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%
111.181874471875971877031876601876131876040.06
211.221854111854821854460.03
单位质量响应值RSD%判断
16780.3216528.161.08数据可信
供试品溶液-2024011223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%
5min15775-57753.1113.2430.603.113.2430.64
25249-52492.8272.83
34806-48062.5892.59
49704-97045.2275.23
55404-54042.9112.91
65112-51122.7542.75
10min115757-157578.4888.766.258.508.776.28
215156-151568.1648.18
316759-167599.0279.04
417958-179589.6739.70
516378-163788.8228.84
615526-155268.3638.38
15min118650-1865010.04610.131.4510.1110.201.53
218663-1866310.05310.11
319070-1907010.27210.34
419226-1922610.35610.44
518735-1873510.09210.16
618531-185319.98210.04
20min119433-1943310.46810.451.5010.5910.581.47
219837-1983710.68510.80
319487-1948710.49710.62
419419-1941910.46010.60
518935-1893510.19910.32
619327-1932710.41010.53
30min119349-1934910.42210.321.3210.6010.501.24
219499-1949910.50310.68
319046-1904610.25910.44
418845-1884510.15110.35
518934-1893410.19910.38
619237-1923710.36210.54
45min119463-1946310.48410.451.6510.7210.691.67
219634-1963410.57610.81
319417-1941710.45910.70
419757-1975710.64210.90
518842-1884210.14910.38
619303-1930310.39810.63
60min119185-1918510.33410.322.0610.6310.622.01
219831-1983110.68210.98
319284-1928410.38710.68
419072-1907210.27310.59
518950-1895010.20710.50
618652-1865210.04710.34
极限119333-1933310.41410.331.5810.7710.681.58
219577-1957710.54510.90
318975-1897510.22110.57
419410-1941010.45510.83
518858-1885810.15810.51
618905-1890510.18310.53
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%
110.961567671568321568241568341566621567840.05
211.021558491559991559240.07
单位质量响应值RSD%判断
14305.1114149.180.78数据可信
供试品溶液-2024011223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%
5min1101086-10108658.69059.135.1758.6959.135.17
296379-9637955.95755.96
397241-9724156.45856.46
4110647-11064764.24164.24
5100970-10097058.62358.62
6104775-10477560.83260.83
10min1143772-14377283.47483.381.1583.8083.711.17
2142177-14217782.54882.86
3142172-14217282.54582.86
4146144-14614484.85185.21
5142470-14247082.71883.04
6144905-14490584.13284.47
15min1156505-15650590.86690.561.2891.6691.351.28
2154754-15475489.85090.62
3153741-15374189.26290.03
4155157-15515790.08490.91
5156187-15618790.68291.47
6159481-15948192.59493.40
20min1162362-16236294.26793.731.5195.5695.021.49
2160601-16060193.24594.51
3160322-16032293.08394.35
4159726-15972692.73794.07
5159647-15964792.69193.98
6165957-16595796.35497.67
30min1165114-16511495.86595.201.7697.6897.021.75
2160970-16097093.45995.25
3160845-16084593.38695.17
4163769-16376995.08496.93
5164561-16456195.54497.35
6168566-16856697.86999.72
45min1167552-16755297.28097.121.4499.6399.471.44
2164317-16431795.40297.71
3166937-16693796.92399.23
4167411-16741197.19899.57
5165921-16592196.33398.67
6171537-17153799.594101.99
60min1167073-16707397.00295.941.1399.8998.831.09
2165353-16535396.00498.84
3165972-16597296.36399.21
4161754-16175493.91496.83
5165043-16504395.82498.69
6166311-16631196.56099.51
极限1167814-16781497.43296.331.43100.8699.751.42
2162536-16253694.36897.74
3163724-16372495.05898.44
4166815-16681596.852100.29
5166014-16601496.38799.79
6168611-16861197.895101.38
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%
111.181848911850031851701853641854491851750.13
211.221887421899741893580.47
单位质量响应值RSD%判断
16563.0616876.831.33数据可信
供试品溶液-2024011223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%
5min19964-99645.3464.6226.635.354.6226.68
210373-103735.5665.57
37706-77064.1354.13
49491-94915.0925.09
59804-98045.2605.26
64329-43292.3232.32
10min117663-176639.4779.195.259.519.225.29
217804-178049.5539.58
317358-173589.3139.34
417945-179459.6289.66
515858-158588.5098.54
616143-161438.6628.67
15min119004-1900410.19710.231.5510.2810.311.55
219174-1917410.28810.37
319527-1952710.47710.55
419175-1917510.28810.37
518675-1867510.02010.10
618859-1885910.11910.18
20min119816-1981610.63210.372.4110.7710.512.35
219193-1919310.29810.44
319791-1979110.61910.75
418949-1894910.16710.31
518684-1868410.02510.16
619558-1955810.49410.61
30min118895-1889510.13810.171.6510.3410.361.57
218992-1899210.19010.39
319346-1934610.38010.57
418463-184639.90610.10
518824-1882410.10010.29
619213-1921310.30910.48
45min118889-1888910.13510.271.6910.3910.521.61
219107-1910710.25210.51
319542-1954210.48510.73
418678-1867810.02210.27
519377-1937710.39710.64
619295-1929510.35310.59
60min119088-1908810.24210.061.7110.5510.371.66
218569-185699.96310.28
319191-1919110.29710.60
418360-183609.85110.16
518677-1867710.02110.32
618634-186349.99810.29
极限117979-179799.64710.083.2310.0110.443.08
218479-184799.91510.28
319241-1924110.32410.69
418408-184089.87710.24
519034-1903410.21310.57
619611-1961110.52210.87
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%
110.961555551556081558031559201558121557400.10
211.021588411598501593460.45
单位质量响应值RSD%判断
14209.8514459.711.24数据可信
供试品溶液-2024011223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%
5min1109045-10904562.83960.795.9062.8460.795.89
2110801-11080163.85163.85
395870-9587055.24655.25
4106879-10687961.59161.59
5110547-11054763.70463.70
699808-9980857.51657.52
10min1143582-14358282.74182.112.3583.0982.452.36
2144143-14414383.06583.42
3136476-13647678.64678.95
4144944-14494483.52683.87
5140688-14068881.07481.43
6145068-14506883.59883.92
15min1154112-15411288.80989.642.3289.6290.442.31
2157439-15743990.72791.54
3150721-15072186.85587.60
4159124-15912491.69892.50
5152613-15261387.94588.75
6159346-15934691.82592.61
20min1163563-16356394.25693.261.9795.5694.551.97
2162084-16208493.40394.72
3156964-15696490.45391.68
4162453-16245393.61694.93
5159750-15975092.05893.35
6166195-16619595.77297.07
30min1163935-16393594.47094.811.7996.3096.621.79
2165502-16550295.37397.21
3159410-15941091.86293.59
4167089-16708996.28798.12
5163828-16382894.40896.21
6167416-16741696.47698.30
45min1164775-16477594.95496.511.8397.3098.841.83
2170538-17053898.275100.64
3162780-16278093.80496.04
4167826-16782696.71299.08
5169108-16910897.45199.78
6169799-16979997.849100.21
60min1166771-16677196.10494.971.4898.9897.851.49
2167131-16713196.31299.23
3160525-16052592.50595.27
4165135-16513595.16198.07
5163667-16366794.31697.19
6165606-16560695.43398.34
极限1160770-16077092.64696.022.3096.0699.422.23
2167129-16712996.31199.76
3165814-16581495.55398.83
4164997-16499795.08298.52
5168988-16898897.382100.78
6172058-17205899.151102.59
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