替米沙坦左氨氯地平项目信息
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%
111.037715477624097659687602987572167634880.73
211.097578667547637563140.30
单位质量响应值RSD%判断
69219.2268197.841.06数据可信
供试品溶液-2024070321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%
5min1245123-24512332.11036.558.6932.1136.558.69
2294238-29423838.54438.54
3286657-28665737.55137.55
4302672-30267239.64939.65
5251965-25196533.00633.01
6293389-29338938.43338.43
10min1459352-45935260.17365.185.7060.3565.385.71
2526555-52655568.97669.19
3498269-49826965.27165.48
4513657-51365767.28767.51
5467033-46703361.17961.36
6520491-52049168.18268.40
15min1597697-59769778.29682.843.7878.8183.403.80
2648000-64800084.88585.48
3624075-62407581.75182.32
4668213-66821387.53388.13
5624942-62494281.86482.39
6631417-63141782.71383.30
20min1704399-70439992.27392.083.0393.2293.103.03
2715974-71597493.78994.86
3711632-71163293.22094.25
4713861-71386193.51294.59
5660213-66021386.48587.46
6711283-71128393.17594.23
30min1733667-73366796.10797.392.5297.5798.932.51
2752677-75267798.597100.19
3712628-71262893.35194.89
4767278-767278100.510102.11
5750950-75095098.37199.83
6743543-74354397.40198.97
45min1753818-75381898.74798.461.95100.74100.531.92
2770046-770046100.872103.01
3760182-76018299.580101.64
4756562-75656299.106101.26
5738654-73865496.76098.77
6730295-73029595.66597.78
60min1747263-74726397.88897.711.18100.43100.341.18
2752671-75267198.596101.29
3740376-74037696.98699.60
4757814-75781499.270101.98
5744252-74425297.494100.04
6733246-73324696.05298.69
极限1761801-76180199.79296.882.97102.88100.052.88
2749433-74943398.172101.42
3739275-73927596.842100.00
4752923-75292398.629101.89
5734652-73465296.23699.32
6699479-69947991.62894.80
替米沙坦左氨氯地平项目信息
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%
111.037557227615897479587538647514537541170.68
211.097455197463857459520.09
单位质量响应值RSD%判断
68369.6367263.481.16数据可信
供试品溶液-2024070421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%
5min1271139-27113935.98639.467.7835.9939.467.77
2298601-29860139.63039.63
3318510-31851042.27342.27
4266739-26673935.40235.40
5316870-31687042.05542.05
6312118-31211841.42441.42
10min1523155-52315569.43372.834.8369.6373.044.83
2533874-53387470.85671.08
3587612-58761277.98878.22
4521956-52195669.27469.47
5562937-56293774.71374.95
6562775-56277574.69174.92
15min1692366-69236691.89192.342.4592.4892.972.46
2678208-67820890.01290.63
3721425-72142595.74796.42
4676800-67680089.82590.41
5704051-70405193.44194.09
6701680-70168093.12793.77
20min1747337-74733799.18699.551.33100.28100.691.35
2738941-73894198.07299.19
3768157-768157101.950103.15
4746091-74609199.021100.10
5753293-75329399.977101.14
6746737-74673799.107100.27
30min1759377-759377100.784100.750.83102.43102.440.84
2750729-75072999.637101.30
3767729-767729101.893103.66
4759976-759976100.864102.49
5763399-763399101.318103.04
6753573-753573100.014101.73
45min1753594-753594100.01799.571.05102.22101.821.01
2751609-75160999.753101.97
3755072-755072100.213102.55
4758092-758092100.614102.80
5736148-73614897.70199.99
6746639-74663999.094101.36
60min1741631-74163198.42999.011.72101.19101.821.67
2751368-75136899.721102.49
3735899-73589997.668100.56
4738525-73852598.017100.77
5739074-73907498.090100.92
6769748-769748102.161104.98
极限1733275-73327597.32097.811.05100.63101.161.03
2745330-74533098.920102.24
3740233-74023398.244101.68
4728471-72847196.68399.98
5729143-72914396.772100.15
6745214-74521498.905102.29
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