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%
111.137530137538107534537538467554737539190.13
211.167515167512667513910.03
单位质量响应值RSD%判断
67737.5667328.940.43数据可信
供试品溶液-2023052121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%
5min1206860-20686027.56829.404.3727.5729.404.36
2235103-23510331.33231.33
3225857-22585730.10030.10
4221033-22103329.45729.46
5220239-22023929.35129.35
6214576-21457628.59628.60
10min1425480-42548056.70357.604.6656.8657.764.66
2471207-47120762.79762.97
3430627-43062757.38957.56
4428175-42817557.06257.23
5425485-42548556.70456.87
6412262-41226254.94255.10
15min1608538-60853881.09978.354.4181.5778.834.40
2628081-62808183.70484.23
3586427-58642778.15278.64
4563825-56382575.14075.62
5562974-56297475.02775.51
6577420-57742076.95277.42
20min1707571-70757194.29793.813.3695.2294.733.36
2746325-74632599.462100.45
3690950-69095092.08293.00
4684491-68449191.22192.12
5684245-68424591.18992.08
6710101-71010194.63495.53
30min1745916-74591699.407102.322.58100.85103.762.55
2786743-786743104.848106.39
3759253-759253101.185102.62
4790942-790942105.408106.81
5776670-776670103.506104.91
6747220-74722099.581101.00
45min1764386-764386101.869100.941.60103.86102.941.53
2741890-74189098.871100.99
3768117-768117102.366104.36
4744710-74471099.247101.24
5769975-769975102.614104.59
6755226-755226100.648102.62
60min1742772-74277298.988100.320.74101.55102.880.74
2757332-757332100.929103.60
3756795-756795100.857103.42
4753751-753751100.452102.99
5755422-755422100.674103.22
6750294-75029499.991102.52
极限1748995-74899599.818100.482.14102.93103.602.04
2729722-72972297.249100.48
3759303-759303101.191104.31
4745132-74513299.303102.40
5774938-774938103.275106.38
6765526-765526102.021105.11
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%
111.137532047532537527847530977529947530660.03
211.167497927473917485920.23
单位质量响应值RSD%判断
67660.9267078.140.62数据可信
供试品溶液-2023052121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%
5min1190178-19017825.40727.976.4225.4127.976.43
2215091-21509128.73528.73
3206621-20662127.60327.60
4200414-20041426.77426.77
5228872-22887230.57630.58
6215170-21517028.74528.75
10min1371333-37133349.60853.605.1749.7553.755.18
2416034-41603455.58055.74
3392159-39215952.39052.54
4387045-38704551.70751.86
5424016-42401656.64656.82
6416554-41655455.64955.81
15min1514162-51416268.68974.816.2069.1175.276.19
2587260-58726078.45478.92
3528148-52814870.55771.00
4549370-54937073.39373.83
5599838-59983880.13580.62
6581212-58121277.64678.12
20min1641299-64129985.67491.022.9786.4791.892.99
2685572-68557291.58892.49
3690453-69045392.24093.08
4682457-68245791.17292.02
5692085-69208592.45893.39
6696200-69620093.00893.91
30min1728105-72810597.27198.992.9198.54100.372.91
2727724-72772497.22098.63
3746372-74637299.711101.06
4721663-72166396.41097.76
5780686-780686104.295105.74
6741471-74147199.056100.47
45min1727906-72790697.24499.521.6399.06101.441.66
2754421-754421100.786102.74
3747722-74772299.891101.79
4739266-73926698.762100.65
5761551-761551101.739103.76
6738620-73862098.675100.64
60min1698886-69888693.36797.592.5695.72100.062.55
2737527-73752798.529101.04
3754995-754995100.863103.32
4723793-72379396.69499.13
5737182-73718298.483101.07
6730411-73041197.579100.09
极限1702690-70269093.87597.822.4196.75100.842.41
2736563-73656398.400101.46
3751660-751660100.417103.44
4720822-72082296.29899.27
5739033-73903398.730101.87
6742457-74245799.188102.25
