坎地沙坦酯氢氯噻嗪片项目信息
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100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数2000
标示量(mg)6.25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%
112.012340342340632341062341262341842341030.03
212.012367682368602368140.03
单位质量响应值RSD%判断
19492.3419718.070.82数据可信
稳定性12月-中间条件-供试品溶液-2023020821批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1128719-12871947.13246.625.6047.1346.625.60
2133559-13355948.90448.90
3120308-12030844.05244.05
4135187-13518749.50049.50
5117331-11733142.96242.96
6128800-12880047.16147.16
10min1249735-24973591.44388.573.4591.5288.653.44
2254184-25418493.07293.15
3234690-23469085.93486.01
4234488-23448885.86085.94
5236703-23670386.67186.74
6241547-24154788.44588.52
15min1271012-27101299.23497.801.1699.4698.021.15
2266858-26685897.71397.95
3269920-26992098.83499.05
4264341-26434196.79197.02
5263058-26305896.32196.54
6267310-26731097.87898.10
20min1271778-27177899.51498.041.2199.9198.421.21
2267176-26717697.82998.23
3271189-27118999.29999.68
4264732-26473296.93497.32
5263942-26394296.64597.02
6267644-26764498.00098.39
30min1272037-27203799.60998.161.11100.1798.711.10
2267386-26738697.90698.47
3271209-27120999.30699.85
4265304-26530497.14497.69
5264972-26497297.02297.56
6267551-26755197.96698.52
45min1271364-27136499.36398.131.05100.0998.841.05
2267246-26724697.85598.58
3271361-27136199.361100.07
4265201-26520197.10697.82
5265157-26515797.09097.79
6267659-26765998.00698.72
60min1271176-27117699.29497.981.10100.1998.861.09
2266900-26690097.72898.62
3270991-27099199.226100.10
4264457-26445796.83497.71
5264813-26481396.96497.83
6267239-26723997.85298.73
极限1270805-27080599.15897.981.07100.2299.031.07
2267092-26709297.79898.85
3271457-27145799.397100.44
4264674-26467496.91397.95
5265513-26551397.22098.24
6266052-26605297.41898.46
坎地沙坦酯氢氯噻嗪片项目信息
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100685-201903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2000
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%
115.901502751500891503421502701506371503230.14
215.931523671524231523950.03
单位质量响应值RSD%判断
9454.289566.540.84数据可信
稳定性12月-中间条件-供试品溶液-2023020821批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139448-3944823.28622.955.0123.2922.955.02
241296-4129624.37724.38
336543-3654321.57121.57
440188-4018823.72323.72
536543-3654321.57121.57
639286-3928623.19023.19
10min194923-9492356.03354.463.6056.0754.503.60
297621-9762157.62557.67
389238-8923852.67752.71
490692-9069253.53553.57
589615-8961552.89952.94
691500-9150054.01254.05
15min1125001-12500173.78772.691.4773.9272.821.47
2125654-12565474.17374.31
3122956-12295672.58072.70
4121366-12136671.64271.77
5121536-12153671.74271.87
6122320-12232072.20572.33
20min1138961-13896182.02880.971.0782.2881.221.07
2138462-13846281.73381.99
3137796-13779681.34081.58
4135518-13551879.99680.24
5135643-13564380.06980.31
6136648-13664880.66380.91
30min1152019-15201989.73688.740.9490.1389.130.94
2150858-15085889.05189.45
3151581-15158189.47789.86
4148382-14838287.58987.97
5149198-14919888.07188.45
6149985-14998588.53588.92
45min1159639-15963994.23493.021.0294.7893.551.02
2157806-15780693.15293.70
3159163-15916393.95394.48
4155620-15562091.86292.39
5156191-15619192.19992.72
6157065-15706592.71593.25
60min1162197-16219795.74494.361.1196.4495.051.11
2159884-15988494.37995.08
3161540-16154095.35696.04
4157849-15784993.17793.86
5158073-15807393.31093.99
6159568-15956894.19294.88
极限1162369-16236995.84694.741.0096.7095.591.00
2160715-16071594.86995.73
3162350-16235095.83496.68
4158676-15867693.66694.50
5159082-15908293.90594.74
6159828-15982894.34695.19
坎地沙坦酯氢氯噻嗪片项目信息
