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)0
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%
110.078380383860838738386583904838610.05
210.068377383801837870.03
单位质量响应值RSD%判断
8327.818328.730.01数据可信
供试品溶液-2024021821批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min188967-8896795.95195.631.5195.9595.631.51
286394-8639493.17693.18
389496-8949696.52196.52
487764-8776494.65394.65
589682-8968296.72296.72
689724-8972496.76796.77
10min192760-92760100.04198.411.58100.2098.561.58
288522-8852295.47195.63
391220-9122098.38098.54
491500-9150098.68298.84
591492-9149298.67498.83
691965-9196599.18499.35
15min192995-92995100.29598.511.69100.6298.831.69
288467-8846795.41195.73
391180-9118098.33798.66
492000-9200099.22299.54
591416-9141698.59298.92
691969-9196999.18899.51
20min192923-92923100.21798.461.65100.7198.951.65
288523-8852395.47295.95
391086-9108698.23698.72
491937-9193799.15499.64
591313-9131398.48198.97
692007-9200799.22999.72
30min192584-9258499.85198.231.90100.5198.881.90
287748-8774894.63695.27
390932-9093298.07098.72
492096-9209699.32599.98
591337-9133798.50799.16
691760-9176098.96399.62
45min192490-9249099.75098.071.74100.5898.881.74
288062-8806294.97495.76
390443-9044397.54298.36
491869-9186999.08099.90
590998-9099898.14198.96
691730-9173098.93099.75
极限192062-9206299.28897.711.79100.2898.691.79
287501-8750194.36995.32
390473-9047397.57598.55
491293-9129398.45999.44
590789-9078997.91698.90
691483-9148398.66499.65
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)0
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)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.851040451035621035321040541032861036960.33
213.971029521037801033660.57
单位质量响应值RSD%判断
7487.087399.140.84数据可信
供试品溶液-2024021821批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1103600-10360090.23392.312.0690.2392.312.06
2105313-10531391.72591.72
3108932-10893294.87794.88
4103583-10358390.21890.22
5107194-10719493.36393.36
6107276-10727693.43493.43
10min1112857-11285798.29598.431.9398.4598.581.93
2112825-11282598.26798.42
3117179-117179102.060102.22
4110859-11085996.55596.71
5111905-11190597.46697.62
6112413-11241397.90998.06
15min1114581-11458199.79799.431.72100.1199.751.72
2113579-11357998.92499.24
3117904-117904102.691103.02
4113469-11346998.82899.14
5112797-11279798.24398.56
6112647-11264798.11298.43
20min1116794-116794101.724100.411.76102.20100.891.75
2115274-115274100.400100.88
3118388-118388103.113103.61
4114585-11458599.800100.28
5112927-11292798.35698.84
6113731-11373199.05699.54
30min1115651-115651100.729100.521.43101.38101.161.43
2115085-115085100.236100.88
3117838-117838102.634103.30
4116535-116535101.499102.14
5113456-11345698.81799.46
6113867-11386799.17599.82
45min1115808-115808100.865100.701.51101.68101.521.51
2115673-115673100.748101.56
3117184-117184102.064102.91
4117777-117777102.580103.39
5113349-11334998.72499.53
6113931-11393199.231100.04
极限1115133-115133100.278100.451.53101.26101.431.53
2114734-11473499.930100.91
3117361-117361102.218103.23
4117545-117545102.378103.36
5113418-11341898.78499.76
6113766-11376699.087100.07
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)0
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%
110.078381083749838318384783809838090.05
210.068371583634836740.07
单位质量响应值RSD%判断
8322.648317.500.05数据可信
供试品溶液-2024021821批-比索洛尔-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187563-8756394.52989.927.1294.5389.927.12
281561-8156188.05088.05
372077-7207777.81177.81
485319-8531992.10792.11
587721-8772194.70094.70
685543-8554392.34992.35
10min192095-9209599.42297.911.3199.5898.061.31
291397-9139798.66898.82
390538-9053897.74197.87
488746-8874695.80795.96
591301-9130198.56598.72
690081-9008197.24897.40
15min193027-93027100.42898.371.59100.7598.681.59
291972-9197299.28999.60
391041-9104198.28498.58
488796-8879695.86096.17
591492-9149298.77199.09
690407-9040797.60097.92
20min192873-92873100.26298.261.61100.7598.741.61
291898-9189899.20999.69
390923-9092398.15798.61
488563-8856395.60996.08
591366-9136698.63599.12
690514-9051497.71598.19
30min192916-92916100.30898.121.76100.9798.761.76
