替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40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%
111.033800953797733799213802993805873801350.09
210.993837743837023837380.02
单位质量响应值RSD%判断
34463.7434917.020.93数据可信
供试品溶液-F11946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%
5min183697-8369721.71517.1220.6321.7217.1220.65
261136-6113615.86215.86
356327-5632714.61414.61
483088-8308821.55721.56
555826-5582614.48414.48
655952-5595214.51714.52
10min1146379-14637937.97831.1716.6838.1031.2616.69
2120018-12001831.13931.23
3108174-10817428.06628.15
4142551-14255136.98537.10
5102408-10240826.57026.65
6101212-10121226.25926.34
15min1200184-20018451.93844.5410.7352.2744.8110.76
2172635-17263544.79045.05
3160299-16029941.58941.83
4185527-18552748.13548.46
5160714-16071441.69741.93
6150709-15070939.10139.33
20min1236100-23610061.25654.467.9561.8854.988.00
2210159-21015954.52655.04
3191941-19194149.79950.27
4221750-22175057.53358.13
5203896-20389652.90153.36
6195615-19561550.75251.20
30min1285650-28565074.11267.076.4175.0767.896.46
2255094-25509466.18467.00
3238864-23886461.97362.72
4266665-26666569.18670.10
5259202-25920267.25068.00
6245560-24556063.71064.44
45min1316365-31636582.08178.305.3283.4579.495.36
2290290-29029075.31576.50
3280745-28074572.83973.93
4321950-32195083.53084.83
5307355-30735579.74380.87
6293965-29396576.26977.35
60min1360765-36076593.60090.533.1395.4392.163.21
2343953-34395389.23890.84
3331625-33162586.04087.53
4358788-35878893.08794.85
5353316-35331691.66793.24
6345113-34511389.53991.04
90min1370634-37063496.16194.042.2498.5196.172.28
2351011-35101191.06993.16
3353698-35369891.76793.74
4365993-36599394.95797.23
5365081-36508194.72096.80
6368299-36829995.55597.56
120min1360768-36076893.60195.131.9696.4897.781.91
2358597-35859793.03895.64
3367560-36756095.36397.84
4377474-37747497.935100.74
5363580-36358094.33096.94
6372056-37205696.53099.06
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1364342-36434294.52894.543.2797.9397.723.23
2344242-34424289.31392.43
3358301-35830192.96195.97
4378031-37803198.080101.43
5370823-37082396.21099.34
6370559-37055996.14199.21
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