替米沙坦左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.612682726774267662680126822267980.11
214.432689126842268660.13
单位质量响应值RSD%判断
1834.221861.821.06数据可信
供试品溶液-2024070321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%
5min113851-1385152.58356.098.3852.5856.098.39
213732-1373252.13152.13
316592-1659262.98962.99
414915-1491556.62356.62
515876-1587660.27160.27
613685-1368551.95351.95
10min121322-2132280.94685.233.5381.4785.793.55
222924-2292487.02787.55
323383-2338388.77089.40
422345-2234584.82985.40
522971-2297187.20687.81
621751-2175182.57483.09
15min122547-2254785.59689.202.8186.9390.612.80
224186-2418691.81893.21
323262-2326288.31189.83
423557-2355789.43190.85
524281-2428192.17993.65
623145-2314587.86689.21
20min123046-2304687.49190.422.4289.6892.722.41
224651-2465193.58495.89
323686-2368689.92092.32
423706-2370689.99692.31
524303-2430392.26394.66
623509-2350989.24891.47
30min122871-2287186.82690.843.7689.8994.053.69
225037-2503795.04998.29
323186-2318688.02291.32
424363-2436392.49095.70
524733-2473393.89597.21
623380-2338088.75991.87
45min123228-2322888.18288.053.7992.1292.173.65
223857-2385790.56994.77
321675-2167582.28686.47
423687-2368789.92494.06
523995-2399591.09395.35
622721-2272186.25790.26
60min122401-2240185.04284.944.8689.8689.944.67
223292-2329288.42493.53
320771-2077178.85483.86
423308-2330888.48593.52
523122-2312287.77992.95
621351-2135181.05685.92
90min121637-2163782.14283.533.5187.8189.383.39
222513-2251385.46791.45
320682-2068278.51684.31
422596-2259685.78291.70
522687-2268786.12892.17
621908-2190883.17088.85
120min121218-2121880.55182.383.0987.0489.063.05
222473-2247385.31592.16
320944-2094479.51186.09
421744-2174482.54889.32
522523-2252385.50592.41
621297-2129780.85187.36
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限121236-2123680.61983.703.4287.9191.213.32
222884-2288486.87694.57
321238-2123880.62788.00
421855-2185582.96990.57
522922-2292287.02094.78
622151-2215184.09391.41
替米沙坦左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.612688227153269572696827046270010.39
214.432689226880268860.04
单位质量响应值RSD%判断
1848.121863.200.58数据可信
供试品溶液-2024070421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%
5min117231-1723165.14368.384.2265.1468.384.22
217377-1737765.69565.69
318908-1890871.48371.48
417668-1766866.79566.80
518393-1839369.53669.54
618940-1894071.60471.60
10min121055-2105579.60083.013.3180.2583.703.32
221405-2140580.92381.58
322939-2293986.72287.44
421599-2159981.65682.32
522174-2217483.83084.53
622575-2257585.34686.06
15min122104-2210483.56686.362.0485.0187.882.07
222593-2259385.41486.88
323464-2346488.70790.29
422807-2280786.22387.71
522995-2299586.93488.47
623102-2310287.33988.91
20min122126-2212683.64985.892.6885.9388.262.68
222011-2201183.21485.53
323626-2362689.32091.79
422886-2288686.52288.87
523077-2307787.24489.65
622582-2258285.37387.82
30min121737-2173782.17885.703.7685.3088.943.63
223197-2319787.69890.85
322772-2277286.09189.45
423200-2320087.70990.92
523590-2359089.18492.46
621515-2151581.33984.64
45min119579-1957974.02081.706.9077.9685.806.62
222268-2226884.18688.22
321170-2117080.03584.26
422577-2257785.35489.44
523626-2362689.32093.49
620448-2044877.30581.42
60min119931-1993175.35079.406.3080.0384.316.00
221808-2180882.44787.32
320197-2019776.35681.38
422706-2270685.84290.78
521949-2194982.98088.04
619424-1942473.43478.32
90min120159-2015976.21280.663.5981.6586.373.53
221452-2145281.10186.80
321732-2173282.15987.95
422037-2203783.31289.11
521979-2197983.09388.98
620660-2066078.10783.72
120min120892-2089278.98480.862.1885.1887.372.21
220970-2097079.27885.79
321825-2182582.51189.12
421637-2163781.80088.43
521937-2193782.93489.66
621062-2106279.62686.02
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限121584-2158481.60082.621.7988.5989.941.69
221392-2139280.87488.17
322249-2224984.11491.55
421660-2166081.88789.34
521861-2186182.64790.20
622381-2238184.61391.81
