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%
1 10.184097243407821240957594094751409414340920220.20
2 10.144096924409278340948540.08
单位质量响应值RSD%判断
401966.80403831.760.33数据可信
供试品溶液-24122601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%
5min1682541-68254115.18614.149.5715.1914.149.57
2697066-69706615.50915.51
3615298-61529813.69013.69
4680164-68016415.13315.13
5544164-54416412.10712.11
6593889-59388913.21313.21
10min11736295-173629538.63136.515.1138.6636.535.11
21656852-165685236.86336.89
31641540-164154036.52236.55
41714227-171422738.14038.16
51508170-150817033.55533.58
61588429-158842935.34135.36
15min12339817-233981752.05851.903.7252.1551.983.72
22339626-233962652.05452.14
32368855-236885552.70452.79
42448804-244880454.48354.57
52183265-218326548.57548.65
62315658-231565851.52151.60
20min12878127-287812764.03563.153.6664.2163.323.66
22859150-285915063.61363.79
32872626-287262663.91364.08
42939526-293952665.40165.58
52637753-263775358.68758.84
62842505-284250563.24263.41
30min13418499-341849976.05876.052.7076.3476.322.70
23388975-338897575.40175.68
33438257-343825776.49776.78
43529123-352912378.51978.81
53258495-325849572.49872.75
63475206-347520677.31977.59
45min13664937-366493781.54183.393.5381.9583.793.53
23730245-373024582.99483.40
33792182-379218284.37284.78
43862829-386282985.94486.36
53540824-354082478.77979.15
63896932-389693286.70287.10
60min13777399-377739984.04386.083.0084.5986.632.99
23838150-383815085.39485.94
33905647-390564786.89687.44
43969330-396933088.31388.88
53710261-371026182.54983.06
64014252-401425289.31389.86
极限13952743-395274387.94489.472.7988.6390.162.79
23959601-395960188.09788.78
34039880-403988089.88390.57
44108075-410807591.40092.11
53882717-388271786.38687.03
64186107-418610793.13693.83
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%
1 10.184088207409142440921274089985408930640902100.04
2 10.144087325408913940882320.04
单位质量响应值RSD%判断
401788.80403178.700.25数据可信
供试品溶液-24122602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%
5min1732867-73286716.32213.4414.4116.3213.4414.40
2616982-61698213.74113.74
3484412-48441210.78910.79
4543640-54364012.10812.11
5586081-58608113.05313.05
6656439-65643914.62014.62
10min11659317-165931736.95635.565.7336.9835.585.74
21683896-168389637.50337.53
31557578-155757834.69034.71
41451344-145134432.32432.34
51554664-155466434.62534.65
61673492-167349237.27237.30
15min12344644-234464452.21951.784.6552.3151.864.66
22453066-245306654.63454.72
32283554-228355450.85950.93
42166374-216637448.24948.32
52269674-226967450.55050.63
62433069-243306954.18954.28
20min12840519-284051963.26363.283.5163.4463.453.51
22962333-296233365.97666.15
32790793-279079362.15662.32
42697804-269780460.08560.24
52810449-281044962.59462.76
62945612-294561265.60465.78
30min13477471-347747177.44977.712.2777.7377.982.28
23592559-359255980.01380.30
33451626-345162676.87477.14
43384058-338405875.36975.62
53456050-345605076.97277.24
63572683-357268379.57079.86
45min13828748-382874885.27385.851.7585.6886.261.76
23958629-395862988.16688.59
33804238-380423884.72785.12
43799293-379929384.61785.00
53818058-381805885.03585.43
63919562-391956287.29687.71
60min14014832-401483289.41788.571.7989.9789.121.80
24061228-406122890.45191.02
33924723-392472387.41187.94
43920120-392012087.30887.83
53897812-389781286.81187.35
64043030-404303090.04590.61
极限14251023-425102394.67891.841.8295.3892.531.82
24145488-414548892.32793.04
34056280-405628090.34191.02
44070993-407099390.66891.33
54067482-406748290.59091.27
64150918-415091892.44893.16
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%
1 10.184081021408362040821534085318408160040827420.05
2 10.144090228409934840947880.16
单位质量响应值RSD%判断
401055.21403825.250.49数据可信
供试品溶液-24122603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%
5min1650573-65057314.49114.157.5314.4914.157.52
2646645-64664514.40414.40
3543016-54301612.09512.10
4649242-64924214.46114.46
5638701-63870114.22714.23
6683539-68353915.22515.23
10min11544413-154441334.40136.124.4034.4236.144.41
21711967-171196738.13338.16
31531434-153143434.11234.13
41631238-163123836.33536.36
51634280-163428036.40336.43
61675879-167587937.32937.35
15min12352707-235270752.40552.413.5852.4952.503.58
22456480-245648054.71754.80
32214139-221413949.31949.40
42323451-232345151.75351.84
52351173-235117352.37152.46
62420316-242031653.91154.00
20min12833199-283319963.10863.893.5263.2864.073.53
22998871-299887166.79866.98
32727075-272707560.74460.90
42820204-282020462.81862.99
52862025-286202563.75063.92
62969752-296975266.14966.33
30min13465951-346595177.20277.133.9277.4877.403.92
23625715-362571580.76181.05
33243132-324313272.23972.50
43404514-340451475.83376.11
53456974-345697477.00277.28
63579089-357908979.72280.01
45min13817572-381757285.03485.953.0485.4486.363.04
24007721-400772189.26989.69
33773329-377332984.04984.43
43729051-372905183.06283.46
53826433-382643385.23185.64
63999211-399921189.08089.50
60min14020329-402032989.55089.112.9790.0989.662.97
24116412-411641291.69192.26
33896992-389699286.80387.32
43851031-385103185.77986.32
53968023-396802388.38588.93
64150554-415055492.45193.02
极限14091676-409167691.14091.812.6391.8392.502.63
24225506-422550694.12194.85
34046242-404624290.12890.79
44026006-402600689.67790.36
54053136-405313690.28190.98
64286876-428687695.48896.21
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