培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.234417794422154439334427084426590.22
210.204416764419784418270.05
单位质量响应值RSD%判断
43270.6743316.370.08数据可信
供试品溶液-2023041511批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1341678-34167888.60984.2216.4988.6184.2216.49
2310791-31079180.59980.60
3222171-22217157.61757.62
4355476-35547692.18792.19
5360040-36004093.37193.37
6358462-35846292.96292.96
10min1382004-38200499.06798.640.6299.2198.780.62
2383336-38333699.41299.55
3379180-37918098.33498.43
4376610-37661097.66897.82
5380974-38097498.80098.96
6379958-37995898.53698.69
15min1382972-38297299.31898.900.7299.6399.200.71
2384913-38491399.821100.12
3382081-38208199.08799.35
4377404-37740497.87498.19
5381733-38173398.99799.32
6378975-37897598.28198.60
20min1381672-38167298.98198.760.7499.4699.230.73
2384717-38471799.770100.24
3382203-38220399.11899.54
4376938-37693897.75398.23
5381080-38108098.82799.31
6378283-37828398.10298.58
30min1381931-38193199.04898.680.6299.6999.310.61
2382904-38290499.30099.93
3381302-38130298.88599.48
4377122-37712297.80198.44
5381700-38170098.98899.64
6378058-37805898.04398.69
极限1380063-38006398.56398.780.8399.3799.580.82
2383893-38389399.557100.35
3382587-38258799.21899.97
4377536-37753697.90898.71
5384274-38427499.655100.47
6377153-37715397.80998.62
培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.234419714429124425144420164419904422810.10
210.204423464418934421200.08
单位质量响应值RSD%判断
43233.7243345.100.19数据可信
供试品溶液-2023041511批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1251849-25184965.31982.2711.4465.3282.2711.44
2347682-34768290.17590.17
3324904-32490484.26784.27
4333654-33365486.53686.54
5344877-34487789.44789.45
6300282-30028277.88177.88
10min1377772-37777297.97997.641.2498.0997.781.23
2369717-36971795.89096.04
3372314-37231496.56396.70
4376711-37671197.70497.85
5381190-38119098.86599.01
6381042-38104298.82798.96
15min1382889-38288999.30697.971.4899.5898.271.47
2369486-36948695.83096.14
3372456-37245696.60096.90
4378320-37832098.12198.43
5380632-38063298.72199.03
6382593-38259399.22999.52
20min1382925-38292599.31597.861.5599.7598.321.54
2368611-36861195.60396.07
3371724-37172496.41096.87
4378323-37832398.12298.59
5380821-38082198.77099.25
6381563-38156398.96299.42
30min1381583-38158398.96797.661.4099.5798.281.39
2368658-36865895.61596.24
3371542-37154296.36396.99
4377718-37771897.96598.60
5378748-37874898.23298.87
6380970-38097098.80899.43
极限1381966-38196699.06697.561.5999.8398.351.58
2367638-36763895.35096.14
3370076-37007695.98396.77
4377497-37749797.90798.70
5378201-37820198.09098.90
6381577-38157798.96699.76
培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.234405764399444405904403374410584405010.10
210.204394044397214395620.06
单位质量响应值RSD%判断
43059.7343094.310.06数据可信
供试品溶液-2023041511批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1356171-35617192.83291.005.0192.8391.005.01
2324654-32465484.61784.62
3330274-33027486.08286.08
4368130-36813095.94995.95
5360250-36025093.89593.89
6355472-35547292.64992.65
10min1374179-37417997.52597.900.7197.6898.060.72
2373155-37315597.25897.40
3372484-37248497.08397.23
4378593-37859398.67698.84
5377924-37792498.50198.66
6377443-37744398.37698.53
15min1374906-37490697.71598.080.4698.0398.400.46
2375406-37540697.84598.15
3374122-37412297.51097.82
4377535-37753598.40098.72
5377827-37782798.47698.80
6378055-37805598.53598.85
20min1375447-37544797.85698.100.3798.3498.580.38
2376124-37612498.03298.50
3374274-37427497.55098.02
4377134-37713498.29598.78
5377946-37794698.50798.99
6377473-37747398.38498.87
30min1375162-37516297.78198.110.5298.4298.750.53
2375196-37519697.79098.42
3373817-37381797.43198.06
4377510-37751098.39399.05
5378712-37871298.70799.36
6378071-37807198.54099.19
极限1375398-37539897.84398.020.4298.6598.830.42
2375249-37524997.80498.60
3373826-37382697.43398.23
4377037-37703798.27099.09
5378115-37811598.55199.36
6376859-37685998.22499.03
培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.234418224423524423084419014426184422000.08
210.204414774412984413880.03
单位质量响应值RSD%判断
43225.8143273.330.08数据可信
供试品溶液批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1364249-36424994.55893.512.2394.5693.512.22
2365984-36598495.00995.01
3357175-35717592.72292.72
4358676-35867693.11293.11
5346518-34651889.95589.96
6368662-36866295.70495.70
10min1375169-37516997.39397.011.0697.5597.161.06
2372828-37282896.78596.94
3373689-37368997.00997.16
4377605-37760598.02698.18
5366458-36645895.13295.28
6376328-37632897.69497.85
15min1375366-37536697.44497.091.1897.7697.411.18
2372753-37275396.76697.09
3373711-37371197.01597.33
4379738-37973898.57998.90
5366442-36644295.12895.44
6375945-37594597.59597.92
20min1374349-37434997.18096.971.1197.6697.451.11
2372717-37271796.75797.24
3373402-37340296.93497.41
4378797-37879798.33598.82
5366307-36630795.09395.56
6375643-37564397.51698.00
30min1374652-37465297.25996.901.2397.9097.541.23
2371414-37141496.41897.06
3373044-37304496.84197.48
4380111-38011198.67699.32
5366106-36610695.04095.67
6374209-37420997.14497.79
极限1373157-37315796.87196.631.1497.6897.441.14
2368746-36874695.72696.53
3372423-37242396.68097.48
4377928-37792898.10998.92
5366200-36620095.06595.85
6375010-37501097.35298.16
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