替米沙坦左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.612680027108269152686926874269130.44
214.432653126540265360.03
单位质量响应值RSD%判断
1842.091838.950.13数据可信
供试品溶液-2024070521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%
5min17766-776629.60151.0922.2329.6051.0922.23
215880-1588060.52860.53
315074-1507457.45657.46
412552-1255247.84347.84
514277-1427754.41854.42
614873-1487356.69056.69
10min118647-1864771.07580.416.4371.3780.926.53
222486-2248685.70886.31
321928-2192883.58184.16
420569-2056978.40178.88
521482-2148281.88182.43
621468-2146881.82882.39
15min121175-2117580.71185.633.2181.7286.953.35
222932-2293287.40888.87
323160-2316088.27789.69
422214-2221484.67185.93
522876-2287687.19488.56
622443-2244385.54486.93
20min122391-2239185.34687.842.5687.1690.002.59
222372-2237285.27387.61
323754-2375490.54192.83
423217-2321788.49490.60
523601-2360189.95892.19
622930-2293087.40089.64
30min122748-2274886.70687.212.5089.3790.262.44
221917-2191783.53986.73
323628-2362890.06193.26
423040-2304087.81990.81
523175-2317588.33491.47
622775-2277586.80989.92
45min122615-2261586.19986.283.7089.7390.203.53
221135-2113580.55884.58
322990-2299087.62991.73
423421-2342189.27293.14
523296-2329688.79592.81
622362-2236285.23589.22
60min121880-2188083.39882.245.0487.7987.024.72
220204-2020477.01081.84
321059-2105980.26985.24
423028-2302887.77492.54
522523-2252385.84990.75
620763-2076379.14083.98
90min121242-2124280.96680.923.3286.2086.533.16
219914-1991475.90481.50
321234-2123480.93686.71
421906-2190683.49789.14
521765-2176582.96088.72
621320-2132081.26386.89
120min120797-2079779.27079.983.0485.3186.402.90
219863-1986375.71082.07
321258-2125881.02787.61
421113-2111380.47486.95
521090-2109080.38786.98
621779-2177983.01389.45
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限120586-2058678.46679.772.4185.3086.982.37
220189-2018976.95284.07
320801-2080179.28586.68
421441-2144181.72589.01
521481-2148181.87789.27
621067-2106780.29987.57
替米沙坦左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.612681126757267722679926743267760.11
214.432661426565265900.14
单位质量响应值RSD%判断
1832.721842.690.39数据可信
供试品溶液-2023052121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%
5min116750-1675063.94366.044.5263.9466.044.52
217579-1757967.10767.11
316640-1664063.52363.52
416620-1662063.44663.45
518594-1859470.98270.98
617609-1760967.22267.22
10min121669-2166982.72181.202.9983.3681.862.99
221636-2163682.59583.27
320692-2069278.99179.63
420255-2025577.32377.96
521761-2176183.07283.78
621617-2161782.52283.19
15min122368-2236885.38983.982.7586.8685.462.76
222236-2223684.88586.38
320971-2097180.05681.48
421584-2158482.39683.80
522580-2258086.19987.74
622258-2225884.96986.47
20min121944-2194483.77183.582.7886.0985.892.77
221969-2196983.86686.21
320898-2089879.77882.00
421679-2167982.75984.99
522114-2211484.42086.82
622764-2276486.90189.25
30min121542-2154282.23683.051.7385.3986.191.73
221409-2140981.72884.91
321345-2134581.48484.51
421892-2189283.57286.63
522230-2223084.86288.11
622107-2210784.39387.61
45min119960-1996076.19779.073.4180.1883.053.33
220723-2072379.10983.11
319773-1977375.48379.32
421053-2105380.36984.26
521276-2127681.22185.32
621488-2148882.03086.09
60min118767-1876771.64376.314.6676.3981.084.45
219557-1955774.65879.45
319378-1937873.97578.57
420693-2069378.99583.69
520254-2025477.31982.23
621296-2129681.29786.18
90min118991-1899172.49874.803.5777.9680.343.47
219759-1975975.42980.97
318497-1849770.61275.94
420087-2008776.68282.17
520276-2027677.40383.08
619960-1996076.19781.89
120min119340-1934073.83071.874.0680.0178.163.85
219696-1969675.18981.48
317668-1766867.44773.49
418245-1824569.65075.91
519286-1928673.62480.08
618731-1873171.50577.96
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限118850-1885071.95968.136.8078.8875.136.30
219089-1908972.87279.92
316224-1622461.93568.65
416850-1685064.32471.28
518780-1878071.69278.88
617287-1728765.99373.16
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