291869-9186999.17899.82
390844-9084498.07198.69
488207-8820795.22595.86
591224-9122498.48299.13
690256-9025697.43798.08
45min193119-93119100.52798.112.05101.3598.912.05
292796-92796100.179100.99
390310-9031097.49598.28
488209-8820995.22796.02
591028-9102898.27099.09
689796-8979696.94097.74
极限191835-9183599.14197.071.64100.1398.041.64
290823-9082398.04999.02
389668-8966896.80297.75
487524-8752494.48795.44
590350-9035097.53898.52
689293-8929396.39797.36
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)0
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)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.851033361042441032361037701039261037020.41
213.971035281032371033820.20
单位质量响应值RSD%判断
7487.517400.290.83数据可信
供试品溶液-2024021821批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189453-8945377.90377.7012.9777.9077.7012.97
279791-7979169.48869.49
371486-7148662.25662.26
4102194-10219488.99989.00
596331-9633183.89383.89
696081-9608183.67583.67
10min1101936-10193688.77491.023.7588.9091.153.76
2100698-10069887.69687.81
3102301-10230189.09289.20
4111461-11146197.06997.22
5104639-10463991.12891.27
6106033-10603392.34292.48
15min1103422-10342290.06891.814.0090.3592.094.00
2100319-10031987.36687.63
3102837-10283789.55989.81
4112195-11219597.70898.02
5105964-10596492.28292.57
6107792-10779293.87494.17
20min1102488-10248889.25591.993.8889.6892.423.89
2101184-10118488.11988.53
3103462-10346290.10390.50
4112193-11219397.70798.18
5106429-10642992.68793.13
6107986-10798694.04394.49
30min1103859-10385990.44992.124.0991.0392.714.10
2100471-10047187.49888.05
3102793-10279389.52090.07
4112171-11217197.68798.32
5106184-10618492.47393.07
6109205-10920595.10495.71
45min1102390-10239089.16991.073.3289.9091.823.33
2101880-10188088.72589.43
3101266-10126688.19088.89
4110263-11026396.02696.82
5104958-10495891.40692.16
6106704-10670492.92693.69
极限1102977-10297789.68091.163.4490.5692.053.45
2101598-10159888.48089.33
3100822-10082287.80488.65
4110174-11017495.94896.91
5105150-10515091.57392.48
6107317-10731793.46094.38
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)0
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%
110.078406983945840648398184015840150.07
210.068369883565836320.12
单位质量响应值RSD%判断
8343.108313.320.26数据可信
供试品溶液-2024021821批-比索洛尔-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%
5min193537-93537100.88097.902.54100.8897.902.54
288854-8885495.83095.83
391711-9171198.91198.91
487229-8722994.07794.08
591355-9135598.52798.53
691983-9198399.20499.20
10min194542-94542101.96499.052.31102.1399.222.31
290042-9004297.11197.27
393006-93006100.308100.47
488708-8870895.67295.83
592068-9206899.29699.46
692693-9269399.970100.14
15min194489-94489101.90798.872.47102.2599.202.47
289589-8958996.62296.94
393128-93128100.439100.77
488458-8845895.40395.72
591849-9184999.06099.39
692550-9255099.816100.15
20min193956-93956101.33298.652.37101.8499.142.37
289536-8953696.56597.05
393218-93218100.536101.04
488300-8830095.23295.71
591787-9178798.99399.49
691991-9199199.21399.71
30min194110-94110101.49898.732.38102.1899.392.38
289685-8968596.72697.37
392949-92949100.246100.91
488235-8823595.16295.80
592021-9202199.24599.91
692263-9226399.506100.17
45min194042-94042101.42598.342.62102.2799.162.62
288964-8896495.94896.75
392682-9268299.958100.79
487733-8773394.62195.41
591459-9145998.63999.46
692216-9221699.456100.29
极限193486-93486100.82598.132.55101.8499.122.55
289330-8933096.34397.31
392537-9253799.802100.80
487305-8730594.15995.11
590920-9092098.05899.05
692343-9234399.593100.59
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)0
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)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.851036501035291038511035791040461037310.21
213.971035331035871035600.04
单位质量响应值RSD%判断
7489.607413.030.73数据可信
供试品溶液-2024021821批-氨氯地平-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%
5min1108771-10877194.63194.031.2794.6394.031.27
2110023-11002395.72195.72
3107371-10737193.41393.41
4107224-10722493.28593.29
5108844-10884494.69594.69
6106263-10626392.44992.45
10min1111910-11191097.36298.222.2697.5298.382.26
