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%
111.163934993938473938333961303996933954000.67
211.183978464008333993400.53
单位质量响应值RSD%判断
35430.1135719.140.58数据可信
供试品溶液-24041801批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1151146-15114638.23937.163.7738.2437.163.77
2153123-15312338.73938.74
3148643-14864337.60637.61
4137585-13758534.80834.81
5144391-14439136.53036.53
6146292-14629237.01137.01
10min1261178-26117866.07665.272.8566.2965.482.84
2245207-24520762.03662.25
3267035-26703567.55867.77
4256013-25601364.77064.96
5261022-26102266.03766.24
6257505-25750565.14765.35
15min1298395-29839575.49279.653.2876.0780.223.26
2314062-31406279.45680.02
3328818-32881883.18983.77
4321741-32174181.39881.95
5315351-31535179.78280.35
6310542-31054278.56579.13
20min1366838-36683892.80891.701.8793.8192.721.86
2351923-35192389.03490.04
3364919-36491992.32293.37
4371108-37110893.88894.89
5361816-36181691.53792.55
6358234-35823490.63191.63
30min1358614-35861490.72792.362.8392.2493.892.77
2363888-36388892.06193.56
3348974-34897488.28889.85
4378160-37816095.67297.20
5370104-37010493.63495.16
6370777-37077793.80495.31
45min1369348-36934893.44393.052.5995.4695.092.54
2364645-36464592.25394.26
3358350-35835090.66092.71
4383226-38322696.95499.01
5372787-37278794.31396.35
6358509-35850990.70092.73
60min1337370-33737085.35292.674.4787.8995.224.37
2356050-35605090.07892.60
3377421-37742195.48598.04
4377974-37797495.62598.22
5375849-37584995.08797.65
6373121-37312194.39796.93
极限1360831-36083191.28892.192.2994.3095.262.21
2375027-37502794.87997.90
3350391-35039188.64791.73
4367363-36736392.94096.07
5368420-36842093.20896.30
6364459-36445992.20695.26
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%
111.163992774047064036434042934066244037090.68
211.184058034022964040500.62
单位质量响应值RSD%判断
36174.6436140.430.07数据可信
供试品溶液-24041801批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1147685-14768536.76035.339.9936.7635.339.98
2158263-15826339.39339.39
3124059-12405930.88030.88
4138800-13880034.54934.55
5155034-15503438.59038.59
6127698-12769831.78531.79
10min1260032-26003264.72564.414.4664.9364.614.48
2268383-26838366.80367.02
3240736-24073659.92260.09
4250550-25055062.36562.56
5271959-27195967.69467.91
6261004-26100464.96765.14
15min1348536-34853686.75480.345.4987.3280.905.48
2335553-33555383.52384.11
3310463-31046377.27877.78
4298550-29855074.31274.85
5320821-32082179.85680.45
6322795-32279580.34780.88
20min1369097-36909791.87289.253.8192.9290.253.81
2358003-35800389.11190.16
3345271-34527185.94286.88
4339607-33960784.53285.48
5373833-37383393.05194.09
6365492-36549290.97591.96
30min1386225-38622596.13692.952.4097.6994.452.41
2371751-37175192.53394.08
3362734-36273490.28891.70
4365512-36551290.98092.40
5373448-37344892.95594.51
6380977-38097794.82996.32
45min1346144-34614486.15987.375.4788.2589.385.32
2369887-36988792.06994.13
3370469-37046992.21494.13
4339032-33903284.38986.32
5321486-32148680.02182.09
6359042-35904289.36991.39
60min1380068-38006894.60388.015.9497.1790.505.82
2374222-37422293.14895.72
3333525-33352583.01885.44
4358158-35815889.14991.54
5346422-34642286.22888.74
6329050-32905081.90484.42
极限1361996-36199690.10588.532.4893.2091.512.44
2361395-36139589.95593.05
3346587-34658786.26989.16
4357654-35765489.02491.91
5342768-34276885.31988.31
6363513-36351390.48293.45
