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%
19.991008451007081008121009951009361008590.12
29.891013131013311013220.02
单位质量响应值RSD%判断
10096.0010244.891.04数据可信
中间条件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%
5min12880-28802.5412.6429.642.542.6429.69
23141-31412.7712.77
34621-46214.0774.08
42947-29472.6002.60
52211-22111.9511.95
62188-21881.9301.93
10min18119-81197.1637.4115.787.187.4315.81
28627-86277.6127.63
310851-108519.5749.60
48178-81787.2167.23
56978-69786.1576.17
67645-76456.7456.76
15min111856-1185610.46110.639.2910.5110.699.36
212120-1212010.69410.75
314047-1404712.39412.47
412083-1208310.66110.72
510642-106429.3909.43
611556-1155610.19610.24
20min114729-1472912.99613.127.4213.1113.237.46
215029-1502913.26013.38
316852-1685214.86915.01
414563-1456312.84912.96
513500-1350011.91112.01
614521-1452112.81212.92
30min118263-1826316.11416.064.7816.3016.254.85
218343-1834316.18416.37
319727-1972717.40517.63
417933-1793315.82216.01
517091-1709115.08015.24
617851-1785115.75015.93
45min120558-2055818.13918.203.1718.4118.483.26
220904-2090418.44418.72
321669-2166919.11919.44
420541-2054118.12418.40
519673-1967317.35817.60
620421-2042118.01818.28
60min122567-2256719.91119.552.4020.2919.932.50
222232-2223219.61620.00
322968-2296820.26520.70
421778-2177819.21519.59
521590-2159019.04919.39
621818-2181819.25019.61
极限123320-2332020.57520.520.7321.0621.010.84
223161-2316120.43520.93
323463-2346320.70221.24
423387-2338720.63521.12
522991-2299120.28520.73
623253-2325320.51620.99
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%
19.991005311004711003421004241004301004400.07
29.891009391008501008940.07
单位质量响应值RSD%判断
10054.0510201.621.04数据可信
中间条件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%
5min12652-26522.3502.7115.022.352.7114.94
22828-28282.5062.51
32728-27282.4172.42
43786-37863.3543.35
52875-28752.5472.55
63461-34613.0673.07
10min19121-91218.0817.618.798.097.638.78
27995-79957.0847.10
38479-84797.5137.53
49793-97938.6778.70
57734-77346.8526.87
68445-84457.4827.50
15min113236-1323611.72711.138.2911.7911.198.29
211862-1186210.51010.56
312078-1207810.70110.76
414375-1437512.73712.80
511657-1165710.32810.38
612195-1219510.80510.86
20min116246-1624614.39413.795.7314.5213.915.74
215411-1541113.65413.77
315115-1511513.39213.51
416964-1696415.03015.17
514502-1450212.84912.96
615131-1513113.40613.53
30min119408-1940817.19616.524.3317.4016.714.37
218263-1826316.18116.37
318351-1835116.25916.45
419881-1988117.61517.84
517945-1794515.90016.08
618001-1800115.94916.14
45min121382-2138218.94518.533.1119.2418.823.14
221219-2121918.80019.08
320195-2019517.89318.17
421814-2181419.32819.65
520361-2036118.04018.31
620516-2051618.17818.46
60min122712-2271220.12319.981.6920.5320.371.72
222731-2273120.14020.52
322360-2236019.81120.19
422973-2297320.35520.78
522632-2263220.05220.42
621883-2188319.38919.77
极限123863-2386321.14320.801.5221.6621.311.55
223841-2384121.12421.62
323343-2334320.68221.17
423632-2363220.93821.48
522974-2297420.35520.84
623235-2323520.58721.08
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%
19.999951399740997899970299773997030.12
29.891007671007831007750.02
单位质量响应值RSD%判断
9980.2810189.591.47数据可信
中间条件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%
5min12975-29752.6472.4017.132.652.4017.14
22193-21931.9511.95
33093-30932.7522.75
42769-27692.4642.46
53120-31202.7762.78
62065-20651.8381.84
10min18319-83197.4037.585.367.427.595.35
29110-91108.1068.12
39009-90098.0178.03
47973-79737.0957.11
58503-85037.5667.58
68181-81817.2807.29
15min112065-1206510.73611.145.1110.7911.195.10
213490-1349012.00412.06
312788-1278811.37911.44
411620-1162010.34010.39
512514-1251411.13511.19
612620-1262011.23011.28
20min114800-1480013.17013.353.8913.2913.473.88
215703-1570313.97314.10
315004-1500413.35113.47
413988-1398812.44712.56
515325-1532513.63713.76
615175-1517513.50313.62
30min118144-1814416.14516.443.3316.3316.633.34
219504-1950417.35517.56
318524-1852416.48316.68
417689-1768915.74015.92
518271-1827116.25816.45
618707-1870716.64616.83
45min120346-2034618.10518.543.9418.3818.823.88
221579-2157919.20219.50
319424-1942417.28417.57
421326-2132618.97719.24
520969-2096918.65918.94
621399-2139919.04219.32
60min121806-2180619.40420.192.6519.7820.582.65
223692-2369221.08221.49
322680-2268020.18220.57
422727-2272720.22320.60
522634-2263420.14120.53
622599-2259920.10920.50
极限123099-2309920.55420.442.6521.0420.942.58
222783-2278320.27320.79
323355-2335520.78221.28
422646-2264620.15120.64
523838-2383821.21221.71
622086-2208619.65320.15
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%
19.999950899662995509946299318995000.13
29.899810997874979920.17
单位质量响应值RSD%判断
9959.969908.190.37数据可信
中间条件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%
5min15413-54134.8895.0714.734.895.0614.75
25143-51434.6454.65
37018-70186.3396.34
46135-61355.5425.54
54777-47774.3154.31
65161-51614.6624.66
10min111524-1152410.4099.619.5110.449.649.50
29941-99418.9799.01
311562-1156210.44410.48
411591-1159110.47010.50
59737-97378.7958.82
69510-95108.5908.62
15min115854-1585414.32013.176.3514.4113.256.38
214445-1444513.04813.12
315063-1506313.60613.70
415045-1504513.59013.68
513462-1346212.16012.23
613611-1361112.29412.37
20min118446-1844616.66216.183.5616.8316.343.61
217715-1771516.00116.15
318731-1873116.91917.09
418087-1808716.33716.50
517487-1748715.79515.94
617004-1700415.35915.50
30min120089-2008918.14618.652.4918.4018.892.49
220741-2074118.73518.97
321171-2117119.12319.39
421200-2120019.14919.40
520004-2000418.06918.30
620646-2064618.64918.88
45min122444-2244420.27320.552.1620.6320.902.16
223128-2312820.89121.23
323023-2302320.79621.16
423152-2315220.91221.27
521901-2190119.78220.11
622862-2286220.65020.98
60min123444-2344421.17621.521.2621.6521.981.26
223929-2392921.61422.07
324320-2432021.96722.45
423708-2370821.41521.89
523650-2365021.36221.80
623872-2387221.56322.01
极限123563-2356321.28421.721.4821.8722.311.48
224176-2417621.83722.41
324401-2440122.04022.65
424281-2428121.93222.53
523647-2364721.35921.92
624237-2423721.89222.46
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