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%
110.212025220215205682027820269203160.71
210.162047920480204800.01
单位质量响应值RSD%判断
1989.812015.750.92数据可信
供试品溶液-2022081901批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122036-2203693.87996.922.9293.8896.922.92
224003-24003102.259102.26
322714-2271496.76796.77
422730-2273096.83696.84
522484-2248495.78895.79
622526-2252695.96795.97
10min123435-2343599.83998.450.97100.8899.530.96
223215-2321598.902100.04
322883-2288397.48798.56
423096-2309698.39599.47
523190-2319098.79599.86
622836-2283697.28798.35
15min123128-2312898.53198.101.30100.68100.271.30
223406-2340699.716101.95
322918-2291897.63799.79
422952-2295297.78199.95
523219-2321998.919101.08
622540-2254096.02698.17
20min123143-2314398.59597.231.57101.84100.491.55
223384-2338499.622102.96
322727-2272796.823100.07
422488-2248895.80599.06
522599-2259996.27899.54
622597-2259796.26999.48
30min122913-2291397.61596.301.11101.96100.651.09
222754-2275496.938101.39
322731-2273196.840101.16
422353-2235395.22999.55
522611-2261196.329100.66
622269-2226994.87299.16
45min122388-2238895.37994.361.49100.8199.771.45
222355-2235595.238100.77
322533-2253395.996101.39
421686-2168692.38897.77
522054-2205493.95699.36
621877-2187793.20298.54
极限122378-2237895.33693.781.13101.82100.241.10
222037-2203793.883100.47
322089-2208994.105100.57
421623-2162392.11998.52
522049-2204993.934100.38
621895-2189593.27899.65
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%
114.128223481644821658184882043819870.30
214.128258283539830600.82
单位质量响应值RSD%判断
5806.445882.440.92数据可信
供试品溶液-2022081901批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127506-2750630.51032.1411.8330.5132.1411.84
235238-3523839.08739.09
325733-2573328.54428.54
429181-2918132.36832.37
526473-2647329.36429.36
629703-2970332.94732.95
10min164641-6464171.70169.933.1472.0470.293.16
265817-6581773.00673.44
361568-6156868.29368.61
463776-6377670.74271.10
561351-6135168.05268.38
661114-6111467.78968.16
15min175323-7532383.55082.131.8284.6983.271.84
275634-7563483.89585.14
373377-7337781.39182.47
473353-7335381.36582.51
574479-7447982.61483.70
672109-7210979.98581.10
20min178965-7896587.59085.741.3689.6587.791.39
278007-7800786.52788.70
376389-7638984.73286.71
477393-7739385.84687.90
576202-7620284.52586.53
676852-7685285.24687.25
30min182437-8243791.44189.201.3494.4892.201.32
279997-7999788.73491.87
380125-8012588.87691.80
480536-8053689.33292.34
580153-8015388.90891.85
679272-7927287.93090.89
45min181789-8178990.72289.560.9794.7893.550.97
280956-8095689.79893.92
381280-8128090.15894.07
480161-8016188.91692.91
580618-8061889.42393.35
679633-7963388.33192.26
极限182175-8217591.15089.601.3496.2194.581.32
281031-8103189.88195.00
380709-8070989.52494.44
480543-8054389.34094.32
581294-8129490.17395.09
678918-7891887.53892.45
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%
110.212032920326202672023120302202910.21
210.162013020092201110.14
单位质量响应值RSD%判断
1987.371979.430.29数据可信
供试品溶液-2022082001批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122806-2280698.10598.191.1598.1198.181.15
222845-2284598.27398.27
322557-2255797.03497.03
422508-2250896.82396.82
523126-2312699.48299.48
623107-2310799.40099.40
10min123431-23431100.79499.940.87101.88101.020.87
223225-2322599.908101.00
323041-2304199.116100.19
422945-2294598.70399.78
523323-23323100.329101.43
623425-23425100.768101.87
15min122947-2294798.71298.271.56100.92100.471.54
222856-2285698.320100.52
322216-2221695.56797.75
422737-2273797.80899.98
523059-2305999.194101.41
623252-23252100.024102.25
20min122789-2278998.03296.961.25101.34100.251.24
222628-2262897.339100.63
322009-2200994.67797.92
422478-2247896.69499.95
522618-2261897.296100.62
622713-2271397.705101.04
30min122444-2244496.54896.381.80100.94100.741.77
222316-2231695.997100.37
321673-2167393.23197.52
422555-2255597.025101.36
522565-2256597.068101.47
622871-2287198.385102.81
45min122023-2202394.73795.131.17100.21100.581.15
222007-2200794.668100.11
321983-2198394.56599.89
421830-2183093.90799.32
522323-2232396.027101.51
622526-2252696.901102.41
极限121932-2193294.34594.211.71100.87100.711.68
221983-2198394.565101.06
321229-2122991.32197.70
421780-2178093.692100.15
522260-2226095.756102.31
622214-2221495.559102.15
