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%
110.304020515402337340190534022266401956840209550.05
210.244021683402072140212020.02
单位质量响应值RSD%判断
390383.98392695.510.42数据可信
长期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%
5min1631432-63143214.45613.903.1714.4613.903.19
2578460-57846013.24413.24
3598977-59897713.71313.71
4625299-62529914.31614.32
5600921-60092113.75813.76
6608759-60875913.93713.94
10min11730108-173010839.61038.963.9939.6338.983.99
21595649-159564936.53136.55
31651330-165133037.80637.83
41787390-178739040.92140.95
51731816-173181639.64939.67
61713828-171382839.23739.26
15min12664762-266476261.00859.473.3461.1059.563.34
22443918-244391855.95256.04
32561136-256113658.63658.72
42682754-268275461.42061.51
52626399-262639960.13060.22
62606645-260664559.67859.77
20min13303982-330398275.64374.072.8375.8374.262.83
23064212-306421270.15370.33
33223086-322308673.79173.97
43311311-331131175.81176.00
53277599-327759975.03975.23
63231283-323128373.97874.17
30min13972078-397207890.93890.592.2991.2690.902.29
23814230-381423087.32587.62
33960511-396051190.67490.98
44040511-404051192.50592.83
54055771-405577192.85593.17
63897824-389782489.23889.55
45min14292824-429282498.28298.101.6598.7598.561.65
24183975-418397595.79096.23
34278546-427854697.95598.41
44351364-435136499.622100.10
54370661-4370661100.064100.53
64232268-423226896.89597.36
60min14340570-434057099.37599.221.62100.0199.841.62
24283975-428397598.07998.68
34346786-434678699.517100.14
44348671-434867199.560100.20
54444902-4444902101.763102.40
64237080-423708097.00697.63
极限14337290-433729099.30099.471.61100.10100.261.61
24331383-433138399.16599.93
34375446-4375446100.173100.96
44375690-4375690100.179100.99
54427707-4427707101.370102.18
64220692-422069296.63097.41
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%
110.303983247398013639777103973322397460139778030.11
210.244033444403303040332370.01
单位质量响应值RSD%判断
386194.47393870.801.40数据可信
长期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%
5min1639314-63931414.69515.129.6814.6915.129.69
2560223-56022312.87712.88
3730121-73012116.78216.78
4618368-61836814.21314.21
5707654-70765416.26516.27
6691620-69162015.89715.90
10min11780303-178030340.92041.914.1140.9441.934.12
21734043-173404339.85739.88
31956285-195628544.96544.99
41815257-181525741.72441.75
51811347-181134741.63441.66
61842557-184255742.35142.38
15min12719544-271954462.50863.082.0462.6063.182.05
22673309-267330961.44661.53
32832072-283207265.09565.20
42782111-278211163.94764.04
52715155-271515562.40862.50
62744842-274484263.09063.19
20min13333473-333347376.62077.491.8176.8277.691.81
23359952-335995277.22877.42
33485707-348570780.11980.33
43384446-338444677.79177.99
53314514-331451476.18476.38
63350336-335033677.00777.21
30min13951143-395114390.81793.051.8491.1493.381.84
24123088-412308894.76995.09
34100102-410010294.24194.59
44083394-408339493.85694.19
53958674-395867490.99091.32
64073829-407382993.63793.97
45min14305869-430586998.970100.581.5899.45101.061.57
24449456-4449456102.270102.75
34403597-4403597101.216101.72
44438874-4438874102.027102.51
54283220-428322098.44998.93
64374147-4374147100.539101.03
60min14339626-433962699.746101.421.63100.39102.081.62
24502701-4502701103.494104.14
34385544-4385544100.801101.47
44484947-4484947103.086103.74
54334837-433483799.636100.28
64427763-4427763101.772102.43
极限14341815-434181599.796101.851.52100.60102.671.52
24531548-4531548104.157104.98
34406357-4406357101.280102.12
44482891-4482891103.039103.87
54395671-4395671101.034101.84
64428303-4428303101.784102.61
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%
110.304032826403340640323714031848403062640322150.03
210.244053486405423540538600.02
单位质量响应值RSD%判断
391477.18395884.770.80数据可信
长期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%
5min1491549-49154911.19313.6215.0411.1913.6215.04
2743619-74361916.93316.93
3608320-60832013.85213.85
4573389-57338913.05613.06
5527574-52757412.01312.01
6645536-64553614.69914.70
10min11597674-159767436.38039.686.2936.4039.716.30
21908242-190824243.45143.48
31786995-178699540.69140.71
41746400-174640039.76639.79
51648336-164833637.53337.55
61769232-176923240.28640.31
15min12545034-254503457.95160.833.9058.0360.923.91
22825418-282541864.33664.44
32746301-274630162.53462.63
42675330-267533060.91861.01
52577748-257774858.69658.78
62659814-265981460.56560.66
20min13218629-321862973.29075.812.6373.4776.002.63
23412371-341237177.70177.91
33440713-344071378.34678.54
43353637-335363776.36476.55
53267905-326790574.41274.59
63282890-328289074.75374.95
30min14003964-400396491.17292.171.6591.4792.491.65
24059978-405997892.44792.78
34161918-416191894.76995.09
44065534-406553492.57492.89
54027939-402793991.71892.02
63968066-396806690.35590.67
45min14375623-437562399.63599.881.41100.08100.351.40
24327282-432728298.53499.03
34476264-4476264101.926102.41
44406902-4406902100.347100.82
54420265-4420265100.651101.11
64311320-431132098.17198.64
60min14473027-4473027101.853100.681.80102.47101.321.78
24356899-435689999.20899.86
34517295-4517295102.861103.51
44412702-4412702100.479101.12
54464294-4464294101.654102.28
64305394-430539498.03698.67
极限14450933-4450933101.350100.890.97102.14101.690.96
24391741-4391741100.002100.82
34481570-4481570102.047102.87
44417563-4417563100.590101.40
54467562-4467562101.728102.52
64374572-437457299.611100.41
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