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(%)99.60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%
110.304061390406200540631824065780406090240626520.05
210.244045184404689640460400.03
单位质量响应值RSD%判断
394432.23395121.090.13数据可信
中间条件18月-供试品溶液-22101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%
5min1592881-59288113.46212.398.7013.4612.398.70
2545569-54556912.38812.39
3536938-53693812.19212.19
4522281-52228111.85911.86
5473441-47344110.75010.75
6602049-60204913.67013.67
10min11628297-162829736.97337.203.5537.0037.223.55
21701315-170131538.63138.65
31636381-163638137.15737.18
41650310-165031037.47337.49
51533465-153346534.82034.84
61679429-167942938.13438.16
15min12497314-249731456.70557.912.3556.7958.002.35
22642269-264226959.99760.08
32517338-251733857.16057.24
42586659-258665958.73458.82
52488417-248841756.50356.58
62570922-257092258.37758.46
20min13168174-316817471.93873.212.2372.1273.392.23
23321107-332110775.41175.60
33174999-317499972.09372.27
43288956-328895674.68174.86
53146282-314628271.44171.61
63246100-324610073.70873.89
30min13900630-390063088.57089.971.9488.8790.271.94
24000848-400084890.84591.16
33863291-386329187.72288.02
44081005-408100592.66592.97
53952415-395241589.74690.03
63974758-397475890.25390.56
45min14285700-428570097.31397.871.6297.7698.321.62
24387642-438764299.628100.09
34195936-419593695.27595.72
44377376-437737699.39599.85
54304504-430450497.74098.18
64310531-431053197.87798.33
60min14275915-427591597.09198.952.0697.7099.572.06
24422594-4422594100.422101.05
34219451-421945195.80996.41
44444724-4444724100.924101.55
54401112-440111299.934100.54
64383940-438394099.544100.16
极限14314559-431455997.96999.471.6098.74100.251.60
24443277-4443277100.891101.69
34279072-427907297.16397.93
44449631-4449631101.036101.83
54386494-438649499.602100.37
64410965-4410965100.158100.94
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(%)99.60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%
110.304073706407383440738684076766408031540756980.08
210.244043807404416040439840.01
单位质量响应值RSD%判断
395698.83394920.310.14数据可信
中间条件18月-供试品溶液-22102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%
5min1583901-58390113.24014.066.5513.2414.066.55
2620266-62026614.06514.07
3630639-63063914.30014.30
4563239-56323912.77212.77
5669333-66933315.17815.18
6653994-65399414.83014.83
10min11685837-168583738.22839.744.6238.2539.764.61
21801500-180150040.85140.87
31664059-166405937.73437.76
41697863-169786338.50138.52
51865792-186579242.30942.33
61798975-179897540.79340.82
15min12591585-259158558.76760.583.8758.8560.673.87
22757159-275715962.52162.61
32549242-254924257.80657.89
42618960-261896059.38759.47
52817155-281715563.88263.98
62694603-269460361.10361.20
20min13250363-325036373.70575.223.6473.8975.413.64
23459058-345905878.43778.63
33155338-315533871.55071.73
43252102-325210273.74473.93
53448005-344800578.18778.39
63338520-333852075.70475.90
30min13957004-395700489.72991.182.9290.0491.492.93
24153399-415339994.18294.51
33855716-385571687.43287.73
43973577-397357790.10590.41
54153338-415333894.18194.51
64032462-403246291.44091.76
45min14288345-428834597.24298.112.4097.7098.582.40
24437693-4437693100.629101.11
34177589-417758994.73195.18
44260432-426043296.60997.07
54437206-4437206100.618101.11
64358187-435818798.82699.30
60min14352120-435212098.68899.062.5299.3199.692.52
24473382-4473382101.438102.09
34181098-418109894.81095.42
44327937-432793798.14098.76
54474662-4474662101.467102.12
64400740-440074099.791100.43
极限14316746-431674697.88699.191.4698.6799.981.47
24457491-4457491101.078101.90
34345834-434583498.54699.31
44296620-429662097.43098.21
54416700-4416700100.153100.98
64411150-4411150100.027100.83
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(%)99.60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%
110.304058154405809740589374059520406071840590850.03
210.243986212398763739869240.03
单位质量响应值RSD%判断
394085.92389348.050.86数据可信
中间条件18月-供试品溶液-22103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%
5min1429852-4298529.83710.5310.329.8410.5310.32
2527878-52787812.08012.08
3494827-49482711.32411.32
4439633-43963310.06110.06
5396890-3968909.0839.08
6471614-47161410.79310.79
10min11447141-144714133.11736.066.6633.1336.086.67
21749434-174943440.03540.06
31595258-159525836.50736.53
41493504-149350434.17834.20
51562879-156287935.76635.78
61607160-160716036.77936.80
15min12361084-236108454.03357.086.0854.1057.166.08
22724798-272479862.35662.44
32533582-253358257.98058.06
42294196-229419652.50252.58
52513916-251391657.53057.60
62538647-253864758.09658.18
20min13011893-301189368.92673.074.4669.0973.244.47
23404403-340440377.90978.10
33218961-321896173.66573.84
43057485-305748569.97070.13
53203894-320389473.32073.49
63261415-326141574.63774.81
30min13765358-376535886.16990.082.6486.4590.382.64
24012286-401228691.82092.14
34033550-403355092.30792.61
43863256-386325688.40988.69
53945247-394524790.28690.58
63998375-399837591.50291.80
45min14247962-424796297.21398.901.7497.6399.341.75
24405335-4405335100.815101.29
34419923-4419923101.149101.60
44248196-424819697.21997.64
54296920-429692098.33498.78
64311411-431141198.66599.12
60min14319100-431910098.841100.661.1999.42101.271.20
24412409-4412409100.977101.62
34467472-4467472102.237102.86
44437131-4437131101.542102.13
54382630-4382630100.295100.90
64373542-4373542100.087100.70
极限14417136-4417136101.085100.891.31101.83101.671.30
24435356-4435356101.502102.31
34451658-4451658101.875102.67
44461957-4461957102.111102.87
54308176-430817698.59199.37
64377107-4377107100.169100.95
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