培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.022127721296211752123921225212420.23
210.022126621277212720.04
单位质量响应值RSD%判断
2119.962122.950.10数据可信
供试品溶液-2022081601批-培哚普利-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%
5min123740-2374095.47796.520.9995.4896.520.98
224197-2419797.31597.31
323817-2381795.78695.79
424335-2433597.87097.87
523853-2385395.93195.93
624060-2406096.76496.76
10min123885-2388596.06096.920.5197.1297.990.51
224240-2424097.48898.57
324145-2414597.10698.17
424109-2410996.96198.05
524050-2405096.72397.79
624162-2416297.17498.25
15min123478-2347894.42396.181.3396.5598.331.31
224045-2404596.70398.87
323570-2357094.79396.94
423994-2399496.49898.66
524135-2413597.06599.21
624263-2426397.58099.73
20min123404-2340494.12595.041.3297.3098.251.30
223909-2390996.15699.40
323243-2324393.47896.67
423765-2376595.57798.81
523444-2344494.28697.51
624018-2401896.59599.83
30min122499-2249990.48692.611.6094.7196.881.56
223520-2352094.59298.90
322834-2283491.83396.07
423150-2315093.10497.40
522864-2286491.95496.22
623293-2329393.67997.99
45min122522-2252290.57891.221.2695.8196.531.24
223005-2300592.52197.88
322277-2227789.59394.85
422775-2277591.59696.93
522547-2254790.67995.97
622967-2296792.36897.72
极限122160-2216089.12290.271.0495.3696.591.03
222670-2267091.17397.56
322260-2226089.52595.78
422457-2245790.31796.67
522372-2237289.97596.27
622756-2275691.51997.90
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.871632981628941628611629041629781629870.11
213.901624411627721626060.15
单位质量响应值RSD%判断
11751.0511698.270.32数据可信
供试品溶液-2022081601批-氨氯地平-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%
5min1103404-10340457.17258.552.4757.1758.552.46
2102941-10294156.91656.92
3107195-10719559.26859.27
4107147-10714759.24159.24
5104962-10496258.03358.03
6109756-10975660.68460.68
10min1138388-13838876.51478.302.3077.1578.962.30
2138934-13893476.81677.45
3144897-14489780.11380.77
4140640-14064077.76078.42
5140559-14055977.71578.36
6146327-14632780.90481.58
15min1146501-14650181.00083.492.3382.4985.012.32
2149121-14912182.44983.93
3152454-15245484.29285.84
4149447-14944782.62984.15
5151790-15179083.92485.43
6156718-15671886.64988.22
20min1151690-15169083.86985.371.8686.2587.821.87
2153531-15353184.88787.29
3155118-15511885.76488.25
4153398-15339884.81387.25
5152928-15292884.55486.99
6159813-15981388.36090.90
30min1149651-14965182.74285.602.0786.0689.002.06
2155119-15511985.76589.11
3156760-15676086.67290.11
4154115-15411585.21088.59
5154079-15407985.19088.57
6159221-15922188.03391.55
45min1154213-15421385.26486.261.4489.5090.611.46
2154751-15475185.56289.86
3158291-15829187.51991.92
4154294-15429485.30989.64
5155182-15518285.80090.13
6159379-15937988.12092.62
极限1158743-15874387.76988.681.2992.9593.981.31
2160437-16043788.70593.95
3160784-16078488.89794.27
4159981-15998188.45393.73
5158294-15829487.52092.80
6164088-16408890.72496.20
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.022122321227212272123421255212330.07
210.022121921251212350.11
单位质量响应值RSD%判断
2119.062119.260.01数据可信
供试品溶液-2022081601批-培哚普利-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%
5min124328-2432897.94796.471.0597.9596.481.05
223752-2375295.62895.63
323898-2389896.21696.22
424180-2418097.35297.35
523941-2394196.38996.39
623673-2367395.31095.31
10min124532-2453298.76997.150.9199.8698.220.91
224171-2417197.31598.38
324006-2400696.65197.72
423916-2391696.28997.37
524145-2414597.21198.28
624007-2400796.65597.71
15min124088-2408896.98196.481.0799.1798.631.06
224301-2430197.83999.98
323846-2384696.00798.15
423954-2395496.44298.59
524047-2404796.81698.97
623544-2354494.79196.92
20min123570-2357094.89694.621.2298.1697.841.19
223520-2352094.69497.93
323258-2325893.64096.85
423899-2389996.22099.44
523662-2366295.26698.49
623103-2310393.01596.20
30min123398-2339894.20393.771.7898.5298.041.73
223147-2314793.19397.48
322980-2298092.52096.77
424029-2402996.744101.04
523323-2332393.90198.19
622864-2286492.05396.27
45min123152-2315293.21392.401.3398.5897.721.29
222840-2284091.95797.28
322786-2278691.73997.02
422937-2293792.34797.71
523427-2342794.32099.65
622557-2255790.81796.06
极限122921-2292192.28391.290.8098.6897.630.80
222575-2257590.89097.23
322568-2256890.86197.16
422616-2261691.05597.45
522877-2287792.10698.48
622484-2248490.52396.77
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.871628661628971627741625911626871627630.08
213.901626251626881626560.03
单位质量响应值RSD%判断
11734.9011701.870.20数据可信
供试品溶液-2022081601批-氨氯地平-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%
5min1112853-11285362.42958.753.3362.4358.753.33
2103922-10392257.48957.49
3102661-10266156.79156.79
4105670-10567058.45658.46
5105826-10582658.54258.54
6106318-10631858.81458.81
10min1148741-14874182.28279.102.1882.9879.752.18
2142481-14248178.81979.46
3142789-14278978.99079.62
4142169-14216978.64779.30
5139249-13924977.03277.68
6142460-14246078.80879.46
15min1156139-15613986.37583.821.7087.9885.351.71
2149843-14984382.89284.41
3151966-15196684.06685.58
4152198-15219884.19585.72
5149625-14962582.77184.28
6149353-14935382.62184.15
20min1158715-15871587.80085.321.8790.3787.781.87
2151982-15198284.07586.51
3152921-15292184.59587.04
4156686-15668686.67889.14
5153738-15373885.04787.47
6151353-15135383.72786.17
30min1158407-15840787.63086.011.3291.1789.421.33
2153451-15345184.88888.26
3155206-15520685.85989.24
4157290-15729087.01290.43
5155292-15529285.90689.28
6153269-15326984.78788.16
45min1160451-16045188.76087.091.5493.2891.451.52
2154546-15454685.49489.81
3157707-15770787.24291.58
4157349-15734987.04491.43
5159637-15963788.31092.64
6154851-15485185.66289.98
极限1163647-16364790.52889.421.2596.0394.751.25
2158179-15817987.50392.77
3161853-16185389.53694.84
4163164-16316490.26195.62
5162465-16246589.87495.18
6160522-16052288.80094.07
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