诺氟沙星胶囊项目信息
介质体积(ml)1000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%
110.013909734391676539181183919564391804539164450.10
210.083917809392728139225450.18
单位质量响应值RSD%判断
391253.25389141.370.39数据可信
加速3月-供试品溶液-pH4.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121138077913808097380794497.20100.222.0198.10%~102.33%
239066383903075390485699.67
339185673914936391675299.98
439104423909606391002499.81
5397033339719563971144101.37
6404618740456024045894103.27
20240302211398545439841823984818101.72101.541.9499.48%~103.59%
2396031139619113961111101.11
338786083878929387876899.01
4393331539336373933476100.40
5399931440027784001046102.13
6410500641098414107424104.85
20240303211395305339538583953456100.91101.921.59100.22%~103.62%
2403974240386054039174103.10
3394788039469853947432100.76
4405693240588954057914103.58
539090023910776390988999.80
6404957940495824049580103.37
诺氟沙星胶囊项目信息
介质体积(ml)1000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%
110.013917196391424539168563911091391268939144150.07
210.083900379390314439017620.06
单位质量响应值RSD%判断
391050.45387079.560.73数据可信
长期3月-供试品溶液-pH4.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211399125239864903988871102.12100.222.5797.52%~102.92%
238925023888652389057799.60
337815273780950378123896.80
4404526840444174044842103.55
538276843825103382639497.96
6395589539577343956814101.30
20240302211391624739168503916548100.27100.912.3798.41%~103.41%
2401720840175554017382102.85
3392587839252593925568100.50
438044863809382380693497.46
5407407140744714074271104.30
6390660239109173908760100.07
20240303211394875839487423948750101.09101.720.90100.76%~102.67%
2394178439420443941914100.91
3400264840034274003038102.48
4393444139346583934550100.73
5399605939908173993438102.23
6401761040174084017509102.85
诺氟沙星胶囊项目信息
介质体积(ml)1000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%
110.013928905393036739307833926463392529739283630.07
210.083916174392011239181430.08
单位质量响应值RSD%判断
392443.86388704.660.68数据可信
中间条件3月-供试品溶液-pH4.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121138961763893336389475699.32100.701.7398.88%~102.53%
2395194239475053949724100.72
3396865939661513967405101.17
4406256340629694062766103.61
538711923860292386574298.58
6395433139523513953341100.82
20240302211398844639889453988696101.72100.541.7598.70%~102.38%
238874543882614388503499.07
3404075740473384044048103.13
438645413859661386210198.49
539106963913737391221699.77
6396283139630783962954101.06
20240303211398046139784133979437101.48102.081.51100.47%~103.69%
2397359339749433974268101.35
3392476739253753925071100.10
4403355840306764032117102.83
5410291741008144101866104.60
6400476640044084004587102.12
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