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%
111.181878551881201876861875401878831878170.12
211.221872811877361875080.18
单位质量响应值RSD%判断
16799.3716711.940.37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%
5min16385-63853.4184.0021.723.424.0021.69
26578-65783.5223.52
36110-61103.2713.27
47128-71283.8163.82
58239-82394.4114.41
610410-104105.5735.57
10min117350-173509.2899.102.129.319.122.12
216863-168639.0289.05
316805-168058.9979.01
416426-164268.7948.82
517308-173089.2669.29
617200-172009.2089.24
15min119164-1916410.26010.201.6210.3310.271.61
219024-1902410.18510.25
319430-1943010.40210.47
418625-186259.97110.04
519298-1929810.33110.41
618777-1877710.05310.13
20min119102-1910210.22710.191.4510.3510.321.49
218848-1884810.09110.22
318985-1898510.16410.29
418639-186399.97910.10
519436-1943610.40510.54
619181-1918110.26910.41
30min118776-1877610.05210.051.2010.2410.241.22
218453-184539.87910.06
318806-1880610.06810.25
418660-186609.99010.17
519140-1914010.24710.44
618808-1880810.06910.26
45min118456-184569.88110.081.9610.1210.321.97
218973-1897310.15710.39
318557-185579.93510.17
418492-184929.90010.14
519215-1921510.28710.54
619253-1925310.30710.56
60min118370-183709.8359.941.8410.1310.231.85
218305-183059.80010.09
318340-183409.81910.11
418402-184029.85210.14
519160-1916010.25810.56
618768-1876810.04810.36
极限118566-185669.94010.052.2510.2910.402.21
218466-184669.88610.23
318691-1869110.00610.35
418708-1870810.01610.36
519615-1961510.50110.86
618591-185919.95310.32
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%
110.961576311579301576621577211577061577300.08
211.021575371573921574640.07
单位质量响应值RSD%判断
14391.4214288.930.51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%
5min1112453-11245364.77466.565.0864.7766.565.08
2111201-11120164.05364.05
3109535-10953563.09363.09
4116841-11684167.30267.30
5117751-11775167.82667.83
6125582-12558272.33772.34
10min1151481-15148187.25587.971.5087.6188.341.51
2150002-15000286.40386.76
3151660-15166087.35887.71
4153097-15309788.18688.56
5153438-15343888.38288.76
6156627-15662790.21990.62
15min1164621-16462194.82495.241.2095.6796.101.22
2163990-16399094.46095.30
3162725-16272593.73194.57
4166935-16693596.15697.02
5165674-16567495.43096.30
6168141-16814196.85197.75
20min1167485-16748596.47397.651.8597.8499.041.85
2166266-16626695.77197.13
3167531-16753196.50097.86
4171672-17167298.885100.28
5169629-16962997.70899.11
6174555-174555100.546101.99
30min1169697-16969797.74798.122.1799.65100.042.16
2165530-16553095.34797.24
3168340-16834096.96698.86
4174085-174085100.275102.22
5169062-16906297.38299.32
6175297-175297100.973102.97
45min1168281-16828196.93299.132.0499.38101.602.04
2171445-17144598.754101.18
3169718-16971897.760100.19
4173358-17335899.856102.36
5171449-17144998.757101.24
6178336-178336102.724105.28
60min1168967-16896797.32798.801.88100.32101.821.88
2168016-16801696.77999.75
3169480-16948097.622100.60
4174403-174403100.458103.52
5172272-17227299.231102.26
6175979-175979101.366104.50
极限1172668-17266899.45999.831.04102.99103.401.05
2170792-17079298.378101.89
3172108-17210899.136102.65
4175599-175599101.147104.76
5174882-174882100.734104.32
6173808-173808100.115103.81
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%
111.181880771881331880631880581880941880850.02
211.221919521923661921590.16
单位质量响应值RSD%判断
16823.3517126.471.27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%
5min112097-120976.3936.489.056.396.489.07
210788-107885.7015.70
312933-129336.8356.83
412072-120726.3806.38
514012-140127.4057.41
611637-116376.1506.15
10min118646-186469.8549.735.639.899.775.64
217044-170449.0089.04
319006-1900610.04410.08
418031-180319.5299.56
519992-1999210.56610.61
617752-177529.3829.42
15min119585-1958510.35010.322.7710.4410.412.83
218700-187009.8839.96
319916-1991610.52510.62
419575-1957510.34510.43
520222-2022210.68710.79
619162-1916210.12710.21
20min119932-1993210.53410.292.5710.6810.442.59
218704-187049.88510.02
319847-1984710.48910.64
419654-1965410.38710.53
519721-1972110.42210.58
619012-1901210.04810.19
30min119615-1961510.36610.291.0610.5710.501.10
219276-1927610.18710.38
319494-1949410.30210.51
419651-1965110.38510.59
519655-1965510.38710.60
619178-1917810.13510.33
45min119609-1960910.36310.141.4310.6310.401.42
219034-1903410.05910.31
319278-1927810.18810.46
419320-1932010.21010.47
519004-1900410.04310.32
618850-188509.96210.22
60min118732-187329.90010.072.9410.2210.392.90
218748-187489.90810.21
319134-1913410.11210.44
420054-2005410.59810.92
519163-1916310.12710.46
618465-184659.75910.07
极限119019-1901910.0519.981.5610.4310.361.55
218985-1898510.03310.39
318916-189169.99710.38
419250-1925010.17310.55
518813-188139.94210.33
618371-183719.70910.07
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%
110.961581901580891581331580521580681581060.04
211.021610581610671610620.01
单位质量响应值RSD%判断
14425.7314615.430.93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%
5min1103818-10381859.05960.542.9959.0660.542.99
2107884-10788461.37261.37
3111095-11109563.19963.20
4108171-10817161.53561.54
5104973-10497359.71659.72
6102620-10262058.37858.38
10min1149773-14977385.20283.991.8685.5384.331.86
2148414-14841484.42984.77
3150935-15093585.86386.21
4147978-14797884.18184.52
5144748-14474882.34382.67
6144053-14405381.94882.27
15min1162228-16222892.28790.511.7393.0991.321.73
2158327-15832790.06890.88
3161824-16182492.05792.89
4160184-16018491.12491.93
5155780-15578088.61989.41
6156334-15633488.93489.71
20min1168807-16880796.03093.302.1097.3494.602.09
2162743-16274392.58093.89
3165804-16580494.32195.66
4165746-16574694.28895.60
5159245-15924590.59091.87
6161694-16169491.98393.26
30min1173036-17303698.43595.801.69100.2897.621.68
2168681-16868195.95897.78
3167194-16719495.11296.98
4169305-16930596.31398.15
5164388-16438893.51695.30
6167780-16778095.44597.23
45min1175552-17555299.86796.441.96102.2698.801.95
2168731-16873195.98698.34
3169537-16953796.44598.84
4169753-16975396.56898.94
5165527-16552794.16496.47
6168089-16808995.62197.94
60min1172124-17212497.91796.511.71100.8799.411.70
2167660-16766095.37798.27
3169643-16964396.50599.43
4174022-17402298.996101.91
5168031-16803195.58898.42
6166457-16645794.69397.54
极限1173848-17384898.89795.961.64102.3999.391.62
2168628-16862895.92899.35
3167621-16762195.35598.82
4169118-16911896.20799.67
5166548-16654894.74598.10
6166374-16637494.64698.02
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