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100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数2000
标示量(mg)6.25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%
112.012386752387692385262382022384212385190.10
212.012342422340482341450.06
单位质量响应值RSD%判断
19860.0319495.841.31数据可信
稳定性12月-中间条件-供试品溶液-2023020921批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1132903-13290348.48645.8311.8148.4945.8311.81
2132884-13288448.47948.48
3119986-11998643.77443.77
4142008-14200851.80851.81
5126634-12663446.19946.20
699312-9931236.23236.23
10min1256363-25636393.52889.475.2993.6189.555.30
2246420-24642089.90089.98
3240721-24072187.82187.89
4258398-25839894.27094.36
5247088-24708890.14490.22
6222467-22246781.16281.22
15min1268443-26844397.93597.680.8198.1797.900.81
2268463-26846397.94298.17
3268538-26853897.97098.19
4270294-27029498.61098.85
5264045-26404596.33096.56
6266690-26669097.29597.49
20min1268934-26893498.11497.890.8498.5198.280.84
2269198-26919898.21098.60
3269261-26926198.23398.62
4270571-27057198.71199.12
5264111-26411196.35496.74
6267925-26792597.74698.10
30min1269109-26910998.17898.190.8398.7498.750.83
2269611-26961198.36198.92
3270324-27032498.62199.17
4271570-27157099.07699.65
5264999-26499996.67897.23
6269317-26931798.25498.77
45min1269023-26902398.14698.090.8498.8798.800.84
2269495-26949598.31999.04
3270297-27029798.61199.32
4271538-27153899.06499.80
5265078-26507896.70797.42
6267777-26777797.69298.38
60min1269139-26913998.18997.920.8899.0898.800.88
2268591-26859197.98998.87
3270107-27010798.54299.42
4270884-27088498.82599.73
5264289-26428996.41997.29
6267456-26745697.57598.42
极限1268645-26864598.00997.730.8299.0698.780.82
2267990-26799097.77098.82
3270157-27015798.56099.60
4269481-26948198.31499.38
5264020-26402096.32197.35
6267054-26705497.42898.44
坎地沙坦酯氢氯噻嗪片项目信息
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100685-201903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2000
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%
115.901539321537421538251535661538421537810.09
215.931516791515101515940.08
单位质量响应值RSD%判断
9671.769516.261.15数据可信
稳定性12月-中间条件-供试品溶液-2023020921批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137686-3768622.05320.7711.7622.0520.7611.76
237464-3746421.92321.92
335587-3558720.82420.82
439590-3959023.16723.17
534924-3492420.43620.44
627667-2766716.19016.19
10min193165-9316554.51751.766.7454.5551.796.75
290513-9051352.96553.00
386954-8695450.88350.92
494120-9412055.07655.11
588293-8829351.66651.70
677644-7764445.43545.46
15min1121999-12199971.39069.942.5571.5270.062.56
2120965-12096570.78570.91
3119640-11964070.01070.13
4122297-12229771.56471.69
5118071-11807169.09269.21
6114203-11420366.82866.93
20min1136089-13608979.63578.511.6079.8878.751.61
2135214-13521479.12379.37
3134301-13430178.58978.82
4136092-13609279.63779.89
5132536-13253677.55677.79
6130755-13075576.51476.73
30min1148777-14877787.06086.851.0687.4487.221.07
2149313-14931387.37387.75
3149261-14926187.34387.71
4150068-15006887.81588.20
5145833-14583385.33785.70
6147296-14729686.19386.53
45min1155864-15586491.20791.200.9891.7391.710.98
2156873-15687391.79792.32
3156974-15697491.85692.37
4157149-15714991.95992.49
5153268-15326889.68890.19
6154964-15496490.68091.17
60min1158486-15848692.74192.750.9093.4293.410.91
2159632-15963293.41294.09
3159310-15931093.22393.89
4159728-15972893.46894.15
5156016-15601691.29691.95
6157800-15780092.34092.98
极限1158977-15897793.02893.070.6693.8693.890.67
2159747-15974793.47994.31
3160042-16004293.65294.47
4159741-15974193.47694.31
5157229-15722992.00692.81
6158597-15859792.80693.60
坎地沙坦酯氢氯噻嗪片项目信息
