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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.444066099406778740674474070657407071040685400.06
210.364087373408628840868300.02
单位质量响应值RSD%判断
389706.90394481.660.87数据可信
供试品溶液-24041601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%
5min14182731-4182731191.257187.375.74191.26187.375.74
24426044-4426044202.383202.38
33826725-3826725174.979174.98
43913057-3913057178.926178.93
54280962-4280962195.749195.75
63957144-3957144180.942180.94
10min14287522-4287522196.049199.891.99196.37200.201.99
24529352-4529352207.106207.44
34299007-4299007196.574196.87
44364330-4364330199.561199.86
54363777-4363777199.535199.86
64384670-4384670200.491200.79
15min14248642-4248642194.271200.982.16194.92201.622.16
24526030-4526030206.954207.64
34346991-4346991198.768199.39
44375993-4375993200.094200.72
54448100-4448100203.391204.05
64426026-4426026202.382203.02
20min14227524-4227524193.305200.232.41194.27201.202.41
24530819-4530819207.173208.20
34302445-4302445196.731197.68
44379953-4379953200.275201.24
54398448-4398448201.121202.12
64434016-4434016202.747203.72
30min14248313-4248313194.256200.122.19195.55201.442.19
24518343-4518343206.603207.98
34298917-4298917196.570197.85
44376582-4376582200.121201.42
54385018-4385018200.507201.84
64432704-4432704202.687204.00
45min14243239-4243239194.024200.322.20195.64201.972.20
24520814-4520814206.716208.43
34310797-4310797197.113198.72
44386618-4386618200.580202.21
54392988-4392988200.871202.54
64431153-4431153202.616204.26
60min1-0.0000.00-1.941.982.38
2-0.0002.06
3-0.0001.93
4-0.0001.97
5-0.0002.00
6-0.0001.99
极限1-0.0000.00-1.941.982.38
2-0.0002.06
3-0.0001.93
4-0.0001.97
5-0.0002.00
6-0.0001.99
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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.444067922406655540691064069455406626740678610.04
210.364085546408128940834180.08
单位质量响应值RSD%判断
389641.86394152.320.82数据可信
供试品溶液-24041601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%
5min13847414-3847414176.012158.808.46176.01158.808.46
23382921-3382921154.763154.76
33663998-3663998167.621167.62
43644673-3644673166.737166.74
53128101-3128101143.105143.11
63160009-3160009144.565144.56
10min14351760-4351760199.085197.061.10199.38197.331.10
24312688-4312688197.298197.56
34311362-4311362197.237197.52
44301563-4301563196.789197.07
54346759-4346759198.856199.09
64220806-4220806193.094193.34
15min14371477-4371477199.987198.541.27200.61199.141.27
24348393-4348393198.931199.52
34329998-4329998198.090198.70
44325840-4325840197.899198.51
54414118-4414118201.938202.51
64249540-4249540194.409194.97
20min14385185-4385185200.614199.161.02201.57200.091.03
24344792-4344792198.766199.68
34370446-4370446199.940200.88
44340919-4340919198.589199.53
54402774-4402774201.419202.33
64276700-4276700195.651196.54
30min14376333-4376333200.209198.500.83201.50199.760.84
24335247-4335247198.330199.58
34370141-4370141199.926201.20
44343830-4343830198.722199.99
54332131-4332131198.187199.43
64276436-4276436195.639196.85
45min14363404-4363404199.618200.171.13201.24201.761.13
24348965-4348965198.957200.54
34413878-4413878201.927203.53
44374159-4374159200.110201.71
54446499-4446499203.419204.99
64306348-4306348197.008198.55
60min1-0.0000.00-1.961.921.62
2-0.0001.91
3-0.0001.94
4-0.0001.93
5-0.0001.91
6-0.0001.87
极限1-0.0000.00-1.961.921.62
2-0.0001.91
3-0.0001.94
4-0.0001.93
5-0.0001.91
6-0.0001.87
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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.444069705406874740690544068441406710640686110.03
