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2000
标示量(mg)10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%
19.952064020451206302041220532205330.51
29.992053320569205510.13
单位质量响应值RSD%判断
2063.622057.160.23数据可信
供试品溶液-2022081601批-培哚普利-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121447-2144788.81290.643.9488.8190.643.94
220452-2045284.69184.69
322064-2206491.36791.37
422850-2285094.62194.62
521925-2192590.79190.79
622591-2259193.54993.55
10min122852-2285294.63096.511.7795.6297.521.78
222798-2279894.40695.35
323229-2322996.19197.21
423584-2358497.66198.71
523665-2366597.99699.01
623714-2371498.19999.24
15min122444-2244492.94095.981.6194.9898.061.61
223197-2319796.05898.05
323333-2333396.62198.71
423473-2347397.20199.34
523368-2336896.76698.86
623251-2325196.28298.41
20min122775-2277594.31195.500.7697.3898.640.79
222937-2293794.98298.04
323254-2325496.29499.45
423137-2313795.81099.03
523126-2312695.76498.94
623139-2313995.81899.02
30min122338-2233892.50194.121.5096.6298.331.51
222398-2239892.75096.86
322611-2261193.63297.86
423173-2317395.959100.24
523044-2304495.42599.66
622812-2281294.46498.73
45min122315-2231592.40693.240.4897.5598.490.49
222576-2257693.48798.63
322609-2260993.62398.89
422504-2250493.18998.54
522511-2251193.21898.51
622576-2257693.48798.80
极限122496-2249693.15593.010.2899.3399.300.32
222359-2235992.58898.77
322423-2242392.85399.16
422498-2249893.16499.55
522531-2253193.30099.63
622465-2246593.02799.38
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2000
标示量(mg)10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%
113.931630881624781628441630441627761628460.15
214.001627361624141625750.15
单位质量响应值RSD%判断
11690.3111612.500.48数据可信
供试品溶液-2022081601批-氨氯地平-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1140542-14054278.19481.724.4678.1981.724.46
2137547-13754776.52876.53
3147790-14779082.22782.23
4152825-15282585.02885.03
5148910-14891082.85082.85
6153702-15370285.51685.52
10min1162340-16234090.32294.602.8391.1995.512.84
2166752-16675292.77793.63
3169398-16939894.24995.16
4173705-17370596.64697.59
5174384-17438497.02397.94
6173615-17361596.59697.55
15min1160999-16099989.57694.272.6891.4596.232.69
2168180-16818093.57295.45
3169849-16984994.50096.46
4172936-17293696.21898.24
5173092-17309296.30598.30
6171531-17153195.43697.46
20min1162788-16278890.57293.822.1593.4496.822.18
2165954-16595492.33395.25
3168716-16871693.87096.88
4171261-17126195.28698.37
5172100-17210095.75398.82
6170939-17093995.10798.19
30min1160042-16004289.04492.872.7392.9296.922.73
2164586-16458691.57295.52
3165765-16576592.22896.28
4171815-17181595.59499.74
5171960-17196095.67599.81
6167368-16736893.12097.26
45min1159445-15944588.71292.042.1093.5897.122.13
2163789-16378991.12996.09
3165494-16549492.07797.16
4169133-16913394.10299.31
5167187-16718793.01998.21
6167553-16755393.22398.40
极限1166800-16680092.80493.700.6698.6599.800.77
2167449-16744993.16599.14
3168810-16881093.922100.02
4168678-16867893.849100.10
5169921-16992194.540100.77
6168766-16876693.898100.11
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2000
标示量(mg)10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%
19.952083820925208712090420893208860.16
29.992088520788208360.33
单位质量响应值RSD%判断
2099.102085.690.46数据可信
供试品溶液-2022081901批-培哚普利-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122211-2221190.56986.302.7990.5786.302.79
220427-2042783.29583.29
321006-2100685.65685.66
421321-2132186.94086.94
520976-2097685.53385.53
621049-2104985.83185.83
10min123236-2323694.74994.202.2295.7695.162.20
223450-2345095.62196.55
322117-2211790.18691.14
422978-2297893.69794.66
523421-2342195.50396.45
623399-2339995.41496.37
15min122802-2280292.97993.492.0195.0495.501.99
222980-2298093.70595.69
322168-2216890.39492.35
422826-2282693.07795.08
523319-2331995.08797.10
623472-2347295.71197.73
20min122649-2264992.35592.271.7995.4595.321.77
222639-2263992.31495.34
321888-2188889.25292.21
422620-2262092.23795.28
522944-2294493.55896.63
623033-2303393.92197.00
30min122295-2229590.91291.562.0495.0395.632.01
222719-2271992.64196.70
321655-2165588.30292.25
422370-2237091.21895.28
522859-2285993.21297.32
622828-2282893.08597.21
45min122226-2222690.63090.781.9695.7695.861.93
222332-2233291.06396.15
321440-2144087.42592.36
422358-2235891.16996.25
522523-2252391.84196.98
622692-2269292.53197.69
极限121775-2177588.79189.822.3094.9395.922.25
222166-2216690.38696.48
321173-2117386.33792.24
422029-2202989.82795.92
522501-2250191.75297.92
