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%
110.531065211066091064461065241064691065140.06
210.551068071066891067480.08
单位质量响应值RSD%判断
10115.2910118.290.03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%
5min14502-45023.9934.2418.523.994.2418.60
24211-42113.7353.73
34084-40843.6223.62
44479-44793.9733.97
56490-64905.7565.76
64930-49304.3734.37
10min110360-103609.1899.027.619.219.047.65
29676-96768.5828.60
310078-100788.9398.96
49667-96678.5748.60
511631-1163110.31610.35
69606-96068.5208.54
15min114012-1401212.42812.445.1512.5012.525.17
213981-1398112.40012.47
314114-1411412.51812.59
413315-1331511.81011.88
515335-1533513.60113.69
613415-1341511.89811.97
20min116517-1651714.65014.803.9114.7914.953.93
217283-1728315.32915.47
316843-1684314.93915.08
416120-1612014.29714.43
517530-1753015.54815.71
615860-1586014.06714.20
30min119952-1995217.69617.792.3817.9218.022.38
220640-2064018.30618.53
320376-2037618.07218.29
419696-1969617.46917.68
520333-2033318.03418.29
619369-1936917.17917.40
45min122127-2212719.62519.532.4619.9519.862.44
222188-2218819.67920.00
322851-2285120.26720.59
421494-2149419.06419.38
522104-2210419.60519.96
621350-2135018.93619.25
60min122790-2279020.21320.411.4420.6420.851.42
223354-2335420.71421.15
323500-2350020.84321.28
422937-2293720.34420.76
522806-2280620.22820.69
622709-2270920.14220.56
极限123774-2377421.08621.090.4521.6321.640.40
223831-2383121.13721.69
323929-2392921.22421.77
423775-2377521.08721.62
523601-2360120.93321.51
623786-2378621.09721.63
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%
110.531074631072321072141070621068201071580.23
210.551074991076691075840.12
单位质量响应值RSD%判断
10176.4510197.540.15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%
5min14499-44993.9634.1412.243.964.1412.21
25358-53584.7194.72
34762-47624.1954.19
44999-49994.4034.40
54881-48814.2994.30
63675-36753.2373.24
10min110042-100428.8458.5611.848.878.5811.82
211349-113499.99710.02
38556-85567.5367.56
49973-99738.7858.81
510140-101408.9328.96
68220-82207.2407.26
15min113691-1369112.05911.758.0712.1311.828.07
214694-1469412.94313.02
311956-1195610.53110.60
413685-1368512.05412.13
513917-1391712.25912.33
612127-1212710.68210.74
20min116356-1635614.40714.275.6414.5514.405.69
217512-1751215.42515.58
315177-1517713.36813.49
416394-1639414.44014.58
516626-1662614.64514.79
615124-1512413.32213.44
30min119276-1927616.97917.104.4017.2017.324.44
220462-2046218.02418.26
318226-1822616.05416.25
419733-1973317.38117.60
520109-2010917.71317.94
618687-1868716.46016.65
45min121478-2147818.91819.402.6019.2319.712.63
222341-2234119.67920.02
321326-2132618.78519.07
422748-2274820.03720.35
522453-2245319.77720.10
621820-2182019.22019.50
60min122963-2296320.22720.471.5820.6420.891.64
223953-2395321.09921.55
322998-2299820.25720.65
423208-2320820.44220.87
523251-2325120.48020.91
623095-2309520.34320.73
极限124870-2487021.90621.241.9722.4421.771.93
224053-2405321.18721.75
324451-2445121.53722.04
423927-2392721.07621.62
523817-2381720.97921.52
623557-2355720.75021.25
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%
110.531076291077581076391074191073791075650.15
210.551071661073091072380.10
单位质量响应值RSD%判断
10215.1010164.740.35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%
5min15808-58085.1145.034.765.115.034.76
25960-59605.2485.25
35485-54854.8304.83
45492-54924.8364.84
56075-60755.3505.35
65455-54554.8044.80
10min110815-108159.5239.272.329.559.292.31
210312-103129.0819.11
310481-104819.2299.26
410274-102749.0479.07
510426-104269.1819.21
610829-108299.5369.56
15min114156-1415612.46612.522.5312.5512.602.52
213639-1363912.01012.09
314144-1414412.45512.53
414473-1447312.74512.82
514210-1421012.51312.59
614703-1470312.94713.03
20min117321-1732115.25314.971.1215.4015.121.10
217062-1706215.02415.17
316988-1698814.95915.11
416839-1683914.82814.98
516785-1678514.78114.93
616992-1699214.96315.11
30min119447-1944717.12517.442.0317.3617.672.00
219973-1997317.58817.82
319995-1999517.60717.84
419987-1998717.60017.83
519175-1917516.88517.12
620232-2023217.81618.05
45min121944-2194419.32319.591.7819.6519.921.77
222036-2203619.40419.73
321968-2196819.34519.67
422891-2289120.15720.49
522055-2205519.42119.75
622580-2258019.88420.22
60min123314-2331420.53020.641.2420.9721.081.20
223640-2364020.81721.25
323868-2386821.01821.45
423192-2319220.42220.86
523114-2311420.35420.79
623535-2353520.72421.17
极限123716-2371620.88421.301.3521.4421.861.31
224097-2409721.21921.77
324015-2401521.14721.70
424622-2462221.68222.24
524455-2445521.53522.08
624260-2426021.36321.92
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%
110.531077961077031074321075651073521075700.18
210.551072831072991072910.02
单位质量响应值RSD%判断
10215.5710169.760.32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%
5min16479-64795.7046.126.735.706.126.77
27020-70206.1806.18
36577-65775.7905.79
46712-67125.9095.91
57721-77216.7976.80
67232-72326.3676.37
10min112020-1202010.58210.822.8710.6110.862.87
212344-1234410.86710.90
311921-1192110.49510.53
412092-1209210.64510.68
512832-1283211.29711.33
612566-1256611.06211.10
15min115472-1547213.62114.393.2913.7114.483.29
216572-1657214.58914.68
316532-1653214.55414.64
416095-1609514.16914.26
517075-1707515.03215.13
616311-1631114.35914.46
20min118619-1861916.39116.832.3916.5617.002.38
219472-1947217.14217.32
319001-1900116.72716.90
418555-1855516.33516.51
519592-1959217.24817.43
619442-1944217.11617.29
30min121695-2169519.09919.522.1119.3619.792.10
222072-2207219.43119.70
321790-2179019.18319.45
422120-2212019.47319.73
522401-2240119.72120.00
622982-2298220.23220.50
45min123768-2376820.92421.472.2421.2921.852.21
223838-2383820.98621.36
325049-2504922.05222.42
424401-2440121.48121.85
524981-2498121.99222.38
624310-2431021.40121.79
60min124382-2438221.46521.791.9921.9422.291.98
225232-2523222.21322.71
324301-2430121.39321.89
424297-2429721.39021.88
525375-2537522.33922.85
624946-2494621.96122.46
极限124274-2427421.36921.911.5221.9722.531.52
224878-2487821.90122.52
325246-2524622.22522.84
424730-2473021.77122.38
525317-2531722.28822.92
624883-2488321.90622.53
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