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%
1 17.842608352609142613772611372610922610710.09
2 17.882635882638922637400.09
单位质量响应值RSD%判断
14634.0214750.560.57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%
5min148373-483733.6823.3811.373.683.3811.27
238700-387002.9462.95
346032-460323.5043.50
10min141727-417273.1763.8437.783.183.8537.70
272293-722935.5025.51
337306-373062.8392.85
15min1119428-1194289.0908.328.359.108.338.35
2101688-1016887.7407.75
3106833-1068338.1318.14
20min1112595-1125958.5709.8640.758.609.8940.64
2188739-18873914.36514.39
387313-873136.6466.67
30min1173788-17378813.22712.585.8613.2712.635.86
2167415-16741512.74212.79
3154774-15477411.78011.82
45min1171169-17116913.02815.5540.8813.0915.6140.75
2299273-29927322.77822.85
3142437-14243710.84110.90
60min1219190-21919016.68316.197.0416.7716.287.10
2223337-22333716.99917.11
3195591-19559114.88714.96
90min1218294-21829416.61519.4934.1316.7319.6134.04
2356033-35603327.09927.24
3193974-19397414.76414.86
120min1300945-30094522.90622.127.7123.0522.267.77
2305845-30584523.27923.46
3264866-26486620.16020.28
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1297529-29752922.64626.5027.2722.8226.6827.20
2457622-45762234.83135.05
3289209-28920922.01222.17
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%
1 17.842632892638472639792639722637362637650.11
2 17.882673482677772675620.12
单位质量响应值RSD%判断
14785.0314964.320.86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%
5min113172-131720.9901.7867.020.991.7866.92
241962-419623.1553.15
315968-159681.2001.20
10min154239-542394.0782.7252.154.082.7352.05
237837-378372.8452.85
316568-165681.2461.25
15min141830-418303.1454.6056.383.154.6156.37
2101065-1010657.5987.61
340752-407523.0643.07
20min1129504-1295049.7366.4846.659.756.5046.56
279172-791725.9525.97
349993-499933.7593.77
30min169917-699175.2567.4152.265.297.4352.18
2157937-15793711.87411.91
367681-676815.0885.10
45min1183363-18336313.7859.5241.1013.829.5640.98
2115381-1153818.6748.73
381129-811296.0996.12
60min197109-971097.30110.2847.797.3610.3347.68
2212152-21215215.95016.02
3100946-1009467.5897.62
90min1224755-22475516.89711.9437.5516.9712.0137.42
2142856-14285610.74010.83
3108745-1087458.1768.22
120min1149479-14947911.23815.1140.0111.3415.2039.88
2293682-29368222.07922.19
3159887-15988712.02012.08
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1284439-28443921.38415.7032.1421.5115.8232.00
2185958-18595813.98014.13
3156215-15621511.74411.82
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%
1 17.842655122651772656312653752656612654710.08
2 17.882620112616522618320.10
单位质量响应值RSD%判断
14880.6614643.851.14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%
5min131730-317302.4046.6456.082.406.6456.14
2124033-1240339.3969.40
3107341-1073418.1328.13
10min195379-953797.22512.9538.317.2312.9638.32
2211215-21121516.00116.02
3206102-20610215.61315.63
15min1153583-15358311.63517.7129.7111.6517.7429.75
2272393-27239320.63520.68
3275306-27530620.85620.90
20min1197461-19746114.95921.7727.3314.9921.8327.37
2322443-32244324.42724.50
3342340-34234025.93426.01
30min1274963-27496320.83028.7625.7820.8928.8625.79
2395151-39515129.93530.05
3468767-46876735.51235.63
45min1358489-35848927.15835.9525.3127.2536.0925.32
2466860-46686035.36735.53
3598314-59831445.32645.50
60min1439740-43974033.31342.4025.5033.4542.6125.50
2521846-52184639.53339.76
3717503-71750354.35554.61
90min1583043-58304344.16954.0827.8144.3654.3627.78
2616373-61637346.69446.99
3942381-94238171.39171.73
120min1698595-69859552.92262.0124.9153.1962.3724.90
2703040-70304053.25953.63
31053873-105387379.83780.30
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11059836-105983680.28882.179.6880.6582.659.73
2994520-99452075.34075.80
31199863-119986390.89691.49
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