2117379-117379102.120102.28
3112116-11211697.54197.70
4112519-11251997.89298.05
5113707-11370798.92699.08
6109747-10974795.48095.63
15min1112748-11274898.09198.371.7898.4198.701.78
2115490-115490100.477100.81
3112241-11224197.65097.97
4112633-11263397.99198.31
5115221-115221100.243100.57
6110106-11010695.79396.11
20min1110947-11094796.52498.452.8197.0198.942.81
2117499-117499102.225102.72
3114457-11445799.578100.06
4112736-11273698.08198.56
5114876-11487699.943100.43
6108472-10847294.37194.84
30min1112011-11201197.45097.532.4498.0998.182.44
2116281-116281101.165101.83
3111707-11170797.18697.83
4110417-11041796.06396.71
5113826-11382699.02999.69
6108373-10837394.28594.92
45min1111536-11153697.03797.722.0797.8498.532.07
2116201-116201101.095101.93
3112320-11232097.71998.53
4110872-11087296.45997.26
5113493-11349398.73999.56
6109519-10951995.28296.07
极限1110233-11023395.90397.542.3796.8798.512.37
2117116-117116101.892102.90
3112331-11233197.72998.70
4110744-11074496.34897.31
5112304-11230497.70598.69
6109932-10993295.64196.59
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)0
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%
110.078350783528834818351983502835070.03
210.068517085157851640.02
单位质量响应值RSD%判断
8292.658465.611.46数据可信
供试品溶液-2024021821批-比索洛尔-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%
5min187521-8752193.82894.311.8693.8394.311.86
289375-8937595.81695.82
388016-8801694.35994.36
490180-9018096.67996.68
585623-8562391.79391.79
687098-8709893.37593.37
10min191951-9195198.57797.412.1898.7397.562.18
291742-9174298.35398.51
391201-9120197.77397.93
492921-9292199.61799.78
587329-8732993.62293.78
690019-9001996.50696.66
15min193816-93816100.57798.642.30100.9098.962.30
292494-9249499.15999.48
392870-9287099.56399.88
493865-93865100.629100.96
588491-8849194.86895.18
690506-9050697.02897.34
20min193551-93551100.29398.932.25100.7899.412.25
292582-9258299.25499.74
393452-93452100.186100.67
494320-94320101.117101.61
588721-8872195.11595.58
691033-9103397.59398.07
30min195027-95027101.87599.872.20102.53100.522.20
293407-93407100.138100.79
394310-94310101.106101.76
494831-94831101.665102.33
589948-8994896.43097.06
691423-9142398.01198.65
45min194509-94509101.32099.712.26102.14100.532.26
293360-93360100.088100.91
394168-94168100.954101.78
495120-95120101.975102.81
589880-8988096.35797.14
691015-9101597.57498.38
极限195000-95000101.84699.652.20102.84100.632.20
293229-9322999.947100.94
393937-93937100.706101.70
494476-94476101.284102.29
589657-8965796.11897.06
691420-9142098.00898.97
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)0
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)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.851029951029711029951029941030121029930.02
213.971055511059671057590.28
单位质量响应值RSD%判断
7436.327570.441.27数据可信
供试品溶液-2024021821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%
5min156854-5685449.12351.924.5749.1251.924.57
264748-6474855.94355.94
358481-5848150.52850.53
458788-5878850.79450.79
560998-6099852.70352.70
660715-6071552.45952.46
10min177364-7736466.84467.973.8466.9368.063.84
283620-8362072.24972.34
375414-7541465.15965.24
476149-7614965.79465.88
579487-7948768.67868.77
680001-8000169.12269.21
15min184348-8434872.87873.993.7173.0774.193.71
290541-9054178.22978.44
383301-8330171.97372.17
481850-8185070.72070.91
585984-8598474.29174.49
687817-8781775.87576.08
20min187212-8721275.35276.623.3375.6776.943.34
293452-9345280.74481.09
386048-8604874.34774.66
485684-8568474.03274.34
589954-8995477.72278.05
689739-8973977.53677.86
30min190512-9051278.20479.163.5178.6479.613.52
296593-9659383.45883.94
388551-8855176.50976.95
488076-8807676.09976.53
592940-9294080.30280.76
693018-9301880.36980.83
45min192694-9269480.08981.582.7080.6682.162.70
297576-9757684.30784.92
391720-9172079.24779.81
492077-9207779.55680.12
595991-9599182.93883.53
696468-9646883.35083.94
极限1108420-10842093.67692.522.7194.3893.242.71
2111867-11186796.65597.41
3104136-10413689.97590.67
4104706-10470690.46891.16
5107868-10786893.20093.93
6105514-10551491.16691.90
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