替米沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.872593026003261112605725919260040.32
213.942636226229262960.36
单位质量响应值RSD%判断
1874.841886.370.44数据可信
供试品溶液-2024100621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%
5min124648-2464894.41792.554.2694.4292.564.26
224204-2420492.71692.72
322148-2214884.84084.84
425041-2504195.92295.92
524324-2432493.17693.18
624604-2460494.24894.25
10min125497-2549797.66994.103.1698.6195.033.16
224070-2407092.20393.13
323847-2384791.34992.20
425521-2552197.76198.72
523886-2388691.49892.43
624577-2457794.14595.09
15min124636-2463694.37189.963.1296.2991.823.11
223704-2370490.80192.65
322659-2265986.79888.56
423700-2370090.78592.72
522722-2272287.03988.89
623481-2348189.94791.83
20min125071-2507196.03793.452.7498.9096.222.70
223352-2335289.45292.21
324520-2452093.92796.56
425055-2505595.97698.82
524463-2446393.70896.43
623915-2391591.60994.39
30min125049-2504995.95390.683.9499.7894.383.88
222623-2262386.66090.31
323012-2301288.15091.72
424530-2453093.96597.77
523540-2354090.17393.83
623281-2328189.18092.88
45min124425-2442593.56389.275.0898.3593.884.95
221661-2166182.97587.49
321969-2196984.15588.61
424185-2418592.64397.39
523861-2386191.40295.96
623723-2372390.87495.46
60min124675-2467594.52087.426.60100.2492.926.31
222644-2264486.74092.09
321732-2173283.24788.54
423140-2314088.64094.31
524123-2412392.40697.88
620610-2061078.94984.45
极限123966-2396691.80488.272.1498.4794.642.19
222584-2258486.51092.73
322710-2271086.99393.12
423124-2312488.57995.14
522987-2298788.05494.45
622884-2288487.66093.95
替米沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.872630326369264282639926492263980.27
213.942650426323264140.49
单位质量响应值RSD%判断
1903.241894.840.32数据可信
供试品溶液-2024100621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%
5min124078-2407891.33888.114.6291.3488.114.61
221891-2189183.04183.04
324396-2439692.54492.54
424064-2406491.28491.28
522458-2245885.19285.19
622475-2247585.25785.26
10min123387-2338788.71689.962.5089.6390.842.49
222835-2283586.62287.45
323719-2371989.97690.90
424382-2438292.49193.40
523614-2361489.57790.43
624356-2435692.39293.24
15min123924-2392490.75389.214.3192.5590.994.28
221571-2157181.82883.52
323687-2368789.85491.68
424529-2452993.04894.89
523877-2387790.57592.32
623522-2352289.22891.00
20min124568-2456893.19690.742.3695.9093.412.37
223206-2320688.03090.54
324140-2414091.57394.30
424482-2448292.87095.64
523688-2368889.85892.51
623437-2343788.90691.57
30min124353-2435392.38188.553.3096.0292.133.25
222891-2289186.83590.23
323509-2350989.17992.82
424051-2405191.23594.93
522334-2233484.72288.27
622918-2291886.93790.50
45min124274-2427492.08187.753.9096.6492.223.80
222930-2293086.98391.25
323087-2308787.57892.11
424108-2410891.45196.06
522141-2214183.99088.39
622253-2225384.41588.84
60min124931-2493194.57387.735.08100.0693.084.92
222018-2201883.52388.66
323504-2350489.16094.57
423511-2351189.18794.71
521674-2167482.21887.46
623123-2312387.71592.99
极限124021-2402191.12184.904.8897.5591.124.73
220759-2075978.74784.72
322226-2222684.31290.61
422909-2290986.90393.32
521831-2183182.81488.88
622545-2254585.52291.67
替米沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.872657526462265862647526387264970.32
213.942654226339264400.55
单位质量响应值RSD%判断
1910.381896.700.51数据可信
供试品溶液-2024100621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%
5min115208-1520857.55457.194.2457.5557.194.24
215331-1533158.02058.02
313845-1384552.39652.40
415197-1519757.51257.51
515523-1552358.74658.75
615568-1556858.91758.92
10min119901-1990175.31573.185.3075.8973.755.27
219783-1978374.86875.45
318416-1841669.69570.22
420227-2022776.54877.12
519988-1998875.64476.23
617708-1770867.01567.60
15min121887-2188782.83178.555.1484.1679.855.09
219989-1998975.64876.98
318986-1898671.85273.07
421144-2114480.01981.36
521183-2118380.16681.51
621343-2134380.77282.03
20min120735-2073578.47177.746.4280.6379.836.26
218846-1884671.32273.41
320006-2000675.71277.65
420441-2044177.35879.50
520346-2034676.99979.14
622872-2287286.55888.63
30min120281-2028176.75375.903.1479.6978.763.01
219218-1921872.73075.53
320731-2073178.45681.15
420218-2021876.51479.43
519344-1934473.20776.12
620540-2054077.73380.67
45min119079-1907972.20473.722.8575.9177.352.75
219029-1902972.01575.54
319608-1960874.20677.69
419169-1916972.54476.22
519487-1948773.74877.40
620511-2051177.62381.33
60min119728-1972874.66069.465.5779.0973.825.25
218002-1800268.12872.37
319100-1910072.28376.51
417660-1766066.83471.24
516923-1692364.04468.43
618711-1871170.81175.30
极限118085-1808568.44270.122.3573.6275.182.23
218475-1847569.91874.85
318014-1801468.17373.12
418561-1856170.24375.32
519033-1903372.03077.06
619001-1900171.90977.10
替米沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.872632226390264602612126109262800.61
213.942634026245262920.26
单位质量响应值RSD%判断
1894.741886.080.33数据可信
供试品溶液-2024100621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%
5min114458-1445855.09555.483.4455.1055.483.44
214485-1448555.19855.20
314489-1448955.21455.21
413811-1381152.63052.63
514758-1475856.23956.24
615355-1535558.51458.51
10min119107-1910772.81173.002.4773.3673.552.44
219253-1925373.36873.92
319222-1922273.25073.80
419492-1949274.27974.80
519599-1959974.68675.25
618265-1826569.60370.19
15min119833-1983375.57876.002.0476.8677.292.01
219624-1962474.78276.07
319990-1999076.17677.46
420354-2035477.56378.83
520450-2045077.92979.24
619415-1941573.98575.27
20min120140-2014076.74877.301.9578.7879.351.93
220540-2054078.27280.31
319981-1998176.14278.19
420359-2035977.58279.63
520888-2088879.59881.69
619802-1980275.46077.48
30min119149-1914972.97275.866.1275.7778.685.91
221035-2103580.15982.97
317958-1795868.43371.24
421223-2122380.87583.70
520074-2007476.49679.38
620007-2000776.24179.02
45min118351-1835169.93173.984.1173.4677.563.97
219657-1965774.90778.53
319410-1941073.96677.46
420718-2071878.95182.58
519465-1946574.17677.83
618883-1888371.95875.50
60min118397-1839770.10671.163.3674.3475.483.24
218807-1880771.66876.04
318197-1819769.34473.58
418400-1840070.11774.54
519885-1988575.77680.17
618354-1835469.94274.20
极限117936-1793668.34971.253.4873.2876.283.25
219462-1946274.16479.25
318909-1890972.05776.98
418925-1892572.11877.24
517861-1786168.06373.21
619092-1909272.75477.71
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