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%
113.792699726887267292664227073268660.67
213.862670026755267280.15
单位质量响应值RSD%判断
1948.221928.430.73数据可信
供试品溶液-2024100721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%
5min115732-1573258.47062.183.6858.4762.183.68
216707-1670762.09362.09
317092-1709263.52463.52
416475-1647561.23161.23
517561-1756165.26765.27
616819-1681962.50962.51
10min119846-1984673.76076.742.5574.3477.362.55
221125-2112578.51379.13
320189-2018975.03475.67
421115-2111578.47679.09
520940-2094077.82678.48
620665-2066576.80477.43
15min121496-2149679.89280.363.2981.2181.753.22
220652-2065276.75578.16
322746-2274684.53885.92
422053-2205381.96283.36
521336-2133679.29780.73
621448-2144879.71481.11
20min121769-2176980.90780.592.5583.0382.782.47
222028-2202881.86984.04
320704-2070476.94879.18
422272-2227282.77684.99
521881-2188181.32383.55
621444-2144479.69981.89
30min120802-2080277.31380.553.7480.2483.543.65
221327-2132779.26482.26
322174-2217482.41285.41
422722-2272284.44987.49
522208-2220882.53885.58
620798-2079877.29880.29
45min121239-2123978.93779.373.1182.6483.183.00
221107-2110778.44682.23
322027-2202781.86685.69
422300-2230082.88086.77
520763-2076377.16881.03
620704-2070476.94880.71
60min120278-2027875.36577.262.7579.8681.862.68
220315-2031575.50380.07
321336-2133679.29783.94
421656-2165680.48785.20
520609-2060976.59581.23
620540-2054076.33980.87
极限119718-1971873.28473.701.3678.5379.071.33
219627-1962772.94678.27
319490-1949072.43777.87
420219-2021975.14680.67
520009-2000974.36579.77
619910-1991073.99779.29
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%
113.792655626605265342638126588265330.34
213.862680926527266680.75
单位质量响应值RSD%判断
1924.081924.100.01数据可信
供试品溶液-2024100721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%
5min116037-1603760.04361.242.8960.0461.242.89
217124-1712464.11264.11
315960-1596059.75459.75
416352-1635261.22261.22
515972-1597259.79959.80
616698-1669862.51762.52
10min120603-2060377.13875.864.0577.7476.484.01
218924-1892470.85271.49
320386-2038676.32576.92
419669-1966973.64174.25
521025-2102578.71879.32
620971-2097178.51679.14
15min120973-2097378.52380.042.4579.8981.402.41
221488-2148880.45181.80
320989-2098978.58379.94
421544-2154480.66182.01
522297-2229783.48084.87
620970-2097078.51279.92
20min122333-2233383.61582.001.7085.7784.171.67
221983-2198382.30484.46
321241-2124179.52681.67
421767-2176781.49683.65
522031-2203182.48484.70
622061-2206182.59684.79
30min120823-2082377.96179.054.0280.9582.043.90
220232-2023275.74978.73
320894-2089478.22781.17
421250-2125079.56082.53
522710-2271085.02688.07
620771-2077177.76780.79
45min120808-2080877.90577.874.5981.6881.654.44
219757-1975773.97077.70
320991-2099178.59082.31
420049-2004975.06478.83
522489-2248984.19988.09
620692-2069277.47181.27
60min119157-1915771.72474.576.0576.2879.135.81
219070-1907071.39875.87
319921-1992174.58479.09
419137-1913771.64976.17
522228-2222883.22287.96
619993-1999374.85479.43
极限120511-2051176.79373.332.5682.0678.632.35
219502-1950273.01678.20
319715-1971573.81379.07
419122-1912271.59376.83
519208-1920871.91577.48
619451-1945172.82578.15
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%
113.792675226768268382680526678267680.23
213.862654226519265300.07
单位质量响应值RSD%判断
1941.121914.140.99数据可信
供试品溶液-2026031621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%
5min19661-966136.10641.6821.0536.1141.6821.05
210418-1041838.93538.94
313508-1350850.48450.48
411769-1176943.98443.98
57734-773428.90428.90
613831-1383151.69151.69
10min115896-1589659.40865.7410.7859.7766.1610.84
216962-1696263.39263.78
319319-1931972.20172.71
417826-1782666.62167.06
515361-1536157.40957.70
620172-2017275.38975.91
15min118330-1833068.50575.405.7169.4676.475.78
220055-2005574.95275.97
321701-2170181.10382.33
419956-1995674.58275.69
519946-1994674.54475.41
621056-2105678.69379.96
20min119281-1928172.05979.575.7173.7081.405.78
221750-2175081.28683.06
322826-2282685.30887.35
421195-2119579.21281.06
520732-2073277.48279.09
621963-2196382.08284.14
30min119585-1958573.19579.744.6475.5682.364.73
221401-2140179.98282.57
322199-2219982.96485.86
421227-2122779.33281.98
521243-2124379.39281.78
622358-2235883.55986.44
45min120853-2085377.93481.852.6181.0385.272.67
222038-2203882.36385.75
322465-2246583.95987.68
421901-2190181.85185.29
522324-2232483.43286.61
621816-2181681.53385.25
60min121069-2106978.74181.111.6582.6185.341.78
222052-2205282.41586.62
322018-2201882.28886.85
421630-2163080.83885.09
521788-2178881.42885.44
621654-2165480.92885.46
极限119950-1995074.55975.763.3879.2280.813.40
219757-1975773.83878.87
321309-2130979.63885.02
419504-1950472.89277.96
520291-2029175.83480.66
620819-2081977.80783.15
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%
113.792695026913268572698527016269440.24
213.862671526877267960.43
单位质量响应值RSD%判断
1953.881933.330.75数据可信
供试品溶液-2026031621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%
5min19446-944635.01250.0220.5835.0150.0220.58
216072-1607259.57159.57
316328-1632860.52060.52
413311-1331149.33749.34
511070-1107041.03141.03
614749-1474954.66754.67
10min114628-1462854.21967.1910.0454.5767.7010.10
219361-1936171.76272.36
319403-1940371.91772.52
418943-1894370.21270.71
517727-1772765.70566.12
618708-1870869.34169.89
15min117686-1768665.55374.506.9266.4575.677.01
221121-2112178.28579.60
320868-2086877.34778.67
421215-2121578.63479.83
519212-1921271.20972.28
620495-2049575.96577.20
20min119375-1937571.81477.574.7273.3679.494.82
220714-2071476.77778.87
322043-2204381.70383.80
421973-2197381.44383.42
520687-2068776.67778.46
620780-2078077.02179.02
30min119785-1978573.33378.374.6975.6081.064.74
220242-2024275.02777.89
322092-2209281.88484.80
422272-2227282.55185.35
521068-2106878.08980.63
621405-2140579.33882.11
45min121502-2150279.69779.244.2482.7082.714.08
219844-1984473.55277.17
321441-2144179.47183.20
422554-2255483.59787.22
521051-2105178.02681.35
621873-2187381.07284.64
60min121451-2145179.50880.075.6083.3084.345.38
219464-1946472.14376.49
322193-2219382.25986.79
423108-2310885.65090.11
521887-2188781.12485.23
621512-2151279.73484.11
极限119544-1954472.44073.733.9377.0378.803.90
219871-1987173.65278.72
319789-1978973.34878.70
421260-2126078.80084.11
518874-1887469.95774.88
620012-2001274.17579.35
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