210.364072640407683240747360.08
单位质量响应值RSD%判断
389713.70393314.290.66数据可信
供试品溶液-24041601批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1410987-41098718.82016.9213.7818.8216.9213.78
2356627-35662716.33116.33
3417713-41771319.12819.13
4305715-30571513.99914.00
5411170-41117018.82818.83
6315294-31529414.43814.44
10min1874820-87482040.06037.647.1040.0937.667.10
2770747-77074735.29435.32
3899000-89900041.16741.20
4777004-77700435.58135.60
5843863-84386338.64338.67
6765900-76590035.07235.10
15min11228990-122899056.27853.494.9356.3853.584.94
21125667-112566751.54751.63
31235075-123507556.55756.66
41114474-111447451.03451.12
51192035-119203554.58654.68
61112533-111253350.94651.03
20min11466576-146657667.15865.113.7667.3565.293.76
21399863-139986364.10364.28
31498442-149844268.61768.81
41378796-137879663.13863.31
51428778-142877865.42765.61
61358741-135874162.22062.39
30min11770439-177043981.07380.072.2381.3880.362.24
21733120-173312079.36479.64
31815458-181545883.13483.44
41720725-172072578.79679.07
51742528-174252879.79580.09
61709316-170931678.27478.54
45min12041943-204194393.50690.402.2793.9490.822.27
21971418-197141890.27690.69
32008282-200828291.96492.41
41965165-196516589.99090.39
51930917-193091788.42188.85
61926681-192668188.22788.63
60min12044854-204485493.63992.231.7194.2392.811.72
22015243-201524392.28392.84
32062466-206246694.44595.05
42003954-200395491.76692.32
51985412-198541290.91791.49
61973186-197318690.35790.91
极限11999679-199967991.57092.161.3092.3292.891.30
21991208-199120891.18291.90
32059654-205965494.31795.07
42025411-202541192.74993.46
51995153-199515391.36392.09
62004512-200451291.79192.49
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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.444074078407251840731564073571407166440729970.03
210.363962222396022539612240.04
单位质量响应值RSD%判断
390133.81382357.531.43数据可信
供试品溶液-24041601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%
5min1896815-89681541.63135.5713.5741.6335.5713.58
2809826-80982637.59337.59
3657935-65793530.54230.54
4851680-85168039.53639.54
5739089-73908934.30934.31
6642356-64235629.81929.82
10min11945486-194548690.31182.217.8690.3882.277.86
21842812-184281285.54585.61
31646530-164653076.43376.48
41869017-186901786.76186.83
51737564-173756480.65980.72
61584170-158417073.53873.59
15min12696385-2696385125.168118.334.64125.39118.524.64
22628440-2628440122.014122.22
32434503-2434503113.011113.19
42622829-2622829121.754121.96
52509537-2509537116.495116.69
62402261-2402261111.515111.69
20min13211587-3211587149.084143.673.24149.51144.063.25
23169210-3169210147.117147.53
33000150-3000150139.269139.64
43162864-3162864146.823147.24
53056833-3056833141.901142.29
62968761-2968761137.812138.17
30min13815847-3815847177.135175.021.89177.81175.651.91
23851405-3851405178.785179.44
33701003-3701003171.803172.40
43829842-3829842177.784178.44
53738947-3738947173.565174.19
63684473-3684473171.036171.62
45min14121713-4121713191.333191.680.98192.31192.610.99
24176373-4176373193.870194.82
34083798-4083798189.573190.46
44162600-4162600193.231194.19
54149333-4149333192.615193.53
64081958-4081958189.488190.36
60min14136367-4136367192.013193.710.92193.30194.960.91
24194107-4194107194.694195.97
34118315-4118315191.175192.38
44191171-4191171194.557195.83
54218751-4218751195.838197.07
64179210-4179210194.002195.19
极限14077591-4077591189.285192.100.97190.90193.660.97
24180240-4180240194.050195.65
34120636-4120636191.283192.80
44150162-4150162192.654194.25
54180810-4180810194.076195.64
64119567-4119567191.233192.75
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