缬沙坦胶囊项目信息
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67824040658对照品来源原料对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
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%
117.842627912624882622622621122625332624370.10
217.882618852614142616500.13
单位质量响应值RSD%判断
14710.5914633.670.38数据可信
供试品溶液-24123001批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min164084-640844.8845.0017.614.884.9917.54
277739-777395.9255.92
354803-548034.1774.18
10min156864-568644.3345.5320.404.345.5320.38
286259-862596.5746.58
374386-743865.6695.68
15min1222754-22275416.97815.4516.8316.9915.4716.79
2222052-22205216.92416.94
3163341-16334112.44912.47
20min1189631-18963114.45317.1916.7114.5017.2416.68
2264795-26479520.18220.23
3222352-22235216.94716.98
30min1391676-39167629.85224.8721.3529.9224.9421.30
2334284-33428425.47825.56
3253051-25305119.28719.35
45min1314225-31422523.94927.7713.8624.0727.8813.81
2415193-41519331.64531.77
3363586-36358627.71127.81
60min1523109-52310939.87032.5222.6140.0332.6822.52
2426839-42683932.53232.71
3330186-33018625.16625.31
90min1432182-43218232.93936.9211.3733.1637.1311.33
2541933-54193341.30441.54
3479135-47913536.51836.70
120min1700921-70092153.42243.0822.6353.7043.3522.52
2547644-54764441.73942.04
3446992-44699234.06834.31
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1620603-62060347.30050.3610.3047.6750.7110.27
2739273-73927356.34556.72
3622337-62233747.43247.74
缬沙坦胶囊项目信息
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67824040658对照品来源原料对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
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%
117.842644852648112653552651432652012649990.14
217.882651282651562651420.01
单位质量响应值RSD%判断
14854.2014828.970.13数据可信
供试品溶液-24123002批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min167473-674735.0844.5863.045.084.5863.11
295267-952677.1787.18
319552-195521.4731.47
10min176036-760365.7292.7494.425.742.7594.22
215418-154181.1621.17
317709-177091.3341.34
15min1204461-20446115.40511.3644.5215.4211.3744.56
2172374-17237412.98813.00
375514-755145.6905.69
20min1198867-19886714.9849.5949.4915.039.6349.42
280099-800996.0356.07
3103016-1030167.7627.78
30min1319821-31982124.09717.4938.7224.1717.5438.75
2236311-23631117.80517.85
3140214-14021410.56510.59
45min1284386-28438621.42716.5231.9121.5416.5931.87
2145318-14531810.94911.02
3227952-22795217.17517.22
60min1435711-43571132.82923.6935.6232.9723.7935.61
2292657-29265722.05022.14
3214929-21492916.19416.27
90min1345241-34524126.01222.4122.4526.2122.5522.40
2221165-22116516.66416.79
3325962-32596224.56024.66
120min1605061-60506145.58933.1733.3945.8333.3533.37
2392827-39282729.59829.76
3322780-32278024.32024.46
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1429811-42981132.38431.0213.5432.7031.2613.46
2349220-34922026.31226.52
3456183-45618334.37134.55
缬沙坦胶囊项目信息
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67824040658对照品来源原料对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
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%
117.842633872629422634352630372635872632780.11
217.882645762646502646130.02
单位质量响应值RSD%判断
14757.7414799.380.20数据可信
供试品溶液-X3456批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1217473-21747316.45620.6129.7216.4620.6129.71
2234355-23435517.73317.73
3365319-36531927.64327.64
10min1463017-46301735.03546.3821.5235.0646.4221.52
2665049-66504950.32250.35
3710934-71093453.79453.84
15min1657854-65785449.77863.0818.2849.8663.1918.28
2915746-91574669.29269.41
3927174-92717470.15770.29
20min1840478-84047863.59775.4113.6063.7775.6313.61
21083165-108316581.96082.19
31066335-106633580.68780.94
30min11056564-105656479.94787.767.8280.2288.107.86
21226452-122645292.80293.17
31196287-119628790.52090.91
45min11183327-118332789.53994.504.8089.9594.994.84
21300830-130083098.43098.95
31262515-126251595.53196.07
60min11230344-123034493.09797.434.4893.6598.074.52
21345693-1345693101.825102.51
31286778-128677897.36798.06
90min11255672-125567295.01398.523.3695.7399.333.41
21342566-1342566101.588102.44
31308003-130800398.97399.83
120min11261558-126155895.45999.283.9296.33100.253.96
21364186-1364186103.224104.25
31310231-131023199.142100.17
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限11261056-126105695.42199.003.4596.45100.143.50
21350838-1350838102.214103.41
31313298-131329899.374100.56
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