替米沙坦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%
110.727243937255787258737248857253677252190.09
210.607245227240387242800.05
单位质量响应值RSD%判断
67651.0368328.300.71数据可信
供试品溶液-2026031621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%
5min1261140-26114034.56933.885.0734.5733.885.08
2247815-24781532.80532.80
3240725-24072531.86631.87
4276470-27647036.59836.60
5247949-24794932.82332.82
6261589-26158934.62834.63
10min1460400-46040060.94660.674.3461.1460.864.34
2460180-46018060.91761.10
3434402-43440257.50557.68
4492469-49246965.19165.39
5443292-44329258.68158.86
6459310-45931060.80260.99
15min1592297-59229778.40678.873.2178.9479.403.21
2605622-60562280.17080.69
3567236-56723675.08975.59
4613765-61376581.24881.81
5581183-58118376.93577.44
6614765-61476581.38081.91
20min1670364-67036488.74088.482.4689.7189.452.47
2671586-67158688.90289.87
3643996-64399685.25086.16
4692903-69290391.72492.74
5657967-65796787.09988.04
6673657-67365789.17690.16
30min1717746-71774695.01395.360.5396.4796.820.54
2727512-72751296.30597.77
3718437-71843795.10496.49
4721578-72157895.52097.05
5719295-71929595.21896.64
6717574-71757494.99096.47
45min1707710-70771093.68495.791.4395.6797.771.41
2730066-73006696.64398.64
3715475-71547594.71296.63
4723648-72364895.79497.85
5735496-73549697.36299.31
6729154-72915496.52398.53
60min1717993-71799395.04595.531.2697.5598.051.18
2724909-72490995.96198.49
3730244-73024496.66799.11
4706675-70667593.54796.14
5730719-73071996.73099.22
6719448-71944895.23897.78
极限1707973-70797393.71995.011.6896.7598.061.64
2719879-71987995.29598.36
3709045-70904593.86196.84
4720735-72073595.40898.52
5739406-73940697.880100.91
6709444-70944493.91496.98
替米沙坦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%
110.727249387232397229627228847225747233190.13
210.607181927179227180570.03
单位质量响应值RSD%判断
67473.7967741.230.28数据可信
供试品溶液-2026031621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%
5min1258355-25835534.39335.785.5034.3935.785.50
2253637-25363733.76533.76
3271303-27130336.11636.12
4285056-28505637.94737.95
5256940-25694034.20434.20
6287194-28719438.23238.23
10min1462481-46248161.56663.145.0261.7663.345.02
2458987-45898761.10161.29
3468523-46852362.37162.57
4510704-51070467.98668.20
5449266-44926659.80760.00
6495874-49587466.01266.22
15min1585807-58580777.98479.722.6778.5280.272.69
2592320-59232078.85179.38
3602865-60286580.25480.80
4618312-61831282.31182.90
5578785-57878577.04977.57
6615124-61512481.88682.47
20min1663223-66322388.28989.313.7189.2690.303.69
2623675-62367583.02583.99
3681156-68115690.67791.67
4689934-68993491.84592.89
5681583-68158390.73491.68
6685553-68555391.26292.30
30min1708437-70843794.30896.332.3295.7797.822.32
2704068-70406893.72795.15
3713764-71376495.01896.51
4735649-73564997.93199.49
5742878-74287898.893100.35
6736912-73691298.09999.64
45min1701249-70124993.35296.942.6295.3398.962.58
2747559-74755999.516101.46
3737859-73785998.225100.25
4736973-73697398.107100.21
5707186-70718694.14296.15
6738410-73841098.298100.38
60min1703862-70386293.69996.372.2896.2098.932.25
2715295-71529595.22197.72
3752565-752565100.183102.75
4720419-72041995.90398.55
5721198-72119896.00798.53
6730267-73026797.21499.85
极限1693046-69304692.26095.412.5195.2898.502.49
2708590-70859094.32997.36
3713250-71325094.94998.08
4746792-74679299.414102.59
5714104-71410495.06398.12
6724366-72436696.42999.60
