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%
1102094921144209702113721113210630.46
2102106321143211030.27
单位质量响应值RSD%判断
2106.302110.300.14数据可信
供试品溶液-2025110421批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114465-1446558.53854.7715.6558.5454.7715.65
29831-983139.78539.78
314298-1429857.86257.86
412308-1230849.80949.81
515667-1566763.40263.40
614630-1463059.20659.21
10min123416-2341694.76196.821.1195.4197.431.08
224113-2411397.58298.02
323872-2387296.60797.25
423994-2399497.10197.65
524110-2411097.57098.27
624047-2404797.31597.97
15min124269-2426998.21396.341.7499.9298.031.67
224006-2400697.14998.68
323883-2388396.65198.37
424048-2404897.31998.95
523498-2349895.09396.88
623140-2314093.64495.38
20min123912-2391296.76996.100.7599.5698.850.69
224010-2401097.16599.77
323556-2355695.32898.12
423633-2363395.64098.35
523718-2371895.98498.83
623645-2364595.68898.47
30min123578-2357895.41794.580.9099.2998.400.83
223643-2364395.68099.37
323347-2334794.48298.33
423285-2328594.23198.01
523299-2329994.28898.20
623076-2307693.38597.23
45min122961-2296192.92092.501.2197.8597.371.12
223231-2323194.01398.76
322460-2246090.89395.79
422624-2262491.55696.38
522891-2289192.63797.60
622969-2296992.95297.83
极限122920-2292092.75491.951.0298.7297.850.94
222971-2297192.96198.75
322577-2257791.36697.28
422748-2274892.05897.90
522764-2276492.12398.11
622349-2234990.44396.36
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4000
标示量(mg)5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%
1137981879644797977997680207798880.27
2138066880313804900.32
单位质量响应值RSD%判断
6145.236191.540.54数据可信
供试品溶液-2025110421批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154534-5453457.31254.7614.7757.3154.7614.77
238319-3831940.27140.27
354927-5492757.72557.72
448446-4844650.91450.91
559603-5960362.63962.64
656824-5682459.71959.72
10min185601-8560189.96291.971.6690.6092.581.59
289158-8915893.70094.15
386496-8649690.90291.54
488910-8891093.43994.00
588214-8821492.70893.40
686683-8668391.09991.76
15min188302-8830292.80092.472.1194.4494.102.01
290376-9037694.98096.47
387409-8740991.86293.51
489420-8942093.97595.58
587390-8739091.84293.57
685056-8505689.38991.06
20min187386-8738691.83791.631.7294.5094.291.62
289740-8974094.31196.86
385601-8560189.96292.63
487837-8783792.31194.96
586445-8644590.84993.60
686136-8613690.52493.19
30min185712-8571290.07890.311.5693.7793.981.46
288209-8820992.70296.29
385215-8521589.55693.23
486734-8673491.15294.83
585173-8517389.51293.27
684536-8453688.84292.52
45min184064-8406488.34688.221.1293.0392.901.04
285653-8565390.01694.64
382820-8282087.03991.71
483648-8364887.90992.60
583763-8376388.03092.78
683733-8373387.99892.66
极限182508-8250886.71187.191.3392.3892.861.22
284658-8465888.97094.59
382808-8280887.02692.66
483911-8391188.18593.85
581956-8195686.13191.86
681970-8197086.14691.79
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%
1102109821095209442113221029210600.36
2102094721031209890.29
单位质量响应值RSD%判断
2106.002098.900.24数据可信
供试品溶液-2025110521批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116155-1615565.55952.8425.1465.5652.8425.14
210412-1041242.25342.25
316777-1677768.08368.08
49037-903736.67336.67
511014-1101444.69644.70
614729-1472959.77259.77
10min123166-2316694.01195.224.0694.7495.814.12
223508-2350895.39995.87
324078-2407897.71298.47
421745-2174588.24488.65
523852-2385296.79597.29
624437-2443799.16999.83
15min123591-2359195.73597.131.1497.5198.771.15
224277-2427798.519100.05
324074-2407497.69699.54
423623-2362395.86597.25
524051-2405197.60299.17
623989-2398997.35199.12
20min123353-2335394.77096.971.5597.6199.701.51
224139-2413997.959100.58
323901-2390196.99399.92
423590-2359095.73198.18
524363-2436398.868101.52
624032-2403297.525100.37
30min123034-2303493.47595.461.0897.3699.261.02
223626-2362695.87799.59
323689-2368996.133100.14
423590-2359095.73199.25
523718-2371896.251100.01
623477-2347795.27399.20
45min122524-2252491.40594.241.7796.3399.101.66
223154-2315493.96298.74
323399-2339994.956100.03
423316-2331694.61999.20
523773-2377396.474101.30
623174-2317494.04399.03
极限122378-2237890.81393.221.5196.7699.131.44
223112-2311293.79299.61
323382-2338294.887101.02
423152-2315293.95499.59
522820-2282092.60798.50
622988-2298893.28899.32
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4000