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100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数2000
标示量(mg)6.25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%
112.012393162397972398632401492400412398330.14
212.012418382419652419020.04
单位质量响应值RSD%判断
19969.4420141.720.61数据可信
稳定性12月-中间条件-供试品溶液-2023021021批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1130586-13058646.74147.1710.4946.7447.1710.49
2121138-12113843.35943.36
3138275-13827549.49349.49
4110929-11092939.70539.71
5141601-14160150.68450.68
6148119-14811953.01753.02
10min1262776-26277694.05693.181.4194.1393.261.41
2254917-25491791.24391.32
3262292-26229293.88393.97
4257182-25718292.05492.12
5264566-26456694.69794.78
6260191-26019193.13193.22
15min1278447-27844799.66599.790.6599.90100.020.64
2278402-27840299.64999.87
3277957-27795799.49099.73
4280027-280027100.231100.45
5281564-281564100.781101.02
6276380-27638098.92599.17
20min1278934-27893499.83999.770.86100.24100.170.85
2278584-27858499.714100.10
3277776-27777699.42599.83
4280362-280362100.351100.74
5281921-281921100.909101.32
6274906-27490698.39898.81
30min1279004-27900499.86499.800.70100.43100.370.70
2278669-27866999.745100.30
3277456-27745699.31099.88
4280235-280235100.305100.86
5281529-281529100.768101.35
6276087-27608798.82099.39
45min1278685-27868599.75099.750.53100.48100.480.52
2278841-27884199.806100.53
3277373-27737399.281100.02
4279951-279951100.203100.92
5280492-280492100.397101.14
6276689-27668999.03699.77
60min1278266-27826699.60099.550.63100.50100.450.62
2278510-27851099.688100.58
3276572-27657298.99499.90
4279617-279617100.084100.97
5280123-280123100.265101.18
6275610-27561098.65099.55
极限1277214-27721499.22499.270.55100.29100.340.54
2277683-27768399.392100.45
3275595-27559598.64499.71
4279272-27927299.960101.02
5278625-27862599.729100.81
6275666-27566698.67099.74
坎地沙坦酯氢氯噻嗪片项目信息
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100685-201903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2000
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%
115.901548181553611552311556301553861552850.20
215.931572991573261573120.02
单位质量响应值RSD%判断
9766.359875.200.79数据可信
稳定性12月-中间条件-供试品溶液-2023021021批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137568-3756821.47521.3310.3021.4821.3310.30
235070-3507020.04720.05
339879-3987922.79622.80
431011-3101117.72717.73
538438-3843821.97321.97
641907-4190723.95623.96
10min192845-9284553.07453.683.5053.1153.713.50
291767-9176752.45752.49
397327-9732755.63655.67
488905-8890550.82150.85
596251-9625155.02155.06
696312-9631255.05655.10
15min1124776-12477671.32771.951.3071.4572.081.31
2124840-12484071.36371.48
3127235-12723572.73272.86
4123969-12396970.86570.98
5128222-12822273.29673.42
6126184-12618472.13172.26
20min1140316-14031680.21080.570.8180.4580.820.82
2140399-14039980.25780.50
3141335-14133580.79281.04
4140350-14035080.22980.46
5143114-14311481.80982.06
6140170-14017080.12680.38
30min1154448-15444888.28888.650.8188.6789.030.81
2154547-15454788.34588.72
3154834-15483488.50988.90
4155375-15537588.81889.18
5157442-15744290.00090.39
6153869-15386987.95788.34
45min1162653-16265392.97993.140.4393.5093.670.43
2162713-16271393.01393.53
3162450-16245092.86293.40
4163744-16374493.60294.12
5163888-16388893.68494.22
6162219-16221992.73093.26
60min1165375-16537594.53594.660.5595.2195.340.55
2165195-16519594.43295.11
3164995-16499594.31795.01
4166344-16634495.08895.76
5167006-16700695.46796.16
6164602-16460294.09394.78
极限1165549-16554994.63494.810.5995.4795.650.59
2165953-16595394.86595.70
3165218-16521894.44595.29
4167015-16701595.47296.30
5166916-16691695.41596.27
6164514-16451494.04294.89
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