依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.851297171299401301271301721300401299990.14
210.881316111316351316230.02
单位质量响应值RSD%判断
11981.4712097.700.69数据可信
供试品溶液-2024061321批-匹伐他汀钙-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%
5min1129025-12902592.88493.333.3992.8893.323.39
2122824-12282488.42088.42
3126424-12642491.01291.01
4133984-13398496.45496.45
5132336-13233695.26895.27
6133239-13323995.91895.92
10min1135573-13557397.59899.161.3197.7599.311.31
2137415-13741598.92499.07
3135717-13571797.70297.85
4139309-139309100.287100.45
5138790-13879099.914100.07
6139647-139647100.531100.69
15min1136611-13661198.34599.531.4498.6699.841.44
2137172-13717298.74999.06
3135779-13577997.74698.06
4140632-140632101.240101.57
5139923-139923100.729101.05
6139388-139388100.344100.67
20min1135966-13596697.88199.191.2698.3699.681.26
2137172-13717298.74999.23
3135876-13587697.81698.29
4140094-140094100.853101.35
5139154-139154100.176100.67
6138427-13842799.652100.15
30min1135480-13548097.53199.011.2398.1899.671.23
2136826-13682698.50099.14
3136031-13603197.92898.57
4139779-139779100.626101.29
5138404-13840499.636100.30
6138717-13871799.861100.52
45min1135397-13539797.47198.921.3298.2899.731.33
2136304-13630498.12498.93
3135686-13568697.67998.48
4139574-139574100.478101.31
5138739-13873999.877100.70
6138729-13872999.870100.70
60min1134979-13497997.17098.701.2698.1499.681.26
2136329-13632998.14299.11
3135472-13547297.52598.49
4138740-13874099.878100.88
5138539-13853999.733100.73
6138585-13858599.766100.76
极限1135572-13557297.59798.571.2198.7399.721.21
2136350-13635098.15799.29
3134624-13462496.91598.04
4138609-13860999.783100.95
5138382-13838299.620100.78
6138000-13800099.345100.50
依折麦布匹伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
1113794543790203806033796873811003799730.23
210.933837893850383844140.23
单位质量响应值RSD%判断
34543.0035170.541.28数据可信
供试品溶液-2024061321批-依折麦布-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%
5min137242-372429.6179.814.119.629.824.13
238016-380169.8179.82
337240-372409.6169.62
439370-3937010.16610.17
535948-359489.2839.28
640229-4022910.38810.39
10min138166-381669.8559.971.729.879.981.74
238914-3891410.04810.06
338980-3898010.06510.08
438485-384859.9389.95
537631-376319.7179.73
639496-3949610.19910.22
15min138469-384699.9339.981.049.9710.021.04
238952-3895210.05810.09
339262-3926210.13810.17
438733-3873310.00210.04
538183-381839.8609.89
638356-383569.9049.94
20min137307-373079.6339.862.309.689.902.28
238975-3897510.06410.11
339467-3946710.19110.24
437899-378999.7869.84
538008-380089.8149.86
637355-373559.6469.70
30min137296-372969.6319.792.159.709.862.15
238849-3884910.03210.10
339041-3904110.08110.15
437162-371629.5969.66
537582-375829.7049.77
637577-375779.7039.77
45min137445-374459.6699.622.929.759.712.89
237734-377349.7449.83
338645-386459.97910.06
437418-374189.6629.74
535353-353539.1299.21
637036-370369.5639.65
60min136316-363169.3789.392.419.479.492.39
235644-356449.2049.30
335581-355819.1889.29
437639-376399.7199.82
535786-357869.2419.34
637214-372149.6099.71
极限137677-376779.7299.711.459.849.821.44
238046-380469.8249.94
338269-382699.88210.00
436725-367259.4839.60
537572-375729.7029.81
637356-373569.6469.76
依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.851297271298931300021303371295181298950.24
210.881331931331861331900.01
单位质量响应值RSD%判断
11971.8912241.731.58数据可信
供试品溶液-2024061321批-匹伐他汀钙-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%
5min1131198-13119893.93391.762.8593.9391.762.85
2121643-12164387.09287.09
3130080-13008093.13393.13
4129164-12916492.47792.48
5126252-12625290.39290.39
6130657-13065793.54693.55
10min1138898-13889899.44697.771.3599.6097.931.36
2134908-13490896.59096.73
3135946-13594697.33397.49
4134676-13467696.42496.58
5136211-13621197.52397.67
6138736-13873699.33099.49
15min1138021-13802198.81898.010.9999.1498.330.99
2135803-13580397.23097.54
3136211-13621197.52397.84
4135290-13529096.86397.18
5137352-13735298.34098.65
6138713-13871399.31499.64
20min1138172-13817298.92797.791.0099.4198.271.00
2135572-13557297.06597.53
3136511-13651197.73798.22
4134545-13454596.33096.81
5136918-13691898.02998.51
6137757-13775798.62999.12
30min1137857-13785798.70197.661.1599.3598.301.15
2135130-13513096.74997.38
3135508-13550897.01997.66
4134588-13458896.36197.00
5136906-13690698.02098.66
6138444-13844499.12199.77
45min1137907-13790798.73797.711.2799.5598.511.27
2134843-13484396.54397.33
3135863-13586397.27398.08
4134478-13447896.28297.08
5136878-13687898.00098.80
6138854-13885499.415100.23
60min1137264-13726498.27796.891.7499.2697.861.73
2131803-13180394.36795.32
3134839-13483996.54097.51
4133580-13358095.63996.60
5136636-13663697.82798.79
6137826-13782698.67999.66
极限1136885-13688598.00597.061.1499.1598.191.14
2134226-13422696.10197.21
3134601-13460196.37097.50
4133863-13386395.84296.96
5136248-13624897.54998.68
6137586-13758698.50799.65
依折麦布匹伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
1113811803808303814843817563814853813470.10
210.933870843867573869200.06
单位质量响应值RSD%判断
34667.9135399.821.48数据可信
供试品溶液-2024061321批-依折麦布-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%
5min142643-4264310.95610.335.1310.9610.345.13
237158-371589.5479.55
338891-388919.9929.99
441212-4121210.58810.59
539535-3953510.15710.16
641897-4189710.76410.76
10min138701-387019.9439.831.419.969.851.40
238375-383759.8599.88
338202-382029.8159.83
437203-372039.5589.58
538529-385299.8999.92
638488-384889.8889.91
15min138586-385869.9149.851.029.959.891.02
238668-386689.9359.97
337944-379449.7499.78
437882-378829.7339.77
538196-381969.8139.85
638791-387919.96610.00
20min138767-387679.9609.851.2210.019.901.22
238511-385119.8949.94
338896-388969.99310.04
438190-381909.8129.86
537652-376529.6749.72
638079-380799.7839.83
30min138702-387029.9439.751.3210.019.821.32
238488-384889.8889.95
337664-376649.6779.74
437644-376449.6729.74
537555-375559.6499.71
637702-377029.6869.75
45min138702-387029.9439.681.4610.039.761.47
237803-378039.7129.79
337171-371719.5509.63
437297-372979.5829.66
537551-375519.6489.73
637565-375659.6519.73
60min137894-378949.7369.502.399.849.602.40
236562-365629.3949.49
335480-354809.1169.21
436846-368469.4679.56
537683-376839.6829.78
637331-373319.5919.69
极限137910-379109.7409.650.829.869.770.82
237973-379739.7569.87
337559-375599.6509.76
437283-372839.5799.69
537458-374589.6249.74
637262-372629.5739.69
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