氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.981487875148785314869261487422148671314873580.04
211.051491348149044814908980.05
单位质量响应值RSD%判断
135460.66134922.900.29数据可信
供试品溶液-2024041521批-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%
60min18257-82570.5640.3870.500.560.3870.45
26434-64340.4400.44
38625-86250.5890.59
48968-89680.6130.61
51314-13140.0900.09
6-0.0000.00
120min137173-371732.5402.537.722.542.537.73
233808-338082.3102.31
339889-398892.7252.73
434766-347662.3752.38
535354-353542.4152.42
640792-407922.7872.79
240min1103826-1038267.0945.7416.007.105.7415.97
280950-809505.5315.53
365741-657414.4924.50
480968-809685.5325.54
594695-946956.4706.47
677531-775315.2975.30
360min1174343-17434311.91210.539.9811.9310.559.97
2144509-1445099.8739.89
3132546-1325469.0569.07
4156684-15668410.70510.72
5167682-16768211.45711.47
6149245-14924510.19710.21
480min1194113-19411313.26214.157.0613.3014.187.03
2206329-20632914.09714.12
3199226-19922613.61213.64
4221867-22186715.15915.19
5227770-22777015.56215.59
6193323-19332313.20813.24
600min1245004-24500416.73915.988.9616.7916.038.92
2242100-24210016.54116.59
3244129-24412916.68016.73
4256433-25643317.52017.57
5209941-20994114.34414.40
6205366-20536614.03114.08
720min1275357-27535718.81318.939.6618.8919.009.64
2281251-28125119.21619.29
3280769-28076919.18319.25
4289546-28954619.78319.86
5307879-30787921.03521.11
6227647-22764715.55415.62
840min1321368-32136821.95721.825.1422.0621.925.14
2321998-32199822.00022.10
3303184-30318420.71420.81
4339855-33985523.22023.33
5332359-33235922.70822.81
6297362-29736220.31720.41
960min1342396-34239623.39423.663.8223.5323.803.83
2345910-34591023.63423.77
3348129-34812923.78523.92
4363138-36313824.81124.95
5354629-35462924.22924.37
6323886-32388622.12922.25
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1080min1375444-37544425.65225.513.6425.8325.683.64
2370663-37066325.32525.50
3363293-36329324.82124.99
4381098-38109826.03826.22
5394243-39424326.93627.11
6355734-35573424.30524.46
1200min1373884-37388425.54525.805.1225.7626.015.11
2353094-35309424.12424.33
3374219-37421925.56825.77
4398939-39893927.25727.48
5401920-40192027.46027.68
6363786-36378624.85525.05
1320min1384396-38439626.26327.674.9226.5127.924.90
2396393-39639327.08327.33
3407451-40745127.83828.08
4416002-41600228.42328.68
5437688-43768829.90430.16
6388133-38813326.51826.75
1440min1411523-41152328.11729.084.0828.4129.364.08
2421983-42198328.83129.12
3429129-42912929.31929.60
4440608-44060830.10430.41
5447996-44799630.60830.91
6402150-40215027.47627.74
极限1417067-41706728.49529.374.3228.8329.704.31
2414960-41496028.35128.68
3436615-43661529.83130.16
4442190-44219030.21230.56
5457742-45774231.27431.62
6410901-41090128.07428.38
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.981495246149551414947321495178149514014951620.02
211.051486620148685814867390.02
单位质量响应值RSD%判断
136171.40134546.520.85数据可信
供试品溶液-2024041521批-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%
60min112309-123090.8400.4767.810.840.4768.14
28640-86400.5900.59
33734-37340.2550.25
4-0.0000.00
511175-111750.7630.76
65609-56090.3830.38
120min142424-424242.8952.5324.302.902.5324.35
235755-357552.4402.44
331993-319932.1832.18
426366-263661.7991.80
533622-336222.2942.30
651962-519623.5463.55
240min188677-886776.0515.8915.376.065.8915.40
293298-932986.3676.37
367834-678344.6294.63
484927-849275.7955.80
5106106-1061067.2417.25
676859-768595.2455.25
360min1174343-17434311.8979.9911.4411.9110.0111.44
2148203-14820310.11410.13
3134663-1346639.1909.20
4147527-14752710.06710.08
5149257-14925710.18510.20
6124705-1247058.5108.52
480min1219026-21902614.94714.054.0914.9814.084.11
2209878-20987814.32214.35
3195340-19534013.33013.35
4199248-19924813.59713.62
5208143-20814314.20414.23
6203752-20375213.90413.93
600min1249748-24974817.04316.025.7217.1016.075.73
2236679-23667916.15116.20
3219600-21960014.98615.03
4217221-21722114.82314.87
5241133-24113316.45516.51
6244416-24441616.67916.73
720min1304685-30468520.79218.568.1820.8718.638.16
2279624-27962419.08219.16
3242284-24228416.53416.60
4283993-28399319.38019.45
5265266-26526618.10218.18
6255599-25559917.44217.51
840min1327907-32790722.37721.826.3622.4921.926.35
2296419-29641920.22820.33
3295148-29514820.14120.23
4341579-34157923.31023.41
5339064-33906423.13823.24
6318614-31861421.74321.84
960min1359886-35988624.55923.406.0724.7023.536.06
2352348-35234824.04524.18
3301543-30154320.57820.70
4347171-34717123.69123.82
5347385-34738523.70623.84
6349084-34908423.82223.95
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1080min1382801-38280126.12325.105.5626.3025.275.55
2360549-36054924.60424.77
3340149-34014923.21223.36
4357451-35745124.39324.56
5398363-39836327.18527.36
6367662-36766225.09025.26
1200min1404824-40482427.62626.778.9527.8526.988.91
2448151-44815130.58230.79
3339898-33989823.19523.38
4388140-38814026.48726.69
5391226-39122626.69826.91
6381589-38158926.04026.24
1320min1422500-42250028.83228.083.8729.0928.333.87
2408662-40866227.88728.14
3389405-38940526.57326.80
4406939-40693927.77028.01
5435824-43582429.74130.00
6405819-40581927.69327.94
1440min1440570-44057030.06529.095.8930.3729.385.87
2425695-42569529.05029.34
3384736-38473626.25526.52
4413410-41341028.21128.50
5457098-45709831.19331.49
6436508-43650829.78830.07
极限1450088-45008830.71429.584.7731.0729.914.78
2422251-42225128.81529.15
3402677-40267727.47927.78
4425016-42501629.00329.33
5458838-45883831.31231.66
6441840-44184030.15230.48
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