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100309-202205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%
112.112347002347582347592345592348142347180.05
212.242349092352222350660.10
单位质量响应值RSD%判断
19382.1619204.740.66数据可信
中间条件36月-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%
5min182145-8214530.56427.8715.3130.5627.8715.31
269734-6973425.94625.95
377177-7717728.71528.72
462451-6245123.23623.24
565050-6505024.20324.20
692809-9280934.53234.53
10min1205856-20585676.59368.3811.0576.6468.4211.05
2192981-19298171.80371.85
3165730-16573061.66361.71
4168535-16853562.70762.75
5163223-16322360.73160.77
6206285-20628576.75376.81
15min1261734-26173497.38494.993.4297.5695.153.43
2262840-26284097.79597.96
3242877-24287790.36890.52
4254308-25430894.62194.76
5247064-24706491.92692.07
6262946-26294697.83598.02
20min1263575-26357598.06998.210.8198.4198.530.82
2264702-26470298.48898.81
3265642-26564298.83899.14
4264836-26483698.53898.84
5259857-25985796.68596.98
6265169-26516998.66299.01
30min1263452-26345298.02398.660.8298.5399.150.81
2264694-26469498.48598.98
3268414-26841499.869100.34
4266805-26680599.27199.74
5262516-26251697.67598.13
6265181-26518198.66699.18
45min1263125-26312597.90198.570.8898.5799.220.87
2264693-26469398.48599.14
3268572-26857299.928100.56
4265881-26588198.92799.56
5261928-26192897.45698.07
6265304-26530498.71299.39
60min1263327-26332797.97798.440.8398.8199.260.83
2264334-26433498.35199.17
3267911-26791199.682100.48
4265847-26584798.91499.71
5261473-26147397.28798.07
6264587-26458798.44599.29
极限1262104-26210497.52298.220.8498.5299.200.84
2263736-26373698.12999.11
3267381-26738199.485100.45
4265183-26518398.66799.63
5261186-26118697.18098.12
6264377-26437798.36799.37
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%
115.551544851548561551681551091550281549290.18
215.721559331558041558680.06
单位质量响应值RSD%判断
9963.289915.270.35数据可信
中间条件36月-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%
5min121297-2129712.02911.2214.6712.0311.2214.67
218570-1857010.48810.49
320612-2061211.64211.64
416838-168389.5109.51
517255-172559.7469.75
624570-2457013.87713.88
10min170954-7095440.07536.899.8540.1036.919.86
267237-6723737.97637.99
360996-6099634.45134.47
459660-5966033.69633.71
558849-5884933.23833.25
674189-7418941.90341.93
15min1113328-11332864.00961.634.5964.1061.714.60
2112926-11292663.78263.86
3102506-10250657.89657.97
4106736-10673660.28560.36
5104969-10496959.28759.36
6114257-11425764.53364.63
20min1132528-13252874.85374.491.5875.0574.671.59
2133758-13375875.54875.73
3130353-13035373.62473.80
4131300-13130074.15974.33
5128964-12896472.84073.01
6134417-13441775.92076.12
30min1148889-14888984.09484.990.9584.4185.300.95
2151947-15194785.82186.13
3151386-15138685.50485.80
4150609-15060985.06585.36
5148590-14859083.92584.22
6151468-15146885.55085.88
45min1157596-15759689.01290.551.3889.4791.001.37
2160994-16099490.93191.39
3162066-16206691.53691.97
4162886-16288691.99992.44
5157737-15773789.09189.52
6160616-16061690.71791.19
60min1160408-16040890.60091.931.1491.2192.531.13
2163613-16361392.41093.02
3164418-16441892.86593.46
4164720-16472093.03593.63
5160735-16073590.78491.36
6162697-16269791.89392.51
极限1160790-16079090.81692.181.1391.5792.931.12
2164179-16417992.73093.49
3165177-16517793.29394.04
4164572-16457292.95293.70
5161155-16115591.02291.75
6163360-16336092.26793.04
