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)2.5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.202675626675266152655926588266390.30
214.272677626751267640.07
单位质量响应值RSD%判断
1875.991875.540.02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%
5min114856-1485655.56160.119.4555.5660.119.45
216565-1656561.95361.95
315327-1532757.32357.32
415630-1563058.45658.46
515128-1512856.57856.58
618930-1893070.79870.80
10min118796-1879670.29773.283.9570.8573.883.99
220180-2018075.47376.09
318790-1879070.27470.85
419658-1965873.52174.11
519394-1939472.53373.10
620744-2074477.58278.29
15min121180-2118079.21377.331.9980.4778.661.94
220616-2061677.10478.48
319985-1998574.74476.02
420728-2072877.52278.84
520982-2098278.47279.76
620564-2056476.90978.39
20min121657-2165780.99779.611.4883.0581.721.45
221374-2137479.93882.08
320751-2075177.60879.63
421491-2149180.37682.47
521297-2129779.65081.73
621148-2114879.09381.35
30min121656-2165680.99378.952.6283.8581.852.43
220806-2080677.81480.76
321356-2135679.87182.67
421372-2137279.93182.83
521335-2133579.79382.66
620136-2013675.30878.35
45min121239-2123979.43477.823.6183.1081.513.38
220246-2024675.72079.44
321287-2128779.61383.21
420737-2073777.55681.25
521679-2167981.07984.75
619658-1965873.52177.32
60min121323-2132379.74876.734.6984.2181.204.40
219642-1964273.46177.94
321310-2131079.69984.09
420110-2011075.21179.68
521438-2143880.17884.66
619266-1926672.05576.59
90min120232-2023275.66775.332.6880.9380.562.51
219991-1999174.76679.98
320521-2052176.74881.94
420143-2014375.33580.56
520761-2076177.64682.93
619197-1919771.79677.05
120min120292-2029275.89275.742.9981.9181.742.78
220124-2012475.26381.23
320893-2089378.13984.10
420286-2028675.86981.85
520744-2074477.58283.64
619178-1917871.72577.70
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120059-2005975.02077.363.6281.8084.113.36
220429-2042976.40483.12
321189-2118979.24785.99
421573-2157380.68387.42
521191-2119179.25486.09
619662-1966273.53680.22
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)2.5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.202670026781265012652826575266170.45
214.272629126407263490.32
单位质量响应值RSD%判断
1874.441846.461.07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%
5min114375-1437554.20859.617.7854.2159.617.78
214219-1421953.62053.62
316825-1682563.44763.45
415992-1599260.30660.31
517080-1708064.40864.41
616352-1635261.66361.66
10min118288-1828868.96474.264.3869.5174.864.40
219399-1939973.15373.69
320886-2088678.76179.40
419639-1963974.05874.66
520158-2015876.01676.66
619791-1979174.63275.25
15min120235-2023576.30678.972.7277.5480.312.73
221266-2126680.19481.46
321445-2144580.86982.29
420190-2019076.13677.48
521231-2123180.06281.47
621281-2128180.25081.61
20min121404-2140480.71482.263.0482.7184.393.02
222136-2213683.47585.54
322441-2244184.62586.86
420722-2072278.14280.25
522388-2238884.42586.63
621796-2179682.19284.36
30min121948-2194882.76683.784.1185.5786.734.02
223231-2323187.60490.51
322368-2236884.34987.43
420597-2059777.67180.56
522849-2284986.16389.21
622308-2230884.12387.11
45min122146-2214683.51284.114.4387.1487.904.33
223140-2314087.26191.04
322730-2273085.71589.64
420483-2048377.24180.90
523101-2310187.11491.02
622233-2223383.84087.67
60min122348-2234884.27481.295.1888.7485.925.00
221719-2171981.90286.56
321764-2176482.07286.85
419526-1952673.63278.07
522708-2270885.63290.41
621278-2127880.23984.91
90min120637-2063777.82279.103.7783.1384.543.71
221140-2114079.71985.19
321309-2130980.35685.95
419923-1992375.12980.30
522246-2224683.88989.53
620605-2060577.70183.17
120min120979-2097979.11279.552.3385.2085.782.38
221270-2127080.20986.48
321678-2167881.74788.15
420257-2025776.38982.31
521416-2141680.75987.24
620971-2097179.08185.33
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120207-2020776.20079.121.9383.0886.141.84
221037-2103779.33086.40
321026-2102679.28986.51
421161-2116179.79886.48
521046-2104679.36486.65
621403-2140380.71087.75