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%
111.163990134005243992794005344009984000700.22
211.183992323999843996080.14
单位质量响应值RSD%判断
35848.5735743.110.21数据可信
供试品溶液-24041901批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1144185-14418536.25237.189.8736.2537.189.87
2148302-14830237.28737.29
3145501-14550136.58336.58
4126446-12644631.79231.79
5171867-17186743.21243.21
6150988-15098837.96237.96
10min1261307-26130765.69965.495.5165.9065.705.52
2261981-26198165.86966.08
3253705-25370563.78863.99
4236832-23683259.54659.72
5277951-27795169.88470.12
6271114-27111468.16568.38
15min1327469-32746982.33481.173.7782.9081.743.78
2316527-31652779.58380.16
3325191-32519181.76282.32
4303196-30319676.23176.74
5339607-33960785.38686.01
6325006-32500681.71582.30
20min1352823-35282388.70988.962.5189.7389.982.50
2354023-35402389.01190.03
3355875-35587589.47690.49
4343582-34358286.38687.32
5347332-34733287.32888.43
6369363-36936392.86893.91
30min1349274-34927487.81792.762.8389.3394.282.79
2373630-37363093.94095.45
3365323-36532391.85293.36
4373743-37374393.96995.38
5374643-37464394.19595.78
6377041-37704194.79896.36
45min1354737-35473789.19090.204.5691.1992.234.46
2362247-36224791.07893.11
3327979-32797982.46384.48
4373912-37391294.01195.94
5366528-36652892.15594.27
6367176-36717692.31894.40
60min1361155-36115590.80492.341.5393.3094.871.53
2361442-36144290.87693.41
3369571-36957192.92095.40
4365054-36505491.78494.24
5371359-37135993.36995.99
6374956-37495694.27496.87
极限1325906-32590681.94188.484.0584.9591.523.95
2352251-35225188.56591.61
3358618-35861890.16693.16
4354322-35432289.08692.05
5368806-36880692.72895.87
6351493-35149388.37591.50
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%
111.164109744287324170034049454050944133502.41
211.184172814097994135401.28
单位质量响应值RSD%判断
37038.5336989.270.10数据可信
供试品溶液-24041901批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1146195-14619535.54834.737.4935.5534.737.49
2142919-14291934.75134.75
3129291-12929131.43731.44
4155403-15540337.78737.79
5151989-15198936.95636.96
6131227-13122731.90831.91
10min1266587-26658764.82161.665.5465.0261.865.54
2255243-25524362.06362.26
3229749-22974955.86456.04
4268600-26860065.31165.52
5251786-25178661.22261.43
6249624-24962460.69760.87
15min1319074-31907477.58375.656.5578.1476.186.54
2322506-32250678.41878.96
3283697-28369768.98169.47
4330394-33039480.33680.91
5324114-32411478.80979.35
6286882-28688269.75670.27
20min1367214-36721489.28984.9112.1490.2885.8612.07
2366831-36683189.19690.17
3266976-26697664.91665.78
4385695-38569593.78394.80
5364260-36426088.57189.55
6344267-34426783.70984.61
30min1373531-37353190.82588.831.1592.3190.261.20
2364073-36407388.52589.99
3361690-36169087.94689.17
4364761-36476188.69290.23
5364933-36493388.73490.21
6362975-36297588.25889.63
45min1369798-36979889.91787.273.9391.9189.193.85
2338438-33843882.29284.25
3367964-36796489.47191.19
4369706-36970689.89591.93
5363823-36382388.46490.43
6343732-34373283.57985.44
60min1357897-35789787.02387.634.6589.5190.034.54
2375399-37539991.27993.70
3371361-37136190.29792.51
4366094-36609489.01691.55
5362879-36287988.23590.69
6328616-32861679.90482.23
极限1350415-35041585.20487.672.7988.1890.562.72
2371360-37136090.29793.22
3355192-35519286.36689.08
4371667-37166790.37293.40
5349838-34983885.06488.01
6364820-36482088.70791.47
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