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100309-202205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%
112.112322762321762320162319872319542320820.06
212.242337682337652337660.01
单位质量响应值RSD%判断
19164.4919098.530.25数据可信
中间条件36月-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%
5min1125718-12571847.17136.5222.1547.1736.5222.15
2119211-11921144.73044.73
379435-7943529.80529.81
476228-7622828.60228.60
581446-8144630.56030.56
6101990-10199038.26838.27
10min1229487-22948786.10778.5110.5286.1978.5810.53
2239588-23958889.89789.97
3181906-18190668.25468.30
4201679-20167975.67375.72
5192334-19233472.16772.22
6210519-21051978.99079.05
15min1262237-26223798.39597.822.4198.6298.012.42
2266897-266897100.144100.37
3248627-24862793.28893.45
4260680-26068097.81197.98
5262838-26283898.62198.79
6262903-26290398.64598.84
20min1263659-26365998.92999.440.7399.3199.800.75
2268339-268339100.685101.08
3263338-26333898.80899.13
4263579-26357998.89999.24
5265910-26591099.773100.11
6265325-26532599.55499.91
30min1264027-26402799.06799.570.6799.62100.090.69
2268368-268368100.696101.25
3264275-26427599.16099.64
4263617-26361798.91399.41
5265959-26595999.792100.29
6265967-26596799.795100.32
45min1262823-26282398.61599.530.8499.33100.220.85
2269010-269010100.936101.66
3264141-26414199.11099.76
4263727-26372798.95499.62
5265691-26569199.691100.36
6266156-26615699.866100.56
60min1264435-26443599.22099.510.81100.10100.370.82
2269057-269057100.954101.85
3263492-26349298.86699.68
4263232-26323298.76899.60
5265749-26574999.713100.55
6265338-26533899.559100.42
极限1263130-26313098.73099.320.8599.78100.340.87
2268614-268614100.788101.85
3263010-26301098.68599.66
4262762-26276298.59299.59
5265114-26511499.475100.48
6265538-26553899.634100.66
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%
115.551536651537151536281535831536881536560.04
215.721549951550961550460.05
单位质量响应值RSD%判断
9881.419862.980.14数据可信
中间条件36月-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%
5min134156-3415619.42315.0122.6319.4215.0122.63
232475-3247518.46718.47
320977-2097711.92811.93
420299-2029911.54311.54
522793-2279312.96112.96
627687-2768715.74415.74
10min185645-8564548.70143.2311.8648.7343.2611.86
287316-8731649.65249.68
365006-6500636.96536.99
470399-7039940.03240.05
570417-7041740.04240.06
677392-7739244.00844.03
15min1120211-12021168.35765.335.0968.4765.435.11
2122103-12210369.43369.55
3105996-10599660.27460.36
4112485-11248563.96464.05
5112696-11269664.08464.17
6115839-11583965.87165.97
20min1137368-13736878.11376.432.5278.3476.642.54
2138666-13866678.85179.08
3129551-12955173.66873.85
4132338-13233875.25375.45
5133166-13316675.72475.92
6135364-13536476.97477.18
30min1153686-15368687.39286.011.1987.7586.341.21
2152894-15289486.94287.30
3149269-14926984.88185.19
4149450-14945084.98485.30
5150778-15077885.73986.06
6151454-15145486.12386.46
45min1161032-16103291.57090.960.8192.0791.430.82
2161081-16108191.59892.10
3159213-15921390.53590.98
4157729-15772989.69190.15
5160266-16026691.13491.60
6160387-16038791.20391.68
60min1163154-16315492.77692.410.6993.4393.040.71
2163943-16394393.22593.88
3161824-16182492.02092.62
4160716-16071691.39092.00
5162751-16275192.54793.16
6162714-16271492.52693.16
极限1164193-16419393.36792.890.6294.1893.670.64
2165013-16501393.83394.65
3162754-16275492.54993.30
4162737-16273792.53993.30
5162701-16270192.51993.29
6162703-16270392.52093.31
