诺氟沙星胶囊项目信息
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130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100 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%
110.624218713422033342211744221884422112942206470.03
210.684193162419407541936180.02
单位质量响应值RSD%判断
397424.39392660.860.86数据可信
供试品溶液-25031批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1107301-1073012.4351.3276.452.431.3276.45
239760-397600.9020.90
374852-748521.6991.70
410720-107200.2430.24
5105343-1053432.3902.39
610024-100240.2270.23
10min1816775-81677518.53415.2128.0118.5415.2128.02
2614099-61409913.93513.94
3959164-95916421.76521.77
4657106-65710614.91114.91
5502102-50210211.39411.40
6471246-47124610.69410.69
15min11493455-149345533.89028.9222.7033.9228.9422.70
21163254-116325426.39726.42
31750148-175014839.71439.75
41118126-111812625.37325.40
5971480-97148022.04522.07
61149857-114985726.09326.11
20min12129674-212967448.32742.8017.1548.4242.8817.16
21744952-174495239.59739.67
32350717-235071753.34353.45
41891128-189112842.91442.98
51421181-142118132.25032.31
61779517-177951740.38140.44
30min13076102-307610269.80362.4912.8169.9862.6312.82
22651531-265153160.16960.30
33171114-317111471.95972.15
42732374-273237462.00362.14
52178413-217841349.43349.55
62712340-271234061.54961.68
45min13925056-392505689.06880.239.1389.3680.489.15
23542904-354290480.39680.63
33781471-378147185.80986.12
43424794-342479477.71677.96
52991236-299123667.87768.07
63547458-354745880.49980.73
60min14280704-428070497.13888.746.5197.5789.126.53
23971895-397189590.13090.50
34008774-400877490.96791.42
43741885-374188584.91185.28
53530719-353071980.11980.43
63928869-392886989.15489.52
极限14509990-4509990102.34194.624.69102.9495.164.71
24188861-418886195.05495.57
34123137-412313793.56294.17
44010995-401099591.01891.53
53959786-395978689.85690.30
64226454-422645495.90796.42
诺氟沙星胶囊项目信息
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130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100 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%
110.624203352420379642050244205765420299742041870.03
210.684201144420366442024040.05
单位质量响应值RSD%判断
395874.48393483.520.43数据可信
供试品溶液-25032批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1165557-1655573.7603.6622.193.763.6622.19
2125488-1254882.8502.85
3131575-1315752.9882.99
4148850-1488503.3813.38
5224074-2240745.0895.09
6172625-1726253.9213.92
10min1999827-99982722.70820.9712.4822.7120.9812.49
2914070-91407020.76120.77
3893885-89388520.30220.31
4739634-73963416.79916.80
51083418-108341824.60724.62
6909434-90943420.65520.66
15min11729663-172966339.28537.699.4439.3337.739.44
21659045-165904537.68137.72
31655848-165584837.60837.65
41392826-139282631.63431.67
51874437-187443742.57342.62
61644488-164448837.35037.39
20min12387559-238755954.22753.136.3354.3453.246.33
22316117-231611752.60452.71
32327591-232759152.86552.97
42138745-213874548.57648.66
52589012-258901258.80358.92
62277765-227776551.73351.84
30min13307677-330767775.12574.123.8075.3374.313.82
23255263-325526373.93574.12
33261324-326132474.07274.26
43083999-308399970.04570.21
53462372-346237278.63978.86
63209448-320944872.89473.08
45min13977036-397703690.32890.342.0990.6590.652.11
23951607-395160789.75090.06
33957009-395700989.87390.19
43899151-389915188.55988.84
54138399-413839993.99394.34
63940877-394087789.50789.82
60min14223473-422347395.92596.481.3496.4096.951.35
24247680-424768096.47596.94
34235718-423571896.20396.67
44190780-419078095.18295.61
54356478-435647898.94699.45
64233413-423341396.15196.61
极限14334791-433479198.45399.271.0699.0999.901.08
24401075-440107599.959100.58
34365252-436525299.14599.77
44302666-430266697.72498.31
54429558-4429558100.606101.28
64390573-439057399.720100.34
诺氟沙星胶囊项目信息
