沙库巴曲缬沙坦钠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%
115.711023971022121021771019881019371021420.19
215.601019311020501019900.09
单位质量响应值RSD%判断
6501.726537.820.40数据可信
供试品溶液-25102301批-氨氯地平-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min185551-8555185.06388.913.5385.0688.913.53
293069-9306992.53892.54
386055-8605585.56485.56
489052-8905288.54488.54
592426-9242691.89991.90
690394-9039489.87889.88
10min190056-9005689.54291.512.2989.6891.662.29
294497-9449793.95894.11
389296-8929688.78688.93
491444-9144490.92291.07
593744-9374493.20993.36
693180-9318092.64892.80
15min190031-9003189.51790.942.1089.8191.242.10
293657-9365793.12293.43
389081-8908188.57388.86
490236-9023689.72190.02
593263-9326392.73193.04
692477-9247791.94992.25
20min190622-9062290.10590.672.1990.5591.122.19
293301-9330192.76993.23
388904-8890488.39788.83
488938-8893888.43088.88
593076-9307692.54593.01
692297-9229791.77092.23
30min189999-8999989.48590.001.6890.0890.611.68
292152-9215291.62692.25
388684-8868488.17888.76
489041-8904188.53389.13
592151-9215191.62592.24
691093-9109390.57391.18
45min189630-8963089.11882.1222.0989.8682.8821.88
292223-9222391.69792.47
388803-8880388.29689.03
488563-8856388.05888.80
545461-4546145.20245.97
690896-9089690.37791.14
60min189565-8956589.05489.191.7089.9490.081.69
290866-9086690.34791.27
387974-8797487.47288.35
487794-8779487.29388.18
591302-9130290.78191.63
690721-9072190.20391.12
极限189040-8904088.53289.301.9589.5790.341.94
292047-9204791.52292.60
388110-8811087.60788.63
487821-8782187.32088.36
591282-9128290.76191.76
690593-9059390.07691.14
沙库巴曲缬沙坦钠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57323100856对照品来源ZZ对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.611586283158533715868391584375158162115848910.13
2 22.501581931158261815822740.04
单位质量响应值RSD%判断
70096.9070323.290.23数据可信
供试品溶液-25102301批-沙库巴曲-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min112091-120910.3480.5241.260.350.5241.16
226540-265400.7640.76
310146-101460.2920.29
420820-208200.6000.60
512418-124180.3580.36
626295-262950.7570.76
10min124513-245130.7061.9567.770.711.9667.66
2110926-1109263.1953.20
346156-461561.3291.33
477454-774542.2312.23
518243-182430.5250.53
6129405-1294053.7273.73
15min131424-314240.9053.4366.730.913.4366.72
2169574-1695744.8844.89
3116159-1161593.3453.35
4150039-1500394.3214.33
522652-226520.6520.65
6223950-2239506.4506.46
20min181123-811232.3365.6049.712.345.6149.75
2278219-2782198.0138.03
3234247-2342476.7466.75
4180290-1802905.1925.20
584403-844032.4312.43
6308105-3081058.8738.89
30min1215205-2152056.1988.9622.036.208.9822.09
2383945-38394511.05711.09
3332708-3327089.5829.60
4250650-2506507.2197.24
5304534-3045348.7708.78
6380603-38060310.96110.99
45min1325534-3255349.37512.5814.449.3912.6114.49
2455489-45548913.11813.16
3448489-44848912.91612.95
4412217-41221711.87211.90
5468231-46823113.48513.51
6510404-51040414.69914.75
60min1380299-38029910.95214.1912.6410.9914.2512.67
2534389-53438915.39015.46
3520709-52070914.99615.05
4464438-46443813.37613.43
5507820-50782014.62514.67
6549135-54913515.81515.89
极限1508840-50884014.65416.437.1014.7116.517.15
2593914-59391417.10417.20
3611595-61159517.61417.70
4534696-53469615.39915.47
5575218-57521816.56616.63
6599551-59955117.26717.37
沙库巴曲缬沙坦钠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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.611033832103319210332021032474103139910328200.09
2 22.501031585103056110310730.08
单位质量响应值RSD%判断
45679.7945825.470.23数据可信
供试品溶液-25102301批-缬沙坦-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min17061-70610.2950.4946.890.300.4946.65
217875-178750.7470.75
36137-61370.2560.26
413575-135750.5670.57
57669-76690.3200.32
618076-180760.7550.76
10min115793-157930.6602.0471.620.662.0571.54
282623-826233.4523.45
332453-324531.3561.36
456100-561002.3442.35
511231-112310.4690.47
695447-954473.9883.99
15min120750-207500.8673.6369.070.873.6469.01
2125899-1258995.2615.27
383832-838323.5033.51
4111294-1112944.6504.66
514011-140110.5850.59
6165592-1655926.9196.93
20min158675-586752.4526.0050.352.456.0150.38
2207087-2070878.6538.67
3171720-1717207.1757.18
4133428-1334285.5755.59
561613-616132.5752.58
6228794-2287949.5609.58
30min1159661-1596616.6729.5921.876.689.6121.92
2283550-28355011.84811.88
3243076-24307610.15710.18
4184240-1842407.6997.72
5225996-2259969.4439.45
6279844-27984411.69311.73
45min1238473-2384739.96513.3614.679.9813.4014.71
2332251-33225113.88313.93
3324906-32490613.57613.61
4300837-30083712.57112.61
5346973-34697314.49814.52
6375613-37561315.69515.75
60min1276394-27639411.54914.9312.6411.5814.9812.69
2387672-38767216.19916.27
3372405-37240515.56115.62
4335424-33542414.01614.07
5371945-37194515.54215.59
6399678-39967816.70116.78
极限1368065-36806515.38017.026.6615.4317.116.74
2423236-42323617.68517.79
3431759-43175918.04118.13
4379430-37943015.85515.93
5412709-41270917.24517.32
6429280-42928017.93818.05
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