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100309-202205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%
112.112358832355692355562352052357582355940.11
212.242360922360562360740.02
单位质量响应值RSD%判断
19454.5019287.090.62数据可信
中间条件36月-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%
5min1101254-10125437.52336.026.6937.5236.026.69
2102877-10287738.12538.12
399900-9990037.02137.02
485443-8544331.66431.66
599748-9974836.96536.97
693958-9395834.81934.82
10min1222476-22247682.44681.885.0882.5181.945.08
2217881-21788180.74480.81
3229215-22921584.94485.01
4204199-20419975.67375.73
5236390-23639087.60387.66
6215467-21546779.84979.91
15min1262938-26293897.44197.640.6797.6497.840.66
2262251-26225197.18697.38
3266546-26654698.77898.98
4264385-26438597.97798.16
5261780-26178097.01297.22
6262944-26294497.44397.63
20min1265554-26555498.41098.090.5598.7798.450.54
2264818-26481898.13898.50
3264298-26429897.94598.31
4266934-26693498.92299.26
5262945-26294597.44497.81
6263563-26356397.67398.03
30min1265663-26566398.45198.340.5998.9898.860.58
2264669-26466998.08298.61
3266279-26627998.67999.21
4266922-26692298.91799.42
5262549-26254997.29797.83
6266068-26606898.60199.12
45min1265114-26511498.24798.240.4898.9498.930.47
2265093-26509398.24098.93
3265971-26597198.56599.26
4266760-26676098.85799.53
5263028-26302897.47498.17
6264668-26466898.08298.76
60min1265854-26585498.52298.060.5199.3898.910.50
2263647-26364797.70498.55
3264230-26423097.92098.78
4266266-26626698.67499.51
5262779-26277997.38298.24
6264925-26492598.17799.02
极限1265436-26543698.36798.150.5399.3999.160.52
2265069-26506998.23199.24
3265768-26576898.49099.51
4265967-26596798.56399.56
5262177-26217797.15998.18
6264618-26461898.06499.07
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%
115.551567091562151565221561871565431564350.15
215.721565311567181566240.09
单位质量响应值RSD%判断
10060.139963.360.69数据可信
中间条件36月-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%
5min125956-2595614.55413.886.9814.5513.876.99
226061-2606114.61314.61
325944-2594414.54814.55
421567-2156712.09312.09
524545-2454513.76313.76
624404-2440413.68413.68
10min176937-7693743.14142.654.8343.1742.684.83
275904-7590442.56242.59
379326-7932644.48044.50
469411-6941138.92138.94
579404-7940444.52444.55
675438-7543842.30042.32
15min1114621-11462164.27164.321.7964.3764.421.79
2113647-11364763.72563.82
3117434-11743465.84965.95
4111438-11143862.48762.57
5115876-11587664.97565.07
6115265-11526564.63264.73
20min1132312-13231274.19174.460.5774.3974.670.58
2132290-13229074.17974.38
3132875-13287574.50774.72
4131969-13196973.99974.19
5133915-13391575.09075.30
6133429-13342974.81875.02
30min1149506-14950683.83284.010.6284.1684.330.62
2148826-14882683.45183.78
3151157-15115784.75885.09
4150181-15018184.21184.52
5148858-14885883.46983.80
6150379-15037984.32284.65
45min1157850-15785088.51188.870.3588.9889.330.34
2158114-15811488.65989.12
3158776-15877689.03089.50
4159234-15923489.28789.74
5158091-15809188.64689.12
6158831-15883189.06189.53
60min1161201-16120190.39090.320.4291.0090.940.42
2160539-16053990.01990.63
3161301-16130190.44691.07
4161434-16143490.52191.12
5160076-16007689.75990.38
6161954-16195490.81291.43
极限1161741-16174190.69390.730.5291.4691.500.52
2161245-16124590.41591.18
3162251-16225190.97991.75
4162427-16242791.07891.83
5160464-16046489.97790.74
6162721-16272191.24292.01
