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%
110.153876249388122938854193884009388828238830380.12
210.123881401387989438806480.03
单位质量响应值RSD%判断
382565.32383463.240.17数据可信
供试品溶液-24072901批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13897427-389742791.21591.884.3491.2191.884.34
23998154-399815493.57293.57
34200094-420009498.29898.30
43778295-377829588.42788.43
53723855-372385587.15387.15
63956083-395608392.58892.59
10min14559703-4559703106.715105.291.21106.87105.441.21
24517535-4517535105.728105.88
34503462-4503462105.398105.56
44408770-4408770103.182103.33
54466653-4466653104.537104.68
64535737-4535737106.154106.31
15min14567028-4567028106.886105.551.17107.22105.881.17
24530134-4530134106.023106.35
34510843-4510843105.571105.91
44414958-4414958103.327103.65
54496133-4496133105.227105.55
64539797-4539797106.249106.58
20min14571939-4571939107.001105.671.30107.51106.171.30
24553869-4553869106.578107.09
34509536-4509536105.541106.06
44407827-4407827103.160103.65
54504374-4504374105.420105.91
64541711-4541711106.294106.80
30min14572461-4572461107.013105.481.33107.70106.161.33
24535892-4535892106.157106.84
34499110-4499110105.297105.99
44397037-4397037102.908103.57
54508941-4508941105.527106.20
64529333-4529333106.004106.69
45min1-0.0000.00-0.860.861.21
2-0.0000.86
3-0.0000.87
4-0.0000.84
5-0.0000.85
6-0.0000.86
60min1-0.0000.00-0.860.861.21
2-0.0000.86
3-0.0000.87
4-0.0000.84
5-0.0000.85
6-0.0000.86
极限1-0.0000.00-0.860.861.21
2-0.0000.86
3-0.0000.87
4-0.0000.84
5-0.0000.85
6-0.0000.86
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%
110.153861179386069238606693859073385989238603010.03
210.123893034389536938942020.05
单位质量响应值RSD%判断
380325.22384802.570.83数据可信
供试品溶液-24072901批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13662860-366286085.82978.005.3485.8378.005.34
23228844-322884475.65975.66
33367388-336738878.90578.91
43157204-315720473.98073.98
53284029-328402976.95276.95
63271292-327129276.65476.65
10min14320818-4320818101.24699.922.11101.39100.042.11
24311832-4311832101.036101.16
34258283-425828399.78199.91
44119943-411994396.53996.66
54205887-420588798.55398.68
64367717-4367717102.345102.47
15min14299893-4299893100.756101.831.66101.07102.121.65
24405982-4405982103.242103.54
34220077-422007798.88699.18
44373021-4373021102.469102.75
54392187-4392187102.919103.21
64382533-4382533102.692102.99
20min14294985-4294985100.641102.421.77101.12102.881.76
24369862-4369862102.395102.86
34268122-4268122100.011100.47
44424596-4424596103.678104.13
54398193-4398193103.059103.52
64469917-4469917104.740105.21
30min14373510-4373510102.481102.972.54103.13103.602.53
24415565-4415565103.466104.10
34183758-418375898.03598.66
44464528-4464528104.614105.24
54432080-4432080103.853104.49
64496231-4496231105.357106.00
45min1-0.0000.00-0.820.811.45
2-0.0000.81
3-0.0000.79
4-0.0000.80
5-0.0000.81
6-0.0000.82
60min1-0.0000.00-0.820.811.45
2-0.0000.81
3-0.0000.79
4-0.0000.80
5-0.0000.81
6-0.0000.82
极限1-0.0000.00-0.820.811.45
2-0.0000.81
3-0.0000.79
4-0.0000.80
5-0.0000.81
6-0.0000.82
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%
110.153899765390258739023813899746389987139008700.04
210.123844673383971138421920.10
单位质量响应值RSD%判断
384322.17379663.240.87数据可信
供试品溶液-24072901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%
5min1613035-61303514.38615.8012.5214.3915.8012.52
2758820-75882017.80717.81
3692498-69249816.25116.25
4647510-64751015.19515.20
5555771-55577113.04213.04
6771679-77167918.10918.11
10min11628154-162815438.20837.803.8038.2337.833.80
21673168-167316839.26539.29
31541293-154129336.17036.20
41605412-160541237.67537.70
51539051-153905136.11736.14
61678014-167801439.37839.41
15min12394721-239472156.19855.003.7556.2955.093.75
22438418-243841857.22357.32
32184383-218438351.26251.35
42364443-236444355.48755.58
52315609-231560954.34154.42
62364285-236428555.48355.58
20min12992163-299216370.21869.142.1470.4069.322.14
23032289-303228971.16071.35
32855037-285503767.00067.17
42957656-295765669.40869.59
52904687-290468768.16568.34
62936342-293634268.90869.10
30min13613276-361327684.79485.821.6385.0986.121.62
23736478-373647887.68587.99
33675502-367550286.25486.54
43672143-367214386.17586.47
53679433-367943386.34686.63
63565838-356583883.68183.98
45min14165247-416524797.74796.721.6998.1997.161.68
24164219-416421997.72398.18
34159267-415926797.60798.03
44143237-414323797.23197.67
54110462-411046296.46196.89
63986281-398628193.54793.99
60min14235639-423563999.39999.531.93100.00100.121.92
24282074-4282074100.489101.11
34363084-4363084102.390102.98
44189273-418927398.31198.91
54252748-425274899.800100.39
64123312-412331296.76397.36
极限14313179-4313179101.219101.671.53101.99102.441.53
24387109-4387109102.954103.74
34432325-4432325104.015104.78
44301257-4301257100.939101.70
54313711-4313711101.231101.99
64247249-424724999.671100.43
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