622523-2252391.84198.02
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2000
标示量(mg)10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%
113.938167181650815918159381854816720.14
214.008186181781818210.07
单位质量响应值RSD%判断
5863.035844.360.23数据可信
供试品溶液-2022081901批-氨氯地平-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min171221-7122178.87275.603.4678.8775.603.46
267674-6767474.94474.94
369262-6926276.70276.70
469960-6996077.47577.48
564720-6472071.67371.67
666766-6676673.93873.94
10min183531-8353192.50492.051.2393.3892.881.21
284167-8416793.20994.04
381217-8121789.94290.79
483220-8322092.16093.02
583618-8361892.60193.40
682946-8294691.85692.68
15min182803-8280391.69892.441.6293.6094.311.58
284483-8448393.55995.43
381102-8110289.81491.67
483621-8362192.60494.49
584668-8466893.76395.59
684182-8418293.22595.07
20min183075-8307591.99991.821.2394.9294.711.20
282717-8271791.60394.51
381092-8109289.80392.65
483009-8300991.92694.84
584129-8412993.16796.03
683463-8346392.42995.31
30min181966-8196690.77191.221.6494.7295.131.59
282715-8271591.60195.53
379982-7998288.57492.42
482821-8282191.71895.65
584015-8401593.04096.94
682745-8274591.63495.54
45min181625-8162590.39490.971.6895.3595.891.63
281722-8172290.50195.44
379829-7982988.40593.24
482970-8297091.88396.84
583153-8315392.08697.02
683563-8356392.54097.46
极限180415-8041589.05490.212.0595.0196.151.97
281630-8163090.39996.35
378694-7869487.14892.96
482195-8219591.02597.00
583290-8329092.23798.20
682545-8254591.41297.36
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2000
标示量(mg)10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%
19.952101521064208712084520902209390.46
29.992080820933208700.43
单位质量响应值RSD%判断
2104.422089.090.52数据可信
供试品溶液-2022081901批-培哚普利-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118521-1852175.36686.416.6375.3786.416.63
220965-2096585.31185.31
322113-2211389.98289.98
421712-2171288.35088.35
521793-2179388.68088.68
622309-2230990.78090.78
10min122655-2265592.18894.542.4793.0395.502.49
222438-2243891.30592.25
323564-2356495.88796.89
423932-2393297.38498.37
523489-2348995.58196.57
623317-2331794.88195.89
15min123090-2309093.95894.732.4295.8296.742.42
222411-2241191.19593.16
323305-2330594.83396.90
424148-2414898.263100.33
523470-2347095.50497.55
623260-2326094.65096.71
20min123180-2318094.32493.912.3197.2396.972.28
222422-2242291.24094.22
322601-2260191.96895.09
423926-2392697.360100.52
523230-2323094.52797.64
623104-2310494.01597.13
30min123315-2331594.87393.642.7498.8397.742.69
222005-2200589.54393.53
322696-2269692.35596.50
423868-2386897.124101.36
523218-2321894.47998.64
622962-2296293.43797.60
45min123253-2325394.62192.472.7799.6397.622.69
221857-2185788.94093.92
322547-2254791.74896.92
423635-2363596.175101.49
522603-2260391.97697.18
622456-2245691.37896.58
极限123447-2344795.41092.152.88101.4798.332.75
221901-2190189.12095.09
322535-2253591.69997.89
423259-2325994.645101.03
522802-2280292.78699.02
621932-2193289.24695.46
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2000
标示量(mg)10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%
113.938168782307816848167481705818110.34
214.008135981537814480.16
单位质量响应值RSD%判断
5873.015817.710.67数据可信
供试品溶液-2022081901批-氨氯地平-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154433-5443360.36875.1410.0860.3775.1410.08
267735-6773575.12075.12
372432-7243280.32980.33
469119-6911976.65576.65
569834-6983477.44877.45
672990-7299080.94880.95
10min178083-7808386.59692.494.0587.2793.334.09
281009-8100989.84190.68
386635-8663596.08096.97
486769-8676996.22997.08
583393-8339392.48593.35
684501-8450193.71494.61
15min180387-8038789.15193.383.6090.7895.243.63
281037-8103789.87291.71
386203-8620395.60197.56
488197-8819797.81399.73
584054-8405493.21895.11
685339-8533994.64396.58
20min181049-8104989.88593.193.1192.5196.093.14
281407-8140790.28293.11
384450-8445093.65796.68
487933-8793397.520100.53
583664-8366492.78695.71
685649-8564994.98797.98
30min181639-8163990.54093.142.9394.1697.082.96
280668-8066889.46393.30
384767-8476794.00998.07
487448-8744896.982101.07
584648-8464893.87797.83
684742-8474293.98198.03
45min182280-8228091.25193.023.2795.8898.003.26
280870-8087089.68794.52
384416-8441693.62098.73
488546-8854698.200103.37
582221-8222191.18596.18
684936-8493694.19699.29
极限185355-8535594.66193.432.21100.3099.442.11
282758-8275891.78197.61
384765-8476594.007100.15
486943-8694396.422102.68
583893-8389393.03999.05
681783-8178390.69996.84
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