替米沙坦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%
110.727205707228367205637217967212397214010.14
210.607244197257037250610.13
单位质量响应值RSD%判断
67294.8768401.981.16数据可信
供试品溶液-2026031721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%
5min1219519-21951929.12132.117.7729.1232.107.78
2256504-25650434.02734.03
3231141-23114130.66330.66
4266855-26685535.40035.40
5226831-22683130.09130.09
6251286-25128633.33533.33
10min1399785-39978553.03456.406.2053.2056.586.20
2450893-45089359.81460.00
3411686-41168654.61354.78
4454595-45459560.30560.50
5394890-39489052.38552.55
6439284-43928458.27458.46
15min1531950-53195070.56774.055.4471.0274.545.45
2585946-58594677.73078.25
3538563-53856371.44471.92
4598485-59848579.39379.93
5525919-52591969.76770.23
6568222-56822275.37975.89
20min1618952-61895282.10986.455.2982.9687.355.29
2678923-67892390.06491.02
3642675-64267585.25686.13
4691244-69124491.69992.67
5606354-60635480.43781.28
6671871-67187189.12990.06
30min1702518-70251893.19495.062.1294.5096.452.16
2717130-71713095.13396.59
3717100-71710095.12996.47
4744250-74425098.730100.21
5703019-70301993.26194.55
6715620-71562094.93296.36
45min1732508-73250897.17396.271.2199.0098.181.23
2724930-72493096.16798.15
3713437-71343794.64396.52
4736802-73680297.74299.77
5718232-71823295.27997.09
6728266-72826696.61098.56
60min1738450-73845097.96196.261.11100.3298.711.04
2723986-72398696.04298.56
3728866-72886696.69099.09
4724617-72461796.12698.70
5724178-72417896.06898.41
6713834-71383494.69597.18
极限1728703-72870396.66895.701.5399.5798.681.55
2726765-72676596.41199.46
3718252-71825295.28198.22
4733537-73353797.309100.42
5702551-70255193.19996.07
6718653-71865395.33598.35
替米沙坦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%
110.727184237197207199697183497185707190060.11
210.607173647154487164060.19
单位质量响应值RSD%判断
67071.4667585.470.54数据可信
供试品溶液-2026031721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%
5min1254063-25406333.96234.562.4833.9634.562.48
2260941-26094134.88134.88
3252690-25269033.77833.78
4267865-26786535.80735.81
5252595-25259533.76633.77
6263250-26325035.19035.19
10min1462037-46203761.76360.801.5661.9561.001.55
2449639-44963960.10560.30
3461195-46119561.65061.84
4444410-44441059.40659.61
5459160-45916061.37861.57
6452720-45272060.51760.71
15min1590282-59028278.90678.441.2079.4478.961.19
2580808-58080877.63978.17
3592328-59232879.17979.71
4596174-59617479.69480.22
5580633-58063377.61678.14
6580362-58036277.58078.11
20min1672622-67262289.91389.052.3690.8890.022.35
2653485-65348587.35588.31
3675246-67524690.26391.23
4685425-68542591.62492.60
5642175-64217585.84386.80
6668174-66817489.31890.28
30min1707944-70794494.63494.541.8396.1096.001.81
2698058-69805893.31394.76
3704953-70495394.23595.71
4714978-71497895.57597.06
5690450-69045092.29693.73
6727198-72719897.20898.67
45min1701420-70142093.76295.293.1695.7697.283.11
2725156-72515696.93598.90
3714182-71418295.46897.46
4750158-750158100.277102.29
5687205-68720591.86293.81
6698974-69897493.43595.43
60min1701158-70115893.72793.891.7696.2496.401.75
2701291-70129193.74596.25
3711454-71145495.10497.63
4720911-72091196.36898.94
5687261-68726191.87094.33
6692090-69209092.51595.03
极限1698783-69878393.41093.021.5996.4596.061.57
2702949-70294993.96796.99
3686191-68619191.72794.78
4712959-71295995.30598.41
5684570-68457091.51094.48
6689705-68970592.19695.23
替米沙坦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%
