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%
111.001297171299401301271301721300401299990.14
210.931316111316351316230.02
单位质量响应值RSD%判断
11818.0912042.361.33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%
5min1129025-12902593.74294.193.3993.7494.193.39
2122824-12282489.23689.24
3126424-12642491.85291.85
4133984-13398497.34597.34
5132336-13233696.14796.15
6133239-13323996.80396.80
10min1135573-13557398.499100.071.3198.66100.241.31
2137415-13741599.83799.99
3135717-13571798.60498.76
4139309-139309101.213101.38
5138790-138790100.836101.00
6139647-139647101.459101.62
15min1136611-13661199.253100.441.4499.57100.771.44
2137172-13717299.66199.98
3135779-13577998.64998.97
4140632-140632102.175102.51
5139923-139923101.659101.99
6139388-139388101.271101.60
20min1135966-13596698.785100.101.2699.27100.591.26
2137172-13717299.661100.14
3135876-13587698.71999.20
4140094-140094101.784102.28
5139154-139154101.101101.60
6138427-138427100.573101.07
30min1135480-13548098.43199.931.2399.08100.591.23
2136826-13682699.409100.06
3136031-13603198.83299.48
4139779-139779101.555102.23
5138404-138404100.556101.22
6138717-138717100.783101.45
45min1135397-13539798.37199.831.3299.19100.661.33
2136304-13630499.03099.84
3135686-13568698.58199.39
4139574-139574101.406102.25
5138739-138739100.799101.63
6138729-138729100.792101.63
60min1134979-13497998.06799.611.2699.05100.611.26
2136329-13632999.048100.03
3135472-13547298.42699.40
4138740-138740100.800101.81
5138539-138539100.654101.66
6138585-138585100.687101.69
极限1135572-13557298.49899.481.2199.64100.641.21
2136350-13635099.063100.21
3134624-13462497.80998.95
4138609-138609100.705101.88
5138382-138382100.540101.71
6138000-138000100.262101.43
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%
110.853794543790203806033796873811003799730.23
210.883837893850383844140.23
单位质量响应值RSD%判断
35020.5535332.170.63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%
5min137242-372429.5299.724.119.539.724.09
238016-380169.7279.73
337240-372409.5289.53
439370-3937010.07310.07
535948-359489.1989.20
640229-4022910.29310.29
10min138166-381669.7659.881.729.789.891.72
238914-389149.9569.97
338980-389809.9739.99
438485-384859.8479.86
537631-376319.6289.64
639496-3949610.10510.12
15min138469-384699.8439.891.059.879.921.05
238952-389529.96610.00
339262-3926210.04610.08
438733-387339.9109.94
538183-381839.7699.80
638356-383569.8149.85
20min137307-373079.5459.772.309.599.822.30
238975-389759.97210.02
339467-3946710.09810.15
437899-378999.6979.75
538008-380089.7259.77
637355-373559.5589.61
30min137296-372969.5439.702.159.619.772.17
238849-388499.94010.01
339041-390419.98910.06
437162-371629.5089.57
537582-375829.6169.68
637577-375779.6149.68
45min137445-374459.5819.542.929.669.622.88
237734-377349.6559.74
338645-386459.8889.97
437418-374189.5749.66
535353-353539.0459.13
637036-370369.4769.56
60min136316-363169.2929.302.419.399.402.39
235644-356449.1209.22
335581-355819.1049.20
437639-376399.6309.73
535786-357869.1569.25
637214-372149.5229.62
极限137677-376779.6409.621.459.759.741.45
238046-380469.7349.85
338269-382699.7919.91
436725-367259.3969.51
537572-375729.6139.72
637356-373569.5589.67
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%
111.001297271298931300021303371295181298950.24
210.931329331328941329140.03
单位质量响应值RSD%判断
11808.6412160.482.08数据不可信!(响应值差异过大,请重新称样测定!)
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%
5min1131198-13119894.90092.712.8594.9092.712.85
2121643-12164387.98987.99
3130080-13008094.09294.09
4129164-12916493.42993.43
5126252-12625291.32391.32
6130657-13065794.50994.51
10min1138898-138898100.47098.781.35100.6398.941.36
2134908-13490897.58497.73
3135946-13594698.33598.49
4134676-13467697.41697.57
5136211-13621198.52698.68
6138736-138736100.353100.51
15min1138021-13802199.83699.020.99100.1699.340.99
2135803-13580398.23198.54
3136211-13621198.52698.85
4135290-13529097.86098.18
5137352-13735299.35299.67
6138713-138713100.336100.66
20min1138172-13817299.94598.791.00100.4499.281.00
2135572-13557298.06498.54
3136511-13651198.74399.23
4134545-13454597.32197.80
5136918-13691899.03899.52
6137757-13775799.645100.14
30min1137857-13785799.71798.671.15100.3899.321.15
2135130-13513097.74498.38
3135508-13550898.01898.67
4134588-13458897.35298.00
5136906-13690699.02999.68
6138444-138444100.142100.80
45min1137907-13790799.75398.711.27100.5899.531.27
2134843-13484397.53798.34
3135863-13586398.27599.09
4134478-13447897.27398.08
5136878-13687899.00999.82
6138854-138854100.438101.26
60min1137264-13726499.28897.891.74100.2898.861.73
2131803-13180395.33896.30
3134839-13483997.53498.51
4133580-13358096.62397.59
5136636-13663698.83499.81
6137826-13782699.695100.69
极限1136885-13688599.01498.061.14100.1799.201.14
2134226-13422697.09198.21
3134601-13460197.36298.50
4133863-13386396.82897.96
5136248-13624898.55399.70
6137586-13758699.521100.68
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%
110.853811803808303814843817563814853813470.10
210.883855593855763855680.01
单位质量响应值RSD%判断
35147.1935438.240.59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%
5min142643-4264310.87510.265.1310.8710.265.10
237158-371589.4769.48
338891-388919.9189.92
441212-4121210.51010.51
539535-3953510.08210.08
641897-4189710.68410.68
10min138701-387019.8699.751.419.899.771.43
238375-383759.7869.80
338202-382029.7429.76
437203-372039.4879.50
538529-385299.8259.84
638488-384889.8159.83
15min138586-385869.8409.781.029.879.811.03
238668-386689.8619.89
337944-379449.6769.71
437882-378829.6609.69
538196-381969.7419.77
638791-387919.8929.93
20min138767-387679.8869.781.229.949.831.23
238511-385119.8219.87
338896-388969.9199.97
438190-381909.7399.79
537652-376529.6029.65
638079-380799.7119.76
30min138702-387029.8709.681.329.949.751.32
238488-384889.8159.88
337664-376649.6059.67
437644-376449.6009.67
537555-375559.5779.64
637702-377029.6159.68
45min138702-387029.8709.611.469.959.691.44
237803-378039.6409.72
337171-371719.4799.56
437297-372979.5119.59
537551-375519.5769.66
637565-375659.5809.66
60min137894-378949.6649.432.399.769.522.36
236562-365629.3249.42
335480-354809.0489.15
436846-368469.3969.49
537683-376839.6109.71
637331-373319.5209.62
极限137910-379109.6689.580.829.789.700.81
237973-379739.6849.80
337559-375599.5789.69
437283-372839.5089.62
537458-374589.5529.67
637262-372629.5029.62
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