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%
111.037548467554837545717544687545247547780.06
211.097507477512107509780.05
单位质量响应值RSD%判断
68429.5667716.680.75数据可信
供试品溶液-2023052121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%
5min163547-635478.4026.9315.568.406.9315.56
251783-517836.8466.85
357180-571807.5607.56
439119-391195.1725.17
553286-532867.0457.05
649618-496186.5606.56
10min1132750-13275017.55114.8913.3417.6014.9313.34
2107112-10711214.16214.20
3124067-12406716.40316.45
488995-8899511.76611.80
5112161-11216114.82914.87
6110738-11073814.64114.68
15min1181905-18190524.05021.0112.2524.1921.1312.24
2140129-14012918.52718.64
3164612-16461221.76421.90
4132075-13207517.46217.56
5174930-17493023.12823.25
6159738-15973821.12021.24
20min1228811-22881130.25226.4311.5130.5326.6711.49
2162532-16253221.48921.71
3204625-20462527.05427.31
4186102-18610224.60524.80
5213399-21339928.21428.46
6204066-20406626.98027.22
30min1287880-28788038.06234.4410.1938.5134.8210.16
2210620-21062027.84728.19
3256771-25677133.94934.35
4267333-26733335.34535.67
5274395-27439536.27936.69
6265691-26569135.12835.51
45min1352575-35257546.61543.7712.4747.2744.3512.39
2252831-25283133.42833.92
3350007-35000746.27646.87
4363996-36399648.12648.65
5348922-34892246.13346.74
6318163-31816342.06642.65
60min1397721-39772152.58450.9414.3853.5051.7614.26
2283453-28345337.47738.16
3442027-44202758.44259.29
4422048-42204855.80156.59
5394031-39403152.09752.96
6372612-37261249.26550.08
极限1515484-51548468.15461.5818.4369.3662.6818.27
2325108-32510842.98443.87
3572385-57238575.67876.85
4502968-50296866.50067.60
5454052-45405260.03261.19
6424696-42469656.15157.24
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%
111.037547527548807548247545667544847547010.03
211.097517497513707515600.04
单位质量响应值RSD%判断
68422.5767769.160.68数据可信
供试品溶液-2023052121批-pH7.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1166957-16695722.06721.058.6622.0721.058.66
2178204-17820423.55323.55
3168573-16857322.28022.28
4144647-14464719.11819.12
5147037-14703719.43419.43
6150160-15016019.84719.85
10min1287285-28728537.97038.6310.0738.0938.7410.05
2349703-34970346.22046.35
3275567-27556736.42236.55
4292286-29228638.63138.74
5280693-28069337.09937.21
6267971-26797135.41835.53
15min1364647-36464748.19552.1111.3248.5352.4411.30
2482031-48203163.71064.10
3376040-37604049.70150.03
4392001-39200151.81152.13
5388274-38827451.31851.63
6362657-36265747.93248.24
20min1431020-43102056.96861.6411.2857.5762.2611.25
2564109-56410974.55875.30
3429714-42971456.79557.40
4472698-47269862.47663.08
5474086-47408662.66063.26
6426742-42674256.40256.98
30min1513985-51398567.93372.5010.7768.8573.4610.74
2633903-63390383.78384.94
3512787-51278767.77568.69
4588416-58841677.77178.73
5568908-56890875.19276.14
6473293-47329362.55563.44
45min1606440-60644080.15385.305.5981.4586.675.65
2702229-70222992.81394.43
3625088-62508882.61883.91
4657104-65710486.84988.24
5664845-66484587.87289.24
6616772-61677281.51982.75
60min1668065-66806588.29891.433.2390.0493.273.32
2727145-72714596.10798.24
3672488-67248888.88390.64
4701903-70190392.77094.64
5700314-70031492.56094.41
6680606-68060689.95591.64
极限1745033-74503398.47199.781.65100.70102.131.72
2771544-771544101.975104.65
3769783-769783101.742103.99
4751784-75178499.363101.75
5747186-74718698.755101.12
6744414-74441498.389100.58
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