依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.181871801870791871111871521871071871260.03
211.221874251875861875060.07
单位质量响应值RSD%判断
16737.5716711.760.11数据可信
供试品溶液-2024011221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%
5min110785-107855.7854.4427.875.784.4427.87
210151-101515.4455.44
36812-68123.6543.65
410099-100995.4175.42
56030-60303.2343.23
65774-57743.0973.10
10min117147-171479.1979.183.459.239.203.48
217732-177329.5119.54
316568-165688.8868.91
417897-178979.5999.63
516594-165948.9008.92
616702-167028.9588.98
15min118847-1884710.10910.004.1210.1910.084.10
219303-1930310.35310.44
317319-173199.2899.36
418510-185109.92810.01
518468-184689.9059.97
619456-1945610.43510.50
20min118977-1897710.17810.181.6410.3210.311.60
219373-1937310.39110.53
318971-1897110.17510.30
418603-186039.97810.12
518669-1866910.01310.14
619275-1927510.33810.46
30min117873-178739.5869.994.289.7810.184.21
219638-1963810.53310.73
318887-1888710.13010.31
418050-180509.6819.88
517884-178849.5929.77
619417-1941710.41410.60
45min118566-185669.9589.982.8010.2110.222.78
219185-1918510.29010.55
318338-183389.83610.07
417888-178889.5949.84
518440-184409.89010.12
619235-1923510.31710.56
60min117538-175389.4079.762.829.7110.062.77
218612-186129.98310.30
318422-184229.88110.17
417902-179029.6029.90
517850-178509.5749.86
618867-1886710.11910.42
极限118140-181409.7299.802.5110.0910.162.46
218475-184759.90910.28
318228-182289.77710.12
418007-180079.65810.01
517743-177439.5169.86
619072-1907210.22910.58
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.961565071565241565421565901564981565320.03
211.021567041567751567400.04
单位质量响应值RSD%判断
14282.1214223.230.30数据可信
供试品溶液-2024011221批-阿托伐他汀钙-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%
5min1120766-12076669.98967.024.9269.9967.024.92
2118170-11817068.48568.48
3113967-11396766.04966.05
4121213-12121370.24870.25
5113611-11361165.84265.84
6106107-10610761.49461.49
10min1150314-15031487.11388.220.9787.5088.590.97
2151656-15165687.89188.27
3152568-15256888.42088.79
4154668-15466889.63790.03
5151425-15142587.75788.12
6152664-15266488.47588.82
15min1163257-16325794.61495.491.0395.4996.361.00
2164205-16420595.16496.03
3166634-16663496.57297.43
4163691-16369194.86695.75
5163696-16369694.86995.72
6167165-16716596.87997.71
20min1166441-16644196.46097.611.3597.8699.001.33
2166343-16634396.40397.80
3172532-17253299.990101.38
4167808-16780897.25298.67
5168844-16884497.85299.23
6168607-16860797.71599.09
30min1167299-16729996.95799.002.3598.89100.932.30
2172685-172685100.078102.01
3176422-176422102.244104.19
4167330-16733096.97598.93
5167394-16739497.01298.94
6173788-173788100.718102.63
45min1167659-16765997.16698.861.8599.64101.341.81
2169633-16963398.310100.80
3174217-174217100.966103.48
4166522-16652296.50799.00
5171917-17191799.633102.10
6173540-173540100.574103.05
60min1165019-16501995.63698.471.9698.65101.511.92
2171070-17107099.142102.18
3174810-174810101.310104.39
4168269-16826997.519100.55
5168922-16892297.898100.91
6171415-17141599.342102.37
极限1169862-16986298.44299.401.27101.99102.991.26
2170566-17056698.850102.44
3175220-175220101.548105.19
4170295-17029598.693102.27
5170032-17003298.541102.10
6173142-173142100.343103.93
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.181895321907451908621912641914011907610.39
211.221875501876241875870.03
单位质量响应值RSD%判断
17062.7016718.981.44数据可信
供试品溶液-2024011222批-依折麦布
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113843-138437.3526.5012.897.356.5012.88
212693-126936.7426.74
312534-125346.6576.66
410735-107355.7025.70
59936-99365.2775.28
613650-136507.2507.25
10min118106-181069.6179.513.469.669.553.48
217587-175879.3419.38
318489-184899.8209.86
417389-173899.2369.27
517179-171799.1249.15
618702-187029.9339.97
15min119440-1944010.32510.271.6410.4210.361.68
219167-1916710.18010.27
319096-1909610.14210.23
419333-1933310.26810.35
519092-1909210.14010.22
619921-1992110.58110.68
20min119499-1949910.35610.322.8310.5110.462.82
220235-2023510.74710.89
319274-1927410.23710.38
418746-187469.95710.10
518969-1896910.07510.21
619814-1981410.52410.68
30min119404-1940410.30610.271.7710.5210.481.77
219896-1989610.56710.77
318966-1896610.07310.28
419339-1933910.27210.47
519001-1900110.09210.28
619465-1946510.33810.55
45min119223-1922310.21010.162.2410.4810.422.25
219355-1935510.28010.54
318859-1885910.01710.28
418875-1887510.02510.28
518617-186179.88810.14
619803-1980310.51810.79
60min118970-1897010.07610.082.1710.4010.402.18
219245-1924510.22210.54
318649-186499.90510.22
418886-1888610.03110.34
518482-184829.81610.12
619615-1961510.41810.75
极限119050-1905010.1189.942.0410.5010.312.05
218709-187099.93710.32
318454-184549.80110.17
418907-1890710.04210.41
518089-180899.6089.97
619051-1905110.11910.51
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.961581941584051583731584771584041583710.07
211.021563721564641564180.05
单位质量响应值RSD%判断
14449.9114194.011.27数据可信
供试品溶液-2024011222批-阿托伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1113572-11357265.50661.803.9565.5161.803.95
2109144-10914462.95262.95
3108852-10885262.78462.78
4101838-10183858.73858.74
5103891-10389159.92359.92
6105584-10558460.89960.90
10min1147876-14787685.29282.552.3685.6682.902.37
2145714-14571484.04584.40
3141671-14167181.71382.06
4138125-13812579.66879.99
5143048-14304882.50882.84
6142340-14234082.09982.44
15min1158868-15886891.63289.932.2892.4790.732.27
2158730-15873091.55392.37
3149677-14967786.33187.13
4154177-15417788.92789.70
5157955-15795591.10691.90
6156085-15608590.02790.82
20min1162081-16208193.48692.451.7194.8393.751.71
2164063-16406394.62995.95
3156345-15634590.17791.46
4158345-15834591.33192.59
5160864-16086492.78494.08
6159997-15999792.28493.58
30min1166323-16632395.93295.121.8897.8096.941.88
2168617-16861797.25599.11
3160253-16025392.43194.21
4163484-16348494.29596.07
5167420-16742096.56598.38
6163402-16340294.24796.05
45min1167994-16799496.89695.661.9099.3098.011.89
2166765-16676596.18798.58
3161566-16156693.18895.49
4162365-16236593.64995.94
5167148-16714896.40898.76
6169297-16929797.64899.98
60min1165982-16598295.73695.591.4198.6798.461.40
2167546-16754696.63899.56
3161724-16172493.28096.09
4164328-16432894.78297.60
5167103-16710396.38299.27
6167650-16765096.69899.57
极限1166875-16687596.25195.281.8699.7298.681.84
2169698-16969897.879101.34
3160395-16039592.51395.85
4165020-16502095.18198.52
5164430-16443094.84098.26
6164718-16471895.00798.42
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