缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.872486892483232481192476792473202480260.22
213.942457592457292457440.01
单位质量响应值RSD%判断
17882.1917628.691.01数据可信
加速6月-供试品溶液-BDJL7批-氨氯地平-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%
5min15097-50971.8611.9821.791.861.9821.85
27026-70262.5652.57
34907-49071.7921.79
44835-48351.7651.77
56687-66872.4422.44
63976-39761.4521.45
10min12233-22330.8150.826.710.820.836.53
22438-24380.8900.89
32350-23500.8580.86
42278-22780.8320.83
52254-22540.8230.83
61988-19880.7260.73
15min12702-27020.9871.2738.640.991.2838.60
25700-57002.0812.09
32981-29811.0881.09
42640-26400.9640.97
54579-45791.6721.68
62309-23090.8430.85
20min13572-35721.3041.304.771.311.314.63
23556-35561.2981.31
33824-38241.3961.40
43605-36051.3161.32
53527-35271.2881.30
63291-32911.2021.21
30min15667-56672.0692.037.502.082.047.59
25626-56262.0542.07
36270-62702.2892.30
45434-54341.9841.99
55075-50751.8531.86
65248-52481.9161.92
45min18568-85683.1283.175.683.143.185.63
28882-88823.2433.26
39507-95073.4713.48
48486-84863.0983.11
58673-86733.1673.18
68016-80162.9272.94
60min111944-119444.3614.433.754.384.443.79
212435-124354.5404.56
312871-128714.6994.72
411700-117004.2724.29
512079-120794.4104.43
611717-117174.2784.29
极限123509-235098.5848.913.258.618.943.25
225755-257559.4049.43
324317-243178.8798.90
424420-244208.9168.94
524703-247039.0209.05
623761-237618.6768.70
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.014793538478865747816754775357476823947814930.22
216.004753918475540047546590.03
单位质量响应值RSD%判断
298656.65297166.190.36数据可信
加速6月-供试品溶液-BDJL7批-缬沙坦-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%
5min174612-746121.3961.437.211.401.437.22
275472-754721.4121.41
385566-855661.6011.60
477489-774891.4501.45
576858-768581.4381.44
668522-685221.2821.28
10min1151917-1519172.8432.823.722.842.833.71
2148261-1482612.7742.78
3160656-1606563.0063.01
4150577-1505772.8182.82
5150721-1507212.8202.82
6143533-1435332.6862.69
15min1211194-2111943.9524.034.303.964.044.29
2226105-2261054.2314.24
3220253-2202534.1214.13
4210548-2105483.9403.95
5221803-2218034.1504.16
6200973-2009733.7613.77
20min1264142-2641424.9434.942.404.964.962.38
2262638-2626384.9144.93
3275758-2757585.1605.17
4260669-2606694.8784.89
5264218-2642184.9444.96
6257025-2570254.8094.82
30min1356150-3561506.6646.692.826.696.722.77
2358571-3585716.7096.73
3374117-3741177.0007.02
4350262-3502626.5546.58
5361864-3618646.7716.79
6344960-3449606.4556.48
45min1480975-4809759.0008.982.329.039.012.34
2481913-4819139.0179.05
3495584-4955849.2739.31
4476518-4765188.9168.95
5482805-4828059.0349.07
6461259-4612598.6318.66
60min1591541-59154111.06911.101.7711.1211.151.76
2595841-59584111.14911.20
3611976-61197611.45111.50
4584629-58462910.93910.99
5593102-59310211.09811.15
6582722-58272210.90410.95
极限1813670-81367015.22515.371.5615.2915.441.55
2841363-84136315.74315.81
3813948-81394815.23015.30
4818685-81868515.31915.38
5832254-83225415.57315.64
6808190-80819015.12315.19
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.872473662475832478102481762484022478670.18
213.942450482451362450920.03
单位质量响应值RSD%判断
17870.7317581.921.16数据可信
加速6月-供试品溶液-BDJL7批-氨氯地平-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%
5min16186-61862.2621.9524.092.261.9524.03
25145-51451.8821.88
34883-48831.7861.79
47418-74182.7132.71
54424-44241.6181.62
63889-38891.4221.42
10min12444-24440.8940.8113.210.900.8213.24
22261-22610.8270.83
32184-21840.7990.80
42442-24420.8930.90
52318-23180.8480.85
61657-16570.6060.61
15min13081-30811.1271.2046.411.131.2046.23
22683-26830.9810.99
32828-28281.0341.04
46286-62862.2992.30
52926-29261.0701.07
61914-19140.7000.70
20min13868-38681.4151.3012.541.421.3112.50
23625-36251.3261.33
33821-38211.3971.40
43490-34901.2761.29
53833-38331.4021.41
62697-26970.9860.99
30min16024-60242.2032.0811.852.212.0911.82
25541-55412.0262.03
36091-60912.2282.24
45555-55552.0322.04
56407-64072.3432.35
64490-44901.6421.65
45min18719-87193.1893.249.643.203.259.68
28502-85023.1093.12
39677-96773.5393.55
49054-90543.3113.33
59763-97633.5713.58
67453-74532.7262.73
60min111732-117324.2914.449.164.314.469.12
211733-117334.2914.31
313061-130614.7774.79
412800-128004.6814.70
513213-132134.8324.85
610296-102963.7653.78
极限124259-242598.8729.014.488.909.044.50
224274-242748.8788.90
324697-246979.0329.06
426035-260359.5229.55
525641-256419.3789.40
622951-229518.3948.41
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.014794755480057548053294813414481479748057740.18
216.004752133475692847545300.08
单位质量响应值RSD%判断
300173.27297158.120.72数据可信
加速6月-供试品溶液-BDJL7批-缬沙坦-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%
5min180534-805341.5031.3916.751.501.3916.87
274970-749701.3991.40
378512-785121.4651.47
474040-740401.3821.38
587738-877381.6381.64
651084-510840.9530.95
10min1155454-1554542.9022.789.022.902.788.93
2151065-1510652.8202.82
3152895-1528952.8542.86
4146767-1467672.7392.74
5163477-1634773.0513.05
6123961-1239612.3142.32
15min1215802-2158024.0283.977.654.043.987.65
2211209-2112093.9423.95
3213645-2136453.9883.99
4229584-2295844.2854.29
5223095-2230954.1644.17
6182425-1824253.4053.41
20min1271492-2714925.0674.896.125.084.906.12
2261702-2617024.8854.90
3268484-2684845.0115.03
4259406-2594064.8424.86
5277527-2775275.1805.19
6231942-2319424.3294.34
30min1370510-3705106.9156.655.816.946.675.84
2352892-3528926.5876.61
3364814-3648146.8096.83
4356306-3563066.6506.67
5376107-3761077.0207.04
6318051-3180515.9365.95
45min1486260-4862609.0768.925.079.118.965.09
2477047-4770478.9048.94
3492318-4923189.1899.22
4483072-4830729.0169.05
5498373-4983739.3029.34
6430876-4308768.0428.07
60min1590292-59029211.01811.024.1611.0711.074.17
2586732-58673210.95111.00
3599313-59931311.18611.23
4600463-60046311.20711.26
5619161-61916111.55611.61
6545832-54583210.18810.23
极限1815905-81590515.22915.342.9715.3015.402.98
2819016-81901615.28715.35
3832991-83299115.54815.62
4841812-84181215.71215.78
5842457-84245715.72415.79
6777379-77737914.51014.57
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