富马酸比索洛尔氨氯地平片项目信息
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100711-202203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)5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%
110.218593585837858748580685992858890.09
210.218691886821868700.08
单位质量响应值RSD%判断
8412.248508.330.81数据可信
供试品溶液-2024021621批-5mg/5mg规格-富马酸比索洛-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%
5min187190-8719092.57089.882.2692.5789.882.26
286403-8640391.73491.73
382685-8268587.78787.79
485306-8530690.56990.57
583411-8341188.55888.56
682953-8295388.07188.07
10min194200-94200100.01297.472.07100.1797.622.07
293237-9323798.99099.14
388991-8899194.48294.63
492513-9251398.22198.37
590529-9052996.11596.26
691351-9135196.98797.13
15min195691-95691101.59598.782.35101.9299.092.36
295254-95254101.131101.45
390035-9003595.59095.89
493126-9312698.87299.19
591353-9135396.99097.30
692756-9275698.47998.79
20min196085-96085102.01498.972.23102.5099.452.23
295125-95125100.994101.48
390612-9061296.20396.67
493179-9317998.92899.41
591578-9157897.22897.70
692732-9273298.45498.93
30min196528-96528102.48499.342.27103.1499.982.27
295537-95537101.432102.09
390960-9096096.57297.20
493523-9352399.29399.94
591957-9195797.63198.26
692874-9287498.60499.24
45min196176-96176102.11099.022.33102.9499.832.33
295413-95413101.300102.12
390879-9087996.48697.27
493330-9333099.08999.90
591206-9120696.83397.63
692583-9258398.29599.10
极限195888-95888101.80498.682.40102.8199.662.40
295069-95069100.935101.93
390173-9017395.73796.68
492908-9290898.64099.62
590983-9098396.59797.55
692678-9267898.39699.36
富马酸比索洛尔氨氯地平片项目信息
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100711-202203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)5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%
110.218590385958859678578085955859130.10
210.218543185536854840.09
单位质量响应值RSD%判断
8414.598372.580.36数据可信
供试品溶液-2024021621批-5mg/5mg规格-富马酸比索洛-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%
5min178794-7879484.31887.969.1784.3287.969.17
272017-7201777.06677.07
380004-8000485.61385.61
486271-8627192.31992.32
594330-94330100.943100.94
681778-8177887.51187.51
10min187951-8795194.11796.794.9094.2696.944.91
285962-8596291.98992.12
387969-8796994.13694.28
494799-94799101.445101.60
597103-97103103.911104.08
688916-8891695.15095.30
15min190100-9010096.41798.753.4996.7199.063.50
291043-9104397.42697.71
389554-8955495.83396.13
495687-95687102.396102.72
597017-97017103.819104.16
690283-9028396.61396.92
20min190658-9065897.01499.613.1297.47100.083.13
292360-9236098.83599.28
391713-9171398.14398.60
496216-96216102.962103.46
597167-97167103.979104.49
690374-9037496.71097.18
30min189914-8991496.21899.433.2296.84100.063.22
292859-9285999.36999.98
391061-9106197.44598.07
496267-96267103.016103.68
596816-96816103.604104.29
690551-9055196.90097.53
45min190015-9001596.32699.213.0997.11100.023.09
292834-9283499.343100.12
390870-9087097.24198.03
495991-95991102.721103.56
596348-96348103.103103.96
690227-9022796.55397.34
极限189859-8985996.15998.943.1897.1099.913.18
292475-9247598.95899.90
390607-9060796.95997.91
495597-95597102.299103.31
596422-96422103.182104.21
689771-8977196.06597.01
富马酸比索洛尔氨氯地平片项目信息
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100711-202203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)5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%
110.218583885709857498563885754857380.09
210.218570785658856820.05
单位质量响应值RSD%判断
8397.458391.970.05数据可信
供试品溶液-2024021621批-5mg/5mg规格-富马酸比索洛-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%
5min171886-7188676.91582.604.0576.9282.604.05
277934-7793483.38683.39
380812-8081286.46686.47
477617-7761783.04783.05
579294-7929484.84184.84
675642-7564280.93480.93
10min186277-8627792.31394.991.8192.4495.131.81
288504-8850494.69694.83
390837-9083797.19297.34
488456-8845694.64494.78
588433-8843394.62094.76
690188-9018896.49896.63
15min190746-9074697.09598.111.5497.3898.401.54
290930-9093097.29197.59
393535-93535100.079100.38
490933-9093397.29597.59
590537-9053796.87197.17
693471-93471100.010100.31
20min192381-9238198.84499.211.8899.2999.671.88
291389-9138997.78398.24
394785-94785101.416101.89
491668-9166898.08198.54
591089-9108997.46297.92
695017-95017101.664102.13
30min193015-9301599.52299.732.17100.13100.352.17
291520-9152097.92398.54
395372-95372102.044102.69
492068-9206898.50999.13
591264-9126497.64998.27
695998-95998102.714103.35
45min193064-9306499.57599.821.98100.35100.611.97
291594-9159498.00298.79
395218-95218101.879102.69
491900-9190098.32999.12
592064-9206498.50599.29
695908-95908102.618103.42
极限192698-9269899.18399.222.12100.12100.172.12
291158-9115897.53598.48
394888-94888101.526102.51
491561-9156197.96798.92
590737-9073797.08598.03
695336-95336102.006102.98
富马酸比索洛尔氨氯地平片项目信息
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100711-202203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)5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%
110.218564285646857048557885475856090.11
210.218565885614856360.04
单位质量响应值RSD%判断
8384.828387.460.03数据可信
供试品溶液-2024021621批-5mg/5mg规格-富马酸比索洛-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%
5min179317-7931784.95384.291.2184.9584.291.21
279177-7917784.80384.80
378598-7859884.18384.18
479737-7973785.40385.40
578282-7828283.84483.84
677082-7708282.55982.56
10min190516-9051696.94795.182.0297.0995.322.02
288821-8882195.13295.27
391220-9122097.70197.84
488121-8812194.38294.52
588234-8823494.50394.64
686260-8626092.38992.53
15min192921-9292199.52398.371.6999.8398.681.69
290900-9090097.35997.66
394111-94111100.798101.10
491070-9107097.54197.84
592253-9225398.80899.11
689834-8983496.21796.51
20min192780-9278099.37299.071.5099.8499.531.50
291474-9147497.97398.44
394483-94483101.196101.67
492117-9211798.66299.12
593462-93462100.103100.56
690650-9065097.09197.54
30min192806-9280699.40099.561.48100.03100.191.47
291865-9186598.39299.02
395152-95152101.913102.55
492420-9242098.98799.61
593954-93954100.630101.26
691536-9153698.04098.65
45min192768-9276899.35999.091.75100.1699.881.75
291403-9140397.89798.69
394669-94669101.396102.21
492095-9209598.63999.43
593876-93876100.546101.34
690272-9027296.68697.46
极限192051-9205198.59198.591.6599.5699.551.64
291083-9108397.55598.51
394371-94371101.076102.05
491155-9115597.63298.59
593275-9327599.902100.87
690383-9038396.80597.74
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