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100309-202205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%
112.112369152369192370632363102359502366310.21
212.242338652340682339660.07
单位质量响应值RSD%判断
19540.1319114.871.56数据可信
中间条件36月-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%
5min174678-7467827.73932.2022.7427.7432.2022.73
2115430-11543042.87742.88
373622-7362227.34727.35
478797-7879729.26929.27
569716-6971625.89625.90
6107908-10790840.08340.08
10min1227182-22718284.38877.9011.7984.4377.9511.80
2240778-24077889.43889.51
3193476-19347671.86771.91
4192145-19214571.37371.42
5178859-17885966.43866.48
6225862-22586283.89783.96
15min1265516-26551698.62797.562.3998.8197.742.40
2264454-26445498.23298.45
3265147-26514798.49098.66
4266391-26639198.95299.12
5249961-24996192.84993.00
6264412-26441298.21798.42
20min1266057-26605798.82899.120.9699.1899.470.95
2265368-26536898.57298.96
3270598-270598100.515100.84
4269299-269299100.032100.36
5263866-26386698.01498.32
6265942-26594298.78599.16
30min1265601-26560198.65899.300.9799.1799.810.96
2265498-26549898.62099.17
3271797-271797100.960101.46
4269089-26908999.954100.45
5265430-26543098.59599.07
6266571-26657199.01999.55
45min1265522-26552298.62999.180.9199.3199.860.90
2265090-26509098.46999.18
3271158-271158100.723101.39
4268738-26873899.824100.49
5265433-26543398.59699.23
6266111-26611198.84899.55
60min1265775-26577598.72399.250.8299.57100.100.79
2265331-26533198.55899.44
3271100-271100100.701101.53
4268104-26810499.588100.42
5267127-26712799.225100.03
6265801-26580198.73399.60
极限1265139-26513998.48798.900.7899.5099.900.77
2264486-26448698.24499.29
3269674-269674100.171101.17
4267531-26753199.375100.37
5264337-26433798.18999.15
6266295-26629598.91699.95
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%
115.551569611570461571341566601564781568560.18
215.721548211549531548870.07
单位质量响应值RSD%判断
10087.209852.861.67数据可信
中间条件36月-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%
5min118615-1861510.48312.3623.8110.4812.3623.82
229349-2934916.52816.53
318384-1838410.35310.35
419515-1951510.99010.99
517914-1791410.08810.09
627927-2792715.72715.73
10min172414-7241440.77940.1012.5340.8040.1212.53
284095-8409547.35747.38
365857-6585737.08737.10
465214-6521436.72536.74
560840-6084034.26134.28
678830-7883044.39244.42
15min1113221-11322163.75962.515.1963.8462.595.19
2118136-11813666.52766.63
3109410-10941061.61361.69
4109382-10938261.59761.68
5101381-10138157.09257.17
6114446-11444664.44964.55
20min1131764-13176474.20273.822.3174.3974.012.32
2134351-13435175.65875.88
3130714-13071473.61073.79
4131657-13165774.14174.32
5125455-12545570.64970.82
6132568-13256874.65474.86
30min1149435-14943584.15384.051.0884.4784.361.08
2149812-14981284.36584.71
3151076-15107685.07785.38
4149836-14983684.37984.68
5146286-14628682.38082.67
6149057-14905783.94084.27
45min1158389-15838989.19589.371.0889.6589.821.08
2158098-15809889.03189.52
3160866-16086690.59091.04
4160391-16039190.32390.77
5156190-15619087.95788.38
6158214-15821489.09789.57
60min1161077-16107790.70991.030.9491.3191.630.93
2161057-16105790.69891.33
3164216-16421692.47793.07
4162678-16267891.61192.21
5160334-16033490.29190.86
6160533-16053390.40391.02
极限1161664-16166491.03991.300.8591.7992.050.85
2161185-16118590.77091.55
3164337-16433792.54593.30
4163033-16303391.81092.56
5160520-16052090.39591.12
6161984-16198491.22091.99
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