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 10.173992609399121439884403989077399365239909980.06
2 10.133994255398903239916440.10
单位质量响应值RSD%判断
392428.52394041.860.30数据可信
加速6月-供试品溶液-25032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%
5min11416226-141622632.28422.3945.3232.2822.3945.32
21257753-125775328.67128.67
31049879-104987923.93323.93
4472058-47205810.76110.76
51309739-130973929.85629.86
6387306-3873068.8298.83
10min14192360-419236095.56793.575.9395.6293.605.93
24123938-412393894.00894.06
34356963-435696399.32099.36
43645099-364509983.09283.11
54093545-409354593.31593.36
64215963-421596396.10596.12
15min14386618-438661899.996100.782.83100.21100.972.83
24376297-437629799.76099.96
34477575-4477575102.069102.27
44212273-421227396.02196.18
54512462-4512462102.864103.07
64561319-4561319103.978104.15
20min14435526-4435526101.111101.193.02101.49101.553.03
24343473-434347399.01299.38
34546876-4546876103.649104.02
44221981-422198196.24396.56
54538742-4538742103.463103.84
64548097-4548097103.677104.02
30min14441280-4441280101.242101.203.25101.79101.733.25
24417877-4417877100.708101.24
34542177-4542177103.542104.09
44166636-416663694.98195.46
54519804-4519804103.032103.58
64548244-4548244103.680104.20
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 10.173989520399132240012454000725399625839958140.14
2 10.133999671400379740017340.08
单位质量响应值RSD%判断
392902.06395037.910.39数据可信
加速6月-供试品溶液-25033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%
5min170630-706301.6071.98101.321.611.98101.36
2193305-1933054.3984.40
338835-388350.8840.88
419380-193800.4410.44
5200926-2009264.5724.57
6-0.0000.00
10min13461899-346189978.76964.8429.7078.7764.8429.70
22519262-251926257.32157.33
33189870-318987072.58072.58
43563877-356387781.08981.09
53069279-306927969.83669.84
61293445-129344529.43029.43
15min14376122-437612299.57190.0812.6199.7090.1912.63
23693862-369386284.04784.15
34076114-407611492.74592.87
44416246-4416246100.484100.62
54101656-410165693.32693.45
63088985-308898570.28470.33
20min14562300-4562300103.80798.745.62104.1199.005.66
24153233-415323394.49994.74
34402259-4402259100.165100.44
44533294-4533294103.147103.45
54447362-4447362101.192101.47
63939996-393999689.64789.81
30min14498549-4498549102.356102.831.32102.83103.261.35
24600962-4600962104.686105.09
34485765-4485765102.065102.51
44557192-4557192103.691104.17
54542076-4542076103.347103.79
64432323-4432323100.849101.16
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 10.173993552399113239921633990027399249939918750.04
2 10.133935454393614639358000.02
单位质量响应值RSD%判断
392514.75388529.120.73数据可信
长期6月-供试品溶液-25031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%
5min1592803-59280313.6076.2584.0913.616.2584.10
2219982-2199825.0505.05
320345-203450.4670.47
4324984-3249847.4607.46
5448263-44826310.29010.29
628029-280290.6430.64
10min13779727-377972786.76281.5710.3286.7881.5810.32
23066249-306624970.38470.39
33574528-357452882.05182.05
44062776-406277693.25993.27
53210559-321055973.69773.71
63627959-362795983.27883.28
15min14248390-424839097.52098.464.0897.6998.614.08
24145584-414558495.16095.29
34456214-4456214102.290102.43
44511904-4511904103.568103.74
54060451-406045193.20693.35
64312802-431280298.99899.14
20min14261145-426114597.812101.092.9298.14101.402.92
24318470-431847099.12899.41
34529431-4529431103.971104.28
44577877-4577877105.083105.42
54313601-431360199.01799.31
64423522-4423522101.540101.84
30min14328897-432889799.368100.932.2699.86101.402.27
24289901-428990198.47398.92
34443691-4443691102.003102.48
44563547-4563547104.754105.27
54341566-434156699.658100.12
64413095-4413095101.300101.77
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