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%
110.304132517413582941276294130041413002841312090.08
210.244127606413986741337360.21
单位质量响应值RSD%判断
401088.25403685.160.46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%
5min13686509-368650982.12679.855.1782.1379.865.17
23544582-354458278.96478.96
33250348-325034872.40972.41
43782588-378258884.26684.27
53568589-356858979.49979.50
63674774-367477481.86481.86
10min14483721-448372199.885102.273.93100.02102.403.92
24505353-4505353100.367100.50
34841501-4841501107.856107.98
44546933-4546933101.293101.43
54781423-4781423106.517106.65
64385646-438564697.70097.84
15min14527142-4527142100.853103.313.75101.16103.623.75
24738704-4738704105.566105.86
34832946-4832946107.665107.97
44558543-4558543101.552101.86
54782435-4782435106.540106.85
64385851-438585197.70598.00
20min14524333-4524333100.790102.383.74101.26102.863.73
24486653-448665399.951100.43
34824637-4824637107.480107.96
44555660-4555660101.488101.97
54786935-4786935106.640107.13
64395982-439598297.93198.39
30min14526674-4526674100.842102.443.77101.48103.093.76
24493405-4493405100.101100.74
34835717-4835717107.727108.39
44551122-4551122101.387102.03
54786319-4786319106.626107.29
64398463-439846397.98698.61
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%
110.304138162414614341464714145880414390041441110.09
210.244114213411686341155380.05
单位质量响应值RSD%判断
402340.87401908.010.08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%
5min13613205-361320580.54473.709.6980.5473.709.69
23191800-319180071.15071.15
32842492-284249263.36463.36
43637124-363712481.07781.08
53474007-347400777.44177.44
63077750-307775068.60868.61
10min14696850-4696850104.700103.481.24104.83103.601.25
24605496-4605496102.664102.78
34618538-4618538102.955103.06
44732147-4732147105.487105.62
54596739-4596739102.469102.60
64603618-4603618102.622102.74
15min14712163-4712163105.042103.861.43105.35104.151.44
24631369-4631369103.241103.53
34623211-4623211103.059103.34
44769198-4769198106.313106.62
54609447-4609447102.752103.05
64608314-4608314102.727103.01
20min14702348-4702348104.823103.691.18105.31104.161.18
24628187-4628187103.170103.63
34619946-4619946102.986103.44
44737054-4737054105.597106.08
54617624-4617624102.934103.41
64604153-4604153102.634103.09
30min14740776-4740776105.680103.771.42106.34104.411.42
24637165-4637165103.370104.00
34591794-4591794102.358102.98
44735381-4735381105.559106.22
54614058-4614058102.855103.50
64611985-4611985102.809103.44
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%
110.304152427414243841514094151006414932841493220.10
210.244119148411464741168980.08
单位质量响应值RSD%判断
402846.80402040.820.15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%
5min13318766-331876673.92271.706.4173.9271.706.40
22944118-294411865.57765.58
33246579-324657972.31472.31
43378235-337823575.24775.25
53438202-343820276.58276.58
62989516-298951666.58866.59
10min14444521-444452198.99799.693.2599.1299.813.25
24524245-4524245100.773100.88
34475430-447543099.68599.81
44208701-420870193.74493.87
54603236-4603236102.532102.66
64597549-4597549102.406102.52
15min14452139-445213999.167100.283.5499.45100.563.54
24555237-4555237101.463101.74
34509981-4509981100.455100.74
44214126-421412693.86594.15
54650936-4650936103.595103.89
64630270-4630270103.134103.42
20min14469858-446985899.561100.183.29100.01100.633.29
24563403-4563403101.645102.09
34498309-4498309100.195100.65
44222122-422212294.04394.48
54624302-4624302103.001103.47
64608287-4608287102.645103.10
30min14469253-446925399.548100.982.31100.17101.602.31
24562968-4562968101.635102.25
34505808-4505808100.362100.98
44378173-437817397.51998.11
54664573-4664573103.898104.54
64621226-4621226102.933103.56
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%
110.304125257412274641192264117698411708341204020.09
210.244127227412504341261350.04
单位质量响应值RSD%判断
400039.03402942.870.52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%
5min13072831-307283168.60758.2514.3268.6158.2414.33
22491152-249115255.62055.62
32429271-242927154.23954.24
42167095-216709548.38548.38
53065113-306511368.43568.43
62427106-242710654.19054.19
10min14541306-4541306101.39498.804.88101.5198.904.88
24179317-417931793.31293.40
34588368-4588368102.445102.54
44119725-411972591.98192.06
54588133-4588133102.440102.55
64534130-4534130101.234101.32
15min14578543-4578543102.225101.203.58102.51101.463.58
24233061-423306194.51294.76
34651079-4651079103.845104.11
44473752-447375299.886100.12
54668247-4668247104.228104.51
64590491-4590491102.492102.75
20min14573425-4573425102.111101.393.57102.56101.823.57
24217682-421768294.16894.57
34624380-4624380103.249103.68
44603227-4603227102.777103.18
54659877-4659877104.041104.50
64568717-4568717102.006102.44
30min14556600-4556600101.736101.553.73102.36102.153.73
24212019-421201994.04294.60
34617861-4617861103.103103.71
44642481-4642481103.653104.22
54672244-4672244104.318104.95
64589204-4589204102.463103.06
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%
110.304107897411236441112594101839410957141085860.11
210.244109265410801441086400.03
单位质量响应值RSD%判断
398891.84401234.380.42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%
5min13252020-325202072.86767.278.1872.8767.278.18
22690040-269004060.27560.27
32839058-283905863.61463.61
43085366-308536669.13369.13
53294294-329429473.81473.81
62853252-285325263.93263.93
10min14698463-4698463105.27797.338.73105.4097.458.73
23635894-363589481.46881.57
34582663-4582663102.682102.79
44495739-4495739100.734100.85
54398354-439835498.55298.68
64252439-425243995.28395.39
15min14791347-4791347107.358101.505.23107.65101.775.23
24290492-429049296.13696.37
34860724-4860724108.913109.19
44455672-445567299.837100.12
54397986-439798698.54498.83
64382194-438219498.19098.46
20min14794060-4794060107.419102.554.55107.89103.004.54
24587063-4587063102.781103.18
34860383-4860383108.905109.36
44440654-444065499.50099.95
54395554-439555498.49098.94
64383679-438367998.22498.65
30min14805283-4805283107.670103.284.36108.33103.894.34
24743483-4743483106.286106.85
34821808-4821808108.041108.68
44440170-444017099.489100.10
54396897-439689798.52099.14
64447537-444753799.654100.25
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