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130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100 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%
110.624184590418333441814874183151418256541830250.03
210.684182522418421341833680.03
单位质量响应值RSD%判断
393881.83391701.120.40数据可信
供试品溶液-25033批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135724-357240.8151.2973.420.821.2973.37
2111406-1114062.5422.54
351852-518521.1831.18
498788-987882.2542.25
542210-422100.9630.96
6-0.0000.00
10min1701612-70161216.01217.2421.0116.0117.2421.00
21021809-102180923.31923.32
3690842-69084215.76615.77
4769126-76912617.55317.56
5806212-80621218.39918.40
6543139-54313912.39512.40
15min11370092-137009231.26733.0713.7631.3033.1113.76
21785821-178582140.75540.80
31325144-132514430.24230.27
41420887-142088732.42732.46
51566217-156621735.74335.78
61227585-122758528.01528.04
20min11918076-191807643.77345.7613.1043.8545.8513.11
22423109-242310955.29955.41
31731379-173137939.51339.59
42042076-204207646.60346.69
52160628-216062849.30949.40
61756147-175614740.07840.15
30min12823431-282343164.43565.8510.3564.5966.0110.36
23319014-331901475.74575.95
32494087-249408756.91957.06
42910832-291083266.42966.59
53106188-310618870.88871.06
62659419-265941960.69260.83
45min13595853-359585382.06383.066.6982.3283.346.71
23986061-398606190.96891.30
33293018-329301875.15175.39
43684918-368491884.09584.37
53801020-380102086.74587.04
63477743-347774379.36779.60
60min13981281-398128190.85991.014.2091.2691.424.23
24257447-425744797.16197.64
33762256-376225685.86086.22
43962771-396277190.43690.85
54070942-407094292.90593.34
63893997-389399788.86789.23
极限14268381-426838197.41196.552.2897.9697.122.31
24353043-435304399.34399.99
34063628-406362892.73893.25
44235785-423578596.66797.23
54264120-426412097.31397.90
64200203-420020395.85596.37
诺氟沙星胶囊项目信息
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130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100 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%
110.624191769419363241920014193989419593941934660.05
210.684196731419667141967010.01
单位质量响应值RSD%判断
394864.97392949.530.35数据可信
供试品溶液-E001批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1678331-67833115.43713.6110.1915.4413.6110.21
2634926-63492614.44914.45
3585111-58511113.31513.32
4496713-49671311.30411.30
5608459-60845913.84713.85
6583699-58369913.28313.28
10min11586230-158623036.09735.402.2936.1235.422.30
21592244-159224436.23436.26
31541635-154163535.08335.10
41493715-149371533.99234.01
51559737-155973735.49535.52
61559860-155986035.49735.52
15min12409655-240965554.83654.581.4254.9254.661.42
22436567-243656755.44855.53
32382456-238245654.21754.30
42341467-234146753.28453.36
52395275-239527554.50954.59
62424534-242453455.17555.26
20min13054245-305424569.50569.310.4469.6869.490.44
23045446-304544669.30469.48
33021510-302151068.76068.93
43042653-304265369.24169.41
53057522-305752269.57969.75
63053781-305378169.49469.67
30min13830050-383005087.16088.440.8787.4588.720.86
23881621-388162188.33388.63
33874141-387414188.16388.45
43928204-392820489.39389.67
53896235-389623588.66688.95
63907125-390712588.91489.20
45min14293046-429304697.69699.321.1098.1399.761.09
24341167-434116798.79199.23
34417561-4417561100.529100.96
44406527-4406527100.278100.71
54339812-433981298.76099.20
64388130-438813099.860100.30
60min14355270-435527099.112101.061.2499.71101.661.24
24416845-4416845100.513101.12
34439538-4439538101.030101.63
44509429-4509429102.620103.22
54432853-4432853100.877101.48
64490266-4490266102.184102.79
极限14347691-434769198.939100.861.2899.71101.631.27
24405467-4405467100.254101.03
34407519-4407519100.301101.07
44485591-4485591102.078102.84
54449526-4449526101.257102.03
64497175-4497175102.341103.12
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