-1463413.20613.34
514569-1456913.14813.28
614894-1489413.44113.57
30min119136-1913617.26916.283.2717.5016.503.30
217596-1759615.87916.08
318255-1825516.47416.70
417580-1758015.86516.07
517794-1779416.05816.26
617910-1791016.16316.36
45min120611-2061118.60018.491.9018.9218.791.91
219981-1998118.03218.33
321022-2102218.97119.29
420125-2012518.16218.45
520471-2047118.47418.76
620737-2073718.71419.00
60min122476-2247620.28319.782.3520.7120.192.31
222150-2215019.98920.38
321369-2136919.28419.71
421663-2166319.55019.94
522482-2248220.28920.68
621395-2139519.30819.70
极限122995-2299520.75220.662.4521.2921.172.39
223646-2364621.33921.84
322764-2276420.54321.08
422699-2269920.48420.98
521992-2199219.84620.35
623246-2324620.97821.48
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%
19.959921699295993029928599388992970.07
29.989905198980990160.06
单位质量响应值RSD%判断
9979.609921.440.42数据可信
加速6月-供试品溶液批-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%
5min16226-62265.6145.476.535.615.466.51
25543-55434.9995.00
36064-60645.4685.47
46009-60095.4195.42
56713-67136.0546.05
65816-58165.2455.24
10min110112-101129.1199.001.969.159.031.96
210085-100859.0949.12
39729-97298.7738.80
410206-102069.2039.23
59975-99758.9959.03
69763-97638.8048.83
15min112913-1291311.64511.782.7711.7311.862.73
212804-1280411.54611.62
312952-1295211.68011.76
413788-1378812.43412.51
512944-1294411.67311.76
612974-1297411.70011.78
20min115682-1568214.14214.312.3814.2914.452.37
215178-1517813.68713.83
316086-1608614.50614.65
415999-1599914.42714.58
516187-1618714.59714.75
616049-1604914.47214.62
30min118062-1806216.28816.852.2316.5117.072.21
218613-1861316.78517.00
318461-1846116.64816.87
419072-1907217.19917.43
518680-1868016.84517.07
619206-1920617.31917.54
45min121350-2135019.25319.091.0319.5719.401.02
220789-2078918.74719.06
321148-2114819.07119.39
421144-2114419.06719.39
521151-2115119.07319.40
621408-2140819.30519.62
60min122225-2222520.04219.862.1120.4620.282.09
221194-2119419.11219.53
321843-2184319.69720.12
422550-2255020.33520.77
522183-2218320.00420.43
622138-2213819.96320.39
极限121944-2194419.78820.231.5420.3220.771.52
222502-2250220.29220.81
322293-2229320.10320.64
422557-2255720.34120.89
522327-2232720.13420.67
622986-2298620.72821.27
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