110.727366397355397362407354757358697359520.07
210.607367067349697358380.17
单位质量响应值RSD%判断
68652.2469418.680.79数据可信
供试品溶液-2026031821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%
5min1243375-24337531.72933.814.3631.7333.814.35
2256499-25649933.44033.44
3268557-26855735.01235.01
4274477-27447735.78435.78
5261269-26126934.06234.06
6251870-25187032.83732.84
10min1444589-44458957.96260.123.4358.1460.303.43
2454959-45495959.31459.50
3468108-46810861.02861.22
4489462-48946263.81264.01
5453231-45323159.08959.28
6456363-45636359.49759.68
15min1577994-57799475.35477.302.1575.8577.822.16
2585960-58596076.39376.91
3597423-59742377.88778.42
4613517-61351779.98580.54
5597960-59796077.95778.47
6584857-58485776.24976.76
20min1660472-66047286.10787.821.8987.0288.771.89
2657086-65708685.66586.61
3684702-68470289.26690.23
4688576-68857689.77190.77
5676662-67666288.21889.17
6674064-67406487.87988.82
30min1721589-72158994.07593.941.5995.4795.381.55
2733298-73329895.60197.02
3735033-73503395.82897.29
4708978-70897892.43193.93
5710778-71077892.66594.11
6713722-71372293.04994.47
45min1710367-71036792.61293.441.2194.5395.401.20
2713869-71386993.06895.02
3734055-73405595.70097.69
4713717-71371793.04995.06
5714833-71483393.19495.15
6713417-71341793.00994.95
60min1707028-70702892.17792.951.4594.6195.431.45
2701831-70183191.49993.96
3724471-72447194.45196.98
4725728-72572894.61497.14
5714514-71451493.15295.63
6704188-70418891.80694.26
极限1689560-68956089.89992.001.4592.8495.001.43
2708779-70877992.40595.38
3701766-70176691.49094.54
4718426-71842693.66296.71
5713536-71353693.02596.02
6702202-70220291.54794.52
替米沙坦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%
110.727327307321277322987323167324777323900.04
210.607248047229357238700.19
单位质量响应值RSD%判断
68319.9668289.620.04数据可信
供试品溶液-2026031821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%
5min1268229-26822935.34232.784.6635.3432.784.66
2250884-25088433.05733.06
3232472-23247230.63130.63
4246254-24625432.44732.45
5249880-24988032.92532.92
6244971-24497132.27832.28
10min1475935-47593562.71060.373.3262.9160.553.32
2459040-45904060.48460.67
3430919-43091956.77956.95
4461457-46145760.80360.98
5454855-45485559.93360.12
6466757-46675761.50161.68
15min1601885-60188579.30678.003.9079.8578.523.89
2595723-59572378.49479.01
3547401-54740172.12772.61
4614888-61488881.01981.54
5595016-59501678.40178.92
6596830-59683078.64079.16
20min1683009-68300989.99589.664.1690.9890.614.15
2676344-67634489.11790.07
3631337-63133783.18684.07
4702903-70290392.61693.58
5676595-67659589.15090.10
6712795-71279593.92094.88
30min1732755-73275596.55095.961.2498.0397.411.24
2717103-71710394.48795.94
3724173-72417395.41996.77
4734957-73495796.84098.32
5720764-72076494.97096.42
6740126-74012697.52199.00
45min1721292-72129295.03996.773.4297.0698.753.37
2713261-71326193.98195.96
3730306-73030696.22798.11
4748156-74815698.579100.60
5714904-71490494.19796.17
6778429-778429102.568104.59
60min1692650-69265091.26594.892.7693.8197.412.71
2707866-70786693.27095.77
3722667-72266795.22097.63
4746816-74681698.402100.97
5713491-71349194.01196.51
6737511-73751197.17699.77
极限1714691-71469194.16995.763.3797.2398.813.33
2714888-71488894.19597.21
3708978-70897893.41796.36
4742255-74225597.801100.92
5709948-70994893.54496.56
6769988-769988101.455104.59
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