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)2.5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.202659826431265262647626684265430.38
214.272662726568265980.16
单位质量响应值RSD%判断
1869.231863.910.21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%
5min116510-1651062.05162.377.4462.0562.377.44
218565-1856569.77569.78
315170-1517057.01557.02
416516-1651662.07462.07
517305-1730565.03965.04
615507-1550758.28258.28
10min120002-2000275.17677.084.1175.8077.704.13
221988-2198882.64083.34
320188-2018875.87576.45
419930-1993074.90575.53
521041-2104179.08179.73
619896-1989674.77875.36
15min120734-2073477.92781.634.6079.3083.034.60
223113-2311386.86888.39
321373-2137380.32981.66
421367-2136780.30681.68
522813-2281385.74187.18
620923-2092378.63779.97
20min121122-2112279.38582.273.1981.5484.483.19
223059-2305986.66589.06
322308-2230883.84385.98
421400-2140080.43082.60
521757-2175781.77284.07
621687-2168781.50983.63
30min121549-2154980.99081.883.0783.9484.923.01
222560-2256084.79088.05
322690-2269085.27988.25
421380-2138080.35583.33
521106-2110679.32582.44
621433-2143380.55483.49
45min120686-2068677.74779.084.5781.5082.934.40
221902-2190282.31786.42
322302-2230283.82087.64
420849-2084978.35982.14
519587-1958773.61677.53
620921-2092178.63082.37
60min120124-2012475.63476.775.7680.1781.415.53
221248-2124879.85984.79
322346-2234683.98688.65
420157-2015775.75880.32
519227-1922772.26376.91
619449-1944973.09777.62
90min119743-1974374.20277.542.8679.4982.952.82
221332-2133280.17585.90
320978-2097878.84484.35
420335-2033576.42781.75
520352-2035276.49181.86
621048-2104879.10784.36
120min120678-2067877.71778.532.4183.7584.722.37
221504-2150480.82187.35
320914-2091478.60484.89
420117-2011775.60881.69
520786-2078678.12284.26
621372-2137280.32586.37
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120038-2003875.31179.183.2982.1286.153.23
222143-2214383.22390.56
321346-2134680.22787.30
420783-2078378.11184.95
520967-2096778.80385.72
621129-2112979.41286.26
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)2.5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.202675626637266502666926582266590.24
214.272611026353262320.66
单位质量响应值RSD%判断
1877.391838.261.49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%
5min117654-1765466.67165.077.4566.6765.077.44
216230-1623061.29361.29
315643-1564359.07659.08
416550-1655062.50162.50
518724-1872470.71170.71
618581-1858170.17170.17
10min120567-2056777.67177.543.4178.3478.193.44
220200-2020076.28676.90
319649-1964974.20574.80
420171-2017176.17676.80
521647-2164781.75082.46
620955-2095579.13779.84
15min121833-2183382.45380.823.2083.9082.253.20
220271-2027176.55477.93
321114-2111479.73781.07
421500-2150081.19582.58
522282-2228284.14885.67
621410-2141080.85582.35
20min121771-2177182.21882.111.3084.4984.341.32
221970-2197082.97085.11
321460-2146081.04483.17
421535-2153581.32783.53
522171-2217183.72986.10
621545-2154581.36583.67
30min121818-2181882.39680.953.6685.4984.013.52
222028-2202883.18986.16
321242-2124280.22183.16
421542-2154281.35484.37
522019-2201983.15586.36
619961-1996175.38378.50
45min120796-2079678.53679.085.4182.4582.945.20
221258-2125880.28184.08
320859-2085978.77482.52
421509-2150981.22985.05
522303-2230384.22888.26
618917-1891771.44075.31
60min120964-2096479.17176.604.9983.8781.264.82
219659-1965974.24278.85
320445-2044577.21181.74
420036-2003675.66680.30
521744-2174482.11686.99
618858-1885871.21775.80
90min119963-1996375.39077.474.4180.8882.894.22
220972-2097279.20184.55
320519-2051977.49082.79
421250-2125080.25185.65
521372-2137280.71286.41
619001-1900171.75777.05
120min120867-2086778.80478.782.7485.0584.972.61
221579-2157981.49387.63
320555-2055577.62683.70
421357-2135780.65586.85
520821-2082178.63185.14
619981-1998175.45881.47
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120227-2022776.38778.233.6783.4285.223.47
221732-2173282.07189.03
319839-1983974.92281.78
421245-2124580.23287.24
521144-2114479.85187.14
620107-2010775.93482.70
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