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%
114.128197382486826238212782466823350.34
214.128209281992820420.09
单位质量响应值RSD%判断
5831.095810.340.26数据可信
供试品溶液-2022082001批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157676-5767664.23465.552.2064.2365.552.20
259749-5974966.54266.54
357729-5772964.29364.29
458526-5852665.18065.18
561012-6101267.94967.95
658477-5847765.12665.13
10min175232-7523283.78683.660.7984.5084.390.80
275253-7525383.80984.55
374398-7439882.85783.57
474415-7441582.87683.60
575766-7576684.38185.14
675658-7565884.26084.98
15min178195-7819587.08687.251.9188.7388.911.89
278762-7876287.71789.39
375896-7589684.52586.16
477598-7759886.42188.07
579584-7958488.63390.33
680023-8002389.12290.78
20min179095-7909588.08888.181.4590.7090.811.45
278854-7885487.82090.46
377347-7734786.14188.72
479028-7902888.01390.62
580679-8067989.85292.53
680083-8008389.18891.84
30min181034-8103490.24889.961.8793.8493.571.85
280840-8084090.03293.65
378056-7805686.93190.46
480464-8046489.61393.20
581923-8192391.23894.91
682362-8236291.72795.37
45min179878-7987888.96090.411.5093.5595.011.49
281117-8111790.34094.96
380177-8017789.29393.79
480605-8060589.77094.35
582441-8244191.81596.50
682848-8284892.26896.93
极限179679-7967988.73989.761.5494.3295.371.53
281500-8150090.76796.39
378919-7891987.89293.38
479930-7993089.01894.59
581820-8182091.12396.83
681729-8172991.02296.71
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%
110.212031120292203542031420199202940.29
210.162041220243203280.59
单位质量响应值RSD%判断
1987.662000.790.47数据可信
供试品溶液-2022082001批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122786-2278697.48897.270.7697.4997.270.76
222613-2261396.74896.75
322921-2292198.06598.07
422934-2293498.12198.12
522615-2261596.75696.76
622536-2253696.41896.42
10min122709-2270997.15897.780.6998.2498.860.69
222668-2266896.98398.06
322929-2292998.10099.19
423101-2310198.83599.93
522830-2283097.67698.75
622885-2288597.91198.98
15min122262-2226295.24696.690.9397.4198.860.92
222516-2251696.33398.49
322589-2258996.64598.82
422878-2287897.881100.07
522613-2261396.74898.91
622744-2274497.30899.47
20min122271-2227195.28495.890.7098.5199.130.69
222365-2236595.68798.91
322320-2232095.49498.75
422676-2267697.017100.29
522524-2252496.36799.60
622315-2231595.47398.71
30min122289-2228995.36194.920.8499.6499.220.82
222054-2205494.35698.64
322302-2230295.41799.73
422409-2240995.875100.23
522158-2215894.80199.11
621901-2190193.70198.00
45min121778-2177893.17594.220.9298.5199.590.90
221929-2192993.82199.16
322148-2214894.758100.13
422260-2226095.237100.66
522188-2218894.929100.29
621837-2183793.42898.77
极限121744-2174493.03093.132.0499.4099.541.94
221227-2122790.81897.19
321541-2154192.16198.59
422559-2255996.517102.99
521831-2183193.40299.82
621708-2170892.87699.26
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%
114.128216081956819898235881707820340.30
214.128256482267824160.26
单位质量响应值RSD%判断
5809.775836.830.33数据可信
供试品溶液-2022082001批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144435-4443549.46564.5811.6449.4764.5811.64
261408-6140868.36068.36
362357-6235769.41669.42
461070-6107067.98467.98
559444-5944466.17466.17
659358-5935866.07866.08
10min165983-6598373.45380.814.8074.0081.534.85
273496-7349681.81682.58
374191-7419182.59083.36
476243-7624384.87485.63
572676-7267680.90481.64
672965-7296581.22581.96
15min170364-7036478.33085.284.1879.7086.904.24
277311-7731186.06387.73
377897-7789786.71688.40
479659-7965988.67790.38
577097-7709785.82587.46
677331-7733186.08687.72
20min173086-7308681.36087.113.3683.6089.683.44
278930-7893087.86690.49
379370-7937088.35591.01
480575-8057589.69792.38
578658-7865887.56390.15
678898-7889887.83090.42
30min174639-7463983.08988.463.2186.2391.993.30
279626-7962688.64092.24
380988-8098890.15793.79
482019-8201991.30494.98
579507-7950788.50892.07
680017-8001789.07692.64
45min174486-7448682.91888.903.4186.9893.423.49
280551-8055189.67094.26
381647-8164790.89095.53
481814-8181491.07695.77
580673-8067389.80694.35
679995-7999589.05193.61
极限175738-7573884.31288.452.7189.3093.962.80
279056-7905688.00693.59
379526-7952688.52994.17
482342-8234291.66497.37
580264-8026489.35194.89
679825-7982588.86294.41
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