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%
111.137520177535227544117532987515637529620.16
211.167484917476557480730.08
单位质量响应值RSD%判断
67651.5767031.630.66数据可信
供试品溶液-2024070421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%
5min1243162-24316232.49931.185.2632.5031.185.27
2241553-24155332.28432.28
3245405-24540532.79832.80
4213797-21379728.57428.57
5227070-22707030.34830.35
6228763-22876330.57430.57
10min1441798-44179859.04655.666.4959.2355.846.49
2441665-44166559.02859.21
3435183-43518358.16258.34
4377921-37792150.50950.67
5407163-40716354.41754.59
6395224-39522452.82252.99
15min1559841-55984174.82373.543.7075.3374.023.71
2573872-57387276.69877.21
3559045-55904574.71675.22
4514329-51432968.74069.18
5551087-55108773.65374.12
6543358-54335872.62073.08
20min1684540-68454091.48989.774.6692.4190.664.65
2677322-67732290.52491.46
3690956-69095692.34693.27
4610455-61045581.58782.41
5695394-69539492.93993.82
6671499-67149989.74690.61
30min1757027-757027101.176100.171.24102.61101.561.27
2761743-761743101.807103.24
3740655-74065598.988100.42
4737716-73771698.59699.87
5751962-751962100.500101.90
6748052-74805299.977101.34
45min1721938-72193896.48799.672.5498.48101.622.51
2745079-74507999.580101.58
3769904-769904102.898104.88
4733103-73310397.97999.80
5766328-766328102.420104.37
6738267-73826798.669100.59
60min1729813-72981397.53999.782.11100.07102.282.07
2738665-73866598.722101.28
3775780-775780103.683106.24
4740876-74087699.018101.38
5747609-74760999.918102.44
6746945-74694599.829102.30
极限1760987-760987101.70698.962.34104.78102.022.31
2738385-73838598.685101.79
3733101-73310197.979101.11
4714542-71454295.49898.42
5758636-758636101.392104.47
6736974-73697498.496101.52
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%
111.137487497489707500237496917493047493470.07
211.167459547478047468790.18
单位质量响应值RSD%判断
67326.7766924.640.43数据可信
供试品溶液-2024070421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%
5min1216144-21614428.98030.206.8528.9830.206.85
2226690-22669030.39430.39
3226032-22603230.30630.31
4205966-20596627.61627.62
5224458-22445830.09530.09
6252295-25229533.82733.83
10min1427566-42756657.32755.676.1657.4955.846.16
2397434-39743453.28753.46
3403963-40396354.16354.33
4379625-37962550.89951.05
5436428-43642858.51558.68
6446173-44617359.82260.01
15min1567348-56734876.06975.865.0476.5576.335.03
2520510-52051069.78970.25
3579271-57927177.66778.14
4544042-54404272.94473.38
5590403-59040379.16079.65
6592966-59296679.50480.02
20min1679537-67953791.11190.001.9292.0190.901.91
2675207-67520790.53091.38
3687517-68751792.18193.08
4652218-65221887.44888.29
5672457-67245790.16291.09
6660566-66056688.56789.53
30min1733379-73337998.33097.843.5399.7499.233.47
2753791-753791101.067102.42
3679905-67990591.16092.57
4730723-73072397.97499.30
5742246-74224699.519100.95
6738120-73812098.966100.42
45min1747281-747281100.19498.911.13102.15100.861.12
2732726-73272698.242100.16
3743493-74349399.686101.61
4730406-73040697.93199.80
5744536-74453699.826101.81
6727989-72798997.60799.61
60min1735021-73502198.55099.753.55101.06102.243.46
2722043-72204396.81099.27
3796303-796303106.767109.24
4740503-74050399.285101.70
5735626-73562698.631101.17
6734258-73425898.448100.99
极限1711385-71138595.38198.123.5598.44101.163.45
2708800-70880095.03498.04
3757814-757814101.606104.67
4735555-73555598.622101.59
5767122-767122102.854105.94
6710011-71001195.19798.29
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