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(%)99.6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%
1 10.184082840408273340822664081331407897140816280.04
2 10.144070835407157140712030.02
单位质量响应值RSD%判断
400945.78401499.310.10数据可信
供试品溶液-25010201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%
5min14241643-424164394.76689.696.4494.7789.706.44
23857683-385768386.18786.19
34009033-400903389.56989.57
43583758-358375880.06780.07
54245293-424529394.84794.85
64150252-415025292.72492.72
10min14478169-4478169100.05099.791.36100.2199.941.35
24393958-439395898.16998.31
34480118-4480118100.094100.24
44565058-4565058101.991102.12
54411531-441153198.56198.72
64469559-446955999.858100.01
15min14491890-4491890100.35799.921.60100.68100.231.59
24415659-441565998.65398.96
34496859-4496859100.468100.78
44579745-4579745102.319102.62
54374387-437438797.73198.05
64475030-447503099.980100.30
20min14522488-4522488101.040100.311.49101.53100.791.49
24426212-442621298.88999.36
34495475-4495475100.437100.92
44586359-4586359102.467102.94
54402417-440241798.35898.84
64506087-4506087100.674101.16
30min14495611-4495611100.440100.111.58101.10100.761.57
24441991-444199199.24299.88
34495194-4495194100.430101.08
44591304-4591304102.578103.22
54376595-437659597.78198.43
64484345-4484345100.188100.84
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(%)99.6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%
1 10.184064500406713440668624065958406738340663670.03
2 10.144079171408129740802340.04
单位质量响应值RSD%判断
399446.66402389.940.52数据可信
供试品溶液-25010202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%
5min13950531-395053188.33086.004.4488.3386.004.44
24039396-403939690.31790.32
33710671-371067182.96782.97
43578392-357839280.00980.01
53869290-386929086.51386.51
63928940-392894087.84787.85
10min14363815-436381597.57099.611.1597.7299.751.14
24437993-443799399.22999.38
34460692-446069299.73699.87
44477870-4477870100.121100.25
54512109-4512109100.886101.03
64477415-4477415100.110100.26
15min14408622-440862298.572100.050.9498.88100.360.94
24452966-445296699.56499.88
34473940-4473940100.033100.34
44502787-4502787100.678100.98
54529907-4529907101.284101.60
64481269-4481269100.197100.51
20min14404156-440415698.472100.211.0198.95100.691.00
24464600-446460099.824100.31
34494349-4494349100.489100.96
44500263-4500263100.621101.09
54539243-4539243101.493101.97
64488918-4488918100.368100.85
30min14457161-445716199.658100.470.71100.30101.120.70
24463028-446302899.789100.44
34520848-4520848101.082101.72
44500258-4500258100.621101.26
54536170-4536170101.424102.07
64483564-4483564100.248100.90
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(%)99.6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%
1 10.184078208407724440806534078295407840440785610.04
2 10.144063302406306740631840.01
单位质量响应值RSD%判断
400644.50400708.480.02数据可信
供试品溶液-25010203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%
5min13720071-372007183.22685.767.7783.2385.767.77
24355483-435548397.44297.44
33987501-398750189.20989.21
43751147-375114783.92183.92
53671275-367127582.13482.13
63515326-351532678.64578.65
10min14442242-444224299.38398.712.3399.5298.852.33
24522592-4522592101.180101.34
34450174-445017499.56099.71
44311251-431125196.45296.59
54484316-4484316100.324100.46
64261453-426145395.33895.47
15min14483083-4483083100.29699.232.01100.6099.542.02
24521424-4521424101.154101.49
34464976-446497699.891100.21
44344700-434470097.20097.50
54495001-4495001100.563100.87
64303988-430398896.29096.58
20min14460336-446033699.78799.231.86100.2699.711.86
24512192-4512192100.947101.45
34464890-446489099.889100.37
44360593-436059397.55698.02
54505902-4505902100.807101.28
64309620-430962096.41696.87
30min14478524-4478524100.19499.441.61100.83100.071.61
24495582-4495582100.576101.24
34453865-445386599.643100.29
44397672-439767298.38599.01
54516368-4516368101.041101.68
64325633-432563396.77497.38
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