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%
110.123964183397327939705623972868397450039710780.11
210.183977263398195939796110.09
单位质量响应值RSD%判断
392399.01390924.460.27数据可信
供试品溶液-24032101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%
5min13921813-392181389.75994.694.1889.7694.694.18
24088353-408835393.57193.57
34292774-429277498.24998.25
44266763-426676397.65497.65
53954680-395468090.51190.51
64298948-429894898.39198.39
10min14525339-4525339103.572102.741.29103.72102.901.29
24456795-4456795102.003102.16
34388603-4388603100.443100.61
44492755-4492755102.826102.99
54530495-4530495103.690103.84
64539207-4539207103.890104.05
15min14532072-4532072103.726102.891.35104.05103.221.34
24452392-4452392101.903102.23
34392743-4392743100.537100.87
44516848-4516848103.378103.71
54538361-4538361103.870104.19
64541576-4541576103.944104.28
20min14522792-4522792103.514103.001.35104.01103.501.35
24458421-4458421102.041102.54
34397456-4397456100.645101.14
44523750-4523750103.536104.04
54554273-4554273104.234104.73
64545112-4545112104.025104.54
30min14527509-4527509103.622103.041.12104.29103.721.11
24466093-4466093102.216102.88
34420626-4420626101.176101.84
44506756-4506756103.147103.83
54541502-4541502103.942104.61
64550711-4550711104.153104.84
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(%)99.60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%
110.123971528397100139719713978445397585139737590.09
210.183969812396630239680570.07
单位质量响应值RSD%判断
392663.93389789.490.52数据可信
供试品溶液-24032102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%
5min14435929-4435929101.64097.635.62101.6497.635.62
24261491-426149197.64397.64
34338581-433858199.40999.41
44349469-434946999.65999.66
53786794-378679486.76686.77
64392559-4392559100.646100.65
10min14597793-4597793105.349102.951.67105.52103.111.67
24365800-4365800100.033100.20
34494563-4494563102.983103.15
44493149-4493149102.951103.12
54520773-4520773103.584103.73
64486097-4486097102.789102.96
15min14608308-4608308105.589103.111.65105.93103.451.65
24377039-4377039100.290100.62
34499898-4499898103.106103.44
44489507-4489507102.867103.21
54523324-4523324103.642103.96
64502991-4502991103.176103.52
20min14588100-4588100105.126103.041.54105.65103.541.54
24376705-4376705100.283100.78
34500177-4500177103.112103.62
44483477-4483477102.729103.24
54522779-4522779103.630104.12
64510723-4510723103.354103.86
30min14575180-4575180104.830102.971.21105.53103.651.21
24406796-4406796100.972101.64
34492189-4492189102.929103.61
44481018-4481018102.673103.35
54513458-4513458103.416104.08
64495762-4495762103.011103.69
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%
110.123979767398203839787073974968397302939777020.10
210.183972497397242439724600.01
单位质量响应值RSD%判断
393053.56390222.000.52数据可信
供试品溶液-24032103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%
5min14227792-422779296.76990.966.0696.7790.966.06
23819587-381958787.42687.43
34078072-407807293.34293.34
44248110-424811097.23497.23
53760405-376040586.07186.07
63709848-370984884.91484.91
10min14460775-4460775102.102102.831.05102.26102.981.06
24470841-4470841102.332102.48
34529509-4529509103.675103.83
44534407-4534407103.787103.95
54423996-4423996101.260101.40
64535061-4535061103.802103.94
15min14450821-4450821101.874102.870.99102.21103.190.99
24470536-4470536102.325102.64
34525422-4525422103.581103.91
44529125-4529125103.666104.00
54443863-4443863101.715102.03
64545118-4545118104.032104.35
20min14453193-4453193101.928102.800.99102.43103.300.99
24459865-4459865102.081102.57
34533909-4533909103.776104.28
44533022-4533022103.755104.26
54440763-4440763101.644102.13
64527720-4527720103.634104.12
30min14443207-4443207101.700102.471.11102.37103.141.11
24424013-4424013101.260101.92
34524448-4524448103.559104.23
44515599-4515599103.357104.04
54429252-4429252101.380102.03
64525480-4525480103.583104.24
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%
110.123984070398651339777603980854397949239817380.09
210.183967361395947439634180.15
单位质量响应值RSD%判断
393452.37389333.790.75数据可信
供试品溶液-24032104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%
5min13751261-375126185.91785.766.4585.9285.766.45
23884587-388458788.97088.97
33924332-392433289.88189.88
43338272-333827276.45876.46
53972440-397244090.98390.98
63595092-359509282.34082.34
10min14531349-4531349103.783101.571.37103.93101.711.37
24437965-4437965101.645101.79
34440713-4440713101.708101.86
44373579-4373579100.170100.30
54456768-4456768102.075102.23
64366900-4366900100.017100.15
15min14498624-4498624103.034101.840.94103.35102.150.94
24449494-4449494101.909102.23
34437100-4437100101.625101.94
44373277-4373277100.163100.46
54460646-4460646102.164102.49
64460021-4460021102.150102.45
20min14517114-4517114103.457101.651.13103.95102.141.14
24439555-4439555101.681102.17
34429509-4429509101.451101.94
44359608-435960899.850100.31
54447070-4447070101.853102.35
64437491-4437491101.634102.11
30min14445748-4445748101.823101.431.00102.48102.081.00
24444913-4444913101.804102.46
34421310-4421310101.263101.92
44343515-434351599.481100.11
54455547-4455547102.047102.71
64461710-4461710102.189102.83
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%
110.123990449398411239881403988200398779539877390.06
210.183991172399112239911470.01
单位质量响应值RSD%判断
394045.36392057.660.36数据可信
供试品溶液-24032105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%
5min13509978-350997880.05081.406.7380.0581.406.73
23195107-319510772.86972.87
33773576-377357686.06186.06
43795666-379566686.56586.57
53410102-341010277.77277.77
63730231-373023185.07385.07
10min14472886-4472886102.010102.651.49102.14102.781.49
24507523-4507523102.800102.92
34557987-4557987103.951104.09
44563166-4563166104.069104.21
54383028-438302899.961100.09
64520222-4520222103.090103.23
15min14483126-4483126102.244103.310.83102.55103.620.83
24526332-4526332103.229103.52
34554295-4554295103.867104.18
44587524-4587524104.625104.94
54501076-4501076102.653102.95
64527886-4527886103.264103.58
20min14476380-4476380102.090103.220.89102.56103.700.89
24527721-4527721103.261103.73
34567855-4567855104.176104.67
44576680-4576680104.377104.87
54494283-4494283102.498102.97
64512881-4512881102.922103.41
30min14469211-4469211101.926103.040.82102.57103.690.83
24528584-4528584103.280103.92
34556489-4556489103.917104.58
44558191-4558191103.956104.62
54483393-4483393102.250102.89
64513078-4513078102.927103.58
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