标示量(mg)5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%
1138012579894801598062579734801070.43
2137997080067800180.09
单位质量响应值RSD%判断
6162.086155.230.08数据可信
供试品溶液-2025110521批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161302-6130264.52653.1024.7964.5353.1024.79
240166-4016642.27842.28
365200-6520068.62968.63
434760-3476036.58836.59
543744-4374446.04446.04
657489-5748960.51260.51
10min184775-8477589.23391.084.7489.9591.664.80
286535-8653591.08691.56
389534-8953494.24295.00
479238-7923883.40583.81
588968-8896893.64694.16
690101-9010194.83995.51
15min186150-8615090.68092.502.0892.3994.102.14
288176-8817692.81394.29
389745-8974594.46496.27
485261-8526189.74591.08
589588-8958894.29995.85
688347-8834792.99394.72
20min185969-8596990.49092.372.2493.2195.002.25
288272-8827292.91495.43
388328-8832892.97395.83
485326-8532689.81392.14
590847-9084795.62498.22
687807-8780792.42495.18
30min183098-8309887.46890.652.2891.1994.312.25
286289-8628990.82794.37
387125-8712591.70795.60
484980-8498089.44992.78
588881-8888193.55597.22
686365-8636590.90794.69
45min181754-8175486.05389.752.5790.7594.422.54
285241-8524189.72394.28
387326-8732691.91896.83
484056-8405688.47692.80
587655-8765592.26496.97
685579-8557990.07994.88
极限181989-8198986.30088.391.6791.9594.051.70
284518-8451888.96294.51
384335-8433588.77094.70
482556-8255686.89792.20
585564-8556490.06395.79
684907-8490789.37295.17
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%
1102097921009208112086320961209250.41
2102108121007210440.25
单位质量响应值RSD%判断
2092.502104.400.41数据可信
供试品溶液-2025110621批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110280-1028041.79759.8717.8641.8059.8717.85
215065-1506561.25361.25
317282-1728270.26770.27
414782-1478260.10260.10
517343-1734370.51570.51
613596-1359655.28055.28
10min123420-2342095.22395.460.8995.6996.120.84
223438-2343895.29695.98
323329-2332994.85395.63
423728-2372896.47597.14
523227-2322794.43895.22
623727-2372796.47197.09
15min123655-2365596.17995.470.7297.7097.200.69
223595-2359595.93597.67
323510-2351095.58997.42
423326-2332694.84196.58
523572-2357295.84197.67
623230-2323094.45196.14
20min123378-2337895.05293.731.1797.6496.521.03
223248-2324894.52497.33
322798-2279892.69495.59
422949-2294993.30896.10
522722-2272292.38595.28
623226-2322694.43497.17
30min122952-2295293.32093.090.9596.9796.920.85
223048-2304893.71197.57
322681-2268192.21896.15
422889-2288993.06496.89
522616-2261691.95495.88
623180-2318094.24798.03
45min123123-2312394.01692.051.1998.7096.911.04
222532-2253291.61396.51
322550-2255091.68696.64
422458-2245891.31296.18
522400-2240091.07696.02
622774-2277492.59797.43
极限122473-2247391.37390.770.6297.1096.660.59
222267-2226790.53596.45
322360-2236090.91396.88
422228-2222890.37796.26
522484-2248491.41797.38
622140-2214090.01995.88
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4000
标示量(mg)5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%
1138001980114802558010180161801300.11
2137999280258801250.24
单位质量响应值RSD%判断
6163.856163.460.01数据可信
供试品溶液-2025110621批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140582-4058242.68159.4516.4042.6859.4516.40
257780-5778060.76960.77
365746-6574669.14769.15
457669-5766960.65260.65
564919-6491968.27768.28
652440-5244055.15355.15
10min185380-8538089.79789.321.3190.2789.981.25
284307-8430788.66889.34
385111-8511189.51490.28
485691-8569190.12490.80
583000-8300087.29488.05
686043-8604390.49491.11
15min186358-8635890.82590.020.7992.3091.680.69
285238-8523889.64891.31
384913-8491389.30691.07
485593-8559390.02191.70
584997-8499789.39491.12
686461-8646190.93492.55
20min185834-8583490.27488.271.8692.7690.921.73
284272-8427288.63291.29
383623-8362387.94990.70
483852-8385288.19090.87
581180-8118085.38088.10
684801-8480189.18891.82
30min184205-8420588.56187.731.6692.0591.361.56
283392-8339287.70691.35
383525-8352587.84691.58
484441-8444188.80992.46
580732-8073284.90888.58
684182-8418288.53792.16
45min183275-8327587.58386.771.3192.0591.381.25
281747-8174785.97690.59
383169-8316987.47192.18
483468-8346887.78692.43
580696-8069684.87189.48
682654-8265486.93091.53
极限182672-8267286.94985.560.9792.3991.130.87
280935-8093585.12290.69
381307-8130785.51391.19
481709-8170985.93691.55
580373-8037384.53190.09
681107-8110785.30390.87
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