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%
110.304080245408411040786924076898407767440795240.07
210.244070537406541540679760.09
单位质量响应值RSD%判断
396070.29397263.280.22数据可信
影响因素30天-供试品溶液-24032501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%
5min13536139-353613979.91165.2914.1679.9165.2914.16
22509494-250949456.71056.71
32782425-278242562.87862.88
42931212-293121266.24166.24
52441697-244169755.17855.18
63133432-313343270.81070.81
10min14751722-4751722107.381102.322.81107.51102.422.81
24586368-4586368103.644103.74
34521616-4521616102.181102.29
44459084-4459084100.768100.88
54413029-441302999.72799.82
64433652-4433652100.193100.31
15min14768795-4768795107.767102.762.70108.08103.042.71
24594305-4594305103.824104.09
34548024-4548024102.778103.05
44462853-4462853100.853101.13
54451984-4451984100.608100.87
64458701-4458701100.759101.04
20min14763244-4763244107.642102.672.72108.13103.122.72
24594296-4594296103.824104.26
34544987-4544987102.709103.16
44465688-4465688100.917101.36
54452381-4452381100.617101.04
64439647-4439647100.329100.78
30min14754248-4754248107.438102.612.62108.11103.242.62
24585906-4585906103.634104.25
34541628-4541628102.633103.25
44464512-4464512100.891101.51
54442966-4442966100.404101.00
64455459-4455459100.686101.31
45min1-0.0000.00-0.850.793.80
2-0.0000.79
3-0.0000.79
4-0.0000.78
5-0.0000.76
6-0.0000.79
60min1-0.0000.00-0.850.793.80
2-0.0000.79
3-0.0000.79
4-0.0000.78
5-0.0000.76
6-0.0000.79
极限1-0.0000.00-0.850.793.80
2-0.0000.79
3-0.0000.79
4-0.0000.78
5-0.0000.76
6-0.0000.79
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%
110.304087611408884240856714089748408587240875490.05
210.244081534408170640816200.01
单位质量响应值RSD%判断
396849.42398595.700.32数据可信
加速1月-供试品溶液-24032501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%
5min13975931-397593189.61175.0312.9689.6175.0312.96
23423667-342366777.16477.16
33471078-347107878.23378.23
43249161-324916173.23173.23
52650675-265067559.74259.74
63203168-320316872.19472.19
10min14497178-4497178101.35999.683.58101.5199.803.58
24444319-4444319100.168100.30
34340459-434045997.82797.96
44441222-4441222100.098100.22
54170254-417025493.99194.09
64641706-4641706104.617104.74
15min14507022-4507022101.581100.053.65101.90100.343.66
24453207-4453207100.368100.66
34365119-436511998.38398.68
44450440-4450440100.306100.59
54183796-418379694.29694.55
64674858-4674858105.364105.66
20min14493142-4493142101.268100.134.30101.76100.594.30
24445549-4445549100.196100.66
34338952-433895297.79398.25
44438116-4438116100.028100.48
54181520-418152094.24594.66
64759474-4759474107.271107.74
30min14498554-4498554101.39099.653.55102.05100.273.55
24440323-4440323100.078100.71
34346295-434629597.95998.58
44430903-443090399.866100.49
54170918-417091894.00694.58
64640187-4640187104.583105.23
45min1-0.0000.00-0.830.794.48
2-0.0000.80
3-0.0000.78
4-0.0000.79
5-0.0000.73
6-0.0000.82
60min1-0.0000.00-0.830.794.48
2-0.0000.80
3-0.0000.78
4-0.0000.79
5-0.0000.73
6-0.0000.82
极限1-0.0000.00-0.830.794.48
2-0.0000.80
3-0.0000.78
4-0.0000.79
5-0.0000.73
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%
110.304059458407068040583234063131406458240632350.13
210.244082199408394040830700.04
单位质量响应值RSD%判断
394488.83398737.300.76数据可信
影响因素30天-供试品溶液-24032501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%
5min1661362-66136214.94813.629.1914.9513.629.20
2633961-63396114.32914.33
3541353-54135312.23612.24
4624956-62495614.12514.13
5628233-62823314.19914.20
6525332-52533211.87411.87
10min11508973-150897334.10632.294.5534.1332.314.55
21415379-141537931.99032.01
31335707-133570730.19030.21
41488224-148822433.63733.66
51441519-144151932.58132.60
61382545-138254531.24831.27
15min12120859-212085947.93645.953.9748.0246.033.97
21989960-198996044.97745.05
31902984-190298443.01143.08
42107543-210754347.63547.71
52052270-205227046.38546.46
62024939-202493945.76845.84
20min12604338-260433858.86356.594.0459.0256.744.03
22453905-245390555.46355.62
32337092-233709252.82352.97
42604690-260469058.87159.03
52498949-249894956.48156.64
62523103-252310357.02757.18
30min13242689-324268973.29171.094.2173.5571.344.20
23089125-308912569.82070.07
32910608-291060865.78666.02
43276989-327698974.06774.32
53161943-316194371.46671.72
