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%
110.531072491070101066101068721065011068480.29
210.551072631074771073700.15
单位质量响应值RSD%判断
10147.0110177.250.22数据可信
长期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%
5min14520-45203.9914.487.923.994.487.93
25168-51684.5634.56
35354-53544.7284.73
44775-47754.2164.22
54995-49954.4114.41
65637-56374.9774.98
10min19966-99668.8009.427.248.829.457.23
211511-1151110.16410.19
310249-102499.0509.08
49937-99378.7748.80
510656-106569.4099.43
611702-1170210.33310.36
15min114002-1400212.36412.773.0112.4312.843.05
214663-1466312.94713.03
314098-1409812.44812.52
414183-1418312.52312.60
514676-1467612.95913.04
615121-1512113.35213.44
20min116475-1647514.54715.094.0014.6915.243.99
217688-1768815.61815.77
316936-1693614.95415.10
416190-1619014.29614.44
517320-1732015.29315.44
617931-1793115.83315.99
30min120067-2006717.71918.002.7817.9418.232.80
220935-2093518.48518.73
319955-1995517.62017.85
419730-1973017.42117.64
520500-2050018.10118.33
621137-2113718.66418.91
45min122057-2205719.47619.761.5019.8020.091.51
222710-2271020.05320.40
322487-2248719.85620.18
422461-2246119.83320.15
521886-2188619.32519.66
622669-2266920.01620.37
60min123879-2387921.08520.701.5521.5121.141.51
223879-2387921.08521.54
323018-2301820.32520.76
423408-2340820.66921.10
523187-2318720.47420.92
623266-2326620.54421.01
极限123917-2391721.11821.251.9021.6621.811.89
223948-2394821.14621.72
324215-2421521.38221.93
423595-2359520.83421.38
523841-2384121.05121.61
624910-2491021.99522.57
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%
110.531063891068251064491064921065541065420.16
210.551065231062281063760.20
单位质量响应值RSD%判断
10117.9510083.030.25数据可信
长期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%
5min15130-51304.5574.8416.704.564.8416.69
25130-51304.5574.56
34671-46714.1504.15
46990-69906.2106.21
56071-60715.3935.39
64696-46964.1724.17
10min19285-92858.2499.5412.398.279.5612.39
211542-1154210.25410.28
39791-97918.6988.72
412819-1281911.38811.42
511103-111039.8649.89
69887-98878.7838.81
15min112820-1282011.38913.089.2711.4613.169.28
215395-1539513.67713.76
314241-1424112.65112.72
416810-1681014.93415.03
515081-1508113.39813.48
614009-1400912.44512.52
20min115293-1529313.58615.236.9513.7215.386.97
217359-1735915.42115.58
316543-1654314.69614.84
418803-1880316.70416.88
517840-1784015.84916.01
617040-1704015.13815.28
30min118991-1899116.87118.034.2417.0818.274.31
220658-2065818.35218.60
320196-2019617.94218.16
421609-2160919.19719.47
520386-2038618.11018.36
619946-1994617.72017.94
45min122319-2231919.82819.922.5320.1320.252.59
222488-2248819.97820.32
321904-2190419.45919.78
423506-2350620.88221.26
522136-2213619.66520.01
622169-2216919.69420.02
60min122342-2234219.84820.772.9920.2621.223.02
223517-2351720.89221.35
323738-2373821.08821.52
424251-2425121.54422.04
522761-2276120.22020.68
623645-2364521.00621.44
极限124230-2423021.52521.361.7522.0521.921.69
224682-2468221.92722.50
323701-2370121.05521.60
423887-2388721.22121.84
523528-2352820.90221.47
624208-2420821.50622.06
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%
110.531069441073261071681071331067511070640.21
210.551066351063111064730.22
单位质量响应值RSD%判断
10167.5210092.230.53数据可信
长期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%
5min14175-41753.6984.4313.813.704.4313.78
24511-45113.9964.00
35739-57395.0845.08
44623-46234.0954.10
55877-58775.2065.21
65084-50844.5034.50
10min17770-77706.8838.1612.336.908.1912.34
28791-87917.7877.81
310001-100018.8598.89
48169-81697.2367.26
59972-99728.8338.86
610594-105949.3849.41
15min111068-110689.80410.9811.039.8611.0511.04
211273-112739.98610.05
313410-1341011.87911.96
411555-1155510.23610.30
512511-1251111.08211.16
614532-1453212.87312.95
20min114868-1486813.17013.567.2013.2813.697.23
214392-1439212.74912.87
316311-1631114.44814.59
414058-1405812.45312.57
515348-1534813.59513.73
616880-1688014.95215.10
30min118070-1807016.00716.365.0716.1916.565.12
218179-1817916.10316.29
319129-1912916.94517.17
417126-1712615.17015.36
518468-1846816.35916.57
619843-1984317.57717.81
45min121657-2165719.18419.113.7619.4619.413.80
221250-2125018.82319.10
322342-2234219.79120.11
420188-2018817.88318.16
521638-2163819.16719.47
622386-2238619.83020.16
60min123267-2326720.61020.552.2620.9920.952.34
222744-2274420.14720.53
323818-2381821.09821.53
422440-2244019.87820.25
523260-2326020.60421.02
623639-2363920.94021.38
极限123564-2356420.87321.892.8521.3722.402.79
224517-2451721.71722.22
324499-2449921.70122.25
425668-2566822.73723.22
524988-2498822.13522.66
625005-2500522.15022.71
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%
110.531060751061771060851063211058771061070.16
210.551070761065391068080.36
单位质量响应值RSD%判断
10076.6410123.980.34数据可信
长期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%
5min15389-53894.7885.869.694.795.879.69
26919-69196.1476.15
36695-66955.9485.95
46502-65025.7765.78
57212-72126.4076.41
66886-68866.1176.12
10min111568-1156810.27710.944.9310.3010.974.95
213027-1302711.57311.61
311932-1193210.60010.63
411848-1184810.52610.56
512646-1264611.23511.27
612865-1286511.42911.46
15min116263-1626314.44814.844.7514.5314.934.74
217069-1706915.16415.26
315770-1577014.01014.10
418052-1805216.03716.13
516346-1634614.52214.62
616728-1672814.86114.96
20min118530-1853016.46217.071.8716.6317.251.87
219321-1932117.16517.35
319385-1938517.22217.39
419500-1950017.32417.50
519427-1942717.25917.44
619131-1913116.99617.18
30min120685-2068518.37619.232.4218.6319.512.43
221972-2197219.52019.80
321771-2177119.34119.61
421651-2165119.23519.51
521618-2161819.20519.48
622210-2221019.73120.01
45min123296-2329620.69621.342.3921.0521.722.37
224072-2407221.38521.77
323857-2385721.19421.57
423804-2380421.14721.53
525036-2503622.24222.62
624077-2407721.39021.77
60min123560-2356020.93121.812.4421.4022.312.44
224967-2496722.18122.69
324675-2467521.92122.41
425314-2531422.48922.99
524407-2440721.68322.19
624407-2440721.68322.19
极限125368-2536822.53722.571.4323.1323.191.40
225785-2578522.90723.54
325776-2577622.89923.51
425345-2534522.51623.14
525371-2537122.53923.16
624795-2479522.02822.65
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