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)5
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1250
标示量(mg)80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%
111.137505017499357492097491767497050.09
211.167443707439567441630.04
单位质量响应值RSD%判断
67358.9466681.270.72数据可信
供试品溶液-2024070321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%
5min183577-8357711.22411.965.9411.2211.965.94
288250-8825011.85111.85
388071-8807111.82711.83
494295-9429512.66312.66
596349-9634912.93912.94
683835-8383511.25811.26
10min1169296-16929622.73521.453.5822.8021.523.56
2151758-15175820.38020.45
3158972-15897221.34921.41
4161326-16132621.66521.74
5157462-15746221.14621.22
6159693-15969321.44521.51
15min1229207-22920730.78131.241.1330.9731.431.12
2231330-23133031.06631.24
3234003-23400331.42531.61
4235696-23569631.65231.84
5230704-23070430.98231.17
6235009-23500931.56031.74
20min1288363-28836338.72540.102.4339.0840.462.41
2297578-29757839.96240.31
3307044-30704441.23341.59
4303699-30369940.78441.15
5292160-29216039.23539.60
6302814-30281440.66541.02
30min1388285-38828552.14352.371.8252.7252.961.79
2395883-39588353.16453.74
3379458-37945850.95851.55
4397595-39759553.39453.99
5393956-39395652.90553.48
6384751-38475151.66952.25
45min1517192-51719269.45466.513.7870.3267.383.73
2502133-50213367.43268.30
3472290-47229063.42564.30
4492649-49264966.15967.05
5512137-51213768.77669.65
6475226-47522663.81964.69
60min1567746-56774676.24377.174.0077.4978.413.93
2598404-59840480.36181.60
3594487-59448779.83581.06
4539057-53905772.39173.65
5587529-58752978.90080.16
6560485-56048575.26876.49
90min1639173-63917385.83588.841.8487.5190.521.80
2663534-66353489.10790.80
3671901-67190190.23191.90
4669219-66921989.87091.53
5657100-65710088.24389.94
6668519-66851989.77691.42
120min1689829-68982992.63892.110.6394.7994.270.62
2685919-68591992.11394.30
3685807-68580792.09894.27
4678171-67817191.07393.23
5685446-68544692.05094.23
6690137-69013792.68094.82
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1719057-71905796.56393.842.2999.2396.512.24
2703866-70386694.52397.22
3682000-68200091.58794.27
4691214-69121492.82495.49
5714001-71400195.88498.58
6682371-68237191.63794.29
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