63189403-318940372.08772.33
45min13727956-372795684.25982.573.8984.6482.943.89
23581136-358113680.94181.30
33415777-341577777.20377.54
43804203-380420385.98386.36
53635338-363533882.16682.53
63755410-375541084.88085.24
60min13866428-386642887.38986.493.8587.9187.003.84
23755906-375590684.89185.39
33595287-359528781.26181.73
44001884-400188490.45190.97
53788822-378882285.63586.14
63952171-395217189.32789.83
极限13899388-389938888.13487.553.9088.8088.203.90
23814417-381441786.21486.85
33630197-363019782.05082.65
44041986-404198691.35792.03
53837982-383798286.74687.39
64017982-401798290.81591.47
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%
110.304070228407427140634704073569407070240704480.11
210.244040062403977440399180.01
单位质量响应值RSD%判断
395189.13394523.240.12数据可信
影响因素30天-供试品溶液-24032501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%
5min1771003-77100317.50312.4128.5317.5012.4128.53
2692511-69251115.72115.72
3445454-44545410.11310.11
4405580-4055809.2079.21
5560007-56000712.71312.71
6406298-4062989.2249.22
10min11807548-180754841.03531.7121.2541.0631.7421.25
21565028-156502835.52935.56
31117661-111766125.37325.39
4999050-99905022.68022.70
51481282-148128233.62833.65
61411333-141133332.04032.06
15min12536845-253684557.59145.8419.0757.6945.9219.08
22201561-220156149.98050.07
31604288-160428836.42036.48
41525139-152513934.62434.68
52153531-215353148.88948.97
62095024-209502447.56147.63
20min13046408-304640869.15956.7716.6769.3556.9216.68
22653588-265358860.24260.41
32120806-212080648.14648.27
41899189-189918943.11543.23
52616777-261677759.40659.56
62668419-266841960.57860.73
30min13583018-358301881.34268.0516.1981.6568.2916.20
23165624-316562471.86672.13
32454320-245432055.71855.92
42356994-235699453.50853.69
53149566-314956671.50171.76
63275461-327546174.35974.61
45min13822191-382219186.77174.2314.8587.2274.5914.86
23429007-342900777.84578.23
32717805-271780561.69961.99
42624469-262446959.58159.85
53450850-345085078.34178.72
63575475-357547581.17081.54
60min13953610-395361089.75577.3214.6590.3477.8014.67
23580922-358092281.29481.81
32837372-283737264.41464.81
42740284-274028462.21062.58
53568759-356875981.01881.53
63754294-375429485.23085.74
极限14234476-423447696.13188.276.8296.8788.886.88
23904109-390410988.63189.29
33595063-359506381.61582.12
43568008-356800881.00181.48
53941373-394137389.47790.12
64086176-408617692.76493.41
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%
110.304033625403694340377184037907404084640374080.07
210.244045043404449240447680.01
单位质量响应值RSD%判断
391981.36394996.880.55数据可信
加速1月-供试品溶液-24032501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%
5min1536291-53629112.21712.7813.4512.2212.7813.44
2597485-59748513.61113.61
3447670-44767010.19810.20
4607775-60777513.84613.85
5658948-65894815.01215.01
6517808-51780811.79611.80
10min11424057-142405732.44235.215.1932.4635.235.20
21595398-159539836.34536.37
31579033-157903335.97235.99
41632206-163220637.18437.21
51571903-157190335.81035.83
61470964-147096433.51033.53
15min12115809-211580948.20152.375.2048.2752.445.20
22339555-233955553.29853.38
32399519-239951954.66454.74
42396223-239622354.58954.67
52356680-235668053.68853.77
62184359-218435949.76249.84
20min12586407-258640758.92164.965.5359.0865.135.52
22917431-291743166.46266.63
32995152-299515268.23368.40
42954241-295424167.30167.48
52921095-292109566.54666.72
62735803-273580362.32562.48
30min13291663-329166374.98880.175.1275.2480.445.12
23584601-358460181.66181.94
33672432-367243283.66283.94
43596281-359628181.92782.22
53677228-367722883.77184.06
63292196-329219675.00075.26
45min13730709-373070984.99089.663.5585.3790.073.55
23927098-392709889.46489.88
34051324-405132492.29492.72
43955477-395547790.11090.54
54113493-411349393.71094.13
63836461-383646187.39987.79
60min13913630-391363089.15792.812.7389.6893.372.73
24075661-407566192.84893.42
34119649-411964993.85094.43
44049909-404990992.26292.84
54251273-425127396.84997.43
64033226-403322691.88192.41
极限14188025-418802595.40897.941.7096.0898.661.70
24294671-429467197.83898.56
34338672-433867298.84099.57
44256812-425681296.97597.70
54401202-4401202100.264101.01
64316159-431615998.32799.01
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